IHEAR IHEAR HD Panduan Pengguna - Halaman 2

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IMPORTANT NOTICE
The iHEAR HD is a hearing device designed for adults
who need hearing enhancement and is not to be worn
by individuals under the age of 18. The Food and Drug
Administration has determined that it is in your best health
interest to have a medical evaluation by a licensed physician
(preferably a physician who specializes in diseases of the ear)
before purchasing a hearing aid. The purpose of a medical
evaluation is to assure that all medically treatable conditions
that may affect hearing are identified and treated before a
hearing aid is purchased. Following the medical evaluation,
the physician can give you a written statement (medical
clearance) that states that your hearing health has been
evaluated and that you may be considered a candidate for
a hearing aid. The physician may refer you to an audiologist
or a hearing aid dispenser, for a hearing aid evaluation. You
may also send (by mail, fax, or e-mail) the signed medical
clearance to iHear Medical for the purpose of purchasing a
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 also permits a fully
informed adult to sign a medical waiver statement declining
the medical evaluation. The exercise of such a waiver is not
in your best health interest and its use is discouraged. iHear
Medical will not sell a hearing device to you unless you either
(1) obtain a signed medical clearance, or (2) review and accept
the medical waiver statement.
Read the User Guide before using the iHEAR HD
Infrequent use of a hearing device does not permit a user to
attain full benefit from it.
Hearing device will not restore normal hearing and will not
prevent or improve a hearing impairment resulting from
organic conditions.
CONTRAINDICATIONS FOR USE
The following conditions contraindicate the use of
the iHEARHD. If you know or suspect you have the
following conditions, do not use the iHEARHD without
consulting your physician.
a. Visible deformity of the ear
b. Current ear infection
c. History of active drainage from the ear within the
past 90 days
d. Sudden or rapid progression of hearing loss within
the past 90 days in one or both ears
e. Acute or chronic dizziness
f. Visible evidence of significant cerumen (ear wax)
accumulation or a foreign body in the ear canal
g. Pain or discomfort in the ear
h. Individuals with poor dexterity, poor vision or
s ignificant dementia
i.
Fluctuating hearing sensitivity
j.
Sudden onset or rapid worsening of tinnitus within
the past 90 days
k. History of conductive or mixed hearing loss or ear
surgery
.
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