44
fDA information
The following additional information is provided in compliance with U.s.
food and Drug Administration (fDA) regulations:
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 concern-
ing the prospective user, that the prospective user has any of the follow-
ing 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.
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 special-
izes 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 otorhinolaryn-
gologists. The purpose of the medical evaluation is to assure