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Intended use
diseases of the ear are often referred to as otolaryngologists, otologists or
otorhinolaryngologists. The purpose of the medical evaluation is to assure that all
medically treatable conditions that 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
that states 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.
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Intended use
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.
Required Custom Tinnitus+
Information for Hearing Care Professionals
™
INDICATIONS FOR USE
The Custom 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 Custom Tinnitus+
Technology is targeted for hearing care professionals, which
™
are treating patients suffering from tinnitus, as well as conventional hearing disorders.
The fitting of the Custom Tinnitus+
™
Technology must be done by a hearing care
professional participating in a Tinnitus Management Program.
INSTRUMENT DESCRIPTION
Custom 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 Custom Tinnitus+
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.
Custom 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.
™
Technology generates the sound and allows a
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