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FDA Information FDA Information
Federal law restricts the sale of hearing aids to those
individuals who have obtained a medical evaluation from a
licensed physician. Federal law permits a fully informed adult
to sign a waiver statement declining the medical evaluation
for religious or personal beliefs that preclude consultation
with a physician. The exercise of such a waiver is not in your
best health interest and its use is strongly discouraged.
A hearing aid will not restore normal hearing and will not
prevent or improve a hearing impairment resulting from
organic conditions. Use of a hearing aid is only part of
hearing habilitation and may need to be supplemented by
auditory training and instruction in lip reading. In most cases
infrequent use of a hearing aid does not permit a user to
attain full benefit from it.
CHILDREN WITH HEARING LOSS. In addition to
seeing a physician for a medical evaluation, a child with
a hearing loss should be directed to an audiologist for
evaluation and rehabilitation since hearing loss may cause
problems in language development and the educational
and social growth of a child. An audiologist is qualified
by training and experience to assist in the evaluation and
rehabilitation of a child with a hearing loss.
For hearing care professionals
INDICATIONS FOR USE
The Multiflex Tinnitus Technology is a tool to generate
sounds to be used in a Tinnitus Management Program to
relieve patients suffering from tinnitus. The target population
is primarily the adult population over 18 years of age.
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.
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.
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