Starkey ITE User manual

OPERATIONS MANUAL
ITE (In-The-Ear),
ITC (In-The-Canal),
CIC (Completely-In-Canal),
IIC (Invisible-In-The-Canal)
Custom
Products

3
My hearing instrument is a/an:
ITE (In-The-Ear)
See page 4
ITC (In-The-Canal)
See page 5
CIC (Completely-In-Canal)
See page 6
IIC (Invisible-In-The-Canal)
See page 7
My hearing instrument uses a:
13 battery (ITE) – Orange
312 battery (ITC) – Brown
10 battery (CIC) – Yellow
10 battery (IIC) – Yellow
Overview
ITE Overview � � � � � � � � � � � � � � � � � � � � � � � � � � 4
ITC Overview � � � � � � � � � � � � � � � � � � � � � � � � � � 5
CIC Overview � � � � � � � � � � � � � � � � � � � � � � � � � � 6
IIC Overview � � � � � � � � � � � � � � � � � � � � � � � � � � 7
Preparation
Batteries/Battery Indicators � � � � � � � � � � � � � � � 8
Insertion and Removal � � � � � � � � � � � � � � � � � � 11
Operation
Power On & Off � � � � � � � � � � � � � � � � � � � � � � � 12
User Controls � � � � � � � � � � � � � � � � � � � � � � � � � 12
Volume Control� � � � � � � � � � � � � � � � � � � � � � � � 13
Volume Control Indicators � � � � � � � � � � � � � � � 15
Memory Change � � � � � � � � � � � � � � � � � � � � � � 16
Mute � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 16
Multiflex Tinnitus Level Control � � � � � � � � � � � 17
Directional Settings � � � � � � � � � � � � � � � � � � � � 17
Telephone Use � � � � � � � � � � � � � � � � � � � � � � � � 17
Multiflex Tinnitus Technology � � � � � � � � � � � � � � � 20
Accessories
Wireless Accessories � � � � � � � � � � � � � � � � � � � 22
Hearing Instrument Care
Instrument Care � � � � � � � � � � � � � � � � � � � � � � � 23
Service and Repair � � � � � � � � � � � � � � � � � � � � � 27
Troubleshooting Guide � � � � � � � � � � � � � � � � � � � 28
Tips for Better Communication � � � � � � � � � � � � � � � 29
Safety Information � � � � � � � � � � � � � � � � � � � � � � � � � � � 31
FDA Information � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 34
FCC Information � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 40
Table of Contents Overview

4 5
Features, Controls and Identification
Your hearing instrument controls include:
1� Microphone
2� Battery compartment (on/off control)
3� Vent (optional)
4� Sound outlet (receiver) and wax protection
5� Multifunction button (optional)
6� Rotary volume control (optional)
Your hearing instrument can be identified by:
7� Location of serial number:
RED Right BLUE Left
Features, Controls and Identification
Your hearing instrument controls include:
1� Microphone
2� Battery compartment (on/off control)
3� Vent (optional)
4� Sound outlet (receiver) and wax protection
5� Multifunction button (optional)
6� Rotary volume control (optional)
Your hearing instrument can be identified by:
7� Location of serial number:
RED Right BLUE Left
ITE Battery Size: 13 ITC Battery Size: 312
Dual Control (Optional)
3
1
2
Multifunction
Button (Optional)
5
0
0
-
0
0
0
0
0
0
0
0
4
2
1
3
Dual Control (Optional)
Multifunction
Button (Optional)
5
Rotary Volume
Control (Optional)
6
Rotary Volume
Control (Optional)
6
7
0
0
-
0
0
0
0
0
0
0
0
7
4
ITE Overview ITC Overview

