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About Start-up Handling Options Tinnitus Warnings More info
Warning to hearing care
professional
A hearing care professional should
advise a prospective hearing aid user
to consult immediately with a licensed
physician (preferably an ear specialist)
before dispensing a hearing aid if the
hearing care professional determines
through inquiry, actual observation, or
review of any other available informa-
tion 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
capability exceeds 132 dB SPL as
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 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 ensure
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.
General warnings
Continues on next page
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