Regulatory Information
Regulatory Information
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PRESCRIPTION USE ONLY
CAUTION:
Federal law restricts this hearing aid to sale by or on the order of a
doctor, audiologist or other hearing care professional licensed to dispense hearing
aids in your state.
The use of any sound generating tinnitus therapy instrument should be only on the
advice and in consultation with your audiologist or hearing care professional. Your
hearing professional will properly diagnose and fit the hearing aid to your personal
needs and requirements. This should include its use in a prescribed tinnitus treatment
program.
Your hearing professional will also be able to offer the appropriate follow-up care. It is
important that you follow 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 hearing aid.
Custom 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 hearing aid and seek a consultation with a medical, audiology
or other hearing professional.
As with any hearing aid, 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 hearing aid out of the reach of children and pets.
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.
TINNITUS TECHNICAL DATA
Custom Tinnitus™ Technology Maximum Output = 87 dB SPL (typical) when
measured in a 2cc coupler per ANSI S3.22 or IEC 60118-7.
