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FDA Information
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 professional�
As with any device, misuse of the tinnitus therapy device could present
some potentially harmful effects� Care should be taken to prevent the
unauthorized use and to keep the device 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 device for more than sixteen (16) hours a day if your
device is set at the maximum output level, nor should you use your device
if your hearing professional has set the device at levels that exceed
your comfort level�
Important notice for prospective
sound generator users
Good health practice requires that a person with tinnitus have a medical
evaluation by a licensed physician (preferably a physician who specializes
in diseases of the ear) before using a sound generator� Licensed
physicians who specialize in diseases of the ear are often referred to as
otolaryngologists, otologists or otorhinolaryngologists�
The purpose of a medical evaluation is to assure that all medically treatable
conditions that may affect tinnitus are identified and treated before the
sound generator instrument is used�
TECHNICAL DATA
Multiflex Tinnitus Technology Maximum Output = 87 dB SPL (typical) when
measured in a 2cc coupler per ANSI S3�22 or IEC 60118-7�
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