[Federal Register Volume 86, Number 200 (Wednesday, October 20, 2021)]
[Proposed Rules]
[Pages 58150-58191]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-22473]



[[Page 58149]]

Vol. 86

Wednesday,

No. 200

October 20, 2021

Part II





 Department of Health and Human Services





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 Food and Drug Administration





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21 CFR Parts 800, 801, 808, and 874





Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-
Counter Hearing Aids; Proposed Rule





Regulatory Requirements for Hearing Aid Devices and Personal Sound 
Amplification Products: Draft Guidance for Industry and Food and Drug 
Administration Staff; Availability; Notice

  Federal Register / Vol. 86, No. 200 / Wednesday, October 20, 2021 / 
Proposed Rules  

[[Page 58150]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 800, 801, 808, and 874

[Docket No. FDA-2021-N-0555]
RIN 0910-AI21


Medical Devices; Ear, Nose, and Throat Devices; Establishing 
Over-the-Counter Hearing Aids

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA, we, or the Agency) is 
proposing to establish a regulatory category for over-the-counter (OTC) 
hearing aids and to make related amendments to update the regulatory 
framework for hearing aids. Specifically, we propose to define OTC 
hearing aids and establish applicable requirements; amend existing 
rules for consistency with a new OTC category; repeal the conditions 
for sale applicable to hearing aids; amend the existing labeling 
requirements for hearing aids; and update regulations relating to 
decisions on applications for exemption from Federal preemption that 
would become obsolete as a result of changes to the hearing aid 
requirements. This action, if finalized, would more clearly define 
prescription hearing aids; however, it would not change the 
classification of existing device types. In creating a regulatory 
category for OTC hearing aids and amending existing rules, we intend to 
provide reasonable assurance of safety and effectiveness for these 
devices as well as foster access to, and innovation in, hearing aid 
technology, thereby protecting and promoting the public health.

DATES: Submit either electronic or written comments on the proposed 
rule by January 18, 2022. Submit written comments (including 
recommendations) on the collection of information under the Paperwork 
Reduction Act of 1995 by November 19, 2021.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before January 18, 2022. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of January 18, 2022. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2021-N-0555 for ``Establishing Over-the-Counter Hearing Aids.'' 
Received comments, those filed in a timely manner (see ADDRESSES), will 
be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.
    Submit comments on information collection issues under the 
Paperwork Reduction Act of 1995 (PRA) to the Office of Management and 
Budget (OMB) at https://www.reginfo.gov/public/do/PRAMain. Find this 
particular information collection by selecting ``Currently under 
Review--Open for Public Comments'' or by using the search function. The 
title of this proposed collection is ``Medical Device Labeling 
Regulations.''

FOR FURTHER INFORMATION CONTACT: Srinivas Nandkumar, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Silver Spring, MD, 20993, 301-796-5620, 
[email protected].
    With regard to the information collection: Amber Sanford, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[email protected].

SUPPLEMENTARY INFORMATION:

[[Page 58151]]

Table of Contents

Executive Summary
    Purpose of the Proposed Rule
    Summary of the Major Provisions of the Proposed Rule
    Legal Authority
    Costs and Benefits
Table of Abbreviations and Acronyms Commonly Used in This Document
I. Background
    A. Need for the Regulation
    B. Current Regulatory Framework for Hearing Aids
    C. History of This Rulemaking
    D. Incorporation by Reference
II. Legal Authority
III. Description of the Proposed Rule
    A. Scope (Proposed Sec.  800.30(a))
    B. Definitions (Proposed Sec. Sec.  800.30(b) and 801.422(b))
    C. Labeling (Proposed Sec.  800.30(c))
    D. Output Limits (Proposed Sec.  800.30(d))
    E. Other Requirements (Proposed Sec.  800.30(e) and (f))
    F. Condition for Sale (Proposed Sec.  800.30(g))
    G. Preemption Provisions (Proposed Sec.  800.30(h))
    H. Proposed Repeal of Conditions for Sale and Modifications for 
Prescription Labeling (Sec. Sec.  801.420, 801.421, 801.422)
    I. Proposed Amendments to Previous Exemption Decisions (Part 
808)
    J. Other Proposed Amendments
IV. Findings Regarding Premarket Notification
V. Proposed Effective and Compliance Dates
    A. Effective Date
    B. Compliance Date for Hearing Aids Not Legally Offered for Sale 
Prior to the Effective Date
    C. Compliance Date for Hearing Aids Legally Offered for Sale 
Prior to the Effective Date
VI. Preliminary Economic Analysis of Impacts
VII. Analysis of Environmental Impact
VIII. Paperwork Reduction Act of 1995
IX. Federalism
X. Consultation and Coordination With Indian Tribal Governments
XI. References

Executive Summary

Purpose of the Proposed Rule

    Hearing loss affects an estimated 30 million people in the United 
States and can have a significant impact on communication, social 
participation, and overall health and quality of life. Despite the high 
prevalence and public health impact of hearing loss, only about one-
fifth of people who could benefit from a hearing aid seek intervention. 
Several barriers likely impede the use of hearing aids in hearing-
impaired individuals such as high cost, stigma of being perceived as 
old or debilitated, and value (perceived hearing benefit relative to 
price). FDA is proposing rules to address some of these concerns.
    Moreover, the FDA Reauthorization Act of 2017 (FDARA) directs FDA 
to establish a category of OTC hearing aids through rulemaking, and 
FDARA sets forth various requirements for OTC hearing aids, including 
preemption provisions. In addition to protecting and promoting the 
public health, we have developed these proposed rules to establish the 
OTC category and implement the requirements of FDARA.

Summary of the Major Provisions of the Proposed Rule

    FDA is proposing to establish a regulatory category for OTC hearing 
aids to improve access to hearing aid technology for Americans. OTC 
hearing aids will be intended to address perceived mild to moderate 
hearing loss in people age 18 or older. Alongside the OTC category, we 
are proposing multiple related changes to the overall regulatory 
framework for hearing aids to harmonize existing rules with the 
eventual OTC category. We believe the proposals set forth in this 
rulemaking will protect the public health by providing reasonable 
assurance of safety and effectiveness for hearing aids, as well as 
promote the hearing health of Americans by lowering barriers to access 
and fostering innovation in hearing aid technology.
    Among other things, FDARA amended the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) by defining OTC hearing aids and providing the 
authorities to establish the OTC category of hearing aids among 
provisions that are, by definition, general controls. We are proposing 
general controls for OTC hearing aids consistent with FDARA. Moreover, 
because the FD&C Act specifies that OTC hearing aids are those that use 
the same fundamental scientific technology as air-conduction hearing 
aids, we would realign the existing classification regulations for 
hearing aids by sound conduction technology. However, the realignment 
would not affect the device class or premarket notification exemption 
status of any existing device. On the effective date of the final rule, 
we would realign current product codes to correspond with the revised 
regulations for consistency but would not otherwise change the codes.
    This rulemaking also affects other existing regulations that apply 
to hearing aids. FDA has established device restrictions for hearing 
aids that include labeling requirements as well as conditions for sale. 
We are proposing to remove these device restrictions for hearing aids, 
and establish a new regulation for prescription hearing aid labeling. 
Further, FDA has by regulation granted or denied exemptions from 
Federal preemption for State requirements pertaining to hearing aids. 
The removal of the device restrictions on hearing aids, as well as 
certain provisions of FDARA, impact most of these previous exemption 
decisions, for example, by altering their scope. We are proposing to 
remove the regulations codifying these decisions and establish other 
regulations clarifying some of the effects of statutory preemption 
under FDARA.

Legal Authority

    The FD&C Act establishes a comprehensive system for the regulation 
of devices intended for human use. Hearing aids are devices intended 
for human use and so are subject to, among other requirements, the 
device provisions of the FD&C Act. FDA has authority to establish 
regulatory controls needed to provide reasonable assurance of safety 
and effectiveness for these devices. As such, FDA is establishing 
regulatory controls for OTC hearing aids and amending regulatory 
controls for prescription hearing aids.
    Specific to OTC hearing aids, the FD&C Act and FDARA authorize 
multiple controls, including authority for FDA to establish 
requirements for device labeling, output limits, conditions for sale 
and distribution, and other requirements that provide reasonable 
assurance of safety and effectiveness of OTC hearing aids. FDARA 
specifically directs FDA to establish a category of OTC hearing aids by 
regulation that must include the aforementioned requirements.
    More generally, the FD&C Act further provides for labeling 
requirements as general controls such that devices (and other medical 
products) will not be misbranded. The FD&C Act also authorizes FDA to 
issue regulations for the efficient enforcement of the FD&C Act. We are 
proposing the following regulations pursuant to these authorities and 
to fulfill the directive under FDARA.
    Additionally, both the FD&C Act and FDARA include preemption 
provisions applicable to hearing aids.

Costs and Benefits

    This proposed rule to establish OTC hearing aids and align other 
regulations, if finalized, would generate potential cost savings for 
consumers with perceived mild to moderate hearing loss who wish to buy 
lower cost hearing aids not bundled with professional services and not 
requiring professional advice, fitting, adjustment, or maintenance but 
who are currently unable to buy such products online because of State 
regulations or because they do not shop online. The proposed rule, if 
finalized,

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would also generate costs for hearing aid manufacturers for changing 
labeling of existing hearing aids as well as for reading the rule and 
revising internal standard operating procedures in response to the 
rule. We estimate benefits of between $6 million and $147 million per 
year based on 5th and 95th percentile Monte Carlo results with a mean 
of $63 million per year. We estimate annualized costs of between $1 
million and $2 million per year based on 5th and 95th percentile Monte 
Carlo results with a mean of $1 million per year. Combining benefits 
and costs, we used Monte Carlo analysis to estimate annualized net 
benefits of between $5 million and $145 million per year based on the 
5th and 95th Monte Carlo percentile results with a mean of $62 million 
per year at both 3 percent and 7 percent discount rates.

   Table of Abbreviations and Acronyms Commonly Used in This Document
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        Abbreviation/acronym                    What it means
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510(k).............................  A premarket notification for
                                      certain devices.
ANSI...............................  American National Standards
                                      Institute.
ASA................................  Acoustical Society of America.
CFR................................  Code of Federal Regulations.
CTA................................  Consumer Technology Association.
dB.................................  Decibel.
dBA................................  A-weighted decibel.
EA.................................  Environmental assessment.
FDA................................  Food and Drug Administration.
FD&C Act...........................  Federal Food, Drug, and Cosmetic
                                      Act.
FDARA..............................  FDA Reauthorization Act of 2017.
FONSI..............................  Finding of no significant impact.
FR.................................  Federal Register.
GMPs...............................  Good manufacturing practices.
Hz.................................  Hertz.
ISO................................  International Organization for
                                      Standardization.
MSW................................  Municipal solid waste.
NASEM..............................  National Academies of Sciences,
                                      Engineering, and Medicine.
NIOSH..............................  National Institute for Occupational
                                      Safety and Health.
OMB................................  Office of Management and Budget.
OSPL90.............................  Output sound pressure level with 90-
                                      dB input.
OTC................................  Over-the-counter.
PCAST..............................  President's Council of Advisors on
                                      Science and Technology.
PRIA...............................  Preliminary Regulatory Impact
                                      Analysis.
PSAP...............................  Personal sound amplification
                                      product.
Pub. L.............................  Public Law.
QS.................................  Quality System.
SPL................................  Sound pressure level.
U.S.C..............................  United States Code.
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I. Background

    FDA is proposing to define and establish general controls for an 
OTC category of hearing aids. We intend these proposals to provide for 
reasonable assurance of safety and effectiveness for these devices and 
improve access to and foster innovation in hearing aid technology for 
Americans, thereby promoting and protecting the public health. We would 
make various other revisions, as described in this document, to align 
existing regulations with statutory requirements and the new OTC 
category.

A. Need for the Regulation

    Hearing loss affects an estimated 30 million people in the United 
States and can have a significant impact on communication, social 
participation, and overall health and quality of life (Refs. 1 and 2). 
Despite the high prevalence and public health impact of hearing loss, 
only about one-fifth of people who could benefit from a hearing aid 
seek intervention (Ref. 3). The use of hearing aids has been linked to, 
among other health benefits, reductions in the incidence or severity of 
cognitive decline, depression, and other health problems in older 
adults (Ref. 3a and 3b). Additionally, benefits of hearing aid use can 
include improved social participation and a better quality of life.
    Besides health benefits for individuals, more-widespread adoption 
of hearing aids could have broader effects. By increasing social 
participation, hearing aids could help to improve inclusion of 
individuals in family, economic, civic, and religious life. Thus, 
reducing barriers to hearing aid access might contribute to such 
improvements. This could be particularly true for people of color, 
rural Americans, low-income individuals, and others for whom barriers 
to hearing aid access may be especially burdensome.
    Several barriers likely impede the use of hearing aids in hearing-
impaired individuals such as high cost, stigma of being perceived as 
old or debilitated, and value (perceived hearing benefit relative to 
price) (Ref. 4). In addition, stakeholders have cited Federal 
regulations that require specific labeling and conditions for sale, 
initially implemented in the late 1970s, as barriers to access (e.g., 
Refs. 5 to 7). This document proposes a number of changes to the 
regulatory framework for hearing aids to remove or reduce barriers to 
certain air-conduction hearing aids for perceived mild to moderate 
hearing impairment--a type of impairment often associated with aging--
that have the potential to be of great benefit to the public health.
    These proposals follow the enactment of FDARA, which included 
provisions directing FDA to establish regulatory requirements for a new 
category of OTC hearing aids and amended the FD&C Act to add section 
520(q) (21 U.S.C. 360j(q); see Pub. L. 115-52). Section 520(q)(1) of 
the FD&C Act defines OTC hearing aids, in part, as devices available 
over-the-counter, without the supervision,

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prescription, or other order, involvement, or intervention of a 
licensed person, to consumers through in-person transactions, by mail, 
or online. Section 520(q)(2) of the FD&C Act requires that such devices 
be subject to the regulations FDA issues for them in accordance with 
section 709(b) of FDARA.
    Section 709(b) of FDARA requires that FDA establish a category of 
OTC hearing aids that includes, among other elements, requirements to 
provide reasonable assurances of the safety and effectiveness of these 
devices. We also make multiple proposals to prevent the sale of OTC 
hearing aids to or for people younger than age 18. This document does 
not, however, propose to create or classify a new device type.\1\ 
Further, this document does not propose to exempt additional devices 
from the premarket notification requirements under section 510(k) of 
the FD&C Act, commonly referred to as ``a 510(k)'' (21 U.S.C. 360(k)). 
Section IV of this document discusses our findings regarding premarket 
notification in more detail.
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    \1\ ``Device type'' as used in this document has the same 
meaning as ``generic type of device'' in 21 CFR 860.3(i) (a 
``generic type of device'' means ``a grouping of devices that do not 
differ significantly in purpose, design, materials, energy source, 
function, or any other feature related to safety and effectiveness, 
and for which similar regulatory controls are sufficient to provide 
reasonable assurance of safety and effectiveness'').
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    We are simultaneously proposing related changes to the regulatory 
framework that currently applies to all hearing aids, as they are 
defined in Sec.  801.420 (21 CFR 801.420), in light of the new OTC 
category and to ensure consistency across rules pertaining to hearing 
aids (see Sec.  801.420(a)(1)). Detailed information about each 
proposal appears in section III.

B. Current Regulatory Framework for Hearing Aids

    Hearing aids, as defined in Sec.  801.420(a)(1), are currently 
restricted class I and class II devices of multiple types. A summary of 
the current regulatory framework for these devices appears in table 1.

                                                    Table 1--Summary of Current Regulatory Framework
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 Classification regulation, 21 CFR
              section                       874.3300                874.3305                874.3315               874.3325               874.3950
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Device Restrictions................  Restricted............  Restricted............  Restricted...........  Restricted...........  Restricted.
Class I, 510(k) exempt \1\.........  Air-conduction
                                      (``legacy'').
Class II, 510(k) exempt \1\........  ......................  Wireless air-
                                                              conduction.
Class II...........................  Bone-conduction.......  ......................  Tympanic membrane      Self-fitting air-      Transcutaneous air-
                                                                                      contact hearing aid.   conduction.            conduction hearing
                                                                                                                                    aid system.
Product codes......................  ESD, LXB, MAH, LRB,     OSM...................  PLK..................  QDD..................  NIX.
                                      LDG.
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\1\ 510(k) exemptions are subject to the limitations in 21 CFR 874.9.

1. Hearing Aid Classifications
    Hearing aids are class I and class II wearable sound-amplifying 
devices intended to compensate for impaired hearing. They currently 
fall under five classification regulations (the following references 
are to sections in Title 21 of the CFR):
    a. Hearing aid (Sec.  874.3300 (21 CFR 874.3300)). This device type 
includes air-conduction (class I, 510(k) exempt, subject to the 
limitations of exemption in Sec.  874.9) and bone-conduction (class II) 
hearing aids. Class II bone-conduction hearing aids require a 510(k) 
notification. These are all restricted devices.
    b. Wireless air-conduction hearing aid (Sec.  874.3305 (21 CFR 
874.3305)). This device type is a hearing aid that incorporates 
wireless technology in its programming or use, for example, controls 
over Bluetooth. These devices are class II restricted, subject to the 
special controls that have been issued for these devices, and 510(k) 
exempt, subject to the limitations of exemption in Sec.  874.9.
    c. Tympanic membrane contact hearing aid (Sec.  874.3315 (21 CFR 
874.3315)). This device type is a prescription device that compensates 
for impaired hearing. Amplified sound is transmitted by vibrating the 
tympanic membrane through a transducer that is in direct contact with 
the tympanic membrane. These devices are class II restricted, subject 
to the special controls that have been issued for these devices, and 
require a 510(k) notification.
    d. Self-fitting air-conduction hearing aids (Sec.  874.3325 (21 CFR 
874.3325)). This device type is a hearing aid that incorporates 
technology, including software, that allows users to program their 
hearing aids. This technology integrates user input with a self-fitting 
strategy and enables users to independently derive and customize their 
hearing aid fittings and settings. These devices are class II 
restricted, subject to the special controls that have been issued for 
these devices, and require a 510(k) notification.
    e. Transcutaneous air conduction hearing aid system (Sec.  874.3950 
(21 CFR 874.3950)). This device type consists of an air-conduction 
hearing aid attached to a surgically fitted tube system, which is 
placed through soft tissue between the post auricular region and the 
outer ear canal. These devices are class II restricted, subject to the 
special controls that have been issued for these devices, and require a 
510(k) notification.
    Devices of these types may be either prescription (for example, 
devices for insertion deep in the ear canal) or non-prescription 
devices (which include the majority of air-conduction hearing aids).\2\ 
For the purposes of this rulemaking, we refer to non-wireless, non-
self-fitting, air-conduction hearing aids as ``legacy hearing aids,'' 
which means all air-conduction hearing aids currently within Sec.  
874.3300 but not air-conduction hearing aids currently within 
Sec. Sec.  874.3305, 874.3325, or 874.3950.
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    \2\ We use the term ``non-prescription'' because the FD&C Act, 
as amended by FDARA, defines OTC hearing aids and requires FDA to 
undertake rulemaking to establish the OTC category. As such, no 
hearing aid is yet OTC within the meaning of section 520(q) of the 
FD&C Act. We use ``non-prescription'' to avoid confusing the 
intended uses of current devices with devices that would eventually 
meet the OTC Hearing Aid Controls.

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[[Page 58154]]

2. Hearing Aid Restrictions
    Hearing aids are currently subject to a set of restrictions on 
sale, distribution, and use, established in accordance with section 
520(e) of the FD&C Act. We will refer to those as ``Hearing Aid 
Restrictions,'' and they include requirements for professional and 
patient labeling, as a well as conditions for sale (see Sec. Sec.  
801.420 and 801.421 (21 CFR 801.420 and 801.421, respectively)). All 
legacy hearing aids, wireless air-conduction hearing aids, and self-
fitting hearing aids (as well as other device types) fall within a 
separate, broader definition of hearing aids in Sec.  801.420(a)(1), 
and therefore are currently subject to these restrictions.
    Among other requirements, Sec.  801.420 specifies that the User 
Instructional Brochure labeling for hearing aids contain a warning 
statement for hearing aid dispensers that prompts them to advise 
prospective purchasers to consult with a physician if any of the listed 
medical conditions are present (see Sec.  801.420(c)(2)). We will refer 
to these medical conditions as ``red flag'' conditions in this 
proposal. The rule further prescribes a notice to prospective users and 
an additional statement about hearing loss in children (see Sec.  
801.420(c)(3)). It also requires the disclosure of technical data 
useful in selecting, fitting, and checking the performance of hearing 
aids (see Sec.  801.420(c)(4)).
    Currently, Sec.  801.421 specifies a number of conditions for sale 
for hearing aids. Such conditions include that a prospective user must 
present to the dispenser a signed statement of medical evaluation from 
a physician prior to sale (see Sec.  801.421(a)(1)). However, a 
prospective user who is 18 years of age or older may waive the medical 
evaluation requirement by signing a statement with a prescribed 
advisement (see Sec.  801.421(a)(2)). A dispenser must provide an 
opportunity for the prospective user to review the User Instructional 
Brochure prior to signing a waiver and the sale of a hearing aid (see 
Sec.  801.421(b)). Manufacturers and distributors must provide 
sufficient copies of User Instructional Brochures to dispensers, and 
upon written request, to prospective users; dispensers must similarly 
provide the brochures (or the name and address of a manufacturer or 
distributor to obtain a brochure) to prospective users upon request 
(see Sec.  801.421(c)). Dispensers generally must retain a copy of a 
medical evaluation statement or signed waiver for 3 years (see Sec.  
801.421(d)).
    However, we announced in a guidance entitled ``Conditions for Sale 
for Air-Conduction Hearing Aids'' that we do not intend to enforce the 
medical evaluation, waiver, or recordkeeping requirements of Sec.  
801.421 with respect to prospective purchasers who are 18 or older 
(Ref. 8).
    In addition to other applicable misbranding and adulteration 
provisions in sections 501 and 502 of the FD&C Act (21 U.S.C. 351 and 
21 U.S.C. 352, respectively), hearing aids are currently subject to 
misbranding provisions for restricted devices under section 502(q) and 
(r) of the FD&C Act. Section 704(a) of the FD&C Act (21 U.S.C. 374(a)) 
authorizes FDA to inspect, among other things, certain records relating 
to restricted devices.
3. State Requirements for Hearing Aids
    Under certain circumstances, State requirements apply to hearing 
aids notwithstanding Federal requirements. In general, FDA's regulation 
of hearing aids preempts State law, meaning that a State or a political 
subdivision (e.g., a city) may not establish or continue in effect its 
own requirement if that requirement is ``different from, or in addition 
to,'' a requirement under the FD&C Act (see section 521(a) (21 U.S.C. 
360k(a))). Many States have established requirements equivalent to 
Sec.  801.420 or Sec.  801.421 (i.e., not ``different from, or in 
addition to'' those regulations), which are not preempted by these 
Federal requirements.
    However, for other State requirements, FDA has granted and denied 
exemptions from preemption under section 521(b) of the FD&C Act for 
some States that have applied. FDA responds to applications for such 
exemptions by regulation, codified in subpart C of part 808 (21 CFR 
part 808). Most of these regulations relate to hearing aids, and in 
some of these regulations, FDA has granted exemptions--meaning those 
States' requirements apply instead of, or in addition to, FDA's 
requirements--for:
     Specifying the physician expertise needed to examine 
prospective purchasers who are younger than 18 years of age;
     Advising purchasers when to seek medical attention based 
on ``red flag'' conditions;
     Providing purchasers with certain information and 
disclosures on receipts and other documentation;
     Recordkeeping requirements in addition to the Hearing Aid 
Restrictions; and
     Providing written notice of a money-back guarantee where a 
State court held the State requirement was preempted.
    And FDA has denied exemptions--meaning the States could not 
establish or continue in effect requirements--for:
     Removing the waiver option for prospective purchasers who 
are 18 years of age or older;
     Lowering the age at which a waiver of medical examination 
prior to purchase was available;
     Changing the expertise for examinations, when conducted, 
for people 18 years of age and older;
     Prohibiting certain marketing claims about improving 
hearing; and
     Adopting different device testing standards.
    FDARA added a separate Federal preemption provision for State and 
local laws, regulations, orders, or other requirements (for brevity, we 
will refer to ``State or local requirements'' in this rulemaking) 
specifically related to hearing products (FDARA section 709(b)(4)).\3\ 
That provision may affect the applicability of State or local 
requirements for OTC hearing aids. Section III.G discusses the OTC 
hearing aid preemption provisions and the effects of this rulemaking.
---------------------------------------------------------------------------

    \3\ Additionally, FDARA section 709(b)(5) addresses the effect 
of section 709 on certain private remedies.
---------------------------------------------------------------------------

4. Hearing Products Not Regulated as Hearing Aids
    FDA does not consider personal sound amplification products (PSAPs) 
to be ``devices'' within the meaning of section 201(h) of the FD&C Act 
(21 U.S.C. 321(h)) when they are not intended to aid a person with, or 
compensate for, impaired hearing and do not otherwise meet the device 
definition. Such PSAPs are not subject to medical device regulations, 
nor would the proposed requirements of this rulemaking apply to such 
PSAPs.\4\ Note that the name of a product on its own would not 
ordinarily demonstrate intended use. Thus, merely calling a product 
something besides ``hearing aid'' would not remove a product from 
device regulation under the FD&C Act if, for example, its labeling 
demonstrated that the product was intended to compensate for hearing 
loss.
---------------------------------------------------------------------------

    \4\ Section 520(q)(1)(B) of the FD&C Act also specifically 
excludes from the definition of OTC hearing aids products intended 
to amplify sound for nonhearing impaired consumers in situations 
including hunting and bird watching.
---------------------------------------------------------------------------

C. History of This Rulemaking

    Although this proposal is the first step in this rulemaking, FDA 
has taken other steps to initiate an update of the regulatory framework 
for hearing aids.

