
[Federal Register Volume 80, Number 61 (Tuesday, March 31, 2015)]
[Notices]
[Pages 17056-17057]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-07300]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]


Ear, Nose, and Throat Devices Panel of the Medical Devices 
Advisory Committee; Amendment of Notice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
amendment to the notice of meeting of the Ear, Nose, and Throat Devices 
Panel of the Medical Devices Advisory Committee. This meeting was 
announced in the Federal Register of March 13, 2015. The amendment is 
being made to reflect a change in the April 30th Agenda portion of the 
document. There are no other changes.

FOR FURTHER INFORMATION CONTACT: Patricio Garcia, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 1535, Silver Spring MD 20993-0002, 
patricio.garcia@fda.hhs.gov, 301-796-6875, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington DC 
area), code EN. Please call the Information Line for up-to-date 
information on this meeting.

SUPPLEMENTARY INFORMATION: In the Federal Register of March 13, 2015 
(80 FR 13392), FDA announced that a meeting of the Ear, Nose, and 
Throat Devices Panel of the Medical Devices Advisory Committee would be 
held on April 30 and May 1, 2015. On page 13393, in the first and 
second columns, the Agenda portion of the document is changed to read 
as follows:
    On April 30, 2015, the Agency is adding three Agenda items to the 
original five agenda items posted in the March 13, 2015, Federal 
Register document. The three additional items are: Speech Training Aids 
for the Hearing Impaired (Battery Powered or Non-Patient), Speech 
Training Aids for the Hearing Impaired (AC-powered and Patient-
Contact), and Nasal Septal Button Devices. The committee will discuss 
and make recommendations regarding the classification of Hearing 
Protectors, Circumaural Hearing Protectors, Tactile Hearing Aids, 
Speech Training Aids for the Hearing Impaired (Battery Powered or Non-
Patient), Speech Training Aids for the Hearing Impaired (AC-powered and 
Patient-Contact), Vestibular Analysis, Middle Ear Inflation Devices, 
and Nasal Septal Button Devices. These devices are considered 
preamendments devices since they were in commercial distribution prior 
to May 28, 1976, when the Medical Devices Amendments became effective. 
Hearing Protectors are currently regulated under the heading, 
``Protector, Hearing (Insert),'' Product Code EWD, as unclassified 
under the 510(k) premarket notification authority. Circumaural Hearing 
Protectors are currently regulated under the heading, ``Protector, 
Hearing (Circumaural),'' Product Code EWE, as unclassified under the 
510(k) premarket notification authority. Tactile Hearing Aid Devices 
are currently regulated under the heading, ``Hearing Aid, Tactile,'' 
Product Code LRA, as unclassified under the 510(k) premarket 
notification authority. Speech Training Aids for the Hearing Impaired 
(Battery Powered or Non-Patient) are currently regulated under the 
heading, ``Aids, Speech Training For The Hearing Impaired (Battery-
Operated or Non-Patient),'' Product Code LFA, as unclassified under the 
510(k) premarket notification authority. Speech Training Aids for the 
Hearing Impaired (AC-Powered and Patient-Contact) are currently 
regulated under the heading, ``Aids, Speech Training For The Hearing 
Impaired (AC-Powered and Patient-Contact),'' Product Code LEZ, as 
unclassified under the 510(k) premarket notification authority. 
Vestibular Analysis Apparatuses are currently regulated under the 
heading, ``Apparatus, Vestibular Analysis,'' Product Code LXV, as 
unclassified under the 510(k) premarket notification authority. Middle 
Ear Inflation Devices are currently regulated under the heading, 
``Device, Inflation, Middle Ear,'' Product Code MJV, as unclassified 
under the 510(k) premarket notification authority. Nasal Septal Button 
Devices are currently regulated under the heading, ``Button, Nasal 
Septal,'' Product Code LFB, as unclassified under the 510(k) premarket 
notification authority. FDA is seeking committee input on the risks, 
safety and effectiveness, and the regulatory classification of Hearing 
Protectors, Circumaural Hearing Protectors, Tactile Hearing Aids, 
Speech Training Aids for the Hearing Impaired (Battery Powered or Non-
Patient), Speech Training Aids for the Hearing Impaired (AC-Powered and 
Patient-Contact), Vestibular Analysis, Middle Ear Inflation Devices, 
and Nasal Septal Button Devices.

[[Page 17057]]

    On May 1, 2015, the committee will discuss key issues related to a 
potential pre- to postmarket shift in clinical data requirements for 
modifications to cochlear implants in pediatric patients. These issues 
are categorized into three broad areas for discussion:
    1. Cochlear implant changes (e.g. sound processing features, 
patient characteristics) that may be suitable for this pre- to 
postmarket shift in clinical data requirements.
    2. Appropriate premarket clinical data requirements to support pre- 
to postmarket shift (e.g. leveraging clinical data from adults and/or 
older children.)
    3. Clinical study design considerations (e.g. study endpoints and 
test metrics, subject characteristics) for postmarket studies to 
confirm safety and effectiveness and inform future labeling.
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its Web site prior to the meeting, the 
background material will be made publicly available at the location of 
the advisory committee meeting, and the background material will be 
posted on FDA's Web site after the meeting. Background material is 
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting 
link.
    This notice is issued under the Federal Advisory Committee Act (5 
U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.

    Dated: March 24, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-07300 Filed 3-30-15; 8:45 am]
BILLING CODE 4164-01-P


