Starkey Laboratories MUSEPOWER13 Muse P+ BTE 13, MUSE iQ P+ BTE 13 User Manual

Starkey Laboratories Inc Muse P+ BTE 13, MUSE iQ P+ BTE 13

user manual

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Date Submitted2017-11-06 00:00:00
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Document TitleBKLT2847-02-EE-XX - SPIII17 Generic BTE Operations Manual SMALL
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BTE
(Behind-The-Ear)
O P E RAT I O N S M A N UA L
Hearing Instrument
Size 312 Battery - Brown Size 13 Battery - Orange
Instrument Controls
Push Button Controls p. 14
Rocker Switch Controls p. 6
Table of Contents
Overview
Push Button mini BTE 312 Overview 
Rocker Switch BTE 13 Overview.............................6
Preparation
Batteries/Battery Indicators 
Insertion and Removal 
12
Table of Contents
Operation
Power On & Off 
User Controls 
Volume Control 
Volume Control Indicators 
Memory Change 
Mute 
BiCROS Balance Control 
Multiflex Tinnitus Level Control 
Directional Settings 
Telephone Use 
CROS/BiCROS Technology 
Multiflex Tinnitus Technology 
Accessories
Wireless Accessories 
Hearing Instrument Care
Instrument Care 
Standard Tubing/Thin Tubing 
Service and Repair 
Troubleshooting Guide 
Tips for Better Communication 
Safety Information 
FDA Information 
FCC Information 
16
16
17
20
21
22
22
23
23
23
28
30
33
34
35 - 37
38
39
40
43
47
57
Push Button mini BTE 312 Overview
Features, Controls and Identification
Your hearing instrument controls
include:
1. Earhook
2. Microphones
3. Push Button (user control)
4. Battery compartment (on/off control)
5.	Location of left/right side instrument
indicator RED is for right ear, BLUE is for
left ear
Your hearing instrument can be
identified by:
6.	Location of serial number (inside the
battery compartment)
7.	Location of manufacturer’s name and
model name
Comfort Fit Solutions:
8. Standard Earmold with tubing
9. Thin tube with Comfort Earbud
10. Thin tube with Custom Eartip
Push Button mini BTE 312 Overview
10
Serial Number
00-000000
Rocker Switch BTE 13 Overview
Features, Controls and Identification
Your hearing instrument controls include:
1. Earhook
2. Microphone
3. Rocker Switch (user control)
4. Battery compartment (on/off control)
5. Side indicator
RED is for right ear, BLUE is for left ear
Your hearing instrument can be
identified by:
6. Location of serial number
7. L ocation of manufacturer’s name
and model name
Comfort Fit Solutions:
8. Standard Earmold with tubing
9. Thin tube with Comfort Earbud
10. Thin tube with Custom Eartip
Rocker Switch BTE 13 Overview
Serial Number
00-000000
10
Preparation
Batteries
Your hearing instrument uses a battery as its
power source. This battery size can be identified
by the brown (312) or orange (13) 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 shutdown will vary
depending on environmental noise levels and brand of battery used.
Preparation
Preparation
Helpful Hints
10
•
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.
Preparation
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: 202-625-3333
11
Preparation
Insertion and Removal
To insert the Custom Earmold
and hearing instrument:
1.	Hold the Custom Earmold with your
thumb and forefinger on the outer side
near the tubing.
2.	Tilt your hand slightly forward and
gently insert the canal tip of the Custom
Earmold into your ear canal.
3. Rotate the Custom Earmold backward.
4.	Softly press the Custom Earmold into
place with your fingertip.
5.	Carefully place the BTE behind your ear
wrapping the earhook over the top of
your ear.
To remove the hearing instrument
and Custom Earmold:
Take the instrument from behind your ear
and gently pull the Custom Earmold outward.
Pulling lightly down on the earlobe may help
loosen the Custom Earmold as it is removed.
12
Preparation
13
Preparation
Comfort Earbud or Custom Eartip
To insert the Comfort Earbud or
Custom Eartip:
1.	Insert the Comfort
Earbud/Custom Eartip
into your ear canal.
2.	Gently wrap the BTE
over your ear until it rests
securely behind your ear.
3.	Place the lock in the
concha bowl of your ear.
14
Preparation
To remove the hearing instrument and
Comfort Earbud or Custom Eartip:
•
Remove the lock from the concha bowl
of your ear.
•
Remove the hearing instrument from
behind your ear.
•
Gently grasp the tubing at the opening
of the ear canal and pull outward.
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 earmold 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.
15
Operation
Power On & Off
To turn ON:
Insert a battery and completely close the battery
door. Your instrument has a power on delay and
may require a few seconds to power on. You
may hear a tone indicating that your instrument
is fully powered on.
