Regulatory Information
Regulatory Information
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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 Professional. Your
Miracle-Ear
®
Hearing Care 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 Miracle-Ear Hearing Care Professional will also be able to offer the appropriate
follow-up care. It is important that you follow your Miracle-Ear Hearing Care
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.
Custom 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 Miracle-Ear Hearing Care 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 recommendations below, your exposure to sound energy has the
potential to exceed noise exposure limits. You should not use your hearing aid
for more than sixteen (16) hours a day if your hearing aid is set at the maximum
output level, nor should you use your hearing aid if your Miracle-Ear
®
Hearing Care
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.
