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Operations Manual

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48 | Regulatory
Information
Regulatory Information | 49
For the Patient
A
tinnitus therapy instrument
is an electronic
instrument
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
ONL
Y
CAUTION: Federal law
restricts
this
hearing
aid 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 instrument 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
hearing
aid to your
personal needs and
r
equirements
.
This should include its use in a prescribed
tinnitus treatment program
.
Your hearing professional
will also be able to
offer
the
appropriate follow-up car
e
.
It is
important
that you follow your hearing professional’s advice and direction
regarding
such car
e
.
WARNING: There are some potential concerns associated with the use of
any sound generating
tinnitus therapy instrument
.
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
hearing aid
.
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 hearing aid and seek a
consultation
with a medical,
audiology or other hearing
professional.
As with any
hearing
aid, misuse of the
tinnitus therapy instrument
could present
some
potentially harmful effects
.
Care
should
be
taken to
prevent
the
unauthorized
use and to keep the
hearing
aid out of the reach of children and pets
.
CAUTION: If set to the
maximum output
level and
worn
for periods of time
exceeding the
recommendations
below,
your
exposure to sound energy has the
potential to exceed noise exposure
limits.
You should not use your hearing aid
for more than sixteen
(16) hours
a day if
your
hearing aid is set at the maximum
output
level, nor should you use
your hearing
aid if
your hearing
professional
has set the
hearing
aid at levels that exceed
your comfort
level
.