
[Federal Register Volume 80, Number 49 (Friday, March 13, 2015)]
[Notices]
[Pages 13392-13393]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-05675]


-----------------------------------------------------------------------

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; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

[[Page 13393]]

    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). The meeting will 
be open to the public.
    Name of Committee: Ear, Nose, and Throat Devices Panel of the 
Medical Devices Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on April 30 and May 1, 2015 
from 8 a.m. to 6 p.m.
    Location: Hilton Washington DC North/Gaithersburg, Salons A, B, C, 
and D, 620 Perry Pkwy., Gaithersburg, MD 20877. The hotel's telephone 
number is 301-977-8900.
    Contact Person: 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). A notice in the Federal Register about last minute modifications 
that impact a previously announced advisory committee meeting cannot 
always be published quickly enough to provide timely notice. Therefore, 
you should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate 
advisory committee meeting link, or call the advisory committee 
information line to learn about possible modifications before coming to 
the meeting.
    Agenda: On April 30, 2015, the committee will discuss and make 
recommendations regarding the classification of Hearing Protectors, 
Circumaural Hearing Protectors, Middle Ear Inflation Devices, Tactile 
Hearing Aid Devices, and Vestibular Analysis Apparatuses. 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. 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. 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. Vestibular Analysis Apparatuses are currently 
regulated under the heading, ``Apparatus, Vestibular Analysis,'' 
Product Code LXV, 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, Middle Ear Inflation 
Devices, Tactile Hearing Aid Devices, and Vestibular Analysis 
Apparatuses.
    On May 1, 2015 the committee will discuss key issues related to a 
potential pre- to post-market 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 post-
market shift in clinical data requirements.
    2. Appropriate premarket clinical data requirements to support pre- 
to post-market 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 post market 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.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
Written submissions may be made to the contact person on or before 
April 22, 2015. Oral presentations from the public will be scheduled 
between approximately 8:45 a.m. and 9:45 a.m. on April 30, 2015 and 
between approximately 1 p.m. and 2 p.m. on May 1, 2015. Those 
individuals interested in making formal oral presentations should 
notify the contact person and submit a brief statement of the general 
nature of the evidence or arguments they wish to present, the names and 
addresses of proposed participants, and an indication of the 
approximate time requested to make their presentation on or before 
April 14, 2015. Time allotted for each presentation may be limited. If 
the number of registrants requesting to speak is greater than can be 
reasonably accommodated during the scheduled open public hearing 
session, FDA may conduct a lottery to determine the speakers for the 
scheduled open public hearing session. The contact person will notify 
interested persons regarding their request to speak by April 16, 2015.
    Persons attending FDA's advisory committee meetings are advised 
that the Agency is not responsible for providing access to electrical 
outlets.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact at James Clark at 
James.Clark@fda.hhs.gov, or 301-796-5293 at least 7 days in advance of 
the meeting.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures 
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: March 9, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-05675 Filed 3-12-15; 8:45 am]
BILLING CODE 4164-01-P


