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Starkey Halo Made for iPhone BTE Manual

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FDA InformationFDA 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:
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 otorhynolaringologists. The purpose of the medical
evaluation is to assure that all medically treatable
conditions which 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 affirming 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.
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
… 21 …


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