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Unitron Quantum Instructions d'exploitation Page 22

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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. 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. 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 aid dispenser
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 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 aid dispensers 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 obtained a medical evaluation from a licensed
physician. Federal law permits a fully informed adult to sign a
waiver statement declining the medical evaluation for religious or
personal beliefs that preclude consultation with a physician. The
exercise of such a waiver is not in your best health interest and its
use is strongly discouraged.
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