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FDA Information
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 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 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�
Your hearing professional will also be able to offer the appropriate follow-
up care� It is important that you follow your hearing professional’s advice
and direction regarding such care�
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