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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.
