User's Manual

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FDA Information FDA Information
Required Information
The following additional information is provided in
compliance with U.S. Food and Drug Administration
(FDA) regulations:
WARNING TO HEARING AID DISPENSERS.
A hearing aid dispenser should advise a prospective
hearing aid user to consult promptly with a licensed
physician (preferably an ear specialist) before dispensing a
hearing aid if the hearing aid dispenser determines through
inquiry, actual observation, or review of any other available
information concerning the prospective user, that the
prospective user has any of the following conditions:
i. Visible congenital or traumatic deformity of the ear.
ii. History of active drainage from the ear within the
previous 90 days.
iii. History of sudden or rapidly progressive hearing loss
within the previous 90 days.
iv. Acute or chronic dizziness.
v. Unilateral hearing loss of sudden or recent onset within
the previous 90 days.
vi. Audiometric air-bone gap equal to or greater than
15 decibels at 500 Hertz (Hz), 1,000 Hz and 2,000 Hz.
vii. Visible evidence of significant cerumen accumulation
or a foreign body in the ear canal.
viii. Pain or discomfort in the ear.
IMPORTANT NOTICE FOR PROSPECTIVE
HEARING AID USERS. Good health practice
requires that a person with a hearing loss have a
medical evaluation by a licensed physician (preferably a
physician who specializes in diseases of the ear) before
purchasing a hearing aid. Licensed physicians who
specialize in diseases of the ear are often referred to as
otolaryngologists, otologists or otorhynolaringologists.
The purpose of the medical evaluation is to assure that all
medically treatable conditions which may affect hearing
are identified and treated before the hearing aid is
purchased.
Following the medical evaluation, the physician will
give you a written statement affirming that your hearing
loss has been medically evaluated and that you may be
considered a candidate for a hearing aid. The physician
will refer you to an audiologist or hearing aid dispenser,
as appropriate, for a hearing aid evaluation.
The audiologist or hearing aid dispenser will conduct a
hearing aid evaluation to assess your ability to hear with
and without a hearing aid. The hearing aid evaluation
will enable the audiologist or dispenser to select and fit a
hearing aid to your individual needs.
If you have reservations about your ability to adapt to
amplification, you should inquire about the availability of
a trial-rental or purchase-option program. Many hearing
aid dispensers now offer programs that permit you to
wear a hearing aid for a period of time for a nominal fee
after which you may decide if you want to purchase the
hearing aid.