User's Manual

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FDA InformationFDA 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 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.