6 7
CIC Battery Size: 10 or 312
00-00000000
2
1
5
4
63
7
IIC Battery Size: 10
5
1
2
3
8
4
7
6
Features, Controls and Identification
Your hearing instrument controls include:
1� Microphone
2� Battery compartment (on/off control)
3� Vent (optional)
4� Sound outlet (receiver) and wax protection
5� Multifunction button (optional)
6� Removal handle
Your hearing instrument can be identified by:
7� Location of serial number:
RED Right BLUE Left
Features, Controls and Identification
Your hearing instrument controls include:
1� Microphone
2� Battery compartment (on/off control)
3� Vent (optional)
4� Removal handle
5� Sound outlet (receiver)
Your hearing instrument can be identified by:
6� Location of serial number
7� Side indicator R for Right, L for Left
8� White dot indicates the top of the
hearing instrument�
CIC Overview IIC Overview

8 9
3
1 2
4
5
Preparation Preparation
Batteries
Your hearing instrument uses a battery as its power
source� This battery size can be identified by the
orange (13), brown (312) or yellow (10) color code on
the packaging�
To insert or replace the battery:
1� Use the nail grip on the battery door�
2� Open the battery door gently and remove
the old battery�
3� Remove the colored tab from the new battery�
Wait 3-5 minutes after removing tab before
inserting battery�
4� Align the battery’s “+” sign (flat side of the battery)
with the “+” on the battery door�
5� Close the battery door�
Battery Indicators
An indicator will sound when the battery voltage is low�
You have approximately five minutes* to replace the
battery� An indicator may also sound just before the
battery stops working�
*Actual time between low battery indicator and shut down will vary depending on
environmental noise levels and brand of battery used.

10 11
Preparation Preparation
2
1
Insertion and Removal
To insert the hearing instrument:
1� Hold the instrument with your
thumb and forefinger on the
outer edges of the case�
2� Tilt your hand slightly forward
and gently insert the
canal tip of the instrument
into your ear canal and rotate the
instrument backward� Softly press
the instrument into place with
your fingertip�
To remove the hearing instrument:
Grasp the instrument with your thumb and forefinger;
gently rotate it as you pull outward�
For instruments with removal handle: grasp removal
handle and gently remove from ear�
Helpful Hints
• Minor irritation and/or inflammation may occur as
your ear becomes accustomed to having an object
in it; if so, please contact your hearing professional�
• If an actual allergic reaction occurs, alternative
materials are available; contact your hearing
professional�
• Severe swelling, discharge from the ear, excessive
wax or other unusual conditions warrant immediate
consultation with a physician�
WARNINGS
Batteries are dangerous if swallowed� To help
prevent the accidental ingestion of batteries:
Keep out of reach of children and pets�
Check your medications before taking them –
batteries have been mistaken for pills�
Never put batteries in your mouth, as they can
easily be swallowed�
NATIONAL BUTTON BATTERY INGESTION
HOTLINE: [phone]
Helpful Hints
• NEVER FORCE THE BATTERY DOOR SHUT� This
could result in serious damage; if the door will
not close securely, check that the battery is
inserted correctly�
• Do not open the battery door too far or damage
is likely to occur�
• Dispose of used batteries immediately in the
proper waste or recycling container�
• Batteries vary in size and performance� Your
hearing professional is your best source for lifespan
estimates and verification that you are using the
proper size and type�

12 13
Volume
Control
Memory
Change
Mute Multiflex
Tinnitus Level
Short Press
(Press and Release)
Long Press
(Press and Hold)
Operation Operation
Power On & Off
To turn ON:
Insert a battery and completely
close the battery door� Your
instrument has a power-on delay
which may require a few seconds�
You may hear a tone indicating
that your instrument is powered on�
To turn OFF:
Open the battery door until the battery is no longer
touching the battery contacts�
User Controls
Your hearing instrument’s user control may have been
customized by your hearing professional� Ask your
hearing professional how the user control on your
instrument is set�
Available User Control Functionality
The user control on your hearing
instrument can respond differently
depending on how long you activate
(press) the button� Your instrument
is capable of having one function
assigned to a short press (press and
release) and one function assigned
to a long press (press and hold)� The options selected
on the next page indicate how your user control is
configured�
Assigned User Control Settings
Volume Control
Power On Volume Level
Your hearing instrument has been set to a specific
volume level by your hearing professional� If sounds
are generally too loud or too soft, please contact
your hearing professional for advice and adjustment�
If your hearing instrument has been set up with a
user adjustable volume control, temporary volume
adjustments can be made�
Your instrument will always power on to the same
volume setting (Volume Home) determined by your
hearing professional�
Sprinkler Volume Control
If your user control is configured as a sprinkler volume
control, each time you activate the user control, the
volume of your hearing instrument changes�
Sprinkler volume control is configured by default to
automatically decrease in volume before it increases�
To make sounds louder, activate the user control�
Repeat this motion until you are at the minimum