[[Page 58155]]

Prior to the enactment of FDARA, FDA had considered means to improve 
access to hearing aids. For example, we considered a report on the 
public health implications of hearing loss in adults that made 
recommendations to improve affordability and accessibility of hearing 
aids and to foster innovative hearing aid technology. The October 2015 
report by the President's Council of Advisors on Science and Technology 
(PCAST) recommended, among other actions, that, ``FDA should approve 
[a] class of hearing aids for over-the-counter (OTC) sale, without the 
requirement for consultation with a credentialed dispenser'' (Ref. 7). 
In addition, the report concluded, among other things, that the Federal 
requirement for a medical examination, or a written waiver of such 
examination, ``provides little patient benefit, while acting as a 
barrier to access for the millions of Americans needing hearing 
assistance'' (Ref. 7).
    Similarly, FDA, other Federal Agencies, and a consumer advocacy 
group co-sponsored a study entitled ``Hearing Health Care for Adults: 
Priorities for Improving Access and Affordability'' through the 
National Academies of Sciences, Engineering, and Medicine (NASEM). The 
resulting NASEM report, published on June 2, 2016, similarly recommends 
that FDA create a new category of OTC ``wearable hearing devices'' 
(using a term distinct from ``hearing aids'') and also that FDA remove 
the medical evaluation requirement for adults for hearing aids (Ref. 
6). After a review of the literature and relevant clinical databases 
from the U.S. Department of Defense and the U.S. Department of Veterans 
Affairs, NASEM concluded that the health risk of missed diagnosis of 
treatable causes of hearing loss in adults is low, and ``[the] 
regulation [requiring a medical examination or waiver] provides no 
clinically meaningful benefit, and the waiver presents a barrier to 
access with no substantial enhancement of patient safety.''
    Both PCAST and NASEM provided recommendations regarding FDA Quality 
System requirements (which set forth requirements for good 
manufacturing practices or GMPs) for the proposed category of OTC 
hearing aids. PCAST stated the following:

    FDA should exempt this class of hearing aids from QSR regulation 
in its present form and substitute compliance with standards for 
product quality and recordkeeping appropriate for the consumer-
electronics industry, developed by an appropriate third-party 
organization and approved by FDA. Similar actions should be taken 
with respect to diagnostic hearing tests used to dispense and fit 
Class I hearing aids.

    However, NASEM recommended that these devices ``[b]e subject to 
quality system regulation (QSR) requirements, but be considered for 
exemption from certain QSR requirements as determined by FDA to be 
appropriate for this category.''
    We held a public workshop on April 21, 2016, entitled 
``Streamlining Regulations for Good Manufacturing Practices (GMPs) for 
Hearing Aids,'' (announced at 81 FR 784; see Ref. 9 for materials). FDA 
requested comments on several topics relating to hearing healthcare 
technology and improved access, including the appropriate level of GMP 
regulation (Quality System requirements) to ensure the safety and 
effectiveness of air-conduction hearing aid devices in consideration of 
the PCAST report recommendations.
    FDA received hundreds of comments to the docket for this workshop 
prior to the (extended) deadline of June 30, 2016. In addition, 2 
keynote speakers (from PCAST and NASEM), 12 invited speakers, and 24 
public speakers offered comments or presentations at the workshop. 
Workshop speakers and submitters of docket comments were generally: 
Healthcare professionals (or healthcare professional organizations), 
members of industry, patients or consumers, academics, consensus 
standards developers, and science organizations.
    Comments from this workshop ranged generally from strong opposition 
to strong support for the PCAST recommendations. Other comments were 
more nuanced. To summarize very broadly, all parties agreed that some 
combination of regulatory requirements and flexibility in compliance 
would provide reasonable assurance of safety and effectiveness. The 
differences in opinion lie in the preferred approach and its 
implementation to achieve these common goals. For example, some 
preferred amending the QS regulation and relying on inspections while 
others preferred allowing voluntary conformity to a consensus standard 
potentially relying on third-party certification.
    In another effort to address the current regulatory framework, FDA 
also issued a guidance document, as noted above, related to the 
conditions for sale for air-conduction hearing aids. In that document, 
we announced our intent to reexamine and modify Sec.  801.421 based on 
the PCAST and NASEM recommendations, as well as from other 
stakeholders, taking into consideration and addressing their 
recommendations as appropriate before adopting regulations for OTC 
hearing aids. The docket no. FDA-2016-D-3466 included commentary that 
expressed support for the creation of a ``basic'' category of hearing 
aids such as OTC hearing aids and provided recommendations for measures 
to support safe and effective use. We also received multiple telephone 
calls expressing similar interest in reducing regulatory burdens and 
questioning how the issuance of the guidance affected States' 
requirements.
    In developing this proposed rule, we considered the input and 
questions we have received on the guidance, as well as the comments 
from the April 2016 public workshop and the recommendations from PCAST 
and NASEM.

D. Incorporation by Reference

    FDA is proposing to incorporate by reference the Method and tables 
for clause 4.1 of ANSI/CTA-2051, ``Personal Sound Amplification 
Performance Criteria,'' dated January 2017, from the American National 
Standards Institute, 1889 L Street NW, 11th floor, Washington, DC 
20036; https://www.ansi.org, 202-293-8020. You may download the 
standard from the web at https://webstore.ansi.org/standards/ansi/cta20512017ansi. The Method and tables for clause 4.1 describe how to 
measure frequency response and include technical data for adaptations 
for different circumstances. The Method and tables would provide a 
standardized way to quantify frequency response for OTC hearing aids 
and meet the related proposed requirements (see section III.E.1).
    FDA is also proposing to incorporate by reference ANSI/ASA S3.22-
2014, ``Specification of Hearing Aid Characteristics,'' dated November 
2014, from the American National Standards Institute, 1889 L Street NW, 
11th floor, Washington, DC 20036; https://www.ansi.org, 202-293-8020. 
ANSI/ASA S3.22-2014 describes tolerances and test methods used for 
certain measurements of hearing aid performance. The application of 
ANSI/ASA S3.22-2014 provides professional hearing aid fitters with 
standardized technical information to help them select the correct 
hearing aid and ensure optimal fit and performance for hearing aid 
users (see section III.H.2).

II. Legal Authority

    The FD&C Act establishes a comprehensive system for the regulation 
of devices, as defined in section 201(h) of the FD&C Act, intended for 
human use. Section 513 of the FD&C Act (21 U.S.C. 360c) defines three 
classes of devices, reflecting the regulatory

[[Page 58156]]

controls needed to provide reasonable assurance of their safety and 
effectiveness. The three classes of devices are class I (general 
controls), class II (special controls), and class III (premarket 
approval) (see 21 U.S.C. 360c). Hearing aids are devices intended for 
human use and are subject to the FD&C Act. Currently, air-conduction 
hearing aids are generally either class I or class II devices.
    FDARA amended the FD&C Act to apply requirements specific to 
certain hearing aids and defined the term ``over-the-counter hearing 
aid'' (see 21 U.S.C. 360j(q)). We are issuing these requirements for 
OTC hearing aids pursuant to section 709(b) of FDARA, which authorizes 
FDA to establish requirements for labeling, output limits, conditions 
for sale and distribution of OTC hearing aids, and other requirements 
that provide for reasonable assurance of safety and effectiveness of 
these devices.
    In addition, the FD&C Act provides that a device is misbranded 
unless, among other requirements, its labeling bears adequate 
directions for use (see section 502(f)(1) of the FD&C Act). Consistent 
with section 502 of the FD&C Act, FDA has issued regulations that 
exempt certain kinds of devices from the requirement for adequate 
directions for use. Section 502(f)(2) further requires adequate 
warnings against use of a device in those pathological conditions, or 
by children, where use of the device may be dangerous to health. The 
labeling must also bear adequate warnings against unsafe dosage or 
methods or duration of administration or application (see section 
502(f)(2) of the FD&C Act). Such warnings must be in such manner and 
form as are necessary for the protection of the users (see section 
502(f)(2) of the FD&C Act).
    A device is also misbranded if its labeling is false or misleading 
in any particular (see section 502(a) of the FD&C Act). Section 201(n) 
of the FD&C Act states that in determining whether labeling or 
advertising is misleading, there shall be taken into account not only 
representations made or suggested but also the extent to which labeling 
or advertising fails to reveal material facts.
    Other misbranding provisions under the FD&C Act would apply as 
well, including section 502(c), which deems a device to be misbranded 
if any word, statement, or other information required by or under 
authority of the FD&C Act to appear on the label or labeling is not 
prominently placed thereon with such conspicuousness and in such terms 
as to render it likely to be read and understood by the ordinary 
individual under customary conditions of purchase and use.
    Additionally, section 701(a) of the FD&C Act authorizes FDA to 
issue regulations for the efficient enforcement of the FD&C Act (21 
U.S.C. 371(a)). The proposals in this rulemaking would be for the 
efficient enforcement of the FD&C Act because, if finalized, they will 
provide standards for the legal marketing of safe and effective hearing 
aid devices.
    Violations of any final rules from this rulemaking, once in effect, 
would render the hearing aids adulterated and/or misbranded under 
sections 501 and/or 502 of the FD&C Act, and subject to enforcement 
action, for example, seizure (see section 304 of the FD&C Act (21 
U.S.C. 334)), injunction (see section 302 of the FD&C Act (21 U.S.C. 
332)), and criminal prosecution (see section 303 of the FD&C Act (21 
U.S.C. 333)). Prohibited acts include, among others, introducing an 
adulterated or misbranded device into interstate commerce (see section 
301 of the FD&C Act (21 U.S.C. 331)).
    Under section 521 of the FD&C Act, no State or political 
subdivision of a State may establish or continue in effect with respect 
to a device intended for human use any requirement that is different 
from, or in addition to, any requirement applicable under the FD&C Act 
to the device and that relates to the safety or effectiveness of the 
device or to any other matter included in a requirement applicable to 
the device under the FD&C Act (21 U.S.C. 360k). Section 521 of the FD&C 
Act also provides that FDA may grant an exemption from preemption under 
certain circumstances. Section 709(b) of FDARA also includes a 
preemption provision with respect to requirements for OTC hearing aids.

III. Description of the Proposed Rule

    We are proposing multiple related actions in this rulemaking:
     Add to part 800, subpart B (21 CFR part 800, subpart B), 
definitions and other rules for OTC hearing aids;
     Remove Sec.  801.420 and repeal Sec.  801.421;
     Add to part 801, subpart H (21 CFR part 801, subpart H), 
Sec.  801.422, labeling requirements for prescription hearing aids;
     Amend part 874, subpart D (21 CFR part 874, subpart D), in 
multiple places to update classification regulations for hearing aids 
and align hearing aid types by sound-conduction technology; and
     Amend part 808, subparts A and C (21 CFR part 808, 
subparts A and C), by updating the Scope and removing most of the 
current regulations codifying previous decisions for exemption from 
Federal preemption for certain States.
    If this action is finalized, all non-OTC hearing aids will be 
prescription devices and would be subject to the labeling requirements 
in new Sec.  801.422 as well as those in the existing Sec.  801.109, 
but they would no longer be restricted devices. Note that a prescriber 
is any practitioner licensed by the law of the State in which the 
practitioner practices to use, or order the use of, the device. When 
the prescriber of a hearing aid need not be a physician, the labeling 
of a prescription hearing aid will describe other prescribers, for 
example, audiologists (see Sec.  801.109(b)(1)).
    We believe the proposed actions will, in combination, promote and 
protect the public health by, among other things, providing reasonable 
assurance of safety and effectiveness of OTC and prescription hearing 
aids. These actions would also help minimize the complexity of the 
applicable regulations, if finalized, through organization. We are 
proposing to add the OTC Hearing Aid Controls to 21 CFR part 800, 
subpart B, entitled ``Requirements for Specific Medical Devices,'' 
which would make them easy to locate. Labeling requirements for 
prescription devices would remain in part 801, Labeling, subpart H, 
``Special Requirements for Specific Devices.'' Table 2 outlines the 
proposed hearing aid rules. Section III.I summarizes the proposed 
revisions to part 808.

              Table 2--Outline of Proposed Hearing Aid Rule
------------------------------------------------------------------------
      800.30            801.422           874.3301          874.3305
------------------------------------------------------------------------
 Over-the-counter     Prescription
   hearing aid        hearing aid      Bone-conduction   Air-conduction
   controls \1\       labeling \1\       hearing aid       hearing aid
------------------------------------------------------------------------
(a) Scope.         (a) Scope.         (a)               (a)
                                       Identification.   Identification.
(b) Definitions.   (b) Definitions.   (b)               (b)
                                       Classification.   Classification.

[[Page 58157]]

 
(c) Labeling.      (c) Labeling.      Product codes      
                                       LXB, MAH.         Legacy.
                                         
 Package.           Package.                             Wireless.
                                          Self-
 Labeling Inside    Labeling Inside                      Fitting.
 the Package.       the Package.
                                        Product codes
 Labeling on the    Labeling on the                      ESD, OSM, QDD,
 Device.            Device.
                                         LRB, and LDG.
 Technical          Technical
 Specifications.    Specifications.
                    
                    Misbranding.
(d) Output         (d) Incorporation
 Limits.            by Reference.
(e)
 Electroacoustic
 Performance.
 
 Distortion
 Control.
  Self-
 generated Noise.
 
 Latency.
 
 Bandwidth.
 
 Smoothness.
(f) Design
 Requirements.
 
 Insertion Depth.
 
 Atraumatic
 Materials.
  Proper
 Fit.
  Tools,
 Tests, or
 Software.
(g) Condition for
 Sale.
(h) Effect on
 State Law.
(i) Incorporation
 by Reference.
------------------------------------------------------------------------
\1\ These requirements would apply in addition to all other applicable
  requirements, including applicable labeling requirements in parts 801
  and 830 (21 CFR parts 801 and 830). For example, for prescription
  devices, the labeling requirements in Sec.   801.109 would continue to
  apply in addition to new Sec.   801.422.

A. Scope (Proposed Sec.  800.30(a))

    The regulation would clarify which devices are subject to the OTC 
Hearing Aid Controls. Among other changes, FDARA amended the FD&C Act 
to define the term ``over-the-counter hearing aid,'' and section 709 of 
FDARA directs FDA to establish certain requirements for labeling, 
output limits, conditions for sale, and other requirements that provide 
reasonable assurances of the safety and effectiveness of OTC hearing 
aids. We propose to call this set of requirements ``Over-the-Counter 
Hearing Aid Controls'' and add Sec.  800.30 to establish the OTC 
category of hearing aids and their requirements.
    The scope, proposed paragraph (a), would specify the devices to 
which the regulation would apply, assisting with the determination of 
applicable requirements. This provision clarifies that a hearing aid is 
either in the prescription or OTC category and that, regardless of 
category, special controls found in the applicable classification 
regulation and other requirements in the FD&C Act apply.

B. Definitions (Proposed Sec. Sec.  800.30(b) and 801.422(b))

    FDA proposes to include the definition of an OTC hearing aid, 
consistent with the definition in section 520(q)(1) of the FD&C Act, 
and the definitions of other terms integral to understanding Sec.  
800.30. In several cases, we are proposing parallel definitions 
(sometimes slightly modified) under the proposed requirements for 
prescription hearing aid labeling in Sec.  801.422.
    Defining hearing aids. FDARA authorizes controls for devices that, 
among other characteristics, use the same fundamental scientific 
technology as air-conduction hearing aids under Sec. Sec.  874.3300 or 
874.3305. Section 520(q)(1)(A)(i) of the FD&C Act does not specifically 
refer to Sec.  874.3325 because, at the time of FDARA's enactment, FDA 
had not classified that device type. However, we consider self-fitting 
hearing aids currently classified under Sec.  874.3325 to be eligible 
for regulation as OTC hearing aids.
    We consider them as such because, although self-fitting hearing 
aids under Sec.  874.3325 differ from hearing aids under Sec. Sec.  
874.3300 and 874.3305 in that they incorporate technology, including 
software, that allows users to program their hearing aids, self-fitting 
hearing aids use the same air-conduction technology as hearing aids 
under Sec. Sec.  874.3300 and 874.3305. Self-fitting hearing aids also 
meet the other elements of the OTC hearing aid definition in section 
520(q)(1)(A) of the FD&C Act. For example, self-fitting hearing aids, 
through tools, tests, or software, allow the user to control the 
hearing aid and customize it to the user's hearing needs (see section 
520(q)(1)(A)(iii) of the FD&C Act).
    The proposed definitions of ``hearing aid'' (which is the current 
definition), ``air-conduction hearing aid,'' ``over-the-counter hearing 
aid,'' and ``prescription hearing aid'' help to delineate the different 
device categories.\5\ As stated in section 520(q)(1)(B) of the FD&C 
Act, the definition of ``over-the-counter hearing aid'' does not 
include PSAPs. Similarly, the definition of ``hearing aid'' more 
generally excludes PSAPs that are not intended to aid with or 
compensate for impaired hearing. The proposed definition of 
``prescription hearing aid'' in proposed Sec.  801.422 is the same as 
that in the OTC Hearing Aid Controls except that the definition for 
prescription devices would cross-reference the OTC Hearing Aid 
Controls, proposed Sec.  800.30.
---------------------------------------------------------------------------

    \5\ Although some have suggested the use of a different name for 
OTC hearing aids, for example, a ``wearable,'' we are proposing to 
continue referring to them as hearing aids to maintain consistency 
with the device type classifications and section 520(q) of the FD&C 
Act.
---------------------------------------------------------------------------

    Defining licensed persons. In that vein, OTC hearing aids will be 
available without the supervision, prescription, or other order, 
involvement, or intervention of a licensed person (section 
520(q)(1)(A)(v) of the FD&C Act). A definition of ``licensed person'' 
would help delineate that a patient or consumer of OTC hearing aids 
will not need to consult an audiologist, a physician, or other licensed 
person prior to or after purchasing an OTC

[[Page 58158]]

hearing aid. The proposed definition of ``licensed person'' also 
clarifies that FDA interprets ``licensed person'' to include businesses 
consistent with the broad definition of ``person'' in section 201(e) of 
the FD&C Act. For example, OTC hearing aids may be available for sale 
from businesses that are not specially licensed to distribute OTC 
hearing aids.\6\
---------------------------------------------------------------------------

    \6\ See section III.G, discussing the codification of the 
preemption provision, section 709(b)(4) of FDARA.
---------------------------------------------------------------------------

    FDA does not interpret section 520(q)(1)(A)(v) of the FD&C Act or 
section 709(b) of FDARA as preempting a State's ability to establish or 
continue in effect generally applicable State business or professional 
licensing requirements. In general, such requirements would not be 
``specifically related to hearing products,'' so they are not subject 
to section 709(b)(4) of FDARA. If a person purports to be a licensed 
professional or business, then a State could regulate the person as 
such. Thus, for example, a person identifying as an ``audiologist'' 
would be subject to State professional or facility licensure 
requirements because an audiologist is a licensed professional.
    However, unlike identifying as an ``audiologist,'' some 
descriptions for professions do not on their own imply licensure in 
relation to OTC hearing aids. Section 709(b)(4) of FDARA lists certain 
activities that may be undertaken with respect to OTC hearing aids 
without the supervision, prescription, or other order, involvement or 
intervention of a licensed person. FDARA specifically lists the 
servicing, marketing, sale, dispensing, use, customer support, or 
distribution of OTC hearing aids. (For convenience, we will refer to 
these activities collectively as ``commercial activity'' in this 
document.) Thus, a person representing as a marketer, seller, 
dispenser, distributor, or customer support representative (or an 
equivalent description) of OTC hearing aids would not be a ``licensed 
person'' for the purposes of Sec.  800.30 solely for that reason. Nor 
could a State require such persons to undertake special licensing or 
equivalent activities. In contrast, a person voluntarily identifying, 
for example, as a ``licensed dispenser'' (i.e., not just a 
``dispenser'') would be subject to corresponding State requirements for 
such dispensers to the extent that the State requirements do not 
restrict or interfere with commercial activity involving OTC hearing 
aids (see section 709(b)(4) of FDARA).
    The proposed definition of ``licensed person'' specifies the 
descriptions of profession, consistent with section 709(b)(4) of FDARA, 
that would not, on their own, imply licensure relating to OTC hearing 
aids. Section III.G of this document describes other preemption 
scenarios in addition to licensed persons.
    Defining tools, tests, or software. Another element of the 
definition of OTC hearing aids requires that users be able to control 
or customize the devices through tools, tests, or software (see section 
520(q)(1)(A)(iii) of the FD&C Act). We interpret this requirement to 
refer to the ability for a layperson to perform such activities. As 
such, the proposed definition of ``tools, tests, or software'' 
clarifies that OTC hearing aids are those devices that allow lay users 
to control the device and customize it, such as the device's output, to 
meet their individual hearing needs.
    Other definitions. The proposed definition of ``used hearing aid'' 
in both the OTC and prescription device provisions clarifies which 
hearing aids would be subject to certain proposed labeling requirements 
for used or rebuilt hearing aids. The proposed definitions are the same 
for OTC and prescription hearing aids, and they are derived from the 
current definition in Sec.  801.420 except that we have revised the 
wording for clarity.
    The proposal for prescription hearing aid labeling in Sec.  801.422 
retains the definition for ``dispenser'' that is currently applicable 
to all hearing aids. However, we propose to revise the wording to 
clarify that the definition applies only for purposes of prescription 
hearing aid labeling and propose other clarifying revisions to track 
the definition of ``person'' in section 201(e) of the FD&C Act more 
closely. We believe the definition will continue to be useful because 
the proposed requirements for prescription hearing aids refer to the 
dispenser.
    FDA welcomes comments on the definitions pertinent to the 
regulation of OTC hearing aids (as well as any other portion of this 
proposal). In particular, we seek comments on the clarity of the 
definitions and ways to improve the definitions to encourage and 
support the broad availability of safe and effective devices.

