Safety Manual
31
DRAFT 2017-07-27
Prescription Use Only
U.S. federal law rericts this device to sale by or on the
order of a doctor or Hearing Care Professional licensed
to dispense hearing inruments in your ate. 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 t 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 oer the appropriate
follow‑up care. It is important that you follow your Hearing
Care Professional’s advice and direction regarding such
care.
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 eects (e.g., dizziness, nausea,
headaches, heart palpitations).
■ Perceived decrease in auditory function
(e.g., decreased loudness, speech not as clear).