14 15
 
Volume Level One*Two*
Volume Max 5 Beeps ••••• 5 Beeps •••••
Volume Step(s) Short Tone –4 Beeps ••••
Volume Home
(Power on volume level) 3 Beeps ••• 3 Beeps •••
Volume Step(s) Short Tone –2 Beeps ••
Volume Min Single Beep — 1 Beep •
Increase Volume
Decrease Volume
Operation Operation
setting� The next time you activate the user control,
the volume will increase one step� Continue to activate
the user control until you reach the desired loudness�
NOTE: If 10 minutes or more have passed since the last
volume change, the volume will automatically decrease
before it increases�
Up/Down Volume Control
If your user control is configured as a dedicated up/
down volume control, each time you activate the user
control, the volume of your hearing instrument always
changes in a specific direction (either up or down)� For
example, a short press and release may increase the
volume while a long press and hold may decrease the
volume in your hearing instrument�
Some user controls can be set for the Right instrument
to increase volume and the Left instrument to decrease
volume� Ask your hearing professional if this setting
would benefit you�
Rotary Volume Control
Your hearing instrument may
be equipped with a rotary
volume control� Ask your hearing
professional if you are not sure�
To make volume adjustments, use
your fingertip to rotate the volume
control�
1� To make sounds louder, continue to rotate the
control forward, toward your nose�
2� To make sounds softer, use
your fingertip to rotate the
control toward the back of
your head�
Volume Control Indicators
Your hearing professional may
enable audible indicators, which
highlight the current volume position�
* Depending on your hearing aid model, you will have one of these
indicator options as the default. Additional options may be enabled
by your hearing professional depending on hearing aid model
options.

16 17
My hearing instruments have the following
telephone setting(s):
Automatic Telephone Memory and
Automatic Telecoil
Manual Telephone Memory and
Manual Telecoil
(Memory #_________________)
None
Operation Operation
Memory Change
Your hearing professional may create
multiple memories within your
hearing instrument� These additional
memories can be accessed by
activating the user control on your
hearing instrument�
If your user control is configured
for memory changes, each time you activate the user
control, the memory of your hearing instrument will
increment through the available memories�
Memory Indicators
Your hearing professional may enable an audible
indicator, which is presented while making a memory
change� The indicator defaults to a voice identifying
which memory your instrument is in�
Mute
Long Press Mute
If your hearing instrument is configured with mute
functionality, a long press and hold of the user control
will mute your hearing instrument� If enabled by your
hearing professional, you may hear an indicator prior to
the hearing instrument muting� To unmute your hearing
instrument, long press and hold the user control until
audio is restored�
Multiflex Tinnitus Level Control
Your user control can also adjust the level of your
Multiflex Tinnitus stimulus� Please refer to the section
labeled Mutiflex Tinnitus Technology (on page 20) for
further information�
Directional Settings
Your hearing instrument may have a directional
microphone to help improve speech understanding in
noisy situations� Ask your hearing professional about
your particular directional settings�
Telephone Use
Your hearing instruments can be customized with
features to help you effectively communicate on the
telephone� Ask your hearing professional about your
telephone solution�

18 19
Operation Operation
Automatic Telephone Memory
and Automatic Telecoil
These options activate the telephone memory
automatically when used with a hearing instrument
compatible telephone� To use, place the telephone
receiver on your ear as you normally would and
the hearing instrument will automatically select the
telephone memory� It might be necessary to move the
telephone receiver slightly to find the best reception�
Once the telephone is removed from the ear, the
hearing instrument will switch back to the last used
memory�
NOTE: Consult with your hearing professional if your
instrument does not switch to the telephone memory
automatically, if it is enabled�
Manual Telephone Memory and
Manual Telecoil
Manual access allows you to switch
the hearing instruments into a
telephone or telecoil memory,
as needed� Ask your hearing
professional which memory you
should access for manual
telephone use�
General Telephone Use
Some hearing instruments work
best by holding the phone close
to, but not fully covering your
ear� In some instances, if you
encounter whistling (feedback),
tilt the receiver at an angle until
the whistling stops� Additionally,
the hearing instrument in the
non-phone ear (ear opposite
the phone) may switch to a
telephone setting to reduce
background sounds� Your
hearing professional can provide
instructions and techniques for
your specific needs�
Ear-to-Ear Phone Streaming
The telephone memory in your hearing instrument
may be equipped with an ear-to-ear phone streaming
option� When you enter your telephone memory, the
audio from your telephone will be streamed from
the phone ear’s hearing instrument to the opposite
ear’s hearing instrument� This allows you to hear the
telephone conversation in both ears� Ask your hearing
professional about your particular telephone settings�

20 21
Multiflex Tinnitus Technology Multiflex Tinnitus Technology
Introduction
Multiflex Tinnitus Technology can be used as a part
of a tinnitus treatment program� Multiflex Tinnitus
Technology plays a tinnitus stimulus through
the hearing instrument� The tinnitus stimulus is
programmed according to your hearing loss, and
your hearing professional can adjust the settings
of the tinnitus stimulus to meet your needs�
Sprinkler Tinnitus Stimulus Control
If your user control is configured as a sprinkler stimulus
control, each time you activate the user control, the
stimulus level in your hearing instrument changes�
Sprinkler stimulus control is configured by default to
automatically decrease in level before it increases�
To make the stimulus level louder, activate the user
control� Repeat this motion until you are at the
minimum setting� The next time you activate the user
control, the level will increase one step� Continue to
activate the user control until you reach the desired
loudness�
NOTE: If 10 minutes or more have passed since the
last stimulus level change, the level will automatically
decrease before it increases�
Up/Down Tinnitus Stimulus Control
If your user control is configured as a dedicated up/
down stimulus control, each time you activate the user
control, the stimulus level in your hearing instrument
always changes in a specific direction (either up or
down)� For example, a short press and release may
increase the stimulus level while a long press and
hold may decrease the stimulus level in your hearing
instrument�
Some user controls can be set for the Right instrument
to increase stimulus level and the Left instrument to
decrease stimulus level� Ask your hearing professional
if this setting would benefit you�

22 23
Hearing Instrument CareAccessories
Wireless Accessories*
There are several wireless accessories that allow you to
control and maximize the full potential of your hearing
instrument� Available functionality includes:
• Ability to adjust your instruments using a
remote control�
• Ability to transmit television audio directly
to your instruments�
• Ability to transmit remote microphone audio
directly to your instruments�
• Ability to transmit your cell phone conversation
directly to your instruments�
Consult with your hearing professional to determine if
your hearing instruments have wireless capabilities and
which accessories may be best for you�
*Wireless accessories are only compatible with hearing instruments that have 900 MHz
wireless technology.
Instrument Care
Keep your hearing instrument clean at all times� Heat,
moisture and foreign substances can result in poor
performance�
• Clean daily over a soft cloth to prevent damage
from a fall to a hard surface�
• Use a cleaning brush to clean debris from around
the microphone, receiver and battery compartment�
• Never use water, solvents, cleaning fluids or oil to
clean your instrument�
Your hearing professional can provide further information
on additional maintenance procedures for your hearing
instrument, if needed�
Helpful Hints
• When not wearing your hearing instruments, open
the battery door to allow any moisture to evaporate�
• Do not take apart your hearing instruments or insert
the cleaning tools inside them�
• When not in use, place your hearing instrument in
the storage container and store:
– In a dry, safe place
– Away from direct sunlight or heat to avoid extreme
temperatures
– Where you can easily find them
– Safely out of reach of pets and children

