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Regulatory Information
Regulatory Information
WARNING TO HEARING CARE PRACTITIONER
A hearing care practitioner should advise a prospective sound generator user to consult
promptly with a licensed physician (preferably an ear specialist) before using a sound
generator if the hearing care practitioner determines through inquiry, actual observation
or review or any other available information concerning the prospective user that the
prospective user has any of the following conditions:
i. Visible congenital or traumatic deformity of the ear.
ii. History of active drainage from the ear within the previous 90 days.
iii. History of sudden or rapidly progressive hearing loss within the previous
90 days.
iv. Acute or chronic dizziness.
v. Unilateral hearing loss of sudden or recent onset within the previous 90 days.
CAUTION:
If set to the maximum output level and worn for periods of time
exceeding the recommendations below, the patient’s exposure to sound energy has
the potential to exceed noise exposure limits. This instrument is intended for use for a
maximum of sixteen (16) hours a day when set at the maximum output level.
For the Patient
A tinnitus therapy instrument is an electronic instrument intended to generate noise of
sufficient intensity and bandwidth to treat ringing in the ears. It can also be used as an
aid in hearing external sounds and speech.
Multiflex Tinnitus Technology is a tool to generate sounds. It is recommended that this
tool be used with appropriate counseling and/or in a tinnitus management program to
relieve patients suffering from tinnitus.
TINNITUS THERAPY CONCEPTS AND BENEFITS
Multiflex Tinnitus Technology can be used as a part of a tinnitus treatment program.
Multiflex Tinnitus Technology plays a white noise through the hearing aid.
Multiflex Tinnitus Technology is programmed according to your hearing loss and
preference, and your hearing professional can adjust the settings of Multiflex Tinnitus
Technology to meet your needs.
Multiflex Tinnitus Technology may provide temporary relief of your tinnitus.
PRESCRIPTION USE ONLY
CAUTION:
Federal law restricts this instrument to sale by or on the order of a
doctor, audiologist or other hearing care practitioner licensed to dispense hearing
instruments 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 practitioner. Your
hearing professional will properly diagnose and fit the instrument 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 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.