C. Labeling (Proposed Sec.  800.30(c))

    We are proposing labeling requirements to provide consumers with 
essential information for the safe and effective use of OTC hearing 
aids. Section 709(b)(2)(C) of FDARA specifically directs FDA to 
include, among appropriate labeling requirements, a conspicuous 
statement that the device is only intended for adults age 18 and older, 
information on how consumers may report adverse events, information on 
any contraindications, conditions, or symptoms of medically treatable 
causes of hearing loss, and advisements to consult promptly with a 
licensed healthcare practitioner. In addition, section 709(b)(2)(A) of 
FDARA directs FDA to establish requirements that provide reasonable 
assurances of the safety and effectiveness of OTC hearing aids, and we 
intend the proposed labeling requirements to do so.
    In considering which statements to require, we note the important 
role of information in supporting broader use of OTC hearing aids. As 
part of the 2016 FDA hearing aid workshop, the Hearing Loss Association 
of America presentation stressed the importance of clear labeling to 
inform consumers so that the consumer ``is empowered and knows what 
they're buying and knows the limitations and what's possible'' (Refs. 9 
and 10). FDA agrees, and we have proposed labeling requirements to 
empower consumers.
    Further the proposed conspicuous statement that OTC hearing aids 
are intended for people age 18 years and older is necessary because the 
use of OTC hearing aids in people younger than 18 presents risks to 
health beyond those typically associated with use in older people. 
Whereas hearing loss in older adults is most commonly related to noise 
exposure and aging, the etiology (causes) of hearing loss in younger 
people is varied and may result from conditions that warrant prompt 
diagnosis to avoid serious risks to health. These conditions may not be 
readily apparent and can include, but are not limited to:
     Congenital malformations (present since birth) of the 
external, middle, or inner ear;
     Infections, for example, otitis media (an inflammation of 
the middle ear) or congenital infections;
     Genetic causes, including hereditary syndromes that can 
involve cardiac, ophthalmic, renal, neurologic, and other organ systems 
(that is, syndromes that can involve the heart, eyes, kidneys, nerves, 
and other organs); or
     Certain exposures, for example, lead poisoning, 
hyperbilirubinemia (a buildup of a metabolic byproduct, bilirubin, in 
the blood), and drug ototoxicity (a toxic effect on the ear or its 
nerves).
    The use of a hearing aid to treat hearing loss related to these 
conditions, without a medical evaluation, may delay diagnosis and 
treatment of the

[[Page 58159]]

underlying condition. Further, prompt diagnosis is critical because, 
left untreated, these conditions may worsen, with potentially lifelong, 
adverse health effects. Because the use of OTC hearing aids in people 
younger than 18 presents risks to health beyond those typically 
associated with use in older people, the proposed conspicuous 
statements are appropriate and provide reasonable assurance of safety 
and effectiveness of OTC hearing aids.
    The proposed labeling provisions include requirements for labeling 
on the package and inside the package, along with requirements for 
labeling on the device itself. These requirements would apply in 
addition to all other applicable labeling requirements in, for example, 
parts 801 and 830. In any of the labeling, manufacturers could continue 
to include additional truthful, non-misleading information provided it 
does not conflict with other requirements (such as those mentioned 
above).
    In proposing where to place labeling statements--on the package or 
inside the package--we have considered when users, prospective users, 
and others should become aware of information (before or after 
purchase). We have also considered the limited space available on the 
packaging as well as simplicity of format.
    FDA welcomes your comments on the proposed labeling requirements, 
including the placement or conspicuousness of statements, as well as 
whether the statements are clear and understandable. For example, in 
reviewing the proposals, did you find important information quickly? 
Did you find the information clear and easy to understand? We are 
particularly interested in your feedback about phrasing or formatting 
to convey information to people who are anticipated users, or more 
generally, who are not hearing health professionals. A rationale or 
evidence would make your feedback more useful. For example, if a 
proposed statement is unclear, telling us why is generally more helpful 
than saying only that you find the statement to be unclear.
1. Package Labeling
    We are proposing that the outside of the package include 
information that consumers would need to know prior to purchasing the 
device, such as who is a candidate for the device, how to determine if 
you are a candidate, and when to seek professional help before trying 
the device. We believe this information empowers consumers and answers 
threshold questions about the suitability of purchasing an OTC hearing 
aid for their hearing needs. This proposal would also emphasize who the 
intended user is, to reduce the likelihood that people younger than 18 
would purchase or use an OTC hearing aid.
    To summarize, the proposed statements on the package describe:
     A conspicuous warning that the device is not for users 
younger than 18 years old;
     The symptoms of perceived mild-to-moderate hearing loss;
     Considerations for seeking a consultation with a hearing 
healthcare professional; and
     Red flag conditions: Warnings to consumers regarding signs 
and symptoms that should prompt a consultation with a licensed 
physician (preferably an ear specialist).
    However, we are not proposing to require other information on the 
package, for example, mobile operating system compatibility or whether 
the package contains the necessary batteries. Further, we are proposing 
language that accurately conveys information to readers without relying 
on specialized knowledge (i.e., for laypeople). We welcome your 
comments on whether to require other information on the package 
labeling and whether you had any difficulty understanding the 
information (and if so, your suggestions for improvements).
    a. Symptoms suggesting perceived mild to moderate hearing loss. 
Prospective users may not know their definitive degree, configuration, 
or etiology of hearing loss. That is, they may not know the exact 
nature or cause, so commenters for the public meeting discussed various 
ways to communicate the signs of perceived mild to moderate hearing 
loss and reasons to seek medical evaluation. They generally agreed that 
such information should appear on the outside of the package. We agree 
with this sentiment and are proposing that the information be readily 
apparent prior to purchase to help people to determine whether an OTC 
hearing aid may benefit them.
    To that end, we are proposing four scenarios that a person may 
recognize (symptoms) that suggest perceived mild to moderate hearing 
loss. We have selected these scenarios because they commonly present 
difficulties to people with perceived mild to moderate hearing loss and 
are situations in which users are likely to benefit from the use of OTC 
hearing aids. We have also based the selection on stakeholder input 
from the public workshops. Although people with normal hearing may 
sometimes experience these scenarios, people with perceived mild to 
moderate hearing loss will experience them more frequently, if not 
regularly. We have phrased the information to emphasize that the device 
is intended for people who are 18 or older, and the phrasing avoids 
medical and technical terms while describing everyday situations.
    b. Considerations for seeking consultation with a hearing 
healthcare professional. However, because a prospective user may have 
hearing impairment beyond, or different from, perceived mild to 
moderate hearing loss, we are proposing a statement to assist people in 
evaluating the potential for increased benefit from an OTC hearing aid. 
We believe this information is important, and have titled it as such, 
and appropriate for users and prospective users who are not familiar 
with hearing aids.
    c. ``Red flag'' conditions. In that vein, we are proposing to 
continue to require a statement advising users and prospective users to 
seek medical care if they exhibit any one of a number of conditions. We 
are not modifying the list of conditions from its present form except 
for phrasing and formatting changes to improve readability, as well as 
a change to the time periods (from 90 days to 6 months). We intend the 
change to the time periods to encourage consumers to consider a longer 
personal history, which may help them to identify the conditions 
without the involvement of a licensed person. The list includes 
reliable indicators of the possibility of an underlying medical 
condition that a hearing aid cannot treat. For example, fluid, pus, or 
blood coming out of the ear may indicate an active infection, as could 
sudden, quickly worsening, or fluctuating hearing loss. An examination 
by a physician, preferably an ear specialist, would determine whether 
such an underlying condition is present and treatable, potentially 
halting or reversing hearing loss.
    d. Other information. We are also proposing to require that the 
outside package include a web address and telephone number for 
consumers to access a digital copy or request a paper copy of all 
labeling, including the labeling inside the package, for that OTC 
hearing aid. A website could provide easy access to the more 
comprehensive information found in the labeling inside the package and 
could allow the use of other media to convey information.
    FDA is proposing to require that this labeling be available online 
or be able to be requested by phone prior to purchase to facilitate 
product familiarity to make a purchasing decision. We believe having 
the information found inside the package will help prospective users

[[Page 58160]]

choose a safe and effective device without the involvement of a 
licensed person. As proposed, this information would be available 
without the need for consumers to register for access, for example, by 
registering for a website member login.
    Further, a download page could include, but would not be required 
to include, additional resources, for example, video explanations or 
tutorials to aid prospective users in selecting and using a device, as 
well as a mechanism for reporting complaints or adverse events. Since 
such additional resources would not be required under this proposal, 
accessing such resources could entail, for example, registering as a 
website member.
    Please note that we are not proposing to require the distribution 
of paper copies for all OTC hearing aids because an analogous provision 
in the Hearing Aid Restrictions yielded little benefit--very few people 
requested a review of the paper copy--while adding to the regulatory 
burden. We are seeking comment on these proposed requirements (and any 
other portion of this proposed rule) regarding equitable access to the 
information and/or OTC hearing aids.
    We are also proposing to require that the manufacturer disclose its 
return policy or, if none, state that it does not accept returns. Such 
a requirement would be appropriate, because prospective users of OTC 
hearing aids may be unsure whether an OTC hearing aid will meet their 
hearing needs. If an OTC hearing aid does not meet a user's hearing 
needs, the user may leave the device in the ``dresser drawer.'' (This 
is a common description of the phenomenon of relegating the device to 
disuse--putting it away, never to use it again--and foregoing the 
potential benefit of a more-satisfactory device). Thus, a statement of 
the return policy would be appropriate because, without the services of 
a licensed person, some users may be more dependent on the 
manufacturer's return policy (as opposed to the licensed person's) to 
avoid leaving an OTC hearing aid in the dresser drawer. A statement of 
the return policy would provide appropriate information to prospective 
users to help them determine the suitability of options given 
individual circumstances and preferences such as budget and willingness 
to try multiple OTC hearing aids. Additionally, consistent with the 
existing hearing aid requirement in Sec.  801.420(c)(5), we are 
proposing that, when an OTC hearing aid is used or rebuilt, the outside 
package declare that fact. These requirements would advance the public 
health by facilitating the purchase of devices that meet users' hearing 
needs.
    We are not proposing to require that manufacturers accept returns 
under these proposed Federal regulations. However, we likely would not 
consider a generally applicable State or local requirement to accept 
returns (i.e., the requirement applies to any product) as a requirement 
specifically related to hearing products. Further, we believe that a 
State or local requirement for retailers (persons who sell to end 
users) to accept returned OTC hearing aids would likely promote--rather 
than restrict or interfere with--commercial activity involving the 
devices by reducing the financial risk to purchasers. As such, 
generally, State or local requirements for returns would continue to 
apply provided they do not conflict with the final rule based on this 
rulemaking. We are seeking comment on whether such a State or local 
requirement would promote, rather than restrict or interfere with, 
commercial activities involving OTC hearing aids.
    Participants at the June 9, 2017, NASEM public workshop generally 
agreed with the importance and utility of requiring certain information 
on the package. Participants discussed potential labeling requirements 
such as these for OTC hearing aids (see Ref. 11). Numerous participants 
focused on the signs and symptoms of consumers who have mild-to-
moderate hearing loss and might potentially benefit from OTC hearing 
aids. Specifically, participants expressed concerns that consumers 
would need information to help decide whether to purchase the products 
and/or whether to seek professional services. The proposed requirements 
in this document have taken these comments into account.
2. Labeling Inside the Package
    We are proposing to require that manufacturers place labeling 
inside of the package with the information that consumers will need 
after purchasing an OTC hearing aid for its safe and effective use. The 
proposed content of this labeling includes:
     Warnings, cautions, and notes, including a conspicuous 
statement warning against the use of the OTC hearing aid in people 
younger than 18 years old as well as a warning regarding ``red flag'' 
medical conditions to prompt consumers to consult with a licensed 
physician and a note about how to report adverse events to FDA;
     Illustration(s) of and information about the controls, 
user adjustments, and the battery compartment;
     A description of any accessory that accompanies the OTC 
hearing aid;
     Adequate directions for use, consistent with Sec.  801.5 
(21 CFR 801.5), including but not limited to information on sizing and 
inserting the eartip as well as the tools, tests, or software that 
allow the user to control and customize the OTC hearing aid to the 
user's hearing needs (e.g., to self-select, self-fit, and self-check 
the performance of the device);
     Technical specifications to allow users, prospective 
users, and others to evaluate and compare the performance of OTC 
hearing aids;
     Description of commonly occurring, avoidable events that 
could adversely affect or damage the OTC hearing aid;
     Identification of known physiological side effects 
associated with using the OTC hearing aid that may warrant consultation 
with a physician, including but not limited to skin irritation and 
accelerated build-up of ear wax (cerumen accumulation);
     Information on repair services; and
     If clinical or non-clinical studies were conducted by or 
for the manufacturer to support the performance of the OTC hearing aid, 
a summary of all such studies.
    We believe these labeling requirements for OTC hearing aids will 
help provide reasonable assurance of safe and effective use of OTC 
hearing aids for consumers with perceived mild-to-moderate hearing 
loss. We intend the proposed labeling requirements to provide lay 
consumers with adequate information, in particular, to ensure that 
those purchasing OTC hearing aids know when to seek professional 
intervention, how to use the device safely and effectively, and where 
and how to obtain additional information or assistance. The 2016 NASEM 
report supports FDA's proposal in that it similarly recommends that OTC 
hearing aids ``[i]nclude thorough consumer labeling, including 
information on:
     Frequency gain characteristics;
     adequate directions for use;
     communication challenges for which it may be helpful to 
seek professional consultation; and
     medical situations, symptoms, or signs for which to 
consult with a physician'' (Ref. 6).
    We agree that thorough consumer labeling will assist users, 
potential users, and others with selecting, fitting, and wearing OTC 
hearing aids. Even so, the proposed requirements in this rulemaking are 
not intended as a substitute for other FDA regulations. Thus, for 
example, if adequate directions for use were to require additional 
information beyond that proposed in this rulemaking, manufacturers 
would need to include

[[Page 58161]]

that additional information (see Sec.  801.5 regarding adequate 
directions for use).
    As for the NASEM report's recommendations for OTC hearing aids 
regarding information about communication challenges and medical 
indicators, we agree that such information will help provide reasonable 
assurance of safety and effectiveness, and we have included that 
information, as well as the full-on gain value in our proposed labeling 
requirements. (Gain is a measure of amplification, and its full-on 
value is its maximum. We provide an explanation of gain in section 
III.D.2.)
    We are not proposing to require additional technical information in 
the labeling for OTC hearing aids other than those in proposed Sec.  
800.30(c)(4); however, the labeling may optionally include such 
information if desirable. For example, technical information similar to 
what is currently required for all hearing aids may be useful in 
assisting audiologists offering services to users (see Sec.  
801.420(c)(4)). Multiple stakeholders voiced a similar view during the 
2016 FDA workshop (Refs. 9, 10, and 12). Some added that scientific or 
technical information (in addition to the information we are proposing 
to require for OTC hearing aids) may be meaningful for consumers to 
make their decisions, especially if they are familiar with the 
technology. Although such additional information may be desirable for 
some consumers, FDA does not believe it is necessary to assist 
consumers in their selection.
    FDA intends to issue at a later date a separate comprehensive 
guidance document that discusses, in part, labeling information and 
communicating that information with the goals of increasing 
transparency and choice to consumers. In accordance with 21 CFR 10.115, 
we will announce the availability of the draft of that guidance 
separately from this rulemaking, and the announcement will include 
information for submitting comments about that guidance, which will be 
separate and distinct from comments for this rulemaking. We do not 
intend to consider comments submitted to the docket for this rulemaking 
unless they pertain to the proposals in this document.
3. Labeling on the Device Itself
    We are proposing to require that the labeling on the device itself 
include the serial number and symbol(s) for proper battery insertion 
orientation when applicable. If the device has been used or rebuilt, a 
tag indicating such would have to be physically attached to the device 
in addition to the statement on the outside of the package.

D. Output Limits (Proposed Sec.  800.30(d))

    FDA is proposing a maximum acoustic output limit requirement for an 
OTC hearing aid to provide reasonable assurance of safety and 
effectiveness. Section 709(b)(2)(B) of FDARA directs FDA to establish 
or adopt output limits appropriate for OTC hearing aids. A high output 
can be unsafe and further impair hearing. However, too low an output 
reduces device effectiveness and can lead to poor device performance, 
including clipping and distortion. In turn, poor performance would 
reduce consumer satisfaction and use of the devices. We believe that 
the proposed output limits balance the above considerations for these 
devices, so the limits are therefore appropriate for OTC hearing aids.
1. Overview of Proposed Output Limits
    We propose a maximum OSPL90 output level of 115 dB sound pressure 
level (SPL) as a general rule to balance consumer safety with device 
performance.\7\ However, we would permit a limit of 120 dB SPL for an 
OTC hearing aid that implements input-controlled compression and a 
user-adjustable device volume control (i.e., volume adjustment). This 
is because a user-adjustable volume control allows the user to reduce 
the output below the maximum, in effect, further reducing the device's 
limit. Input-controlled compression is an automatic function that 
dynamically reduces the output of frequency ranges based on the input. 
Both of these design features thus reduce the likelihood that a user 
will experience high acoustic outputs, at the device's limit, at any 
given moment. Relatedly, we are proposing that the device labeling 
state the value of the maximum OSPL90 level (see section III.C.1).
---------------------------------------------------------------------------

    \7\ OSPL90 is an abbreviation for the sound output as measured 
in a standardized way. ANSI/ASA S3.22-2014 defines it as the SPL 
developed in the specified 2-cm\3\ earphone coupler when the input 
SPL is 90 dB with the gain control of the hearing aid full-on. To 
simplify, this describes a way to simulate amplifying a sound into 
the ear canal, providing a standardized measurement for the 
amplified output.
---------------------------------------------------------------------------

    We have proposed output limits to prevent injuries from exposure to 
loud sounds when amplified by OTC hearing aids while still allowing a 
sufficient dynamic range of outputs, called ``headroom,'' to provide 
effective amplification for users with perceived mild to moderate 
hearing loss. A device without sufficient headroom (when the output 
limit is too low) would not be as effective as a device with a higher 
output. However, a device with too high an output limit could further 
worsen hearing impairment.
2. Data and Stakeholder Perspectives on the Proposed Output Limit
    We base the proposed limits on physiological data and stakeholder 
input, some of which appear in Clause 4.3 of ANSI/CTA-2051, a voluntary 
consensus standard (Ref. 13). Note that, although ANSI/CTA-2051 is a 
consensus standard for PSAPs, we believe that this standard is also 
relevant for OTC hearing aids, which provide personal sound 
amplification, albeit for purposes of aiding with or compensating for 
impaired hearing. The standard's basis for the output limit is a 
national workplace safety guideline, Occupational Noise Exposure, from 
the National Institute for Occupational Safety and Health (NIOSH) (Ref. 
14). NIOSH developed this standard, which we will refer to as NIOSH-98, 
to define permissible exposure time depending on the intensity of the 
sound.
    In general, the relationship between the loudness (SPL) and the 
time before damage to hearing is inversely related: The louder the 
sound, the shorter the time before hearing damage. Above about 85 dBA 
(A-weighted decibels), the exposure time is cut in half for every 3 dB 
increase in sound level (Ref. 14).\8\ Thus, the difference between 
recommended exposure times for 115 dB SPL and 120 dB SPL is 
approximately 61 seconds, where 115 dB SPL provides approximately 
triple the permissible exposure time than 120 dB SPL (see the next 
section for a more detailed explanation of the ``3-dB exchange rate'').
---------------------------------------------------------------------------

    \8\ Weighting sound levels means that different frequency ranges 
have different values (weights) added or subtracted to them, so for 
example, lower frequencies may receive more weight than higher 
frequencies for the purpose of expressing the sound level. Different 
sets of weighting values have different purposes. A-weighting tries 
to account for the fact that the human ear is less sensitive to 
lower frequencies, which generally do not sound as loud to people as 
higher frequencies at the same SPL. Therefore, A-weighted decibels 
can be useful to express how a listener might perceive a sound level 
when considering the ear's variable sensitivity to different 
frequencies. This weighting method is common but is not the only one 
that accounts for human hearing perception. C-weighting is another.
---------------------------------------------------------------------------

    Appendix A of ANSI/CTA-2051 describes this tradeoff between output 
level and exposure time, providing a rationale for a maximum OSPL90 
output limit of 120 dB based on NIOSH-98. For the purposes of that 
standard, NIOSH found that 115 dBA SPL is acceptable for up to about 30 
seconds. ANSI/CTA-2051 explains that this allows the user sufficient 
time to turn off or remove the hearing aid before the exposure becomes

