July 12, 2007
Linda S. Kahan, Esq.
Deputy Director
Center for Devices and Radiological Health
Department of Health and Human Services
Food and Drug Administration
9200 Corporate Boulevard
Rockville, MD
Dear Ms. Kahan:
Thank you for your letter of December 18, 2006 in response
to a letter from the Hearing Industries Association (HIA)
dated December 15, 2005 regarding proposed voluntary hearing
aid labeling about compatibility with digital cellular phones.
In that letter, the Agency made recommendations regarding
draft labeling language developed by HIA to provide consumers
with information about compatibility.
HIA members carefully considered the Agency's comments in
the December 18, 2006 letter and have incorporated those
comments in the language that companies will now include
in their user manuals. The text that companies will use is
as follows:
Some hearing aid users have reported a buzzing sound
in their hearing aids when they are using cell phones,
indicating that the cell phone and hearing aid may not
be compatible. According to the ANSI C63.19 standard (ANSI
C63.19-2006 American National Standard Methods of Measurement
of Compatibility Between Wireless Communications Devices
and Hearing Aids), the compatibility of a particular hearing
aid and cell phone can be predicted by adding the rating
for the hearing aid immunity to the rating for the cell
phone emissions. For example, the sum of a hearing aid
rating of 2 (M2/T2) and a telephone rating of 3 (M3/T3)
would result in a combined rating of 5. Any combined rating
that equals at least 5 would provide “normal use;” a
combined rating of 6 or greater would indicate “excellent
performance.”
The immunity of this hearing aid is at least M2/T2.
The equipment performance measurements, categories
and system classifications are based upon the best information
available but cannot guarantee that all users will be satisfied.
NOTE: The performance of individual hearing aids may
vary with individual cell phones. Therefore, please
try this hearing aid with your cell phone or,
if you are purchasing a new phone, be sure to try it with
your hearing aid prior to purchase. For additional
guidance, please ask your cell phone provider for the booklet
entitled "Hearing Aid Compatibility with
Digital Wireless Cell Phones."
Let me also provide some additional information regarding
this voluntary effort by HIA members:
- Companies will provide this information with their relevant
products on a prospective basis as user manuals are prepared,
revised or reprinted
- Companies may choose to modify the wording of this statement
for readability or greater consumer clarity, but the information
above will be the basis
- Companies will maintain documentation of compatibility
testing in their files
The members of HIA have partnered with the cellular telephone
industry, the FDA and the FCC and, importantly, consumer
groups representing people with hearing losses and hearing
aids to provide the best possible guidance to the users of
our products. We are confident that this collaborative
effort will result in the broadest possible access to digital
cellular technology by hearing aid users.
Sincerely,
Carole M. Rogin
Executive Director
cc: HIA Members
Larry Kessler,
ScD
Jeffrey Gibbs, Esq.
Peter Tannenwald, Esq.
515 KING STREET SUITE
420 ALEXANDRIA,
VIRGINIA 22314
PHONE: (703) 684-5744 FAX:
(703) 684-6048 www.hearing.org
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