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DEVICE DESCRIPTION
Multiflex Tinnitus Technology is a software function that generates sound
which is programmed into a hearing aid. The hearing aid may be used in
one of three modes of operation: as a hearing aid, as a tinnitus treatment
device, or as a hearing aid and tinnitus treatment device.
When enabled, the Multiflex Tinnitus Technology generates the sound
and allows a patient’s hearing care professional to design and program
appropriate settings for an individually prescribed sound treatment plan.
The treatment plan should be used in a tinnitus management program for
relief of tinnitus.
Multiflex Tinnitus Technology generates a broadband white noise signal
that varies in frequency and amplitude. These characteristics are adjustable
by the hearing care professional and are specific to the prescribed therapy
designed by the professional for the patient’s needs and comfort.
The patient may have some control of the level or volume of the signal and
the patient should discuss this adjustment as well as his or her comfort level
and sound of the signal with their hearing care professional.
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 device is
intended for use for a maximum of sixteen (16) hours a day when set at the
maximum output level.
FDA Information
For the patient
A tinnitus therapy device is an electronic device 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 care 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 device 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 device should be only
on the advice and in consultation with your audiologist or hearing care
practitioner. Your hearing care professional will properly diagnose and fit
the device to your personal needs and requirements. This should include its
use in a prescribed tinnitus treatment program.
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.
FDA Information