[[Page 58162]]

unacceptably dangerous to hearing ability. ANSI/CTA-2051 observes that 
sound levels of desirable, ``real-life sonic events'' can approach the 
NIOSH-98 level, for example, a live symphony in which a user would want 
to experience ``occasional peaks'' undistorted. However, a lower output 
limit would not allow enough headroom for a faithful reproduction of 
such peaks and would lead to output clipping or distortion. Thus, a 
limit that allows desirable peaks, but sufficient time to react to 
undesirably loud sounds, would be ideal. As ANSI/CTA-2051 explains, 115 
dBA is equivalent to an OSPL90 value of approximately 120 dB SPL with 
an allowance of 28 seconds to react.
    FDA agrees that an OTC hearing aid should provide sufficient 
headroom to amplify relatively loud sounds such as those in a symphony, 
yet the device should not have an output so high that the user does not 
have time to act before sustaining injury. Further, the output should 
not be consistently at a limit of 120 dB SPL, accomplished through the 
inclusion of input-controlled compression and user-adjustable volume 
control.
    In addition to considering the ANSI/CTA and NIOSH standards 
supporting the proposed limits, we considered stakeholder input. On 
June 9, 2017, NASEM held a public workshop meeting where participants 
discussed, among other topics, a 120-dB SPL maximum output limit for an 
OTC hearing aid (see Ref. 11). Numerous speakers commented that an 
OSPL90 output limit somewhat lower than 120 dB SPL for OTC devices 
would likely still provide sufficient amplification and headroom for 
individuals with perceived mild to moderate hearing loss while 
providing a safety margin in terms of sound-intensity exposure.
    Additional comments during the NASEM workshop raised the importance 
of input-controlled compression and the inclusion of a user-adjustable 
volume control in order to help reduce overamplification. Each of those 
features can limit the device's output by dynamically reducing device 
gain as the input level increases, thus increasing the safety profile 
of a device: The user generally would not be listening at louder output 
levels as often as would occur without these features.
    FDA has also reviewed numerous public comments on the risk of harm 
from excessive output, stemming from our 2016 public workshop, 
Streamlining Good Manufacturing Practices (GMPs) for Hearing Aids (see 
Refs. 9, 15, and 16). We agree that excessive amplification from OTC 
hearing aids could pose a risk to individuals' health and thus are 
proposing that the maximum output (OSPL90) of OTC hearing aids not 
exceed a certain value, depending on device design features, that would 
provide users enough time to react to loud sounds to prevent injuries.
    Some stakeholders have suggested inclusion of gain limits for OTC 
hearing aids. Gain is a measurement based on the ratio between the 
output and the input or, to simplify further, how much the device 
amplifies (or reduces) the input. A gain limit would further reduce the 
maximum device output because the device would sometimes reach the gain 
limit, providing no further amplification, before it reached the output 
limit. We are proposing not to limit the device gain because we believe 
that the proposed maximum output limit (together with the other 
proposed requirements) will provide reasonable assurance of safety and 
effectiveness without limiting the device gain also.
    Moreover, a gain limit may unduly constrain the design of effective 
devices. Appropriate gain characteristics can depend on the 
implementation of the amplification circuit design (e.g., linear 
amplification versus wide dynamic range compression). Thus, appropriate 
gain settings for one device may not be appropriate for another device 
of a different design. We believe that allowing flexibility in the gain 
settings will help maximize the effectiveness of the particular circuit 
design a manufacturer implements for a device to address perceived mild 
to moderate hearing loss. In light of this, and since a maximum output 
limit would also in effect limit gain, we do not believe a separate, 
additional gain limit is necessary to provide reasonable assurance of 
safety and effectiveness. We also note that the NASEM report does not 
recommend any limit on gain for OTC devices, only on maximum output 
(Ref. 6).
3. The Proposed Output Limit Requirements Help Provide Reasonable 
Assurance of Safety and Effectiveness
    In further consideration of user-adjustable volume controls and 
input-controlled compression, we believe that these two design features 
together will sufficiently mitigate the risk of a higher maximum output 
limit (from 115 dB SPL up to and including 120 dB SPL) by reducing the 
likelihood that the user will experience excessive sound levels for 
periods long enough to sustain damage to hearing (Ref. 14). Input-
controlled compression such as wide dynamic range compression is also 
associated with hearing performance benefits in realistic environments 
that have varying levels of sound intensity for persons with mild-to-
moderate sensorineural hearing loss (see, e.g., Refs. 17 to 21). That 
is, besides reducing the device's effective output limit, input-
controlled compression also generally helps users hear better in daily 
situations.
    In reaching this proposal on output limits, we note that hearing 
aids, including OTC hearing aids, are intended to be worn during all 
waking hours in a wide variety of listening environments and 
situations. Thus, user comfort is relevant to safety and effectiveness, 
and input-controlled compression and user-adjustable volume control 
increase comfort by dynamically adjusting gain and keeping outputs 
lower. This contributes to effectiveness and user satisfaction because 
users are generally more willing to wear a comfortable device 
consistently, maximizing the benefits of the device and the impact on 
public health.
    We are not proposing to require input-controlled compression and a 
user-adjustable volume control for all OTC hearing aids, however. Thus, 
devices that do not have both of these features (which, in effect, 
reduce the device's output limit) would have to respect a 115 dB SPL 
limit, which would more than triple the safe exposure time compared to 
a 120 dB SPL limit (Ref. 14).\9\ Users would have ample time to take 
appropriate action to mitigate unacceptably high sound levels, for 
example, by adjusting the volume (if the device has a user-adjustable 
volume control), turning the device off, removing the device from the 
ear, or moving out of the loud environment. As noted above, the device 
labeling would also be required to include a reminder to consumers 
that, if they are in a loud listening environment that warrants hearing 
protection, they should remove their hearing aid(s) and use hearing 
protection.
---------------------------------------------------------------------------

    \9\ Based on the 3-dB exchange rate--above 85 dB SPL, the time 
halves for each 3-dB increase--of Clause 1.1.1 of NIOSH-98, which is 
used by ANSI/CTA-2051, exposure to 115 dB SPL is 2(\5/
3\) or 3.17 times the ANSI/CTA-2051 recommended exposure 
limit of 28 seconds for 120 dB SPL, equaling approximately 89 
seconds.
---------------------------------------------------------------------------

    To summarize, we believe that a 115 dB SPL output limit would help 
provide reasonable assurance of safety and effectiveness for the 
intended population. However, we acknowledge that 120 dB SPL could have 
additional effectiveness potential in certain circumstances, for 
example, when listening to a symphony by a live orchestra (Ref. 13). As 
discussed above, we believe that achieving that potential would be safe 
only if the device also

[[Page 58163]]

includes input-controlled compression and a user-adjustable volume 
control. Overall, we believe this device-design contingent proposal for 
output limits helps provide reasonable assurance of safety and 
effectiveness of OTC hearing aids while providing ample design space 
for innovation.

E. Other Requirements (Proposed Sec.  800.30(e) and (f))

    Although certain labeling and output limits are necessary for 
reasonable assurance of safety and effectiveness of OTC hearing aids, 
these requirements alone are not sufficient to do so. FDA is therefore 
proposing that the devices must meet certain performance and design 
requirements in order to help provide reasonable assurance of safety 
and effectiveness, pursuant to section 709(b)(2)(A) of FDARA.
1. Electroacoustic Performance Requirements To Help Provide a 
Reasonable Assurance of Safety and Effectiveness
    We are proposing to establish electroacoustic performance 
requirements to help ensure that the output of an OTC hearing aid 
safely and effectively compensates for perceived mild to moderate 
hearing loss in people age 18 and older. Electroacoustic performance 
describes how well a hearing aid converts an electrical signal, either 
digital or analog, into a sound (acoustic energy) or vice versa. 
Currently, hearing aid labeling must include technical data for certain 
performance characteristics gathered according to the test methods 
specified in ANSI/ASA S3.22-2003 (see Sec.  801.420(c)(4)). We do not 
believe, however, that the data that conform to ANSI/ASA S3.22 are 
adequate for consumers to select their own hearing aid without the 
supervision, involvement, or intervention of a licensed person (among 
other reservations).
    This is because ANSI/ASA S3.22 does not specify any minimum 
performance requirements. Instead, it specifies tolerances, which are 
acceptable ranges of deviation from manufacturer-stated specifications. 
The manufacturer, not a standard, determines how the hearing aid 
performs. As a result, achieving optimal hearing aid performance 
currently depends in part on interpreting the technical data supplied 
by the manufacturer for selection and adjustment. The interpretation of 
this information is highly technical, so the information is useful to a 
professional but generally not the lay user.
    For OTC hearing aids, we believe that the devices must meet certain 
electroacoustic performance specifications so that any OTC hearing aid 
would perform safely and effectively for perceived mild to moderate 
hearing loss after the user customizes the device for individual needs. 
To that end, we are proposing to use several applicable specifications 
for device performance from ANSI/CTA-2051 for OTC hearing aids. A 
device that met these performance specifications would safely and 
effectively reproduce sounds without the need for professional 
involvement.
    Specifically, an OTC hearing aid should provide amplification with 
high fidelity so that the user can accurately perceive daily social and 
environmental sounds. High-fidelity (accurate) output means that the 
device reproduces the input frequencies clearly, without distortion and 
without undue frequency shaping. We believe such an OTC hearing aid 
will have certain performance characteristics to achieve fidelity: The 
OTC hearing aid would have sufficiently low distortion, would not 
introduce excessive self-generated noise or time delays between input 
and output, and would provide a sufficient frequency response bandwidth 
and smoothness. An OTC hearing aid would have to achieve these, after 
customization to the individual's hearing needs, without the 
intervention of a licensed professional; that is, by design.
    We have reviewed ANSI/CTA-2051:2017, which includes specifications 
for electroacoustic performance, and we believe that performance 
requirements based primarily on its Category 1 specifications would 
help provide reasonable assurance of safety and effectiveness of OTC 
hearing aids.\10\ These specifications relate to the device's 
processing of the input sound (the sounds detected by the device) to 
generate the output sound (the amplified sound that the device produces 
to assist the user). To summarize, FDA believes that the specifications 
that would help provide reasonable assurance of safety and 
effectiveness, as well as set an objective baseline for device 
performance, are:
---------------------------------------------------------------------------

    \10\ Note that the consensus standard includes a maximum 
acoustic output as a Category 1 specification; however, we are 
proposing a different maximum output level rather than the consensus 
standard's (see section III.D). Additionally, we are proposing a 
latency limit, which the standard includes as a Category 2 
specification.
---------------------------------------------------------------------------

     Distortion control limits;
     Self-generated noise limits;
     Latency limit;
     Frequency response bandwidth; and
     Frequency response smoothness limits.
    We believe that the above listed electroacoustic requirements would 
ensure that an OTC hearing aid can accurately reproduce daily speech 
and other environmental sounds without the need for professional 
involvement. We believe that this performance level is requisite for 
the device to meet the needs of people with perceived mild to moderate 
hearing loss. Likewise, the performance requirements would help ensure 
that undesirable effects (such as distortion) do not impair safety and 
effectiveness.
    ANSI/CTA-2051 is, to FDA's knowledge, the first voluntary consensus 
standard to describe performance characteristics for hearing amplifiers 
(as opposed to standardized test methods and tolerances). Upon 
reviewing the voluntary consensus standard, and in consideration of 
related presentations during FDA's 2016 hearing aid workshop, we 
believe that the rationale and methodology of the standard are sound, 
and we believe that adhering to the specifications in this standard 
would yield high-fidelity OTC hearing aids. However, we are proposing 
to establish as requirements the subset of those specifications that we 
believe would help provide reasonable assurance of safety and 
effectiveness in conjunction with the other proposals in this 
rulemaking.
    Whether to require such electroacoustic performance specifications 
for OTC hearing aids, and the specific values, were topics of 
discussion during the June 9, 2017, NASEM public workshop (Ref. 11). 
Additionally, public presentations of amplification measurements at 
FDA's hearing aid workshop showed performance differences and 
suitability in terms of frequency response bandwidth and smoothness 
across devices that presenters considered (Refs. 9, 15, 16, 22). After 
seeing such information, several participants opined that the Category 
1 limits of ANSI/CTA-2051, together with the device latency limits (a 
Category 2 limit in ANSI/CTA-2051), would collectively help ensure 
safety and effectiveness of an OTC hearing aid with respect to its 
electroacoustic performance.
    In addition to the performance aspects of the voluntary consensus 
standard, we recognize that aligning FDA regulations with a voluntary 
consensus standard may reduce administrative burdens while encouraging 
and facilitating greater availability of safe and effective OTC hearing 
aids. Note that we are not proposing to apply the electroacoustic 
performance requirements to

[[Page 58164]]

prescription hearing aids, nor are we proposing to establish 
requirements for OTC hearing aids that mirror the technical data 
requirements under current Sec.  801.420(c)(4). We expect that the 
involvement of a licensed professional for prescription hearing aids 
will help provide for reasonable assurance of safety and effectiveness 
for those devices. Similarly, although the technical data in current 
Sec.  801.420(c)(4) will assist licensed professionals to select and 
fit a prescription hearing aid, we do not believe that the technical 
data are generally helpful for lay users of OTC hearing aids that meet 
electroacoustic performance requirements.
    a. Distortion control limits. Distortion control limits describe 
how faithfully an OTC hearing aid reproduces a given frequency or range 
of frequencies at a given sound pressure level. An OTC hearing aid that 
produces less perceptible total harmonic distortion, plus hearing-aid-
originated noise (i.e., total harmonic distortion plus noise), will 
deliver a higher-fidelity sound to the user, meaning that the user will 
be able to perceive sounds more accurately or clearly than a device 
with higher perceptible total harmonic distortion plus noise. Total 
harmonic distortion plus noise can depend on both the input and output 
sound pressure levels and the corresponding (level-dependent) gain 
settings of the device if applicable. We believe that the proposed 
allowable levels of total harmonic distortion plus noise, when measured 
as proposed at the specified sound pressure levels, will help ensure 
accurate or clear amplification for the user of an OTC hearing aid.
    b. Self-generated noise level limit. The self-generated noise level 
limit describes the maximum sound pressure level of noise that the OTC 
hearing aid may produce, where ``self-generated noise'' means sounds 
that are present in the output but not the input. Excessive self-
generated noise can obscure or overwhelm softer output sounds, 
preventing the user from hearing such sounds. Excessive self-generated 
noise may also distract or annoy users. Appropriately limiting self-
generated noise will therefore help users to hear softer output sounds 
as well as improve their experience by avoiding the production of 
perceptible noise or sounds that are not input sounds. We believe that 
the proposed rule will appropriately limit self-generated noise.
    c. Latency limit. The latency limit describes how quickly an OTC 
hearing aid produces the output sound relative to the input sound. A 
shorter latency interval means that the device takes less time to 
produce the output, and when short enough, the user will not perceive a 
delay. A perceived delay is generally most noticeable when the device 
amplifies the user's own voice, causing an effect much like an echo 
that can be disorienting, distracting, or annoying. We believe that the 
proposed latency limit will help to avoid perceptible output delays 
that would reduce the benefit from an OTC hearing aid.
    d. Frequency response bandwidth. The frequency response bandwidth 
of an OTC hearing aid is the range of frequencies that the device can 
reproduce for the user to hear. Cutoff frequencies, both lower and 
upper, are the limits of the bandwidth. The device would generally not 
sufficiently amplify signals with frequencies outside of these limits, 
meaning, below the lower cutoff or above the upper cutoff. A wider 
bandwidth means that the device can amplify a broader range of sound 
frequencies for users to hear. A bandwidth that is too narrow, 
especially if the upper cutoff is too low, will result in insufficient 
amplification of critical high-frequency sounds, including but not 
limited to speech sounds such as /s/,/z/,/t/, and/sh/. We believe that 
the proposed required frequency bandwidth, 250 Hz to 5 kHz, will ensure 
amplification of daily speech or other environmental sounds because 
almost all such sounds typically fall between these proposed lower and 
upper cutoff frequencies.
    e. Frequency response smoothness limit. The frequency response 
smoothness limit describes how uniformly the OTC hearing aid amplifies 
different frequencies over its bandwidth. A uniform frequency response 
when graphed would correspond to a smooth and relatively uniform curve, 
which is the ``smoothness'' described by this limit. To describe this 
requirement, we divide the frequency range into multiple, narrower 
ranges called one-third octave bands. Any given peak in a one-third 
octave band would have to remain below a set level compared to 
neighboring bands, two bands above and two bands below, based on the 
averages. Meeting this requirement for frequency response smoothness 
means that the amplification performance is consistent across 
frequencies for users.
    If a device does not amplify sounds uniformly across frequencies, 
the user would potentially perceive differences in intensity for 
different frequencies, reducing the audio fidelity and consequently the 
user's hearing perception. This may include a perceptibly altered 
speech quality (such as undue changes in the tone or timbre of the 
intended sound), which may be distracting or annoying. In addition, 
device output that is relatively excessive at lower frequencies 
(compared to higher frequencies) poses an increased risk for damaging a 
user's hearing at lower frequencies. This is because the typical user 
has more residual hearing (i.e., better hearing thresholds) at lower 
frequencies, consistent with a typical sloping hearing loss, the kind 
of hearing loss associated with aging. We believe that the proposed 
frequency response smoothness limit will ensure consistent performance 
across frequency ranges and thereby help to provide reasonable 
assurance of device safety and effectiveness.
    f. Performance test methods. For each of these proposed 
electroacoustic requirements, we are specifying performance test 
methods, including input and output sound pressure levels when 
appropriate. We are proposing specific performance test methods because 
different test methods could yield different results for the same 
metric of device performance. Thus, specifying test methods helps 
establish a common baseline to benchmark performance for any given 
device. Additionally, a common baseline would allow prospective users 
and others to compare electroacoustic performance across devices. 
Facilitating comparison shopping may also promote users' satisfaction 
with the OTC hearing aids that they decide to purchase.
2. Design Requirements To Ensure Proper Physical Fit and Prevent User 
Injury
    We are proposing that the design of an OTC hearing aid must meet 
certain requirements for safety and effectiveness:
     Maximum insertion depth;
     Eartip made from atraumatic materials;
     Proper physical fit; and
     Tools, tests, or software allowing the lay user to control 
the device and customize it to the user's hearing needs.
    The above listed requirements seek to balance effective fit and 
safe fit of an OTC hearing aid, accomplished by users themselves, 
without professional assistance. An OTC hearing aid eartip (the part of 
the OTC hearing aid that contacts and fits into the user's ear) must 
fit the user so the device performs optimally, but an OTC hearing aid 
must not damage the ear, including the ear canal and eardrum (tympanic 
membrane).
    The device could damage the ear by scratching (abrading) the skin 
around the eartip parts, puncturing the eardrum, or exacerbating 
hearing loss if

[[Page 58165]]

the device is too close to the eardrum. In particular, the skin that 
lines the ear canal is especially thin and delicate. The lateral 
(outer) third of the canal is composed of cartilage, and the medial 
(inner) two-thirds, which ends at the ear drum, of bone. Each of these 
parts of the ear is therefore quite sensitive and easily injured. To 
provide reasonable assurance of safety and effectiveness, the design of 
an OTC hearing aid must allow insertion and prolonged contact with 
these sensitive areas while preventing injury to them. We believe the 
above listed requirements would ensure proper physical fit for optimal 
performance while avoiding injury to the user's ear canal skin, bony 
inner ear canal, the eardrum, or other middle ear structures.
    a. Maximum insertion depth. We considered whether we could express 
a design requirement for manufacturers for maximum insertion depth as a 
given length. However, specific anatomical dimensions such as the 
length of the cartilaginous and bony portions of the external auditory 
canal and distance to the tympanic membrane can vary greatly among 
adults. That is, the distance to the eardrum differs greatly from 
person to person. A given length may be too long for one person 
(potentially resulting in injury with device insertion or placement) 
but too short for another (potentially impairing device performance by 
too shallow of an insertion). In contrast, we believe that the bony-
cartilaginous junction is a readily identifiable and consistent 
anatomical landmark that can serve as a design limit for manufacturers 
of OTC hearing aids. That is, we believe a practical way to describe 
the depth limit is to base it on the area of the ear canal 
corresponding to where cartilage meets bone. However, we welcome 
comments, particularly those with support from peer-reviewed sources, 
about other design requirements (e.g., in terms of absolute length) to 
limit the insertion depth and prevent damage to the tympanic membrane 
or other injuries while also promoting device effectiveness.
    b. Construction from atraumatic materials. We are proposing that 
the eartip be encased by atraumatic materials, that is, materials that 
prevent injuries to the skin and bone, for example, because they are 
very flexible. The use of atraumatic materials reduces the chance that 
daily use or accidental contacts will cause damage to the delicate skin 
or bone of the ear.
    c. Proper physical fit. We are proposing that the OTC hearing aid 
have features that enable users to readily achieve a safe, customized, 
acoustically favorable, and comfortable physical fit in the ear canal 
and/or external ear. For example, the manufacturer may wish to provide 
interchangeable eartips of varying sizes. However, we are not proposing 
a specific design feature or strategy because such specificity may 
constrain the design of an OTC hearing aid and impede design 
innovations. This proposed requirement corresponds with the proposed 
labeling requirements to describe how users may obtain such a fit, 
including sizing or inserting the eartip to minimize the risk of 
injury.
    d. Tools, tests, or software. We are proposing to codify the 
requirement that an OTC hearing aid must include tools, tests, or 
software through which a lay user can control the device and customize 
it to the user's hearing needs. Examples of tools, tests, or software 
include but are not limited to: A user-adjustable volume control, a 
user-adjustable tone control, the ability for a user to change preset 
listening programs manually, interactive software for self-selecting, 
testing, and fitting, or a switch to enable or disable automatically 
determined settings, such as acoustic environment sensing or noise 
cancellation. An OTC hearing aid would need to include tools, tests, or 
software, or some combination of those features, sufficient to 
customize the device to meet the user's hearing needs.
3. QS Requirements
    We are soliciting further input on potential revisions to the 
applicable QS requirements for OTC hearing aids. The input that we have 
already received, while valuable, is sometimes contradictory and does 
not fully address FDA's concerns for the quality of medical devices. As 
described in section I.C, we received stakeholder input suggesting that 
FDA reduce the provisions of the QS regulation applicable to the 
devices as the provisions are overly burdensome. We also received input 
that the current requirements are important and not unduly burdensome 
(Ref. 9). While FDA wishes to minimize regulatory burdens, we must have 
reasonable assurance of safety and effectiveness, which a quality 
system helps to provide.
    In considering the range of feedback already received, we note that 
the QS requirements are interdependent yet inherently flexible. This 
scheme relies on each of the provisions working together. Further, 
because hearing aids are medical devices, a quality system for medical 
devices specifically, as opposed to a quality system for consumer 
electronics more generally, is necessary to provide reasonable 
assurance of safety and effectiveness. This is because medical device 
quality systems address regulatory concerns regarding safety and 
effectiveness that systems for consumer electronics do not.
    While the use of the quality system described in part 820 would be 
more appropriate for OTC hearing aids and straightforward to implement 
than another standard with various reservations, exceptions, and 
modifications, FDA is open to considering alternatives to the existing 
QS requirements. Any such changes would be proposed in a separate 
rulemaking proceeding, and interested parties would have an opportunity 
to comment during that rulemaking. However, we welcome proposals for 
how the QS requirements could be modified, or an alternate approach 
implemented, to ensure the quality of OTC hearing aids and provide a 
reasonable assurance of safety and effectiveness.
    Finally, with regard to the QS requirements, FDA is undertaking 
other separate efforts to minimize regulatory burdens for manufacturers 
by proposing the harmonization of part 820 with an international 
consensus standard.
    In light of the foregoing--including contradictory input already 
received, the inherent flexibility of the QS requirements, the need for 
a quality system suited to medical devices, and other changes that FDA 
is proposing--we are seeking further input on potential modifications 
to the QS requirements that would be applicable to OTC hearing aids to 
inform future rulemaking.

F. Condition for Sale (Proposed Sec.  800.30(g))

    FDA is proposing to establish a condition for sale of OTC hearing 
aids to prevent sale to people younger than 18, helping to provide 
reasonable assurance of safety and effectiveness. We are proposing the 
condition for sale pursuant to section 709(b)(2)(D) of FDARA, which 
directs FDA to describe the requirements under which the sale of OTC 
hearing aids is permitted, without the supervision, prescription, or 
other order, involvement, or intervention of a licensed person, to 
consumers through in-person transactions, by mail, or online. For the 
purposes of this provision, we interpret ``sale'' broadly to include, 
among other transactions, leases and rentals.
    The proposed condition for sale is consistent with 709(b)(2)(C) of 
FDARA and section 520(q)(1)(A)(ii) of the FD&C Act, which establish 
that OTC hearing aids are only intended for people age 18 and older. As 
described above, the use of OTC hearing aids in people younger

[[Page 58166]]

than 18 presents risks to health beyond those typically associated with 
use in older people. Accordingly, we are proposing to prohibit the sale 
of an OTC hearing aid to or for a person younger than 18 years.
    FDA has considered whether other conditions for sale for OTC 
hearing aids are necessary in addition to the proposed labeling that 
includes conspicuous statements that OTC hearing aids are only intended 
for people age 18 and older. This proposed condition for sale provides 
a basis for comments on the subject.
    FDA also considered whether requirements on sellers to verify the 
age of purchasers or, in the case of online or mail-order sales, the 
age of the recipient, would promote the public health. However, mindful 
that the current conditions for sale have been criticized as described 
above, we believe that a requirement to obtain proof of age could make 
hearing aids more difficult to obtain. For example, people with limited 
means or mobility may not have a government-issued photographic 
identification that shows their birthdate. Similarly, age verification 
for online or mail-order sales could impede delivery of OTC hearing 
aids or reduce the number of willing sellers, which could 
disproportionately affect OTC hearing aid access in remote or rural 
areas. Moreover, FDA does not expect high demand for OTC hearing aids 
from or for people younger than 18. Thus, a requirement for age 
verification could impose a barrier to access, particularly for 
underserved populations, without a corresponding benefit to the public 
health.
    FDA welcomes your comments on whether a prohibition of sales to or 
for people younger than 18 years, without the need to verify age, would 
best promote access to OTC hearing aids while protecting the hearing 
health of people younger than 18 years. Alternatively, we welcome your 
comments on what other conditions for sale may protect the hearing 
health of people younger than 18 years. In the case of alternative 
conditions for sale, FDA is particularly interested in conditions that 
would not disproportionately burden underserved communities. FDA is 
also interested in your comments on whether labeling, without the 
prohibition on sales, adequately protects the health of people younger 
than 18.
    We intend to minimize burdens and provide flexibility for sellers, 
while also protecting the hearing health of people younger than 18, 
helping to promote the public health by promoting the availability of 
OTC hearing aids for people who are 18 and older.

