User's Manual

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FDA InformationFDA Information
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 conditions or any
dizziness, nausea, headaches or heart palpitations, you
should immediately discontinue use of the instrument and
seek a consultation with a medical, audiology or other
hearing professional.
As with any instrument, misuse of the tinnitus therapy
instrument could present some potentially harmful
effects. Care should be taken to prevent the unauthorized
use and to keep the instrument out of the reach of
children and pets.
CAUTION: If set to the maximum output level and
worn for periods of time exceeding the following
recommendations, your exposure to sound energy has
the potential to exceed noise exposure limits. You should
not use your hearing instrument for more than sixteen
(16) hours a day if your instrument is set at the maximum
output level, nor should you use your instrument if your
hearing professional has set the instrument at levels that
exceed your comfort level.
Important notice for prospective
sound generator users
Good health practice requires that a person with tinnitus
have a medical evaluation by a licensed physician
(preferably a physician who specializes in diseases of the
ear) before using a sound generator. Licensed physicians
who specialize in diseases of the ear are often referred to
as otolaryngologists, otologists or otorhinolaryngologists.
The purpose of a medical evaluation is to assure that all
medically treatable conditions that may affect tinnitus
are identified and treated before the sound generator
instrument is used.