24 25
Wax Guard Small Microphone Cover
Guard
PKGS2603-01-EE-XX 81060-007 2/13 Rev. B
© 2013 All Rights Reserved.
Microphone cover
Hearing Instrument Care Hearing Instrument Care
Hear Clear™
Receiver Wax Guards
The hearing instrument
integrates disposable Hear
Clear earwax protection� The
innovative wax guards prevent
earwax accumulation in the
hearing instrument receiver�
Custom Microphone Cover
The custom microphone cover protects the microphone
from wax and debris� Your hearing professional will
instruct you on maintenance of
the microphone cover�
There are two sizes of custom microphone covers:
one is small and one is large� The size of the
microphone cover determines the method for
removing and replacing�

26 27
Large Microphone Cover
Guard
PKGS2605-01-EE-XX 81071-007 2/13 Rev. B
© 2013 All Rights Reserved.
Microphone cover
Hearing Instrument Care Hearing Instrument Care
Service and Repair
If, for any reason, your hearing instrument does not
operate properly, do NOT attempt to fix it yourself�
Not only are you likely to violate any applicable
warranties or insurance, you could easily cause
further damage�
Should your hearing instrument fail or perform
poorly, check the guide on the next page for possible
solutions� If problems continue, contact your hearing
professional for advice and assistance� Many common
problems may be solved in your hearing professional’s
office or clinic�

28 29
Tips for Better CommunicationHearing Instrument Care
Troubleshooting Guide
SYMPTOM POSSIBLE
CAUSES
SOLUTIONS
Not Loud
Enough
Low battery Replace battery
Blocked
earmold/tubing/
earbud
Clean or replace wax
guard as needed
Hearing change Contact your hearing
professional
Debris buildup Clean both microphone and
receiver with brush
Inconsistent
Performance
Low battery Replace battery
Blocked
earmold/tubing/
earbud
Clean or replace wax
guard as needed
Unclear,
Distorted
Performance
Low battery Replace battery
Blocked
earmold/tubing/
earbud
Clean or replace wax
guard as needed
Defective hearing
instrument Contact your hearing professional
Dead
Low battery Replace battery
Blocked
earmold/tubing Clean or replace wax guard as needed
Crimped tubing Contact your hearing
professional
Your hearing professional will recommend an
appropriate schedule to help you adapt to your new
hearing instrument� It will take practice, time and
patience for your brain to adapt to the new sounds that
your hearing instrument provides� Hearing is only part
of how we share thoughts, ideas and feelings� Reading
lips, facial expressions and gestures can help the
learning process and add to what amplification alone
may miss�
Please review the following simple communication tips:
For You
• Move closer to and look at the speaker
• Sit face-to-face in a quiet room
• Try different locations to find the best place to
listen
• Minimize distractions
• Background noises may be frustrating at first;
remember, you have not heard them for a while
• Let others know what you need; keep in mind that
people cannot “see” your hearing loss
• Develop realistic expectations of what your hearing
instruments can and cannot do
• Better hearing with hearing instruments is a learned
skill combining desire, practice and patience

30 31
Safety InformationTips for Better Communication
For Your Family and Friends
Your family and friends are also affected by your
hearing loss� Request that they:
• Get your full attention before beginning to speak
• Look at you or sit face-to-face in a quiet room
• Speak clearly and at a normal rate and level;
shouting can actually make understanding more
difficult
• Rephrase rather than repeat the same words;
different words may be easier to understand
• Minimize distractions while speaking
Safety Information
INTENDED USE: An air conduction hearing instrument
is a wearable sound-amplifying device intended to
compensate for impaired hearing� Hearing instruments
are available in multiple gain/output levels appropriate
to treat hearing losses ranging from mild-to-profound�
Your hearing instruments are designed to comply
with the most stringent Standards of International
Electromagnetic Compatibility� However, it is still
possible that you may experience interference caused
by power line disturbances, airport metal detectors,
electromagnetic fields from other medical devices,
radio signals and electrostatic discharges�
If you use other medical devices or wear implantable
medical devices such as defibrillators or pacemakers
and are concerned that your hearing instruments might
cause interference with your medical device, please
contact your physician or the manufacturer
of your medical device for information about the risk
of disturbance�
Your hearing instruments should not be worn during
an MRI procedure or in a hyperbaric chamber�
Your hearing instruments are classified as a Type B
applied part under the IEC 60601-1 medical device
standard�
Your hearing instruments are not fully certified to
operate in explosive atmospheres that may be found
in coal mines or certain chemical factories�

