24
25
FDA Information
Required Information
The following additional information is provided in compliance with
U .S . Food and Drug Administration (FDA) regulations:
WARNINGTOHEARINGINSTRUMENTDISPENSERS.
A hearing
instrument dispenser should advise a prospective hearing instrument user
to consult promptly with a licensed physician (preferably an ear specialist)
before dispensing a hearing instrument if the hearing instrument
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 .
Special care should be exercised in selecting and fitting a hearing
instrument whose maximum sound pressure level exceeds 132 decibels
because there may be risk of impairing the remaining hearing of the
hearing instrument user .
IMPORTANTNOTICEFORPROSPECTIVEHEARINGINSTRUMENT
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 instrument . Licensed physicians who specialize in diseases
of the ear are often referred to as otolaryngologists, otologists, or
otorhynolaryngologists . The purpose of the medical evaluation is to
assure that all medically treatable conditions that may affect hearing
are identified and treated before the hearing instrument is purchased .
FDA Information
Following the medical evaluation, the physician will give you a written
statement that states that your hearing loss has been medically evaluated
and that you may be considered a candidate for a hearing instrument .
The physician will refer you to an audiologist or hearing instrument
dispenser, as appropriate, for a hearing instrument evaluation .
The audiologist or hearing instrument dispenser will conduct a hearing
instrument evaluation to assess your ability to hear with and without a
hearing instrument . The hearing instrument evaluation will enable the
audiologist or dispenser to select and fit a hearing instrument 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 instrument dispensers now offer programs
that permit you to wear a hearing instrument for a period of time for
a nominal fee after which you may decide if you want to purchase the
hearing instrument .
Federal law restricts the sale of hearing instruments to those individuals
who have obtained a medical evaluation from a licensed physician .
Federal law permits a fully informed adult to sign a waiver statement
declining the medical evaluation for religious or personal beliefs that
preclude consultation with a physician . The exercise of such a waiver is
not in your best health interest and its use is strongly discouraged .
A hearing aid will not restore normal hearing and will not prevent or
improve a hearing impairment resulting from organic conditions . Use
of a hearing aid is only part of hearing habilitation and may need to be
supplemented by auditory training and instruction in lip reading . In most
cases infrequent use of a hearing aid does not permit a user to attain full
benefit from it .
CHILDRENWITHHEARINGLOSS.
In addition to seeing a physician for
a medical evaluation, a child with a hearing loss should be directed to
an audiologist for evaluation and rehabilitation since hearing loss may
cause problems in language development and the educational and social
growth of a child . An audiologist is qualified by training and experience
to assist in the evaluation and rehabilitation of a child with a hearing loss .
