32
Warning to hearing care professionals (to comply with the U.S. Food and
Drug Administration (FDA) regulations)
Hearing care professionals 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 care professional determines through
inquiry, actual observation, or review or 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), 1000 Hz and 2000 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 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.
33
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 care professional, as appropriate, for a hearing aid
evaluation.
The audiologist or hearing care professional will conduct a hearing aid
evaluation to assess your degree of hearing. The hearing aid evaluation will
enable the audiologist or dispenser to select and fit a hearing aid to your
individual 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 restricts the sale of hearing aids to those individuals who have not
obtained a medical evaluation from a licensed physician. Federal law permits a
fully informed adult to sign a waiver statement declining the nominal fee after
which you may decide if you want to purchase the hearing aid or medical
evaluation for religious or personal beliefs that preclude consultation with a
physician. The exercise of such waiver is not in your best interest and its use is
strongly discouraged.
Children with hearing loss
In addition to seeing a physician for a medical evaluation, a child with hearing
loss should be directed to an audiologist for evaluation and rehabilitation since
hearing loss may cause problems in language development and the educational
and social growth of a child. An audiologist is qualified by training and
experience to assist in the evaluation and rehabilitation of a child with hearing
loss.
