Regulatory Information | 27
26 | Regulatory Information
phone emissions� For example, the sum of a hearing aid rating of 2 (M2/T2) and
a telephone rating of 3 (M3/T3) would result in a combined rating that equals
at least 5 would provide “normal use”; a combined rating of 6 or greater would
indicate “excellent performance”� See the Product Card or 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�
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 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 device 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 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 professional can adjust the settings of Multiflex
Tinnitus Technology to meet your needs�
Multiflex Tinnitus Technology may provide temporary relief of your tinnitus�
