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FDA Information FDA Information
WARNING TO HEARING CARE PRACTITIONER
A hearing care practitioner should advise a prospective
sound generator user to consult promptly with a
licensed physician (preferably an ear specialist) before
using a sound generator if the hearing care practitioner
determines through inquiry, actual observation, or
review or 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.
CAUTION: If set to the maximum output level and
worn for periods of time exceeding the recommendations
below, the patient’s exposure to sound energy has the
potential to exceed noise exposure limits. This device is
intended for use for a maximum of sixteen (16) hours a
day when set at the maximum output level.
For the patient
A tinnitus therapy device is an electronic device intended
to generate noise of sufficient intensity and bandwidth to
treat ringing in the ears. It can also be used as an aid in
hearing external sounds and speech.
Multiflex Tinnitus Technology is a tool to generate
sounds. It is recommended that this tool be used with
appropriate counseling and/or in a tinnitus management
program to relieve patients suffering from tinnitus.
TINNITUS THERAPY CONCEPTS
AND BENEFITS
Multiflex Tinnitus Technology can be used as a part of a
tinnitus treatment program.
Multiflex Tinnitus Technology plays a white noise through
the hearing aid.
Multiflex Tinnitus Technology is programmed according
to your hearing loss and preference, and your hearing
care professional can adjust the settings of Multiflex
Tinnitus Technology to meet your needs.
Multiflex Tinnitus Technology may provide temporary
relief of your tinnitus.
PRESCRIPTION USE ONLY
CAUTION: Federal law restricts this device to sale by or
on the order of a doctor, audiologist or other hearing care
practitioner licensed to dispense hearing instruments in
your state.
The use of any sound generating tinnitus therapy device
should be only on the advice and in consultation with
your audiologist or hearing care practitioner. Your hearing
care professional will properly diagnose and fit the device
to your personal needs and requirements. This should
include its use in a prescribed tinnitus treatment program.
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