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FDA Information FDA Information
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
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 care
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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