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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 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.
General warnings
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 evalu-
ation 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 Otorhi-
nolaryngologists. 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.
The audiologist or hearing care professional
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 individ-
ual needs. If you have reservations about
your ability to adapt to amplification, you
should inquire about the availability of a
trial, rental or purchase-option program.
Many hearing care professionals now offer
programs that permit you to wear a hearing
aid for a period of time for a nominal fee,
after which you may decide if you want to
purchase the hearing aid. Federal law limits
the sale of hearing aids to those individuals
who have obtained a medical evaluation
from a licensed physician.
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