Indications For Use; Device Description - Siemens HS Manual Del Usuario

• U nusual side effects (e.g., dizziness, nausea, headaches, heart
palpitations).
• Perceived decrease in auditory function (e.g., decreased loudness,
speech not as clear).
WARNING
Risk of further impairment to the user's hearing health.
The volume of the tinnitus noiser can be set to a level which could lead to
permanent hearing damage when used for a prolonged period of time.
The tinnitus noiser should never be used at uncomfortable levels.
FOR HEARING CARE PROFESSIONALS

Indications for Use

The tinnitus noiser 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 21 years of
age. The tinnitus noiser is targeted for healthcare professionals treating
patients suffering from tinnitus, as well as conventional hearing
disorders. The fitting of the tinnitus noiser should be done by a hearing
care professional participating in a tinnitus management program.

Device Description

The tinnitus noiser is a software function that generates sound which is
programmed into a hearing instrument. Depending on the type of hearing
instrument, the hearing instrument may be used in up to three modes of
operation: as a hearing instrument, as a tinnitus treatment device, or as a
hearing instrument and tinnitus treatment device.
When enabled, the tinnitus noiser 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.
The tinnitus noiser generates a broadband 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. The
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