Hansaton sound ST R312, Manual

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12. 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.
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.
Children with hearing loss
In addition to seeing a physician for a medical evaluation, a
child with a 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 a hearing loss.