User's Manual

54
FDA Information
your hearing professional’s advice and direction regarding
such care.
WARNING: There are some potential concerns
associated with the use of any sound generating tinnitus
therapy instrument. 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 instrument.
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 instrument and
seek a consultation with a medical, audiology or other
hearing professional.
As with any instrument, misuse of the tinnitus therapy
instrument could present some potentially harmful
effects. Care should be taken to prevent the unauthorized
use and to keep the instrument out of the reach of
children and pets.
CAUTION: If set to the maximum output level and
worn for periods of time exceeding the recommendations
below, your exposure to sound energy has the potential
to exceed noise exposure limits. You should not use
your hearing instrument for more than sixteen (16) hours
a day if your instrument is set at the maximum output
level, nor should you use your instrument if your hearing
professional has set the instrument at levels that exceed
your comfort level.