Safety Manual
32
DRAFT 2017-07-27
For Hearing Care Professionals
Indications for use
The tinnitus feature is a tool to generate sounds to be
used in a tinnitus management program to relieve patients
suering from tinnitus. The target population is primarily
the adult population over 21 years of age. The tinnitus
feature is targeted for healthcare professionals treating
patients suering from tinnitus, as well as conventional
hearing disorders. The tting of the tinnitus feature should
be done by a Hearing Care Professional participating in a
tinnitus management program.
Device description
The tinnitus feature is a software function that generates
sound which is programmed into a hearing inrument.
Depending on the type of hearing inrument, the hearing
inrument may be used in up to three modes of operation:
as a hearing inrument, as a tinnitus treatment device, or
as a hearing inrument and tinnitus treatment device.
When enabled, the tinnitus feature 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 feature generates a broadband noise
signal that varies in frequency and amplitude. These
characteriics are adjuable by the Hearing Care