G. Preemption Provisions (Proposed Sec.  800.30(h))

    FDA is proposing to codify the provisions regarding preemption and 
private remedies under section 709(b)(4) and (5) of FDARA to assist 
stakeholders in understanding the legal framework for OTC hearing aids. 
These provisions are not codified in the FD&C Act, meaning they do not 
appear under Title 21 of the U.S. Code, but apply nonetheless. We 
believe that including these provisions in the Code of Federal 
Regulations will assist our stakeholders, who may not be as familiar 
with requirements that are not codified in the FD&C Act, such as these, 
by consolidating applicable requirements in one location that is more 
familiar.
    This may be particularly helpful because FDARA added to the 
existing preemption framework for devices. In general, under section 
521(a) of the FD&C Act, device requirements established by a State (or 
a political subdivision) are preempted when the requirements are 
different from, or in addition to, requirements applicable to the 
device under the FD&C Act and which relate to the safety or 
effectiveness of the device or to any other matter included in the 
requirements applicable to the device. FDA may by regulation grant or 
deny exemptions to this preemption in response to an application from a 
State (or political subdivision) under certain conditions specified in 
section 521(b) of the FD&C Act. Prior to the enactment of FDARA, FDA 
issued regulations in response to such applications, most of them 
relating to hearing aids, which are codified in part 808.
    However, section 709(b)(4) of FDARA established preemption specific 
to OTC hearing aids that is different from the general rule for 
preemption under section 521(a) of the FD&C Act. Although FDARA did not 
explicitly address the existing exemptions from preemption related to 
hearing aids, section 709(b)(4) of FDARA applies preemption to any 
requirement of a State (or local government) specifically related to 
hearing products, that would restrict or interfere with commercial 
activity involving OTC hearing aids (which, as mentioned above, we will 
use as shorthand in this document for the servicing, marketing, sale, 
dispensing, use, customer support, or distribution of OTC hearing aids 
through in-person transactions, by mail, or online), that is different 
from, in addition to, or otherwise not identical to, FDA's regulations 
issued under FDARA section 709(b). We are therefore proposing to amend 
the scope of part 808 to reflect the additional preemption set by FDARA 
(see section III.I.1).
1. FDARA Preempts State Regulation of OTC Hearing Aids
    Under FDARA section 709(b)(4), the OTC Hearing Aid Controls that 
are the subject of this rulemaking, proposed Sec.  800.30, if 
finalized, would preempt any State or local requirement specifically 
related to hearing products that would restrict or interfere with 
commercial activity involving OTC hearing aids, that is different from, 
in addition to, or otherwise not identical to, the OTC Hearing Aid 
Controls, including any State or local requirement for the supervision, 
prescription, or other order, involvement, or intervention of a 
licensed person for consumers to access OTC hearing aids.
    FDA interprets section 709(b)(4) of FDARA, including the terms 
therein, as consistent with its purpose that State or local government 
requirements specifically related to hearing products not restrict or 
interfere with commercial activity involving OTC hearing aids. For 
example, we interpret this provision as preempting State or local 
requirements specifically related to hearing products that would 
restrict or interfere with leases, consignments, or deliveries of OTC 
hearing aids, though not explicitly mentioned in FDARA, because such 
activities fall within the commercial activity involving OTC hearing 
aids covered by the provision, in this example, within the marketing, 
sale, dispensing, use, and/or distribution. Further, the FDARA 
preemption provision applies to requirements specifically related to 
hearing products generally, as opposed to devices or hearing aids more 
specifically, where such requirements restrict or interfere with 
commercial activity involving OTC hearing aids.
    As explained, we do not interpret section 709(b) of FDARA as 
necessarily preempting State requirements regulating professional 
services such as speech pathology, audiology, or fitting. A State 
could, for example, continue to regulate such professional services 
generally. However, to the extent State or local governments require 
that purchasers of OTC hearing aids seek those services, such 
requirements would be preempted by section 709(b)(4) of FDARA as 
interfering with or restricting commercial activity involving OTC 
hearing aids. The same would be true were a State, for example, to 
require providers to undertake an activity, such as certification and 
examination specific

[[Page 58167]]

to hearing aids, in order to sell OTC hearing aids.
2. Generally Applicable State and Local Requirements Are Not 
Necessarily Preempted Under FDARA
    As noted in section III.B, FDA does not interpret FDARA to preempt 
generally applicable requirements. By ``generally applicable,'' we mean 
that the requirement relates to other products in addition to hearing 
products, to services not specific to hearing products, or to unfair 
trade practices in which the requirements are not limited to hearing 
products.\11\ Requirements that apply to any place of business that 
offers goods or services for sale would likely be generally applicable 
and therefore not preempted (see also Sec.  808.1(d)(1)). Similarly, 
requirements that apply to certain places of business may be generally 
applicable provided the requirements do not attach on account of 
selling, or other commercial activity involving, hearing products. 
State or local requirements that make compliance with Federal 
regulations enforceable by State or local authorities would also not 
generally be preempted. The examples below focus only on the FDARA 
preemption provision that applies to OTC hearing aids.
---------------------------------------------------------------------------

    \11\ We refer to hearing products more generally, not just OTC 
hearing aids. We wish to make clear that a State or locality may not 
establish requirements for hearing products if those requirements 
would restrict or interfere with commercial activity involving OTC 
hearing aids. However, we do not interpret section 709 of FDARA as 
preempting requirements that apply only to prescription hearing aids 
(provided they do not restrict or interfere with commercial activity 
involving OTC hearing aids) but such requirements could be preempted 
under section 521 of the FD&C Act.
---------------------------------------------------------------------------

    a. Example 1. For example, any given pharmacy may be subject to 
certain State licensing requirements that apply regardless of whether 
the pharmacy sells OTC hearing aids; it would not be exempt from such 
licensing requirements merely because it sells OTC hearing aids. 
Similarly, a requirement to include terms of sale or return on the 
receipt that applied also to the sales of other (non-hearing) products 
would not be preempted.
    b. Example 2. In contrast, requirements that attach on account of 
the sale of hearing products (or would not attach but for the sale of 
hearing products), would not be ``generally applicable.'' For example, 
a requirement that any place of business must obtain a license or 
certification to sell OTC hearing aids would be a requirement 
specifically related to hearing products. In addition, it would serve 
to restrict or interfere with commercial activity involving OTC hearing 
aids and would be different from, in addition to, or not otherwise 
identical to, the regulations issued under section 709(b) of FDARA. 
Therefore, it would be preempted.
    A requirement may attach on account of the sale of hearing products 
in a more indirect manner as well, and if it was in effect different 
from, in addition to, or not otherwise identical to the terms of the 
statute or Federal regulations, and if it restricted or interfered with 
commercial activity involving OTC hearing aids, it would be preempted. 
That is, a State or local requirement may appear on its face to be 
generally applicable, but if in practice it was specifically related to 
hearing products and would restrict or interfere with commercial 
activity involving OTC hearing aids, the State or local requirement 
would be preempted.
    c. Example 3. A requirement that a retailer may only sell OTC 
hearing aids when it has an audiologist on premises would require the 
involvement of a licensed person in at least some cases. This 
requirement would restrict or interfere with commercial activity 
involving OTC hearing aids, including by requiring the involvement of a 
licensed person, and would be preempted.
    d. Example 4. Similarly, a requirement that sellers advise 
purchasers of any hearing aids, whether prescription or OTC, of 
specific medical information not required in the OTC Hearing Aid 
Controls would be preempted with respect to the sale of OTC hearing 
aids. Although the requirement attaches on account of the sale of 
hearing aids more generally (not just OTC devices), it is 
``specifically related to hearing products'' and would operate as a 
condition of sale that is different from, in addition to, or otherwise 
not identical to those proposed in this rulemaking. The requirement 
would also restrict or interfere with commercial activity involving OTC 
hearing aids. Therefore, the requirement would be preempted as applied 
to the sale of OTC hearing aids.
    e. Example 5. A professional or ethical requirement that deemed a 
sale to be professional malpractice if the dispenser permitted the sale 
of any hearing aid without consultation would be preempted under FDARA. 
It specifically relates to hearing products and by requiring 
consultation prior to the sale of an OTC hearing aid, it would restrict 
or interfere with commercial activity involving OTC hearing aids even 
though the requirement on its face applies only to the dispenser (who 
must meet licensing requirements).
    f. Example 6. A requirement that a seller maintain a statement of 
medical examination, in connection with the sale of a hearing product, 
would be preempted under FDARA because such a condition of sale would 
restrict or interfere with commercial activity involving an OTC hearing 
aid. Moreover, the requirement for a statement of medical evaluation 
would restrict or interfere with commercial activity involving OTC 
hearing aids by requiring the involvement of a licensed person during 
the course of the commercial activity.
3. Requirements for Professionals and Establishments
    As with generally applicable requirements, we do not interpret 
section 709 of FDARA as generally prohibiting the regulation of 
professionals or establishments or exempting them from applicable 
professional requirements, even in the case that the professional or 
establishment only undertakes activities related to OTC hearing aids. 
Thus, a person that purports to be a specially licensed professional or 
establishment would be subject to applicable State and local 
requirements. Such requirements may include periodic professional 
examination or mandating the availability of testing equipment.
    FDA does, however, interpret section 709 of FDARA as preempting 
certain kinds of professional or establishment requirements. To use one 
specific example, many States have established definitions for hearing 
aid fitters, dispensers, or other sellers and servicers. In some cases, 
State or local requirements may deem an individual or establishment to 
be a dispenser (or other defined term) by virtue of engaging in the 
sale of or providing services for hearing aids. That status in turn 
incurs legal obligations. As explained, we interpret section 709 of 
FDARA as preempting such requirements to the extent that they would 
require the involvement of a licensed person for consumers to access 
OTC hearing aids or would otherwise restrict or interfere with 
commercial activity involving (the servicing, marketing, sale, 
dispensing, use, customer support, or distribution of) OTC hearing 
aids.
    For the reasons explained in section III.B regarding the definition 
of ``licensed person,'' we are specifying certain related terms that 
would not on their own, as they relate to OTC hearing aids, indicate 
professional or specialized obligations. For example, under the 
proposed definition of ``licensed person,'' identifying as a

[[Page 58168]]

hearing aid ``dispenser'' would not imply licensure. Note that we would 
consider a person identifying as a ``licensed dispenser'' to be subject 
to State or local requirements applicable to licensed dispensers and 
therefore considered a ``licensed person'' under section 709(b)(4) of 
FDARA.
    The examples below focus only on the FDARA preemption provision 
that applies to OTC hearing aids.
    a. Example 7. In contrast to identifying as a dispenser (without 
using the word ``licensed''), as proposed, identifying as an 
audiologist or hearing aid fitter, for example, may imply licensure, 
depending on State and local requirements. Thus, a person who 
advertises as an audiologist or hearing aid fitter--professional 
services that may be provided, but cannot be required to be provided, 
to sell OTC hearing aids--would be subject to State requirements that 
apply to audiologists or hearing aid fitters. This would be true even 
if such an audiologist or fitter only sold OTC hearing aids.
    b. Example 8. In contrast, a person who advertises as a hearing aid 
dispenser or seller, and who only sells OTC hearing aids, cannot be 
required to obtain specialized licenses to engage in commercial 
activity involving OTC hearing aids.
    c. Example 9. As in Example 7, a person who only sells OTC hearing 
aids but advertises as a licensed dispenser even though such licensing 
is not required to sell OTC hearing aids--the person purports to be a 
licensed person, not a ``dispenser'' more generally--would be subject 
to State or local requirements that apply to licensed dispensers.
    We are proposing a preemption provision that speaks specifically to 
professional requirements in order to clarify in the regulations that 
the servicing, marketing, sale, dispensing, customer support, or 
distribution of OTC hearing aids, on its own, does not obligate a 
person to obtain specialized licenses, certificates, or any other State 
or local sanction.

H. Proposed Repeal of Conditions for Sale and Modifications for 
Prescription Labeling (Sec. Sec.  801.420, 801.421, 801.422)

    FDA is proposing to repeal the conditions for sale for hearing 
aids, Sec.  801.421, because these would no longer be necessary. 
Currently, those conditions apply to all hearing aids, but section 
520(q)(2) of the FD&C Act specifies that OTC hearing aids will be 
exempt from Sec. Sec.  801.420 and 801.421 or any successor 
regulations. Instead of continuing to apply those conditions to non-OTC 
hearing aids, FDA is proposing to repeal them. Additionally, FDA is 
proposing to remove the current labeling requirements for hearing aids 
in Sec.  801.420 and issue prescription labeling requirements under 
Sec.  801.422, which would be in addition to the prescription labeling 
requirements in Sec.  801.109.
    The repeal of Sec.  801.421 and the amendments to the labeling 
requirements (amending the current labeling requirements, moving them 
to a new section, and removing Sec.  801.420) would have further 
regulatory implications. In proposing new Sec.  801.422, FDA is not 
relying on its restricted device authority in section 520(e) of the 
FD&C Act. Therefore, if this proposed rule is finalized, class I and 
class II hearing aids would no longer be ``restricted devices'' under 
section 520(e) of the FD&C Act. As such, certain Federal requirements 
related to restricted devices would no longer apply to class I and 
class II hearing aids. Further, the basis for some of FDA's exemption 
decisions about preempted State requirements would change. The next 
section of this document discusses those changes along with the 
additional Federal preemption implications of FDARA and how we would 
remove, update, or clarify those regulations. Repeal of the conditions 
for sale would also obviate the need for the guidance entitled 
``Conditions for Sale for Air-Conduction Hearing Aids''; if the repeal 
of the conditions for sale is finalized, we would withdraw that 
guidance (Ref. 8).
1. Repeal of Conditions for Sale Sec.  801.421
    As summarized in section I.C.2, the conditions for sale of hearing 
aids under Sec.  801.421 require a statement of medical evaluation, 
unless waived by a user 18 years of age or older; the availability of a 
user instructional brochure and an opportunity to review it; and 
records of the statements of medical evaluation or waiver. The 
conditions also provide an exemption from the requirements in Sec.  
801.421 for auditory trainers.
    In light of the fact that FDA is proposing to clarify that non-OTC 
hearing aids would be prescription devices, such hearing aids would be 
subject to State and local requirements for obtaining written or oral 
authorization of a practitioner licensed by State law to administer the 
use of the devices. For example, some States license audiologists to 
administer the use of prescription hearing aids for an adult, so adults 
could obtain a prescription for hearing aids from an audiologist in 
those States. In the case of people younger than age 18, the proposed 
prescription labeling statements described in the next section of this 
document would in manner and form emphasize the importance of medical 
evaluations. Because prescription hearing aids will require a written 
or oral authorization from a practitioner licensed by law to administer 
the device, and because we are proposing certain labeling requirements 
in a certain manner and form, FDA is proposing to repeal the conditions 
for sale (including the requirement for a medical evaluation and for 
providing a user instructional brochure) because they would no longer 
be necessary to provide reasonable assurance of safety and 
effectiveness of prescription hearing aids. Thus, hearing aids that do 
not meet the definition of, or the requirements for, OTC hearing aids 
would all be prescription hearing aids, but they would no longer be 
restricted devices. We expect that the application of prescription 
requirements with the removal of device restrictions will not increase 
the burden to obtain non-OTC hearing aids, and that the change will 
promote consistency with other products, easing the burden on 
purchasers. Specifically, hearing aids will be either prescription or 
OTC; users and other interested people would not also need to inquire 
whether a device is restricted.
    Additionally, repeal of the requirements discussed above would 
obviate the need for the exemption for group auditory trainers, which 
we are correspondingly proposing to repeal.
2. Revised Labeling for Prescription Hearing Aids
    We continue to believe that the labeling requirements are necessary 
to provide reasonable assurance of safety and effectiveness of 
prescription hearing aids. As such, we are proposing to retain most of 
the required information currently in Sec.  801.420 in substance, 
except as revised below, and place the proposed revised labeling 
requirements that would be specific to prescription hearing aids in 
Sec.  801.422, thereby removing Sec.  801.420. These proposed revisions 
are to ensure that the wording is consistent with and similar to the 
proposed labeling statements for OTC hearing aids when appropriate. In 
particular, we are proposing to revise the labeling statements to be 
more understandable and, when addressed to users and prospective users, 
less technical.
    In general, as summarized in section II, a device's labeling must 
bear adequate directions for use and certain adequate warnings in the 
manner and form necessary to protect the user (see section 502(f) of 
the FD&C Act). We

[[Page 58169]]

have defined ``adequate directions for use,'' in part, as directions by 
which a layperson can use the device safely and for the purposes for 
which it is intended (see Sec.  801.5). However, we have exempted 
prescription devices from the requirement for labeling to bear adequate 
directions for use provided they meet certain conditions (see Sec.  
801.109). For prescription devices, labeling must bear, among other 
statements, information for use under which practitioners licensed by 
law to administer the device can use it safely and for the purpose for 
which it is intended (see Sec.  801.109(c)). In any case, the labeling 
for a device must not be false or misleading in any particular (see 
section 502(a)(1) of the FD&C Act). Labeling may be false or misleading 
because, among other reasons, it fails to reveal facts material to its 
use (see section 201(n) of the FD&C Act). Therefore, prescription 
hearing aid labeling must include certain adequate warnings as well as 
information for the licensed professional to use the device safely and 
for the purpose for which it is intended, and the labeling must not 
fail to reveal certain material facts.
    To determine whether those requirements are met, we consider the 
sale, distribution, and use of prescription hearing aids. In the case 
of prescription hearing aids, a prospective user would obtain one from 
a practitioner licensed by law in that State. However, the professional 
qualifications for fitters and other licensed practitioners, as well as 
dispensers more generally, vary widely. Therefore, we are proposing to 
require information for dispensers to ensure necessary warnings are 
conveyed in an adequate manner and form for every device. The proposal 
includes warnings: (1) Of possibilities for underlying pathological 
conditions, (2) against use in people younger than 18 without a medical 
evaluation, and (3) of injury potential from high output.
    We are further proposing to require the disclosure of certain 
technical specifications, which is necessary to provide fitters and 
dispensers information for the safe and effective use of the device. 
This information is material to the use of the device, as this 
information would be necessary for a hearing health professional to 
select an appropriate device. Without this information, a hearing 
health professional would be unable to determine a safe and effective 
device for the user without unnecessarily increasing the risks to 
health to the user. This provision includes a proposed requirement that 
measurement of the specifications conforms to ANSI/ASA S3.22-2014, 
``Specification of Hearing Aid Characteristics,'' to provide for 
uniformity in testing and measurement, which in turn aids hearing 
health professionals in selecting or fitting an appropriate 
prescription hearing aid.
    The proposed user labeling requirements are also intended to 
provide adequate warnings against use in certain pathological (``red 
flag'') conditions, and by children, where the use would be dangerous 
to health; as well as adequate warnings against unsafe dosage or 
methods or duration of administration or application. We propose that 
this manner and form are necessary for the protection of the users.
    Once a user obtains a prescription hearing aid, use of the device 
occurs without direct supervision of a licensed professional, and 
notably, such use is generally intended to occur over long periods each 
day, every day. Therefore, in addition to the proposed information for 
hearing health professionals summarized above, we are proposing 
warnings and information specifically for users. We intend this 
information to be more understandable for laypeople while communicating 
warnings against use in certain pathological (``red flag'') conditions, 
against use in children without a medical evaluation, and in a manner 
and form that are necessary for the protection of the users.
    For the reasons explained above, we believe that the proposed 
labeling requirements for prescription hearing aids are necessary to 
provide reasonable assurance of safety and effectiveness. This proposal 
also maximizes consistency with OTC hearing aid labeling to reduce the 
burden on manufacturers that wish to offer both categories of hearing 
aids. Although we are proposing the foregoing warnings and information 
in manner and form as are necessary for the protection of users, the 
specificity of this proposal would also encourage uniformity while 
conveying essential information appropriate for the type of hearing 
healthcare delivery. By minimizing burdens and fostering familiarity, 
the specificity and consistency would also help promote availability 
and use of prescription devices.
    To provide for clarity and efficient enforcement of the FD&C Act, 
FDA is proposing to provide explicitly that a prescription hearing aid 
that does not satisfy the labeling requirements of proposed Sec.  
801.422, if finalized, would be misbranded under sections 201(n), 
502(a), and 502(f) of the FD&C Act. Moreover, as explained, we believe 
that the labeling statements as we propose to revise them are material 
to and necessary for the safe and effective use of prescription hearing 
aids. Thus, we believe that an explicit misbranding provision in the 
prescription labeling requirements will provide for clarity as well as 
the efficient enforcement of the FD&C Act.
    If we finalize the repeal of the conditions for sale under Sec.  
801.421, we would correspondingly withdraw the guidance document 
entitled ``Conditions for Sale for Air-Conduction Hearing Aids'' 
because that guidance announces our policy regarding certain provisions 
of Sec.  801.421 and would cease to be relevant (Ref. 8).

