Miracle-Ear EarENERGY 5 RIC R EV User Manual page 26

Regulatory Information
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.
Custom Tinnitus Technology is a tool to generate sounds. It is recommended that
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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
• Custom Tinnitus ™ Technology can be used as a part of a tinnitus treatment
program.
• Custom Tinnitus Technology plays a white noise through the hearing aid.
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• Custom Tinnitus ™ Technology is programmed according to your hearing loss
and preference, and your Miracle-Ear
settings of Custom Tinnitus Technology to meet your needs.
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• Custom Tinnitus ™ Technology may provide temporary relief of your tinnitus.
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Hearing Care Professional can adjust the
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Regulatory Information
PRESCRIPTION USE ONLY
CAUTION:
Federal law restricts this hearing aid to sale by or on the order of a
doctor, audiologist or other hearing care professional 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 hearing aid
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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 hearing aid and seek a consultation with a medical, audiology
or other Miracle-Ear Hearing Care Professional.
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