To turn OFF:
 pen 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
16
Operation
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
Memory
Change
Mute
Multiflex
Tinnitus Level
Short Press
(Press & Release)
Long Press
(Press & Hold)
Volume Control
Power On Volume Level
Your hearing instrument has been set to
a specific volume level by your hearing
17
Operation
professional. If sounds are generally too
loud or too soft, please contact your hearing
professional for advice and adjustment.
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.
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
18
Operation
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.
Rocker Switch Volume Control
If your rocker switch is configured to control
volume, pressing the top part of the
switch increases the volume while pressing
the lower portion of the switch decreases
volume.
My hearing aid is configured with the
following control:
Press and Release Volume Control.
Press and Hold Volume Control.
19
Operation
Volume Control Indicators
Your hearing professional may enable
audible indicators, which highlight the
current volume position.


One*
Two*
5 Beeps •••••
5 Beeps •••••
Volume Step(s)
Short Tone –
4 Beeps ••••
Volume Home
3 Beeps •••
3 Beeps •••
Volume Step(s)
Short Tone –
2 Beeps ••
Single Beep —
1 Beep •
Volume Level
Volume Max
(Power on volume level)
Volume Min
20
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 saying “One, Two, Three
or Four” to identify which memory your
instrument is in.
21
Operation
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.
BiCROS Balance Control
Your user control on the transmitter can
also adjust the balance between your
hearing instrument and transmitter. Please
refer to the section labeled CROS/BiCROS
Technology (on page 28) for further
information.
22
Operation
Multiflex Tinnitus Level Control
Your user control can also adjust the level
of your Multiflex Tinnitus stimulus. Please
refer to the section labeled Multiflex
Tinnitus Technology (on page 30) 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.
23
Operation
My hearing instruments have the following
telephone setting(s):
	Automatic Telephone Memory and
Automatic Telecoil. See below.
	Manual Telephone Memory and
Manual Telecoil. See next page.
(Memory # ________________ ).
None
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
24
Operation
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.
25
Operation
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.
26
Operation
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.
27
CROS/BiCROS Technology
Introduction
A Contralateral Routing Of Signals (CROS)
hearing system is a type of hearing
instrument that is used to treat unilateral
hearing loss. It takes sound from the ear with
poorer hearing and transmits it to the ear
with better hearing. CROS picks up sound
from the unaidable ear, while BiCROS picks
up sound from both ears. This helps the
patient to receive sounds from both sides of
the head without the head-shadow effect.
Balance Control
Your hearing system uses the button to adjust
the balance between the hearing instrument
and the transmitter. This control adjusts the
level of sound coming from the transmitter.
Press and release the button until the desired
level is reached. Each press and release
changes the balance level one increment.
NOTE: Balance Control is only applicable for
BiCROS memories.
28
CROS/BiCROS Technology
CROS Streaming
Your hearing system is equipped with
a CROS transmitter. When you enter a
memory with either CROS or BiCROS
streaming enabled, audio from
transmitter is streamed to your hearing
instrument. When CROS streaming begins
you may hear an alert tone. If for some
reason the CROS stream is unexpectedly
interrupted you may also hear an alert tone.
Please ask your hearing professional about
your particular settings.
29
Multiflex Tinnitus Technology Operation
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.
30
Multiflex Tinnitus Technology Operation
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.
31
Multiflex Tinnitus Technology Operation
Rocker Switch Tinnitus Stimulus
Control
If your rocker switch is configured for
Tinnitus Stimulus Control, pressing the top
part of the switch increases the stimulus
level while pressing the bottom part of the
switch decreases the stimulus level.
My hearing aid is configured with the
following control:
Press and Release Tinnitus Stimulus Control.
Press and Hold Tinnitus Stimulus Control.
32
Accessories
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.
33
Hearing Instrument Care
Instrument Care
Keep your hearing instrument clean at all
times. Heat, moisture and foreign substances
can result in poor performance.
•
Use a cleaning brush or soft cloth to
clean debris from around the user
control, microphone 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.
My hearing instrument has:
		 Standard Tubing. See next page.
Thin Tubing. See page 36.
34
Hearing Instrument Care
Standard Tubing
1.	Separate the Custom
Earmold from the BTE
by gently pulling the
tubing away from the
earhook.
– Use a soft, damp
cloth or a cleaning
brush to clean debris
from the Custom
Earmold
– Wash the Custom
Earmold with warm
soapy water
– Never use solvents
2.	Slide the Custom
Earmold tubing onto
the BTE earhook when
completely dry.
Your hearing professional can provide
further information on additional
maintenance procedures for your hearing
instrument, if needed.
