Regulatory Information
Regulatory Information
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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 device 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 device is an electronic device 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
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.
Custom Tinnitus
™
Technology is programmed according to your hearing loss and
preference, and your Miracle-Ear
®
Hearing Care Professional can adjust the settings
of Custom Tinnitus
™
Technology to meet your needs.
Custom Tinnitus
™
Technology may provide temporary relief of your tinnitus.
PRESCRIPTION USE ONLY
CAUTION:
Federal law restricts this device 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 device 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 device 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 device. 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 device.
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 device and seek a consultation with a medical, audiology or
other Miracle-Ear Hearing Care Professional.
As with any device, misuse of the tinnitus therapy device could present some
potentially harmful effects. Care should be taken to prevent the unauthorized use and
to keep the device out of the reach of children and pets.
