44 | Regulatory Information
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 instrument 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 instrument is an electronic instrument 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 instrument to sale by or on the order
of a doctor, audiologist or other hearing care practitioner licensed to dispense
hearing aids in your state�
The use of any sound generating tinnitus therapy instrument 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 instrument 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�
WARNING: There are some potential concerns associated with the use of
any sound generating tinnitus therapy instrument� Among them are the potential
for worsening of tinnitus, a possible change in hearing thresholds, and possible
skin irritation at the point of contact with the hearing aid�
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