Regulatory Information | 47 46 | Regulatory Information
The Multiflex Tinnitus Technology is targeted for healthcare professionals, which
are treating patients suffering from tinnitus, as well as conventional hearing
disorders. The fitting of the Multiflex Tinnitus Technology must be done by a
hearing professional participating in a Tinnitus Management Program.
INSTRUMENT 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 instrument or as a
hearing aid and tinnitus treatment instrument.
When enabled, the Multiflex Tinnitus Technology generates the sound and allows
a patient’s hearing 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 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 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 hearing aid 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 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 hearing aid to sale by or on the order
of a doctor, audiologist or other hearing care practitioner 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 practitioner.
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.
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 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.
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