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Prescription Use for Sound Generator Users
Please use the device as prescribed by your doctor, audiologist, or hearing care professional. Should you
develop any side effects from using the instrument, such as dizziness, nausea, headaches, perceived de-
crease in auditory function or increase in tinnitus perception, you should discontinue 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 professional or the guardian for the insertion and
removal of the device.
CAUTION – Tinnitus Sound Generator
i
The maximum output of the Tinnitus Breaker Pro feature falls into the range that can cause hearing loss
according to OSHA regulations.
The user should not use the sound generator for more than eight (8) hours a day when this is set below
90dB SPL. Above that level, the device should not be used for more than two hours per day. In no case
should the sound generator be worn at uncomfortable levels.
Children and physically or mentally challenged users will require guardian supervision while wearing the
device.
General warnings/or precautions
Hearing instruments and sound generators can be dangerous if improperly used.
Sound generators should be used only as advised by your doctor, audiologist, or hearing care professional.
Sound generators are not toys and should be kept out of reach of anyone (especially children and pets) who
might cause themselves injury.