I. Proposed Amendments to Previous Exemption Decisions (Part 808)

    A State or a political subdivision (e.g., a city) may not establish 
or continue in effect its own requirement with respect to a device for 
human use if that requirement is different from, or in addition to, a 
requirement applicable under the FD&C Act to the device (see section 
521(a) of the FD&C Act). Under section 521(b) of the FD&C Act, upon 
application of a State or political subdivision of a State, FDA may, by 
regulation, exempt from preemption a State or political subdivision 
requirement applicable to a device if: (1) The requirement is more 
stringent than a requirement under the FD&C Act that would be 
applicable to the device if an exemption were not in effect or (2) the 
requirement is required by compelling local conditions and compliance 
with the requirement would not cause the device to be in violation of 
the FD&C Act. FDA has granted some exemption requests and most, if not 
all, of FDA's decisions to grant exemption from preemption were based 
on the State or local requirement being more stringent.
    FDA's decisions on States' applications for exemption from Federal 
preemption under section 521 of the FD&C Act are codified in 
regulations under part 808, subpart C. The regulations codifying these 
decisions include both granting and denial of exemption from 
preemption. Therefore, ``exemption decisions'' as used in this document 
include both types of decisions. Most of the applications for exemption 
from Federal preemption related to State medical device requirements 
that apply to hearing aids, as they existed at the time of the 
exemption decisions, and that were different from or in addition to the 
requirements in Sec. Sec.  801.420 and/or 801.421. Because FDARA 
directs FDA to establish different requirements for some hearing aids 
that are not subject to section 521(b) of the FD&C Act, many of the 
current exemption decisions would not accurately reflect the regulatory

[[Page 58170]]

framework for hearing aids under FDARA and the FD&C Act as amended. 
Moreover, if we finalize the changes we are proposing to the existing 
requirements for hearing aids in Sec. Sec.  801.420 and 801.421, the 
previous exemption decisions based on those requirements may no longer 
apply.
1. Exemption Decisions Under Section 521(b) Are Affected by FDARA 
(Proposed Sec.  808.1(g))
    As explained in section III.G of this document, and as indicated 
above, some decisions on exemption from Federal preemption under 
section 521(b) of the FD&C Act would no longer accurately reflect the 
applicability of State requirements after the enactment of FDARA and 
upon establishing the OTC category of hearing aids. To assist 
stakeholders to understand the changes effected by FDARA, we are 
proposing to codify how FDARA limits the scope of exemption decisions 
under section 521(b) of the FD&C Act. We believe this proposal will 
provide a concise reference for stakeholders to ascertain the changes 
effected by FDARA.
    Note that we are not considering exemptions from section 709(b)(4) 
of FDARA for State or local requirements. This is because FDARA does 
not provide a parallel mechanism to exempt State or local requirements 
regarding hearing products that would restrict or interfere with 
commercial activity involving OTC hearing aids. We refer to preemption 
under section 709(b)(4) simply to clarify how FDARA affects State and 
local requirements.
2. Removal of Regulations Codifying Exemption Decisions Affected by 
Amendments to Sec.  801.420 and Repeal of Sec.  801.421 if Finalized
    As explained above, FDA's exemption decisions are codified in 
regulations under part 808, subpart C. These decisions were issued in 
the 1980s and apply to the specific State provisions identified in the 
regulations and the specific Federal requirements in effect at the 
time. As mentioned above, most of the exemption decisions related to 
State medical device requirements that apply to hearing aids and that 
were different from or in addition to the requirements in Sec. Sec.  
801.420 and/or 801.421. We are proposing to remove all of the 
regulations in part 808 related to hearing aids; that is, almost all 
regulations codifying the previous decisions in Sec. Sec.  808.53 
through 808.101, except for the portions of Sec.  808.55 (California) 
that do not relate solely to hearing aids. We are proposing this 
because the exemption decisions codified in those regulations may no 
longer apply due to changes to the Federal hearing aid requirements as 
proposed in this rulemaking and changes to the specific State 
provisions we have identified in those regulations since the decisions 
were made over 30 years ago.
    In particular, the repeal of the conditions for sale would 
eliminate specific Federal requirements that preempt certain State or 
local requirements. As such, whether we previously granted or denied 
exemptions, the exemption decisions would no longer apply because the 
State or local requirements that differed from, or were in addition to, 
Sec.  801.421 would no longer be preempted. Therefore, we are proposing 
to remove the State-specific regulations in part 808 codifying 
exemption decisions pertaining to the conditions for sale for hearing 
aids because those decisions would no longer be applicable if the 
conditions for sale are repealed.
    Also, the proposed amendments to the hearing aid labeling 
requirements may affect the exemption decisions relating to Sec.  
801.420. Although the proposed Sec.  801.422 is similar to Sec.  
801.420 in that it too would address labeling for hearing aids, the 
labeling requirements are not identical to those in Sec.  801.420 and 
include substantive changes. Moreover, FDA is aware that several States 
have modified their requirements that were the subject of the exemption 
decisions since they applied for exemptions, in which case the 
exemption decision may no longer be applicable. Thus, not only will the 
Federal requirements change, but the State requirements that were the 
subject of the exemption decisions may have changed too since the 
decisions were made.
    Given that the exemption decisions were based on specific Federal 
requirements and specific State requirements that existed at the time 
of the decision, changes in either may affect those decisions such that 
they are no longer applicable. Because the exemption decisions relating 
to hearing aid labeling requirements may no longer be applicable, we 
are proposing to remove the regulations codifying these decisions. We 
specifically seek comments from the States regarding the proposed 
removal of the regulations in part 808, subpart C, codifying these 
exemption decisions. For example, if a State disagrees with the 
proposed removal of the regulation(s) in part 808, subpart C, because 
the State believes the exemption decision still applies, a statement 
and explanation why in the comments may be helpful.
    We note that when Sec.  801.422 is finalized and in effect, no 
State or political subdivision of a State may establish or continue in 
effect with respect to prescription hearing aids, any requirement which 
is different from, or in addition to, any requirement in Sec.  801.422 
(see section 521(a) of the FD&C Act). However, a State or political 
subdivision thereof may apply for an exemption from preemption by 
following the process in part 808 for any requirement that is preempted 
by Sec.  801.422 (see also section 521(b) of the FD&C Act).

J. Other Proposed Amendments

    FDA is proposing several amendments to provide for consistency, 
including with the proposals in this rulemaking, if finalized, and to 
improve clarity. We are proposing the following:
     To realign the hearing aid classification regulations by 
sound conduction mode so that legacy air-conduction hearing aids, 
wireless air-conduction hearing aids, and self-fitting air-conduction 
hearing aids would be under one classification regulation; bone-
conduction hearing aids would be under a separate classification 
regulation.
     To clarify that air-conduction hearing aids are subject to 
Sec.  800.30 or Sec.  801.422, as applicable, and bone-conduction 
hearing aids are subject to Sec.  801.422.
     To revise the special control currently in Sec.  
874.3305(b)(1) for consistency with the special control currently in 
Sec.  874.3325(b)(3). Although the proposed revision to Sec.  
874.3305(b)(1) would require demonstration of electrical safety and 
thermal safety, we believe that generally manufacturers of wireless 
air-conduction hearing aids regulated under Sec.  874.3305 have been 
evaluating these safety aspects for their devices and therefore, this 
proposed revision would have little to no impact on these 
manufacturers.
     To revise the special controls for wireless hearing aids 
currently in Sec.  874.3305(b) and for self-fitting hearing aids 
currently in Sec.  874.3325(b) to eliminate redundancy, for example, 
removing special controls that would be addressed by the proposed 
labeling requirements for both OTC and prescription hearing aids.
     To revise Sec. Sec.  874.3315 and 874.3950 to clarify that 
these devices are subject to the prescription hearing aid labeling 
requirements, including in proposed Sec.  801.422.
     To clarify that a tympanic membrane contact hearing aid 
under Sec.  874.3315 is a wearable device for

[[Page 58171]]

purposes of prescription hearing aid labeling.
    We are also proposing non-substantive modifications to the 
decisions regarding exemption from Federal preemption in part 808 to 
assist stakeholders to understand the subject matter of the individual 
exemption decisions.
1. Realignment of Hearing Aid Classification Regulations by Sound 
Conduction Mode
    To increase clarity and to reduce administrative burdens associated 
with interpreting regulations, we are proposing to separate the 
classification regulations for bone-conduction and air-conduction 
hearing aids. We believe this will increase clarity because air-
conduction devices are technologically more similar to each other than 
they are to bone-conduction devices. In addition, section 
520(q)(1)(A)(i) defines an OTC hearing aid as a device that, among 
other criteria, uses the same fundamental scientific technology as air-
conduction hearing aids that are wearable devices. Therefore, bone-
conduction hearing aids do not fall within the scope of the OTC hearing 
aid definition and moving them to a separate classification regulation 
(proposed Sec.  874.3301) will help make that clear. Tympanic membrane 
contact hearing aids also do not fall within the scope of the OTC 
hearing aid definition because, among other reasons, they do not use 
the same fundamental scientific technology as air-conduction hearing 
aids, and as specified in Sec.  874.3315, they will continue to be 
regulated as prescription devices.
    The proposed realignment of the air-conduction hearing aid types 
would also locate all OTC hearing aids within the same classification 
regulation; however, not all air-conduction hearing aids would be OTC 
hearing aids. For example, high-output air-conduction devices would be 
prescription. Further, transcutaneous air conduction hearing aid 
systems entail surgical implantation of a tube to conduct sound, so we 
do not consider them suitable for OTC availability; the devices will 
continue to be regulated under Sec.  874.3950. The realignment will not 
affect any device that does not use the same fundamental scientific 
technology, such as cochlear implants (product code MCM) or implantable 
middle ear hearing devices (product code MPV).
    In realigning the regulations by sound conduction mode, we are not 
proposing to reclassify any device or change the exemption status under 
section 510(m)(2) of the FD&C Act for premarket notification for any 
device type (see 21 U.S.C. 360(m)(2)). For example, wireless air-
conduction hearing aids regulated under Sec.  874.3305 would continue 
to be class II exempt, subject to the limitations of exemption in Sec.  
874.9, and special controls would continue to apply to these devices in 
addition to the general controls. (The proposed general controls under 
Sec.  800.30 or Sec.  801.422, if finalized, would also apply.) As of 
the effective date of the final rule, we would realign current product 
codes to correspond with the revised regulation numbers for consistency 
but would not otherwise change the codes. Also, we would change the 
name of each classification regulation to reflect the sound conduction 
mode.
    Note that the regulation for air-conduction hearing aids would 
embody a split classification, where different devices under the 
regulation would have different classifications and special controls 
depending on the technology and design. As discussed above, we would 
also amend the wireless hearing aid special controls to provide for 
consistency with the special controls for self-fitting hearing aids, 
and we would amend the special controls for wireless hearing aids and 
self-fitting hearing aids to eliminate redundancy.
2. Non-Substantive Revisions to Exemption Decisions for Clarity and 
Ease of Use
    In addition to the amendments in part 808 explained in section 
III.I., we are proposing to amend the remaining State-specific 
regulation in part 808 to include paragraph headings that would appear 
in italics. Currently, the regulations do not include paragraph 
headings and, as such, require stakeholders to look elsewhere to 
understand the content of the State or local requirements as they were 
at the time FDA made an exemption decision. The paragraph headings will 
assist stakeholders by briefly describing the subject of the individual 
exemption decisions, thereby providing additional information and 
context for stakeholders.

IV. Findings Regarding Premarket Notification

    FDA may, in appropriate circumstances, exempt a class II device 
from premarket notification requirements under section 510(m)(2) of the 
FD&C Act. Section 709(b)(3) of FDARA directs FDA to make such findings, 
that is, to determine whether OTC hearing aids require a report under 
section 510(k) to provide reasonable assurance of safety and 
effectiveness. As described in section I.B, legacy and wireless air-
conduction hearing aids are exempt from section 510(k) subject to the 
limitations of exemption, and we are not proposing to alter the 
exemption status of such devices.
    Self-fitting air-conduction hearing aids are not currently exempt. 
FDA classified this device type in October 2019 (see 84 FR 57610), and 
the Agency does not have sufficient information or experience with this 
device type to exempt these devices from premarket notification. 
Accordingly, FDA has determined that, at this time, reports under 
section 510(k) continue to be necessary to provide reasonable assurance 
of safety and effectiveness. We therefore do not propose to exempt them 
at this time.

V. Proposed Effective and Compliance Dates

A. Effective Date

    FDA proposes that this rule, if finalized, be effective 60 days 
after the publication of the final rule in the Federal Register. We 
propose the following compliance dates:

B. Compliance Date for Hearing Aids Not Legally Offered for Sale Prior 
to the Effective Date

    For hearing aids that have not been offered for sale prior to the 
effective date of the final rule, or have been offered for sale but are 
required to submit a new 510(k) under 21 CFR 807.81(a)(3), compliance 
with the new or revised requirements applicable to the hearing aid, and 
obtaining 510(k) clearance if applicable, must be achieved before 
marketing the device on or after the effective date of the final rule. 
If a person (e.g., manufacturer) markets such a device without 
complying with the new or revised requirements or if applicable, 
receiving 510(k) clearance, then FDA would consider taking action 
against such person under our usual enforcement policies.

C. Compliance Date for Hearing Aids Legally Offered for Sale Prior to 
the Effective Date

    For hearing aids that have been legally offered for sale prior to 
the effective date of the final rule, including those that already have 
a 510(k) clearance, compliance with the new or revised requirements 
that apply to the hearing aid must be achieved 180 days after the 
effective date of the final rule (i.e., 240 days after the publication 
of the final rule). After that date, if a person (e.g., manufacturer) 
continues to market such a device but does not comply with the new or 
revised requirements that apply to the device, then FDA would consider 
taking action

[[Page 58172]]

against such person under our usual enforcement policies.
    At present, legacy and wireless air-conduction hearing aids are 
exempt from section 510(k) of the FD&C Act, subject to the limitations 
of exemption described in Sec.  874.9. (Legacy hearing aids are class I 
devices and are 510(k) exempt under section 510(l)(1) of the FD&C Act.) 
However, self-fitting air-conduction hearing aids are not exempt and, 
therefore, are subject to premarket notification requirements. We 
believe that modifications to hearing aids, including labeling changes, 
to comply with the proposed OTC Hearing Aid Controls may exceed the 
limitations of exemption, for example because the device was formerly 
intended for use by healthcare professionals only. We believe that 
labeling changes for such hearing aids to comply with the proposed 
prescription hearing aid labeling requirements are less likely to 
exceed the limitations of exemption.

VI. Preliminary Economic Analysis of Impacts

    We have examined the impacts of the proposed rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct us to assess all costs 
and benefits of available regulatory alternatives and, when regulation 
is necessary, to select regulatory approaches that maximize net 
benefits (including potential economic, environmental, public health 
and safety, and other advantages; distributive impacts; and equity). 
Based on our preliminary analysis, OMB's Office of Information and 
Regulatory Affairs has determined that this proposed rule is an 
economically significant regulatory action as defined by Executive 
Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. We believe we can certify that the proposed rule will not 
have a significant economic impact on a substantial number of small 
entities. The estimated annualized cost over 10 years is $0.009 million 
per firm, which is unlikely to represent more than 3 percent to 5 
percent of the revenue of an affected manufacturer. However, we note 
that some uncertainty exists as to these impacts, so we have chosen to 
draft an initial regulatory flexibility analysis. We request comments 
relating to the effect of this proposed rule on small manufacturers.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires 
us to prepare a written statement, which includes an assessment of 
anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $158 million, using the most current (2020) Implicit 
Price Deflator for the Gross Domestic Product. This proposed rule would 
not result in an expenditure in any year that meets or exceeds this 
amount.
    The proposed rule, if finalized, would define a new regulatory 
category for OTC hearing aids and make corresponding changes to the 
existing regulatory framework, including defining hearing aids not 
meeting the proposed OTC requirements as prescription medical devices, 
as well as providing new labeling requirements for both OTC and 
prescription hearing aids. This proposed rule, if finalized, would 
generate potential cost savings for consumers with perceived mild to 
moderate hearing loss who wish to buy lower cost hearing aids not 
bundled with professional services and not requiring professional 
advice, fitting, adjustment, or maintenance but who are currently 
unable to buy such products online because of State regulations or 
because they do not shop online. The proposed rule, if finalized, would 
also generate costs for hearing aid manufacturers for changing labeling 
of existing hearing aids as well as for reading the rule and revising 
internal standard operating procedures in response to the rule. Table 3 
summarizes our estimate of the annualized costs and the annualized 
benefits of the proposed rule, if finalized.

                                     Table 3--Summary of Benefits, Costs and Distributional Effects of Proposed Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                         Units
                                                                                   ------------------------------------------------
             Category                   Primary      Low estimate    High estimate                                      Period              Notes
                                       estimate                                      Year dollars    Discount rate      covered
                                                                                                          (%)           (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized Monetized $millions/            $63              $6            $147            2020               7              10
     year.                                      63               6             147            2020               3              10
    Annualized Quantified.........  ..............  ..............  ..............  ..............               7
                                                                                                                 3
                                   ---------------------------------------------------------------------------------------------------------------------
    Qualitative...................  Potential increase in hearing aid and hearing
                                    technology use, leading to associated health
                                    benefits, potential fostering of innovation in
                                    hearing aid technology.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs:
    Annualized Monetized $millions/              1               1               2            2020               7              10
     year.                                       1               1               2            2020               3              10
    Annualized Quantified.........  ..............  ..............  ..............  ..............               7
                                                                                                                 3
                                   ---------------------------------------------------------------------------------------------------------------------
    Qualitative...................  Potential loss of consumer utility from
                                    inability to buy existing hearing aids under
                                    existing conditions
--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers:
    Federal Annualized Monetized    ..............  ..............  ..............  ..............               7
     $millions/year.                                                                                             3
                                   ---------------------------------------------------------------------------------------------------------------------
    From/To.......................  From:
                                    To:                                             ..............
                                   ---------------------------------------------------------------------------------------------------------------------

[[Page 58173]]

 
    Other Annualized Monetized      ..............  ..............  ..............  ..............               7
     $millions/year.                                                                                             3
                                   ---------------------------------------------------------------------------------------------------------------------
    From/To.......................  From:
                                    To:                                             ..............
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
    State, Local or Tribal Government:..................................................................................................................
    Small Business:.....................................................................................................................................
    Wages:..............................................................................................................................................
    Growth:.............................................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------

    We have developed a comprehensive Preliminary Economic Analysis of 
Impacts that assesses the impacts of the proposed rule. The full 
analysis of economic impacts is available in the docket for this 
proposed rule (Ref. 23) and at https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.

VII. Analysis of Environmental Impact

    FDA has carefully considered the potential environmental impact of 
this proposed rule and of possible alternative actions. In doing so, 
the Agency focused on the environmental impacts of its action as a 
result of increased use and eventual disposal of OTC hearing aids that 
will need to be handled if the proposed rule is finalized.
    The environmental assessment (EA) considers environmental impacts 
related to additional waste to landfills at municipal solid waste (MSW) 
facilities. The proposed action would increase the availability and use 
of hearing aid devices, which would result in additional waste from 
increased disposal of these devices and their associated batteries and 
an increase in industrial waste associated with any domestic production 
to meet market demand for the new devices. Overall, given the current 
limited use of these devices, projected slow growth with increase in 
availability, and the small mass of waste material to be disposed or 
recycled, the proposed action is not expected to have a significant 
impact on MSW, landfill facilities, and the environment.
    The Agency has concluded that the proposed rule will not have a 
significant impact on the human environment, and that an environmental 
impact statement is not required. FDA's finding of no significant 
impact (FONSI) and the evidence supporting that finding, contained in 
an EA prepared under 21 CFR 25.40, are on display with the Dockets 
Management Staff (see ADDRESSES) and are available for viewing by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday; 
they are also available electronically at https://www.regulations.gov. 
FDA invites comments and submission of data concerning the EA and 
FONSI.

VIII. Paperwork Reduction Act of 1995

    This proposed rule contains information collection provisions that 
are subject to review by OMB under the PRA (44 U.S.C. 3501-3521). A 
description of these provisions is given in the Description section of 
this document with an estimate of the annual recordkeeping and third-
party disclosure burden. Included in the estimate is the time for 
reviewing instructions, searching existing data sources, gathering, and 
maintaining the data needed, and completing and reviewing each 
collection of information.
    FDA invites comments on these topics: (1) Whether the proposed 
collection of information is necessary for the proper performance of 
FDA's functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.
    Title: Medical Device Labeling Regulations; OMB Control Number 
0910-0485--Revision.
    Description: FDA is proposing to establish a regulatory category 
and related rules for OTC hearing aids to improve access to hearing aid 
technology for Americans. FDARA amended the FD&C Act by placing the 
authorities to establish the OTC category of hearing aids among 
provisions that are, by definition, general controls, which is what 
these rules would be. Alongside the OTC category, we are proposing 
multiple related changes to the overall regulatory framework for 
hearing aids to harmonize existing rules with the eventual OTC category 
while continuing to provide a reasonable assurance of safety and 
effectiveness. We believe the proposals set forth in this rulemaking 
will promote the hearing health of Americans by lowering barriers to 
access and fostering innovation in hearing aid technology. The set of 
general controls we are proposing, Over-the-Counter Hearing Aid 
Controls, would apply to all hearing aids that meet the definition of 
an OTC hearing aid under the FD&C Act, regardless of the device's 
class. Among other provisions, the controls would include requirements 
for labeling and device design, as well as a condition for sale to 
prevent the sale and use of the devices by people younger than age 18. 
We are also proposing to remove the labeling requirements in the 
existing restrictions but establish a new regulation for labeling 
specific to prescription hearing aids. The new prescription labeling 
requirements would be similar to the current labeling requirements but 
maintain consistency with the new labeling requirements for OTC hearing 
aids (for example, so that ``red flag'' conditions, as revised, will be 
the same). We are proposing to repeal the other existing restrictions, 
i.e., the conditions of sale, because, if this rule is finalized as 
proposed, the new labeling requirements for prescription hearing aids, 
the requirement for a prescription, and other existing requirements 
would provide reasonable assurance of safety and effectiveness.
    Description of Respondents: Respondents to the information 
collection are manufacturers of hearing aids.

[[Page 58174]]

    We estimate the burden of the collection of information as follows:

                                                       Table 4--Estimated One-Time Burden \1\ \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                             Number of                    Average burden
                        Activity                             Number of      records per    Total annual         per         Total hours    Total capital
                                                           recordkeepers   recordkeeper       records      recordkeeping                       costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Understanding and implementing new regulatory                        105               1             105             284          29,820      $4,100,000
 requirements from hearing aids rule....................
Hearing aids relabeling; one-time burden................             105               8             840              68          57,120       6,000,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs associated with this collection of information.
\2\ Numbers have been rounded to the nearest whole number.


                                                 Table 5--Estimated Annual Recordkeeping Burden \1\ \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of                       Average burden
                      Activity; 21 CFR section                          Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
Proposed labeling disclosures under 800.30(c)(2) and 801.422(c)(2);             105                8              840                1              840
 Hearing aids; electronic version of user instructional brochure...
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Numbers have been rounded to the nearest whole number.


                         Table 6--Estimated Annual Third-Party Disclosure Burden \1\ \2\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
    Activity; 21 CFR Section         Number of      disclosures    Total annual   Average burden    Total hours
                                    respondents   per respondent    disclosures   per disclosure
----------------------------------------------------------------------------------------------------------------
OTC Hearing Aid Controls--800.30             105               7             735              19          13,965
Prescription Hearing Aid                     105               1             105              19           1,995
 Labeling--801.422..............
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          15,960
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Numbers have been rounded to the nearest whole number.

