User's Manual

38
FDA 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 instruments 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 instrument.
Multiflex Tinnitus Technology has been designed to minimize these
concerns. However, should you experience or notice any of the above