Fda Information - Sonetik Gohear Manual Del Usuario

FDA Information

REQUIRED INFORMATION. The following additional
information is provided in compliance with U.S. Food
and Drug Administration (FDA) regulations:
WARNING TO HEARING AID DISPENSERS. 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:
IV. Visible congenital or traumatic deformity of the ear.
V. History of active drainage from the ear within the
previous 90 days.
VI. History of sudden or rapidly progressive hearing
loss within the previous 90 days.
VII. Acute or chronic dizziness.
VIII. Unilateral hearing loss of sudden or recent onset
within the previous 90 days.
IX. Audiometric air-bone gap equal to or greater than
15 dB at 500 Hertz (Hz), 1,000 Hz and 2,000 Hz.
X. Visible evidence of significant cerumen accumulati-
on or a foreign body in the ear canal.
XI. Pain or discomfort in the ear.
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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 otorhynolaryngologists.
The purpose of the 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 hearing aid dispenser,
as appropriate, for a hearing aid evaluation.
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