Operation Manual

48
FDA Information
PRESCRIPTION USE ONLY
CAUTION:
Federal law restricts this device to sale by
or on the order of a doctor, audiologist or other hearing
care practitioner 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 audiologist or hearing care practitioner. 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: 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.
Multiflex 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
hearing care professional.
As with any device, misuse of the tinnitus therapy device