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Warning to hearing aid dispensers
(to comply with the U.S. Food and Drug
Administration (FDA) regulations)
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. Special
care should be exercised in selecting and fitting a hearing aid
whose maximum sound pressure level exceeds 132 decibels
because there may be risk of impairing the remaining hearing
of the hearing aid user. [This provision is required only for those
hearing aids with a maximum sound pressure capability greater
than 132 decibels (dB).]
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 otorhinolaryngologists.
The purpose of medical evaluation is to assure that all medically
treatable conditions that 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 that
states 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 a 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. Federal
law restricts the sale of hearing aids 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.
Children with hearing loss
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 who is qualified by training and experience to
assist in the evaluation and rehabilitation of a child with hearing loss
is recommended.
