Starkey RIC 312, Operation Manual

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FDA Information
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.
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.