32 33
Safety Information Safety Information
Your hearing instruments should be stored within the
temperature and humidity ranges of -40oC (-40oF) to
+60oC (140oF) and 10 to 95 percent rH�
Your hearing instruments are designed to operate
beyond the range of temperatures comfortable to you,
from very cold up to 50oC (122oF)�
Use on Aircraft*
The optional wireless capabilities that may be featured
in your hearing instruments can be used on an aircraft
as hearing instruments are exempt from the rules
applied to other personal electronic devices on an
aircraft�
International Use*
The optional wireless capabilities that may be featured
in your hearing instruments are approved to operate at
a radio frequency specific to your country or region and
might not be approved for use outside your country or
region� Be aware that operation during international
travel may cause interference to other electronic
devices, or other electronic devices may cause
interference to your hearing instruments�
We are required by regulations to provide the following
warnings:
WARNING: Use of wireless hearing aids directly next to
other electronic equipment should be avoided because
it could result in improper performance� If such use is
*Applies to wireless hearing instruments only.
necessary, note as to whether your hearing aids and the
other equipment are operating normally�
WARNING: Use of accessories, components or
replacement parts other than those provided by the
manufacturer of your hearing aids could result in
increased electromagnetic emissions and decreased
electromagnetic immunity and could result in
degradation of performance�
WARNING: If Portable Radio Frequency communications
equipment is used closer than 30 cm (12 inches) from
your hearing aid, degradation of the performance of
your hearing aid could result� If this occurs, move away
from the communications equipment�

34 35
Required Information
The following additional information is provided in compliance with U�S�
Food and Drug Administration (FDA) regulations:
WARNING TO HEARING AID DISPENSERS.
A hearing aid dispenser should advise a prospective hearing aid user to
consult promptly with a licensed physician (preferably an ear specialist)
before dispensing a hearing aid if the hearing aid dispenser determines
through inquiry, actual observation or review of 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�
vi� Audiometric air bone-gap equal to or greater than 15 decibels at 500
Hertz (Hz), 1,000 Hz and 2,000 Hz�
vii� Visible evidence of significant cerumen accumulation or a foreign
body in the ear canal�
viii� Pain or discomfort in the ear�
IMPORTANT NOTICE FOR PROSPECTIVE
HEARING AID USERS.
Good health practice requires that a person with a hearing loss have a
medical evaluation by a licensed physician (preferably a physician who
specializes in diseases of the ear) before purchasing a hearing aid�
Licensed physicians who specialize in diseases of the ear are often referred
to as otolaryngologists, otologists or otorhynolaringologists� The purpose
of the medical evaluation is to assure that all medically treatable conditions
that may affect hearing are identified and treated before the hearing aid
is purchased�
Following the medical evaluation, the physician will give you a
written statement that states that your hearing loss has been medically
evaluated and that you may be considered a candidate for a hearing aid�
FDA Information FDA Information
The physician will refer you to an audiologist or hearing aid dispenser,
as appropriate, for a hearing aid evaluation�
The audiologist or hearing aid dispenser will conduct a hearing aid
evaluation to assess your ability to hear with and without a hearing aid�
The hearing aid evaluation will enable the audiologist or dispenser to
select and fit a hearing aid to your individual needs�
If you have reservations about your ability to adapt to amplification,
you should inquire about the availability of a trial-rental or purchase-option
program� Many hearing aid dispensers now offer programs that permit
you to wear a hearing aid for a period of time for a nominal fee after which
you may decide if you want to purchase the hearing aid�
Federal law restricts the sale of hearing instruments to those individuals
who have obtained a medical evaluation from a licensed physician� Federal
law permits a fully informed adult to sign a waiver statement declining
the medical evaluation for religious or personal beliefs that preclude
consultation with a physician� The exercise of such a waiver is not in your
best health interest and its use is strongly discouraged�
A hearing aid will not restore normal hearing and will not prevent or
improve a hearing impairment resulting from organic conditions� Use
of a hearing aid is only part of hearing habilitation and may need to be
supplemented by auditory training and instruction in lip reading� In most
cases infrequent use of a hearing aid does not permit a user to attain full
benefit from it� Special care should be exercised in selecting and fitting a
hearing aid whose maximum sound pressure level exceeds 132 decibels
because there may be risk in impairing the remaining hearing of the
hearing aid user�
CHILDREN WITH HEARING LOSS.
In addition to seeing a physician for a medical evaluation, a child with
a hearing loss should be directed to an audiologist for evaluation
and rehabilitation since hearing loss may cause problems in language
development and the educational and social growth of a child� An
audiologist is qualified by training and experience to assist in the
evaluation and rehabilitation of a child with a hearing loss�

