Warning To Hearing Aid Dispensers (To Comply With The U.s. Food And Drug Administration (Fda) Regulations) - Unitron InseraMD B1-312 Guide D'utilisation

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).]
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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
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