Troubleshooting Guide

Regulatory Information | 49 48 | Regulatory Information
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�
CAUTION: If set to the maximum output level and worn for periods of time
exceeding the recommendations below, the patient’s exposure to sound energy has
the potential to exceed noise exposure limits� This device is intended for use for a
maximum of sixteen (16) hours a day when set at the maximum output level�
For the Patient
A tinnitus therapy device is an electronic device intended to generate noise of
sufficient intensity and bandwidth to treat ringing in the ears� It can also be used
as an aid in hearing external sounds and speech�
Multiflex Tinnitus Technology is a tool to generate sounds� It is recommended
that this tool be used with appropriate counseling and/or in a tinnitus
management program to relieve patients suffering from tinnitus�
TINNITUS THERAPY CONCEPTS AND BENEFITS
Multiflex Tinnitus Technology can be used as a part of a tinnitus treatment program�
Multiflex Tinnitus Technology plays a white noise through the hearing aid�
Multiflex Tinnitus Technology is programmed according to your hearing loss and
preference, and your hearing professional can adjust the settings of Multiflex
Tinnitus Technology to meet your needs�
Multiflex Tinnitus Technology may provide temporary relief of your tinnitus�
PRESCRIPTION USE ONLY
CAUTION: Federal law restricts this device to sale by or on the order
of a doctor, audiologist or other hearing care practitioner licensed to dispense
hearing aids in your state�
The use of any sound generating tinnitus therapy device should be only on the
advice and in consultation with your audiologist or hearing care practitioner� Your
hearing professional will properly diagnose and fit the device to your personal
needs and requirements� This should include its use in a prescribed tinnitus
treatment program�
Your hearing professional will also be able to offer the appropriate follow-up care�
It is important that you follow your hearing professional’s advice and direction
regarding such care�
WARNING: There are some potential concerns associated with the use
of any sound generating tinnitus therapy device� Among them are the potential
for worsening of tinnitus, a possible change in hearing thresholds and possible
skin irritation at the point of contact with the device�
Multiflex Tinnitus Technology has been designed to minimize these concerns�
However, should you experience or notice any of the above conditions or any
dizziness, nausea, headaches or heart palpitations, you should immediately
discontinue use of the device and seek a consultation with a medical, audiology
or other hearing professional