    Our burden estimate is based on FDA Uniform Registration and 
Listing System data; FDA's Operational and Administrative System for 
Import Support data; informal communications with industry; and our 
knowledge of and experience with information collection pertaining to 
medical device labeling. We intend the burden estimates to be 
consistent with our Preliminary Regulatory Impact Analysis (PRIA) for 
this rulemaking (Ref. 23).
    Estimated One-Time Burden: OTC Hearing Aids proposed rule--one-time 
burden (Recordkeeping): As noted in the PRIA for this proposed rule, we 
estimate it will take 3 hours each for an executive, a lawyer, and a 
marketing manager to read and understand the rule. Also included in our 
estimate is time for revising guidelines or standard operating 
procedures. We assume this may take up to 25 hours for one executive, 
up to 100 hours for one marketing manager, and up to 150 hours for one 
technical writer. Therefore, we estimate a one-time recordkeeping 
burden of 284 hours for each manufacturer.
    OTC Hearing Aids proposed rule--one-time relabeling burden (Third-
Party Disclosure):
    The proposed rule would necessitate the relabeling of all current 
hearing aids (approximately 840). The labeling cost model used in the 
PRIA suggests, based on a compliance period of 6 months, a one-time 
estimated third-party disclosure burden for relabeling of about 68 
hours per product.
    We request comments on these estimates.
    Estimated Annual Burden: Over-the-Counter Hearing Aid Controls--
Sec.  800.30 (Recordkeeping and Third-Party Disclosure): Proposed Sec.  
800.30 sets forth labeling requirements for OTC hearing aids. Proposed 
Sec.  800.30(c)(1) describes the warnings and other important 
information that the outside package must bear. Additionally, 
manufacturers must include on the outside package label a weblink to 
all labeling and any additional resources, their return policy or lack 
thereof, and, if the OTC hearing aid is used or rebuilt, they must 
declare that fact.
    Proposed Sec.  800.30(c)(2) describes device-specific requirements 
for labeling, inside the package. Among the labeling requirements 
listed are a user instructional brochure, an electronic version of 
which is to be made available for download; additional warnings; 
caution and notices for users; other specified information; and any 
other information necessary for adequate directions for use as defined 
in Sec.  801.5. Also required under proposed Sec.  800.30(c)(2) is the 
identification of any known physiological side effects associated with 
the use of the OTC hearing aid that may warrant consultation with a 
physician; the technical specifications required by Sec.  800.30(c)(4); 
a description of commonly occurring, avoidable events that could 
adversely affect or damage the OTC hearing aid; if applicable, 
information regarding repair service; and, if applicable, a summary of 
all clinical or non-clinical studies

[[Page 58175]]

conducted to support the performance of the OTC hearing aid.
    Proposed Sec.  800.30(c)(3) provides requirements for the labeling 
on an OTC hearing aid itself, specifically, name of the manufacturer, 
model name or number, serial number, and year of manufacture and if 
applicable, information regarding the battery. Also, if the OTC hearing 
aid is used or rebuilt, the manufacturer must physically attach a 
removable tag to the hearing aid declaring that fact.
    We include no estimate for provisions under proposed Sec.  
800.30(c)(1)(i)(A) through (D), (c)(2)(i)(A) and (B), and 
(c)(2)(iii)(A) through (D) because we consider the labeling to be 
``public disclosure of information originally supplied by the Federal 
government to the recipient for the purpose of disclosure to the 
public,'' consistent with 5 CFR 1320.3(c)(2). Thus, those labeling 
provisions are not within the definition of collection of information.
    The PRIA for this proposed rule estimates that 105 firms 
manufacture air-conduction hearing aids sold in the United States, 
based on FDA Medical Device Registration data. We estimate that each 
manufacturer has an average of eight products that would need 
relabeling.
    For each hearing aid product, we assume a 1-hour annual 
recordkeeping burden for maintaining the electronic version of the user 
instructional brochure (under proposed Sec. Sec.  800.30(c)(2) and 
801.422(c)(2)).
    The proposed rule would necessitate the relabeling of all current 
hearing aids (approximately 840) according to either the proposed OTC 
or prescription hearing aid labeling requirements. While we lack 
specific data regarding what portion of hearing aids will be relabeled 
as prescription devices and what portion will be relabeled as OTC 
hearing aids, for this analysis, we assume that 10 percent will be 
relabeled as prescription medical devices (about 1 product per 
manufacturer) and 90 percent as OTC hearing aids (about 7 products per 
manufacturer). The labeling cost model used in the PRIA suggests an 
annual estimated third-party disclosure burden of about 19 hours per 
product.
    We request comments on these estimates and assumptions.
    Prescription Hearing Aid Labeling--Sec.  801.422 (Third-Party 
Disclosure):
    Proposed Sec.  801.422(c) sets forth labeling requirements for 
prescription hearing aids. However, as with some of the provisions 
under proposed Sec.  800.30(c), we include no estimate for provisions 
under proposed Sec.  801.422(c)(1)(i)(A) and (B), (c)(2)(i)(A) through 
(C), and (c)(2)(ii)(A) through (E) because we consider the labeling to 
be ``public disclosure of information originally supplied by the 
Federal government to the recipient for the purpose of disclosure to 
the public,'' consistent with 5 CFR 1320.3(c)(2).
    Proposed Sec.  801.422(c)(1) provides the warnings that must be on 
the outside package labeling and, if applicable, that the prescription 
hearing aid is used or rebuilt.
    Proposed Sec.  801.422(c)(2) describes requirements for 
prescription hearing aid labeling, inside the package. Among the 
labeling requirements listed are a user instructional brochure, an 
electronic version of which is to be made available for download; 
additional warnings; caution and notices for users; and additional 
information that must be included in the user instructional brochure.
    Proposed Sec.  801.422(c)(3) provides the requirements for the 
labeling on a prescription hearing aid itself, specifically, name of 
the manufacturer, model name or number, serial number, and year of 
manufacture; as well as information regarding the battery if 
applicable; and if the prescription hearing aid is used or rebuilt, the 
manufacturer must physically attach a removable tag to the hearing aid 
declaring that fact.
    Proposed Sec.  800.422(c)(4) provides the technical specification 
elements that must appear in the user instructional brochure or in 
separate labeling that accompanies the device.
    The PRIA estimates that 105 firms manufacture air conduction 
hearing aids sold in the United States, based on FDA Medical Device 
Registration data. We estimate that each manufacturer has an average of 
eight products that would need relabeling.
    For each hearing aid product, we assume a 1-hour annual 
recordkeeping burden for maintaining the electronic version of the user 
instructional brochure (under proposed Sec. Sec.  800.30(c)(2) and 
801.422(c)(2)).
    The proposed rule would necessitate the relabeling of all current 
hearing aids (approximately 840) according to either the proposed OTC 
or prescription hearing aid labeling requirements. While we lack 
specific data regarding what portion of hearing aids will be relabeled 
as prescription devices and what portion will be relabeled as OTC 
hearing aids, for this analysis, we assume that 10 percent will be 
relabeled as prescription medical devices (about 1 product per 
manufacturer) and 90 percent as OTC hearing aids (about 7 products per 
manufacturer). The labeling cost model used in the PRIA suggests an 
annual estimated third-party disclosure burden of about 19 hours per 
product.
    We request comments on these estimates and assumptions.
    To ensure that comments on information collection are received, OMB 
recommends that written comments be submitted through https://www.reginfo.gov/public/do/PRAMain (see ADDRESSES). All comments should 
be identified with the title of the information collection.
    In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 
3407(d)), the Agency has submitted the information collection 
provisions of this proposed rule to OMB for review. These information 
collection requirements will not be effective until FDA publishes a 
final rule, OMB approves the information collection requirements, and 
the rule goes into effect. FDA will announce OMB approval of these 
requirements in the Federal Register.

IX. Federalism

    FDA has analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. Section 4(a) of the 
Executive Order requires Agencies to ``construe . . . a Federal statute 
to preempt State law only where the statute contains an express 
preemption provision or where there is some other clear evidence that 
the Congress intended preemption of State law, or where the exercise of 
State authority conflicts with the exercise of Federal authority under 
the Federal statute.'' Federal law includes an express preemption 
provision that preempts certain state requirements ``different from, or 
in addition to, any requirement applicable under'' chapter V of the 
FD&C Act that is applicable to devices. (See section 521 of the FD&C 
Act; Medtronic v. Lohr, 518 U.S. 470 (1996); and Riegel v. Medtronic, 
552 U.S. 312 (2008)). Federal law also preempts State or local laws 
``specifically related to hearing products that would restrict or 
interfere with the servicing, marketing, sale, dispensing, use, 
customer support, or distribution of [OTC hearing aids] through in-
person transactions, by mail, or online, that [are] different from, in 
addition to, or otherwise not identical to, the regulations promulgated 
under'' section 709(b) of FDARA (see section 709(b)(4) of FDARA).
    Section 521(b) of the FD&C Act provides that the Commissioner of 
Food and Drugs may, upon application of a State or local government, 
exempt a requirement from preemption, if the State or local requirement 
for the device is more stringent than the requirement

[[Page 58176]]

under the FD&C Act, or if the requirement is necessitated by compelling 
local conditions and compliance with it would not cause the device to 
be in violation of a requirement under the FD&C Act.'' Following this 
process, and if this rule becomes final, a State or local government 
may request an exemption from preemption for those State or local 
requirements pertaining to hearing aid products that are preempted by 
the Agency's final rule under section 521 of the FD&C Act. However, 
because FDARA does not provide a parallel mechanism to exempt State or 
local requirements from its express preemption provision, FDA is not 
considering exemptions under section 709(b)(4) of FDARA for OTC hearing 
aids.
    Thus, if this proposed rule is made final, the final rule would 
create requirements that fall within the scope of section 521 of the 
FD&C Act and/or section 709(b)(4) of FDARA. If made final, it would 
also amend Sec.  801.420 and repeal Sec.  801.421, and such changes 
would affect many of the decisions on applications for exemption from 
preemption that were issued in relation to these two regulations under 
section 521(b) of the FD&C Act, resulting in the removal of the 
regulations codifying such decisions, as discussed further in section 
III.I. above. The scope of preemption of this proposed rule, if 
finalized, is discussed in more detail in sections III.G through I, 
above.

X. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13175. We have tentatively 
determined that the rule does not contain policies that would have a 
substantial direct effect on one or more Indian Tribes, on the 
relationship between the Federal Government and Indian Tribes, or on 
the distribution of power and responsibilities between the Federal 
Government and Indian Tribes. The Agency solicits comments from tribal 
officials on any potential impact on Indian Tribes from this proposed 
action.

XI. References

    The following references marked with an asterisk (*) are on display 
at the Dockets Management Staff (see ADDRESSES) and are available for 
viewing by interested persons between 9 a.m. and 4 p.m., Monday through 
Friday; they are also available electronically at https://www.regulations.gov. References without asterisks are not on public 
display at https://www.regulations.gov because they have copyright 
restriction. Some may be available at the website address, if listed. 
References without asterisks are available for viewing only with the 
Dockets Management Staff. FDA has verified the website addresses, as of 
the date this document publishes in the Federal Register, but websites 
are subject to change over time.

1. Lin, F., J. Niparko, and L. Ferruci, ``Hearing Loss Prevalence in 
the United States.'' Archive of Internal Medicine, 171:1851-1853, 
2011.
2. Dalton, D.S., ``The Impact of Hearing Loss on Quality of Life in 
Older Adults.'' The Gerontologist, 43(5):661-668, 2005.
*3. NIH. Hearing Aids Fact Sheet. National Institute on Deafness and 
Communication Disorders. 2010. Available at: https://www.nidcd.nih.gov/health/statistics/quick-statistics-hearing.
3a. Maharani, A., Dawes, P., et al., ``Longitudinal Relationship 
Between Hearing Aid Use and Cognitive Function in Older Americans.'' 
Journal of the American Geriatrics Society, 66(6):1130-1136, 2018.
3b. Mahmoudi, E., Basu, T., et al., ``Can Hearing Aids Delay Time to 
Diagnosis of Dementia, Depression, or Falls in Older Americans?'' 
Journal of the American Geriatrics Society, 67(11):2362-2369, 2019.
4. McCormack, A. and H. Fortnum, ``Why Do People Fitted With Hearing 
Aids Not Wear Them?'' International Journal of Audiology, 52(5):360-
368, 2013.
*5. Gudmundsen, G., Citizen Petition, FDA-2003-P-0342. Received 
August 11, 2003.
6. NASEM, ``Hearing Health Care for Adults: Priorities for Improving 
Access and Affordability.'' Board on Health Sciences Policy, 
Committee on Accessible and Affordable Hearing Health Care for 
Adults; Blazer, D.G., S. Domnitz, and C.T. Liverman, Eds., 2016. 
DOI: 10.17226/23446. Available at: https://www.nap.edu/catalog/23446/hearing-health-care-for-adults-priorities-for-improving-access-and.
*7. Executive Office of the President. ``Aging America & Hearing 
Loss: Imperative of Improved Hearing Technologies.'' PCAST. 2015. 
Available at: https://obamawhitehouse.archives.gov/sites/default/files/microsites/ostp/PCAST/pcast_hearing_tech_letterreport_final.pdf.
*8. FDA, ``Immediately in Effect Guidance Document: Conditions for 
Sale for Air-Conduction Hearing Aids.'' Guidance for Industry and 
Food and Drug Administration Staff. December 12, 2016. Available at: 
https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm531995.pdf.
*9. FDA, ``Streamlining Good Manufacturing Practices (GMPs) for 
Hearing Aids,'' public workshop. Silver Spring, MD; April 21, 2016. 
Available at: https://wayback.archive-it.org/7993/20171114234227/https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm480336.htm.
*10. Wallhagen, M., ``HLAA Response to Call for Comment.'' For 
Streamlining Good Manufacturing Practices (GMPs) for Hearing Aids. 
Silver Spring, MD; April 21, 2016. Available at: https://wayback.archive-it.org/7993/20171115155122/https://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM497333.pdf.
11. NASEM, ``Over-The-Counter Hearing Devices Discussion: Safety and 
Quality Requirements and Considerations Session.'' MP3, 1:15:39 
(English). National Academies' Hearing Health Care Report: June 2017 
Dissemination Meeting; Washington, DC, 2017.
*12. Lintz, J.S., ``FDA Testimony.'' For Streamlining Good 
Manufacturing Practices (GMPs) for Hearing Aids. Silver Spring, MD; 
April 21, 2016. Available at: https://wayback.archive-it.org/7993/20171114234227/https://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM500626.pdf.
13. ANSI/CTA 2051: Personal Sound Amplification Performance Criteria 
(voluntary consensus standard). 2017. Available at: https://webstore.ansi.org/standards/ansi/cta20512017ansi.
*14. NIOSH, Occupational Noise Exposure, publication number 98-126. 
June 1998. Available at: https://www.cdc.gov/niosh/docs/98-126/pdfs/98-126.pdf.
*15. Killion, M.C., ``Presentation on the Work of the CTA PSAP 
Standard Committee.'' For Streamlining Good Manufacturing Practices 
(GMPs) for Hearing Aids. Silver Spring, MD; April 21, 2016. 
Available at: https://wayback.archive-it.org/7993/20171115155142/https://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM497364.pdf.
*16. Laureyns, M., ``The Potential Risk of Using PSAPs.'' For 
Streamlining Good Manufacturing Practices (GMPs) for Hearing Aids. 
Silver Spring, MD; April 21, 2016. Available at: https://wayback.archive-it.org/7993/20171115155108/https:/www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM497406.pdf.
17. Dillon, H., Hearing Aids. 2nd ed. New York, NY: Thieme 
Publishers, 2012.
18. Kuk, F.K., ``Theoretical and Practical Considerations in 
Compression Hearing Aids.'' Trends in Amplification, 1(1):5-39, 
1996.
*19. Bose, ``Hearing Health and Technology Workshop,'' public 
comment, P171200 #00140, to FTC. Received May 18, 2017. Available 
at: https://www.ftc.gov/policy/public-comments/2017/05/18/comment-00140.
20. Hearing Review, ``NASEM Committee Looks at Regulations for OTC 
Hearing Devices.'' June 12, 2017. Available at: https://www.hearingreview.com/2017/06/nasem-committee-looks-regulations-otc-hearing-devices/.
21. Starkey Hearing Technologies, The Compression Handbook: An 
Overview of the Characteristics and Applications of Compression 
Amplification. 4th ed., 2017. Visit https://starkeypro.com/pdfs/The_Compression_Handbook.pdf.

[[Page 58177]]

22. Smith, C., L.A. Wilber, and K. Cavitt, ``PSAPs vs Hearing Aids: 
An Electroacoustic Analysis of Performance and Fitting 
Capabilities.'' Hearing Review, June 14, 2016, 2016. Available at: 
https://www.hearingreview.com/2016/06/psaps-vs-hearing-aids-electroacoustic-analysis-performance-fitting-capabilities/.
*23. FDA, ``Preliminary Regulatory Impact Analysis; Initial 
Regulatory Flexbility Analysis; Unfunded Mandates Reform Act 
Analysis.'' 2019. Available at: https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

List of Subjects

21 CFR Part 800

    Administrative practice and procedure, Incorporation by reference, 
Medical devices, Ophthalmic goods and services, Packaging and 
containers, Reporting and recordkeeping requirements.

21 CFR Part 801

    Incorporation by reference, Labeling, Medical devices, Reporting 
and recordkeeping requirements.

21 CFR Part 808

    Intergovernmental relations, Medical devices.

21 CFR Part 874

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act, and 
under authority delegated to the Commissioner of Food and Drugs, we 
propose that 21 CFR parts 800, 801, 808, and 874 be amended as follows:

PART 800--GENERAL

0
1. The authority citation for part 800 is revised to read as follows:

    Authority:  21 U.S.C. 321, 334, 351, 352, 355, 360e, 360i, 360j, 
360k, 361, 362, 371.
    Section 800.30 also issued under Sec. 709, Pub. L. 115-52, 131 
Stat. 1065-67.

0
2. Add Sec.  800.30 to subpart B to read as follows:


Sec.  800.30  Over-the-Counter Hearing Aid Controls.

    (a) Scope. This section specifies the requirements for over-the-
counter (OTC) air-conduction hearing aids. Air-conduction hearing aids 
that satisfy the requirements in paragraphs (c) through (f) of this 
section are considered ``available'' over the counter as section 
520(q)(1)(A)(v) of the Federal Food, Drug, and Cosmetic Act uses the 
term. Air-conduction hearing aids that do not meet the definition in 
section 520(q) of the Federal Food, Drug, and Cosmetic Act and do not 
satisfy the following requirements are prescription hearing aids. 
Unless otherwise specified, the requirements in this section are in 
addition to other applicable requirements, including but not limited to 
special controls found in the applicable classification regulation.
    (b) Definitions for the purposes of this section. This section uses 
the following definitions:
    Air-conduction hearing aid. An air-conduction hearing aid is a 
hearing aid that conducts sound to the ear through the air.
    Hearing aid. A hearing aid is any wearable device designed for, 
offered for the purpose of, or represented as aiding persons with or 
compensating for, impaired hearing.
    Licensed person. A licensed person is a person as defined in 
section 201(e) of the Federal Food, Drug, and Cosmetic Act that holds a 
license or degree for the diagnosis, assessment, or treatment of 
hearing loss; or that holds a license to sell or distribute hearing 
aids. A person that must meet generally applicable licensing or 
operating requirements such as annual health and safety inspections, 
provided the generally applicable licensing or operating requirement is 
consistent with this section and other applicable requirements under 
the Federal Food, Drug, and Cosmetic Act, is not a ``licensed person'' 
solely for that reason. A person that represents as a marketer, seller, 
dispenser, distributor, or customer support representative (or an 
equivalent description) is not a ``licensed person'' solely by making 
such representations.
    Over-the-counter hearing aid. An over-the-counter (OTC) hearing aid 
is an air-conduction hearing aid that does not require implantation or 
other surgical intervention, and is intended for use by a person age 18 
or older to compensate for perceived mild to moderate hearing 
impairment. The device, through tools, tests, or software, allows the 
user to control the hearing aid and customize it to the user's hearing 
needs. The device may use wireless technology or may include tests for 
self-assessment of hearing loss. The device is available over-the-
counter, without the supervision, prescription, or other order, 
involvement, or intervention of a licensed person, to consumers through 
in-person transactions, by mail, or online, provided that the device 
satisfies the requirements in this section.
    Prescription hearing aid. A prescription hearing aid is a hearing 
aid that is not an OTC hearing aid as defined in this section or a 
hearing aid that does not satisfy the requirements in this section.
    Sale. Sale includes a lease, rental, or any other purchase or 
exchange for value.
    Tools, tests, or software. Tools, tests, or software are components 
of the device that, individually or in combination, allow a lay user to 
control the device and customize it sufficiently, such as the device's 
output, to meet the user's hearing needs.
    Used hearing aid. A hearing aid is ``used'' if a user has worn it 
for any period of time. However, a hearing aid shall not be ``used'' 
merely because a prospective user wore it as part of a bona fide 
hearing aid evaluation to determine whether to select that particular 
hearing aid for that prospective user. A hearing aid evaluation is 
``bona fide'' if it was conducted in the presence of the dispenser or a 
hearing health professional selected by the dispenser to assist the 
prospective user in making a determination.
    (c) Labeling. An OTC hearing aid shall bear all of the following in 
the labeling.
    (1) Outside package labeling. The outside package of an OTC hearing 
aid shall bear all of the following:
    (i) Warnings and other important information. All of the following 
shall appear on the outside package:
BILLING CODE 4164-01-P

[[Page 58178]]

[GRAPHIC] [TIFF OMITTED] TP20OC21.008


[[Page 58179]]


[GRAPHIC] [TIFF OMITTED] TP20OC21.009

    (ii) Statement of build condition. If the OTC hearing aid is used 
or rebuilt, the outside package shall declare that fact. A sticker 
under and visible through the outer wrapper will suffice to declare 
such fact.
    (2) Labeling, inside the package. The manufacturer or distributor 
of an OTC hearing aid shall include a user instructional brochure 
inside the package and shall make an electronic version available for 
download without site or customer registration and without requiring 
purchase of any product or service. The user instructional brochure 
shall include all of the following:
    (i) The following warnings, which shall appear in the following 
order and prior to any content except the cover page:

[[Page 58180]]

[GRAPHIC] [TIFF OMITTED] TP20OC21.010

    (ii) Any additional warnings the manufacturer may include prior to 
the caution and notices to users in paragraph (c)(2)(iii) of this 
section.
    (iii) The following caution and notices for users, which shall 
appear prior to any content except the cover page and the warnings 
under paragraphs (c)(2)(i) and (ii) of this section:

[[Page 58181]]

[GRAPHIC] [TIFF OMITTED] TP20OC21.011


[[Page 58182]]


[GRAPHIC] [TIFF OMITTED] TP20OC21.012

    (iv) An illustration(s) of the OTC hearing aid that indicates 
operating controls, user adjustments, and the battery compartment.
    (v) Information on the function of all controls intended for user 
adjustment.
    (vi) A description of any accessory that accompanies the OTC 
hearing aid, including but not limited to wax guards and accessories 
for use with a computer, television, or telephone.
    (vii) Specific instructions for all of the following:
    (A) Instructions for sizing or inserting the eartip of the OTC 
hearing aid to prevent insertion past the bony-cartilaginous junction 
of the external auditory canal and damage to the tympanic membrane.
    (B) The tools, tests, or software that allow the user to control 
the OTC hearing aid, including self-select, self-fit, and self-check 
the performance of the OTC hearing aid, and customize it to the user's 
hearing needs, including information about properly fitting eartips.
    (C) Use of the OTC hearing aid with any accompanying accessories.
    (D) Maintenance and care of the OTC hearing aid, including the 
procedure to follow in washing the earmold, when replacing tubing on 
those hearing aids that use tubing, and in storing the hearing aid when 
it will not be used for an extended period of time.
    (E) If the battery is replaceable or rechargeable, how to replace 
or recharge the battery, including a generic designation of replacement 
batteries.
    (F) Expected battery life.
    (G) Any other information necessary for adequate directions for use 
as defined in Sec.  801.5.
    (viii) Identification of any known physiological side effects 
associated with the use of the OTC hearing aid that may warrant 
consultation with a physician, including if applicable, skin irritation 
and accelerated accumulation of cerumen (ear wax).
    (ix) The technical specifications required by paragraph (c)(4) of 
this section.
    (x) A description of commonly occurring, avoidable events that 
could adversely affect or damage the OTC hearing aid, including but not 
limited to ear wax buildup, drops, immersion in water, or exposure to 
excessive heat.
    (xi) If the hearing aid incorporates wireless technology in its 
programming or use, appropriate warnings, instructions, and information 
relating to electromagnetic compatibility and wireless technology and 
human exposure to non-ionizing radiation.
    (xii) If the manufacturer provides a repair service or licenses or 
certifies third-party repair services, information on how and where to 
obtain repair service, including at least one specific address where 
the user can go or send the OTC hearing aid to obtain such repair 
service.
    (xiii) If clinical or non-clinical studies were conducted by or for 
the manufacturer to support the performance of the OTC hearing aid, a 
summary of all such studies.
    (3) Labeling on the device. The labeling on an OTC hearing aid 
itself shall bear all of the following clearly and permanently, except 
as provided in paragraph (c)(3)(iii) of this section:
    (i) The serial number.
    (ii) If the battery is removable, a ``+'' symbol to indicate the 
positive terminal for battery insertion unless the battery's physical 
design prevents inserting the battery in the reversed position.
    (iii) If the OTC hearing aid is used or rebuilt, the manufacturer 
shall physically attach a removable tag to the hearing aid declaring 
that fact.
    (4) Technical specifications. All of the following technical 
specifications shall appear in the user instructional brochure that 
accompanies the device. You may additionally include it on the outside 
package.
    (i) The maximum output limit value (OSPL90).
    (ii) The full-on gain value, which is the gain with a 50 dB SPL 
pure-tone input and volume set to full on.
    (iii) The total harmonic distortion value.
    (iv) The self-generated noise value.
    (v) The latency value.
    (vi) The upper and lower cutoff frequencies for bandwidth.
    (d) Output limits. The output limit for an OTC hearing aid shall be 
the device maximum acoustic output sound pressure level (SPL) in a 2-
cubic centimeter (cm\3\) coupler when the device input is a 90 dB SPL 
pure-tone, and the gain/volume control is full on. An OTC hearing aid 
shall not exceed the following limits:
    (1) General output limit. An OTC hearing aid shall not exceed an 
output limit of 115 dB SPL at any frequency except as provided in 
paragraph (d)(2) of this section.
    (2) Output limit for a device with input-controlled compression and 
user-adjustable volume control. An OTC hearing aid that includes input-
controlled compression and a user-adjustable volume control shall not 
exceed an output limit of 120 dB SPL at any frequency.
    (e) Electroacoustic performance limits. An OTC hearing aid shall 
perform within all of the following electroacoustic limits. Measure 
each electroacoustic performance characteristic using a 2-cm\3\ coupler 
where applicable.
    (1) Output distortion control limits. Test the output distortion of 
the OTC hearing aid as follows to ensure that it does not exceed the 
limit specified in paragraphs (e)(1)(i) through (iii) of this section.
    (i) The total harmonic distortion plus noise shall not exceed 5 
percent for output levels within one of the following sets of levels, 
depending on the test method:

[[Page 58183]]

    (A) Using sine wave-based testing, measure at 70 dB SPL and 100 dB 
SPL; or
    (B) Using a 500-Hz one-third-octave pulsed-noise signal, measure at 
67 dB SPL and 97 dB SPL.
    (ii) You must measure the total harmonic distortion using a 500-Hz 
input tone with an analyzer that has a bandwidth at least as wide as 
the frequency limits of the OTC hearing aid.
    (iii) You must measure the output distortion at the OTC hearing 
aid's maximum volume and the input sound level to the OTC hearing aid 
adjusted to produce the required outputs.
    (2) Self-generated noise level limits. Self-generated noise shall 
not exceed 32 dB SPL. You must disable any methods that artificially 
lower the apparent noise floor for the measurement. Such methods would 
include but are not limited to auto-muting and downward expansion.
    (3) Latency. Latency shall not exceed 15 ms. You must measure the 
latency with a method that is accurate and repeatable to within 1.5 ms.
    (4) Frequency response bandwidth. The lower cutoff frequency shall 
extend to 250 Hz or below, and the upper cutoff frequency shall extend 
to 5 kHz or greater. You must measure the frequency response bandwidth 
as specified in the Method for clause 4.1 in ANSI/CTA-2051:2017.
    (5) Frequency response smoothness. No single peak in the one-third-
octave frequency response shall exceed 12 dB relative to the average 
levels of the one-third-octave bands, two-thirds octave above and below 
the peak. You must measure the frequency response smoothness using 
values for a diffuse field and the corrected one-third-octave frequency 
insertion response as specified in the Method for clause 4.1 in ANSI/
CTA-2051:2017.
    (f) Design requirements. An OTC hearing aid must conform to all of 
the following design requirements.
    (1) Insertion depth. The design of an OTC hearing aid shall limit 
the insertion of the eartip to the bony-cartilaginous junction of the 
external auditory canal and no deeper.
    (2) Use of atraumatic materials. The material for the eartip of an 
OTC hearing aid shall be atraumatic.
    (3) Proper physical fit. The OTC hearing aid shall be designed to 
enable consumers to readily achieve a safe, customized, acoustically 
favorable, and comfortable physical fit in the ear canal and/or 
external ear.
    (4) Tools, tests, or software. The OTC hearing aid shall, through 
tools, tests, or software, permit a lay user to control the device and 
customize it to the user's hearing needs.
    (g) Condition for sale of an OTC hearing aid. The sale of an OTC 
hearing aid to or for a person younger than 18 years of age is 
prohibited.
    (h) Effect on State law. Any State or local government requirement 
for an OTC hearing aid is preempted to the following extent.
    (1) Preemption. No State or local government shall establish or 
continue in effect any law, regulation, order, or other requirement 
specifically related to hearing products that would restrict or 
interfere with the servicing, marketing, sale, dispensing, use, 
customer support, or distribution of OTC hearing aids through in-person 
transactions, by mail, or online, that is different from, in addition 
to, or otherwise not identical to, the regulations issued under section 
709(b) of the FDA Reauthorization Act of 2017, including any State or 
local requirement for the supervision, prescription, or other order, 
involvement, or intervention of a licensed person for consumers to 
access OTC hearing aids.
    (2) Professional requirements.--(A) General rule. The servicing, 
marketing, sale, dispensing, customer support, or distribution of OTC 
hearing aids, or an equivalent activity, whether through in-person 
transactions, by mail, or online, shall not cause, require, or 
otherwise obligate a person providing such services to obtain 
specialized licensing, certification, or any other State or local 
sanction unless such requirement is generally applicable to the sale of 
any product or to all places of business regardless of whether they 
sell OTC hearing aids. However, although a State or local government 
may not require the order, involvement, or intervention of a licensed 
person for consumers to access OTC hearing aids, a licensed person may 
service, market, sell, dispense, provide customer support for, or 
distribute OTC hearing aids.
    (B) Sale of OTC hearing aids is not an exemption. The servicing, 
marketing, sale, dispensing, customer support, or distribution of OTC 
hearing aids does not exempt a person from any State or local 
government's professional or establishment requirements that are 
consistent with this section.
    (C) Representations may create professional obligations. A person 
shall not incur specialized obligations by representing as a servicer, 
marketer, seller, dispenser, customer support representative, or 
distributor (or an equivalent description) of OTC hearing aids. 
However, a person representing as any other defined professional or 
establishment, or as a State licensed dispenser, is subject to 
applicable State and local requirements even if the person undertakes 
commercial or professional activities only in relation to OTC hearing 
aids.
    (3) Private remedies. This section does not modify or otherwise 
affect the ability of any person to exercise a private right of action 
under any State or Federal product liability, tort, warranty, contract, 
or consumer protection law.
    (i) Incorporation by reference. (A) The standard required in this 
section is incorporated by reference into this section with the 
approval of the Director of the Federal Register under 5 U.S.C. 552(a) 
and 1 CFR part 51. All approved material is available for inspection at 
the Food and Drug Administration, Dockets Management Staff, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, and is 
available from the sources indicated below. It is also available for 
inspection at the National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, email 
[email protected] or go to https://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
    (B) ANSI. The American National Standards Institute, 1889 L Street 
NW, 11th floor, Washington, DC 20036, [email protected], https://www.ansi.org, 202-293-8020.
    (1) ANSI/CTA-2051, ``Personal Sound Amplification Performance 
Criteria,'' clause 4.1, dated January 2017.
    (2) [Reserved]
    (ii) [Reserved]

PART 801--LABELING

0
3. The authority citation for part 801 is revised to read as follows:

    Authority: 21 U.S.C. 321, 331-334, 351, 352, 360d, 360i, 360j, 
371, 374.


Sec.  801.420  [Removed]

0
4. Remove Sec.  801.420.


Sec.  801.421  [Removed]

0
5. Remove Sec.  801.421.
0
6. Add Sec.  801.422 to subpart H to read as follows:


Sec.  801.422  Prescription hearing aid labeling.

    (a) Scope. This section specifies the labeling requirements for 
prescription hearing aids. Any hearing aid that does not satisfy the 
requirements of Sec.  800.30 of this chapter shall be a prescription 
device. Unless otherwise specified, the requirements in this section 
are in addition to other applicable requirements, including but not 
limited to special controls found in the

[[Page 58184]]

applicable classification regulation. This section does not apply to 
group auditory trainers.
    (b) Definitions for the purposes of this section. This section uses 
the following definitions:
    Dispenser. A dispenser is any person, as defined in section 201(e) 
of the Federal Food, Drug, and Cosmetic Act, engaged in the sale of 
prescription hearing aids to any member of the consuming public or any 
employee, agent, salesperson, and/or representative of such a person.
    Hearing aid. A hearing aid is any wearable device designed for, 
offered for the purpose of, or represented as aiding persons with or 
compensating for, impaired hearing.
    Prescription hearing aid. A prescription hearing aid is a hearing 
aid that is not an over-the-counter (OTC) hearing aid as defined in 
Sec.  800.30 of this chapter or a hearing aid that does not satisfy the 
requirements in Sec.  800.30 of this chapter.
    Sale. Sale includes a lease, rental, or any other purchase or 
exchange for value.
    Used hearing aid. A hearing aid is ``used'' if a user has worn it 
for any period of time. However, a hearing aid shall not be ``used'' 
merely because a prospective user wore it as part of a bona fide 
hearing aid evaluation to determine whether to select that particular 
hearing aid for that prospective user. A hearing aid evaluation is 
``bona fide'' if it was conducted in the presence of the dispenser or a 
hearing health professional selected by the dispenser to assist the 
prospective user in making a determination.
    (c) Labeling. A prescription hearing aid shall bear all of the 
following labeling.
    (1) Outside package labeling. The outside package of a prescription 
hearing aid shall bear all of the following:
    (i) Warnings. All of the following shall appear on the outside 
package:
BILLING CODE 4164-01-P

[[Page 58185]]

[GRAPHIC] [TIFF OMITTED] TP20OC21.013

    (B) Statement of build condition. If the prescription hearing aid 
is used or rebuilt, the outside package shall declare that fact. A 
sticker under and visible through the outer wrapper will suffice to 
declare such fact.
    (2) Labeling, inside the package. The manufacturer or distributor 
of a prescription hearing aid shall include a user instructional 
brochure inside the package and shall make an electronic version 
available for download without site or customer registration and 
without requiring purchase of any product or service. The user 
instructional brochure shall include all of the following:
    (i) The following warnings, which shall appear in the following 
order and prior to any content except the cover page:

[[Page 58186]]

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[[Page 58187]]


[GRAPHIC] [TIFF OMITTED] TP20OC21.015


[[Page 58188]]


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BILLING CODE 4164-01-C
    (iii) An illustration(s) of the prescription hearing aid that 
indicates operating controls, user adjustments, and the battery 
compartment.

[[Page 58189]]

    (iv) Information on the function of all controls intended for user 
adjustment.
    (v) A description of any accessory that accompanies the 
prescription hearing aid, including but not limited to wax guards, and 
accessories for use with a computer, television, or telephone.
    (vi) Specific instructions for all of the following:
    (A) Use of the prescription hearing aid with any accompanying 
accessories.
    (B) Maintenance and care of the prescription hearing aid, including 
the procedure to follow in washing the earmold, when replacing tubing 
on those hearing aids that use tubing, and in storing the hearing aid 
when it will not be used for an extended period of time.
    (C) If the battery is replaceable or rechargeable, how to replace 
or recharge the battery, including a generic designation of replacement 
batteries.
    (D) Expected battery life.
    (vii) Identification of any known physiological side effects 
associated with the use of the prescription hearing aid that may 
warrant consultation with a physician, including if applicable, skin 
irritation and accelerated accumulation of cerumen (ear wax).
    (viii) The technical specifications required by paragraph (c)(4) of 
this section unless such specifications appear in separate labeling 
accompanying the prescription hearing aid.
    (ix) A description of commonly occurring, avoidable events that 
could adversely affect or damage the prescription hearing aid, 
including but not limited to ear wax buildup, drops, immersion in 
water, or exposure to excessive heat.
    (x) If the hearing aid incorporates wireless technology in its 
programming or use, appropriate warnings, instructions, and information 
relating to electromagnetic compatibility and wireless technology and 
human exposure to non-ionizing radiation.
    (xi) If the manufacturer provides a repair service or licenses or 
certifies third-party repair services, information on how and where to 
obtain repair service, including at least one specific address where 
the user can go or send the prescription hearing aid to obtain such 
repair service.
    (xii) If clinical or non-clinical studies were conducted by or for 
the manufacturer to support the performance of the prescription hearing 
aid, a summary of all such studies.
    (3) Labeling on the device. The labeling on a prescription hearing 
aid itself shall bear all of the following clearly and permanently, 
except as provided in paragraph (c)(3)(iii) of this section:
    (i) The serial number.
    (ii) If the battery is removable, a ``+'' symbol to indicate the 
positive terminal for battery insertion unless the battery's physical 
design prevents inserting the battery in the reversed position.
    (iii) If the prescription hearing aid is used or rebuilt, the 
manufacturer shall physically attach a removable tag to the hearing aid 
declaring that fact.
    (4) Technical specifications. Technical specifications useful in 
selecting, fitting, and checking the performance of the prescription 
hearing aid shall appear in the user instructional brochure or in 
separate labeling that accompanies the device. You must determine the 
technical specification values for the prescription hearing aid 
labeling in accordance with the test procedures of the American 
National Standard, ``Specification of Hearing Aid Characteristics,'' 
ANSI/ASA S3.22-2014. As a minimum, the user instructional brochure or 
such other labeling shall include the appropriate values or information 
for the following technical specification elements as these elements 
are defined or used in such standard:
    (i) Saturation output curve (SSPL 90 curve).
    (ii) Frequency response curve.
    (iii) Average saturation output (HF-Average SSPL 90).
    (iv) Average full-on gain (HF-Average full-on gain).
    (v) Reference test gain.
    (vi) Frequency range.
    (vii) Total harmonic distortion.
    (viii) Equivalent input noise.
    (ix) Battery current drain.
    (x) Induction coil sensitivity (telephone coil aids only).
    (xi) Input-output curve (only for hearing aids with automatic gain 
control).
    (xii) Attack and release times (only for hearing aids with 
automatic gain control).
    (5) Misbranding. A prescription hearing aid that is not labeled as 
required under this section and Sec.  801.109 of this chapter shall be 
misbranded under sections 201(n), 502(a), and/or 502(f) of the Federal 
Food, Drug, and Cosmetic Act.
    (d) Incorporation by reference. (1) The standard required in this 
section is incorporated by reference into this section with the 
approval of the Director of the Federal Register under 5 U.S.C. 552(a) 
and 1 CFR part 51. All approved material is available for inspection at 
the Food and Drug Administration, Dockets Management Staff, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, and is 
available from the sources indicated below. It is also available for 
inspection at the National Archives and Records Administration (NARA). 
For information on the availability of this material at NARA, email 
[email protected] or go to https://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.:
    (2) ANSI. The American National Standards Institute, 1889 L Street 
NW, 11th Floor, Washington, DC 20036, [email protected], https://www.ansi.org, 202-293-8020.
    (i) ANSI/ASA S3.22-2014, ``Specification of Hearing Aid 
Characteristics,'' dated November 2014.
    (ii) [Reserved]

PART 808--EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL 
MEDICAL DEVICE REQUIREMENTS

0
7. The authority citation for part 808 is revised to read as follows:

    Authority: 21 U.S.C. 360j, 360k, 371.
    Section 808.1 also issued under Sec. 709, Pub. L. 115-52, 131 
Stat. 1065-67.

PART 808--[AMENDED]

0
8. In part 808, remove the words ``the act'' and add in their place 
``the Federal Food, Drug, and Cosmetic Act''.
0
9. In Sec.  808.1, add headings to paragraphs (a) through (f) and add 
paragraph (g) to read as follows:


Sec.  808.1   Scope.

    (a) Introduction. * * *
    (b) General rule for State and local requirements respecting 
devices. * * *
    (c) Exempting from preemption certain State or local requirements 
respecting devices. * * *
    (d) Meaning of ``requirements applicable to a device.'' * * *
    (e) Determination of equivalence or difference of requirements 
applicable to a device. * * *
    (f) Applicability of Federal requirements respecting devices. * * *
    (g) Exemptions not applicable to certain State or local government 
requirements specifically related to hearing products. An exemption 
under this part shall not apply to any State or local government law, 
regulation, order, or other requirement specifically related to hearing 
products, including any requirement for the supervision, prescription, 
or other order, involvement, or intervention of a licensed person for 
consumers to access over-the-counter hearing aids, that:
    (1) Would restrict or interfere with the servicing, marketing, 
sale, dispensing, use, customer support, or distribution of

[[Page 58190]]

over-the-counter hearing aids, as defined under section 520(q) of the 
Federal Food, Drug, and Cosmetic Act, through in-person transactions, 
by mail, or online; and
    (2) Is different from, in addition to, or otherwise not identical 
to, the regulations issued under section 709(b) of the FDA 
Reauthorization Act of 2017.
0
10. Revise Sec.  808.3 to read as follows:


Sec.  808.3   Definitions.

    Compelling local conditions includes any factors, considerations, 
or circumstances prevailing in, or characteristic of, the geographic 
area or population of the State or political subdivision that justify 
exemption from preemption.
    More stringent refers to a requirement of greater restrictiveness 
or one that is expected to afford to those who may be exposed to a risk 
of injury from a device a higher degree of protection than is afforded 
by a requirement applicable to the device under the Federal Food, Drug, 
and Cosmetic Act.
    Political subdivision or locality means any lawfully established 
local governmental unit within a State which unit has the authority to 
establish or continue in effect any requirement having the force and 
effect of law with respect to a device intended for human use.
    State means any State or Territory of the United States, including 
but not limited to, the District of Columbia and the Commonwealth of 
Puerto Rico.
    Substantially identical to refers to the fact that a State or local 
requirement does not significantly differ in effect from a Federal 
requirement.


Sec.  808.53   [Removed and Reserved]

0
11. Remove and reserve Sec.  808.53.
0
12. Revise Sec.  808.55 to read as follows:


Sec.  808.55   California.

    The following California medical device requirements are preempted 
under section 521(a) of the Federal Food, Drug, and Cosmetic Act, and 
FDA has denied them exemption from preemption:
    (a) Medical devices; general provisions. Sherman Food, Drug, and 
Cosmetic Law, Division 21 of the California Health and Safety Code, 
sections 26207, 26607, 26614, 26615, 26618, 26631, 26640, and 26441, to 
the extent that they apply to devices; and
    (b) Ophthalmic devices; quality standards. California Business and 
Professions Code, section 2541.3 to the extent that it requires 
adoption of the American National Standards Institute standards Z-80.1 
and Z-80.2.


Sec. Sec.  808.57 through 808.101   [Removed and Reserved]

0
13. Remove and reserve Sec. Sec.  808.57 through 808.101.

PART 874--EAR, NOSE, AND THROAT DEVICES

0
14. The authority citation for part 874 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
15. Redesignate Sec.  874.3300 as Sec.  874.3301 and revise to read as 
follows:


Sec.  874.3301   Bone-conduction hearing aid.

    (a) Identification. A bone-conduction hearing aid is a wearable 
sound-amplifying device intended to compensate for impaired hearing and 
that transmits sound to the inner ear through the skull. A bone-
conduction hearing aid is subject to the requirements in Sec.  801.422 
of this chapter.
    (b) Classification. Class II.
0
16. Revise Sec.  874.3305 to read as follows:


Sec.  874.3305  Air-conduction hearing aid.

    (a) Identification. An air-conduction hearing aid is a wearable 
sound-amplifying device intended to compensate for impaired hearing 
that conducts sound to the ear through the air. An air-conduction 
hearing aid may be wireless, self-fitting, or both. An air-conduction 
hearing aid is subject to the requirements in Sec.  800.30 or Sec.  
801.422 of this chapter, as applicable. Air-conduction hearing aid 
generic types exclude the group hearing aid or group auditory trainer, 
master hearing aid, and the tinnitus masker, regulated under Sec. Sec.  
874.3320, 874.3330, and 874.3400, respectively.
    (b) Classification. (1) Legacy hearing aid. Class I for an air-
conduction hearing aid that is not a wireless or self-fitting device. 
This hearing aid is exempt from premarket notification procedures in 
subpart E of part 807 of this chapter subject to the limitations in 
Sec.  874.9.
    (2) Wireless hearing aid. Class II (special controls) for an air-
conduction hearing aid that incorporates wireless technology in its 
programming or use. A wireless hearing aid may also be a self-fitting 
hearing aid. A wireless hearing aid that is not a self-fitting hearing 
aid is exempt from the premarket notification procedures in subpart E 
of part 807 of this chapter subject to the limitations in Sec.  874.9. 
The special controls for a wireless hearing aid are:
    (i) Performance data must demonstrate the electromagnetic 
compatibility (EMC), electrical safety, and thermal safety of the 
device;
    (ii) Performance testing must validate safety of exposure to non-
ionizing radiation; and
    (iii) Performance data must validate wireless technology functions.
    (3) Self-fitting hearing aid. Class II (special controls) for a 
wireless air-conduction hearing aid that incorporates technology, 
including software, that allows users to program their hearing aids. 
This technology integrates user input with a self-fitting strategy and 
enables users to independently derive and customize their hearing aid 
fittings and settings. A self-fitting hearing aid is not exempt from 
premarket notification procedures, notwithstanding the exemption in 
paragraph (b)(2) of this section. The special controls for a self-
fitting hearing aid, in addition to the special controls for a wireless 
hearing aid if the device incorporates wireless technology, are:
    (i) Clinical data must evaluate the effectiveness of the self-
fitting strategy;
    (ii) Electroacoustic parameters, including maximum output limits, 
distortion levels, self-generated noise levels, latency, and frequency 
response, must be specified and tested;
    (iii) Software verification, validation, and hazard analysis must 
be performed; and
    (iv) Usability testing must demonstrate that users can correctly 
use the device as intended under anticipated conditions of use.
0
17. In Sec.  874.3315, revise paragraph (a) to read as follows:


Sec.  874.3315  Tympanic membrane contact hearing aid.

    (a) Identification. A tympanic membrane contact hearing aid is a 
prescription wearable device that compensates for impaired hearing. 
Amplified sound is transmitted by vibrating the tympanic membrane 
through a transducer that is in direct contact with the tympanic 
membrane. A tympanic membrane contact hearing aid is subject to the 
requirements in Sec.  801.422 of this chapter.
* * * * *

[[Page 58191]]

Sec.  874.3325   [Removed]

0
18. Remove Sec.  874.3325.
0
19. In Sec.  874.3950, add a sentence at the end of paragraph (a) to 
read as follows:


Sec.  874.3950   Transcutaneous air conduction hearing aid system.

    (a) * * * A transcutaneous air conduction hearing aid system is 
subject to the requirements in Sec.  801.422 of this chapter.
* * * * *

    Dated: October 8, 2021.
Janet Woodcock,
Acting Commissioner of Food and Drugs.
[FR Doc. 2021-22473 Filed 10-19-21; 8:45 am]
BILLING CODE 4164-01-P


