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FDA statements
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 aid users
Good health practice requires that a person with 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
