Regulatory Information | 43
42 | Regulatory Information
IMPORTANT NOTICE FOR PROSPECTIVE
HEARING AID USERS
Good health practice requires that a person with a hearing loss have a medical
evaluation by a licensed physician (preferably a physician who specializes
in diseases of the ear) before purchasing a hearing aid� Licensed physicians
who specialize in diseases of the ear are often referred to as otolaryngologists,
otologists or otorhynolaringologists� The purpose of the medical evaluation
is to assure that all medically treatable conditions which may affect hearing are
identified and treated before the hearing aid is purchased�
Following the medical evaluation, the physician will give you a written statement
affirming that your hearing loss has been medically evaluated and that you may
be considered a candidate for a hearing aid� The physician will refer you to an
audiologist or hearing aid dispenser, as appropriate, for a hearing aid evaluation�
The audiologist or hearing aid dispenser will conduct a hearing aid evaluation
to assess your ability to hear with and without a hearing aid� The hearing aid
evaluation will enable the audiologist or dispenser to select and fit a hearing
aid to your individual needs�
If you have reservations about your ability to adapt to amplification, you should
inquire about the availability of a trial-rental or purchase-option program� Many
hearing aid dispensers now offer programs that permit you to wear a hearing aid
for a period of time for a nominal fee after which you may decide if you want to
purchase the hearing aid�
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�
Special care should be exercised in selecting and fitting a hearing aid whose
maximum sound pressure level exceeds 132 decibels because there may be risk in
impairing the remaining hearing of the hearing aid user�
Some hearing aid users have reported a buzzing sound in their hearing aid when
they are using mobile phones, indicating that the mobile phone and hearing aid
may not be compatible� According to the ANSI C63�19 standard (ANSI C63�19-2007
American National Standard Methods of Measurement of Compatibility Between
Wireless Communications Devices and Hearing Aids), the compatibility of a particular
hearing aid and mobile phone can be predicted by adding the rating for the hearing
aid immunity to the rating for the mobile 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 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�
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