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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.
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
