Safety Manual

36
■ Chronic skin irritation on, near, or around the site of
device placement.
■ Unusual side e󰘯ects (e.g., dizziness, nausea,
headaches, heart palpitations).
■ Perceived decrease in auditory function (e.g.,
decreased loudness, speech not as clear).
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 su󰘯ering 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 su󰘯ering 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 in󰘵rument.
Depending on the type of hearing in󰘵rument, the
hearing in󰘵rument may be used in up to three modes
of operation: as a hearing in󰘵rument, as a tinnitus
treatment device, or as a hearing in󰘵rument 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