Regulatory Information | 41
rating of 6 or greater would indicate “excellent performance”. See the Quick
Start Guide included with your hearing aid for the exact M/T rating of your
hearing aid.
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 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.
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.
