Operation Manual

45
FDA Information
For hearing care 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 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.
Multiflex Tinnitus Technology generates a broadband
white noise signal that varies in frequency and amplitude.