Starkey RIC 312, Operation Manual

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FDA Information
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.
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.