Bedienungsanleitung Starkey Tinnitus (Seite 16 von 21) (Englisch)

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FDA Information FDA 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 care 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 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.

Multiﬂex 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

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 care professional.

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Starkey Tinnitus Seite 16

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