36 37
FDA Information FDA 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 instruments 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�

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FDA Information FDA Information
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�
As with any device, misuse of the tinnitus therapy device could present
some potentially harmful effects� Care should be taken to prevent the
unauthorized use and to keep the device out of the reach of children
and pets�
CAUTION: If set to the maximum output level and worn for periods of
time exceeding the following recommendations, your exposure to sound
energy has the potential to exceed noise exposure limits� You should not
use your hearing device for more than sixteen (16) hours a day if your
device is set at the maximum output level, nor should you use your device
if your hearing professional has set the device at levels that exceed
your comfort level�
Some hearing instrument users have reported a buzzing sound in their
hearing instrument when they are using mobile phones, indicating that
the mobile phone and hearing instrument may not be compatible�
According to the ANSI C63�19 standard (ANSI C63�19-2007 American
National Standard Methods of Measurement of Compatibility Between
Wireless Communications Devices and Hearing Aids), the compatibility
of a particular hearing instrument and mobile phone can be predicted by
adding the rating for the hearing instrument immunity to the rating for the
mobile phone emissions� For example, the sum of a hearing instrument
rating of 2 (M2/T2) and a telephone rating of 3 (M3/T3) would result in
a combined rating that equals at least 5 would provide “normal use”; a
combined rating of 6 or greater would indicate “excellent performance”�
See the Product Card included with your hearing aid for the exact M/T
rating of your hearing instrument�
Important Notice for Prospective
Sound Generator Users
Good health practice requires that a person with tinnitus have a medical
evaluation by a licensed physician (preferably a physician who specializes
in diseases of the ear) before using a sound generator� Licensed
physicians who specialize in diseases of the ear are often referred to as
otolaryngologists, otologists or otorhinolaryngologists�
The purpose of a medical evaluation is to assure that all medically treatable
conditions that may affect tinnitus are identified and treated before the
sound generator instrument is used�
TECHNICAL DATA
Multiflex Tinnitus Technology Maximum Output = 87 dB SPL (typical) when
measured in a 2cc coupler per ANSI S3�22 or IEC 60118-7�
WIRELESS TECHNICAL DESCRIPTION
Your hearing aids may contain a radio transceiver operating in the 902-
928 MHz (North America) or 863-865 MHz (EU) frequency band with
a maximum effective radiated power of -20 dBm with transmission
modulation type of 342KFXD� The receiver section of the radio has a
bandwidth of 300kHz�
This hearing aid model has been tested to, and has passed, the following
emissions and immunity tests:
• IEC 60601-1-2 radiated emissions requirements for a Group 1
Class B device as stated in CISPR 11�
• RF radiated immunity at a field level of 10 V/m between 80 MHz
and 2�7 GHz as well as higher field levels from communications
devices as stated in Table 9 of IEC 60601-1-2�
• Immunity to power frequency magnetic fields at a field level of
30 A/m�
• Immunity to ESD levels of +/- 8 kV conducted discharge and +/-
15 kV air discharge