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Intended use
The patient may have some control of the level or volume of the signal and the
patient should discuss this adjustment as well as his or her comfort level and sound of
the signal with their hearing care professional.
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 hearing aid 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.
Custom Tinnitus+
Technology is a tool to generate sounds. It is recommended
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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.
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Custom Tinnitus+
Technology plays a white noise through the hearing aid.
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Custom Tinnitus+
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Technology is programmed according to your hearing loss
and preference, and your hearing care professional can adjust the 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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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.
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Intended use
Your hearing care professional will properly diagnose and fit the hearing aid to your
personal needs and requirements. This should include its use in a prescribed tinnitus
treatment program.
Your hearing care professional will also be able to offer the appropriate follow-up
care. It is important that you follow your hearing care professional's advice and
direction regarding such care.
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 hearing care professional has set the hearing aid 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.
TINNITUS TECHNICAL DATA
Custom Tinnitus+
Technology Maximum Output = 87 dB SPL (typical) when
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measured in a 2cc coupler per ANSI S3.22 or IEC 60118-7.
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