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The purpose of a medical evaluation is to assure that all medically
treatable conditions that may affect hearing and/or tinnitus are
identified and treated before the hearing instrument and/or sound
generator is used.
The sound generator instrument is a tool to generate sounds to be
used with appropriate counselling and/or in a tinnitus management
program to relieve patients suffering from tinnitus.
Prescription use for sound generator users
If your instrument has been enabled with the Tinnitus Breaker
sound generator function for tinnitus management, please use
the device as prescribed by your doctor, audiologist, or hearing
care practitioner. In order to avoid the possibility of damaging your
hearing, the maximum daily usage depends on the level of the
generated sound.
Should you develop any side effects from using the instrument,
such as dizziness, nausea, headaches, perceived decrease in audi-
tory function or increase in tinnitus perception, you should disconti-
nue use of the device and seek medical evaluation.
The target population is primarily the adult population over 18 years
of age. This product may also be used with children 5 years of age
or older. However, children and physically or mentally challenged
users will require training by a doctor, audiologist, hearing care
practitioner or the guardian for the insertion and removal of the
device.
Summary of Contents for TO1715
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