Starkey Hearing Technologies CIC, Руководство по эксплуатации

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Regulatory Information | 39
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�
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 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