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Tinnitus Therapy Feature
TINNITUS THERAPY FEATURE:
Your hearing instrument may be equipped with a tinnitus therapy
feature. Many tinnitus patients also suffer from some degree of
hearing loss. Many hearing instruments can be used alone or in
combination with the tinnitus therapy feature. The tinnitus therapy
feature is fixed to a broadband noise that can be adjusted by your
Hearing Care Professional for your tinnitus therapy. The feature may
provide temporary relief of your tinnitus.
Prescription Use Only
Federal law restricts this device to sale by or on the order of a doctor
or hearing care professional licensed to dispense hearing instruments
in your state. The use of any sound generating tinnitus therapy
device should be only on the advice and in consultation with your
hearing care professional. Your 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 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.
WARNING
Risk of further impairment to the user’s hearing health.
There are some potential concerns associated with the use of any
sound generating tinnitus therapy device. Discontinue use and
seek medical evaluation if any of the following conditions occur:
• Chronic skin irritation on, near, or around the site of device
placement.
• Unusual side effects (e.g., dizziness, nausea, headaches, heart
palpitations).
• Perceived decrease in auditory function (e.g., decreased
loudness, speech not as clear).
WARNING
Risk of further impairment to the user’s hearing health.
The volume of the tinnitus therapy feature can be set to a level
which could lead to permanent hearing damage when used for a
prolonged period of time.
The tinnitus therapy feature should never be used at
uncomfortable levels.
FOR HEARING CARE PROFESSIONALS
Indications for Use
The tinnitus therapy feature is a tool to generate sounds to be
used in a tinnitus management program to relieve patients
suffering from tinnitus. The target population is primarily the
adult population over 21 years of age. The tinnitus therapy
feature is targeted for healthcare professionals treating patients
suffering from tinnitus, as well as conventional hearing disorders.
The fitting of the tinnitus therapy feature should be done by a
hearing care professional participating in a tinnitus management
program.
Device Description
The tinnitus therapy feature is a software function that generates
sound which is programmed into a hearing instrument.
Depending on the type of hearing instrument, the hearing
instrument may be used in up to three modes of operation: as a
hearing instrument, as a tinnitus treatment device, or as a hearing
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