35
Hearing Instrument Care
Thin Tubing
1.	Unscrew the tubing
from the tip of the
hearing instrument.
2.	Thread cleaner through
the tubing, starting at
the end just removed
from the hearing
instrument, until it
extends from the other end of the tubing.
3.	Brush the debris off prior to removing
cleaner.
4.	Clean the Earbud/Eartip with a dry cloth
or brush.
5.	If necessary, the Earbud/Eartip may be
washed in warm, soapy water. Remove
the Earbud/Eartip from the tubing prior
to washing. Allow the Earbud/Eartip to
dry overnight.
6.	When completely dry, reassemble the
Thin Tubing to the hearing instrument.
36
Hearing Instrument Care
Helpful Hints
•
Make sure the Custom Earmold/
Earbud/Eartip and tubing are
completely dry before reconnecting
to your hearing instrument earhook.
•	When not wearing your hearing
instrument, 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, remove the batteries
completely; place your hearing
instrument in the storage container
and store:
– In a dry, safe place
– A
 way from direct sunlight or heat
to avoid extreme temperatures
– Where you can easily find them
– Safely out of reach of pets & children
37
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 right in your
hearing professional’s office or clinic.
38
Troubleshooting Guide
SYMPTOM
Not Loud
Enough
POSSIBLE
CAUSES
SOLUTIONS
Low battery
Replace battery
Blocked
earmold/tubing/
earbud
Clean or replace wax
guard as needed
Hearing change
Debris buildup
Inconsistent
Performance
Unclear,
Distorted
Performance
Dead
Contact your
hearing professional
Clean both
microphone and
receiver with brush
Low battery
Replace battery
Blocked
earmold/tubing/
earbud
Clean or replace wax
guard as needed
Low battery
Replace battery
Blocked
earmold/tubing/
earbud
Clean or replace wax
guard as needed
Hearing instrument
needs repair/
maintenance
Contact your
hearing professional
Low battery
Replace battery
Blocked
earmold/tubing
Clean or replace wax
guard as needed
Crimped tubing
Contact your
hearing professional
39
Tips for Better Communication
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
40
•
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
Tips for Better Communication
•
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
41
Tips 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
42
•
Rephrase rather than repeat the same
words; different words may be easier
to understand
•
Minimize distractions while speaking
Safety Information
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-toprofound.
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
43
Safety Information
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.
Your hearing instruments should be stored
within the temperature and humidity ranges
of -40oC (-40oF) to +60oC (140oF) and 10%95% rH.
Your hearing instruments are designed to
operate beyond the range of temperatures
comfortable to you, from very cold up to
50oC (122oF).
44
Safety Information
Use on Aircrafts*
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 instruments on an
aircraft.
International Use*
Your hearing instruments are approved to
operate at a radio frequency that is 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 instruments, or
other electronic instruments 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
*Applies to wireless hearing instruments only
45
Safety Information
should be avoided because it could result
in improper performance. If such use is
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.
46
FDA Information
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.
47
FDA Information
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 otorhinolaringologists. 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. 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.
48
FDA Information
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.
49
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.
INSTRUMENT 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
instrument or as a hearing aid and tinnitus treatment
instrument.
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.
50
FDA Information
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 on
51
FDA Information
the next page, the patient’s exposure to sound energy
has the potential to exceed noise exposure limits. This
instrument 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 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.
52
FDA Information
PRESCRIPTION USE ONLY
CAUTION: Federal law restricts this instrument 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
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 instrument 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
53
FDA Information
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 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 instrument.
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 instrument and
seek a consultation with a medical, audiology or other
hearing professional.
As with any instrument, 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 instrument 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 instrument for more than sixteen (16) hours
a day if your instrument is set at the maximum output
level, nor should you use your instrument if your hearing
professional has set the instrument at levels that exceed
your comfort level.
54
FDA Information
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.
55
FDA Information
TECHNICAL DATA
Multiflex Tinnitus Technology Maximum Output = 87dB
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 863865 MHz (EU) frequency band with a maximum effective
radiated power of -20dBm 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.
56
FCC Information
REGULATORY NOTICES
FCC ID: EOA-MUSEPOW ER13
IC: 6903A-MUSEPOW ER13
(Muse P+ BTE 13, A4 P+ BTE 13, Start 1200 P+ BTE 13,
Start 1000 P+ BTE 13, AGXsm P+ BTE 13, Summit P+ BTE
13, Muse iQ P+ BTE 13, A4 iQ P+ BTE 13, Start iQ 1200 P+
BTE 13, Start iQ 1000 P+ BTE 13, AGXsm iQ P+ BTE 13
Summit iQ P+ BTE 13)
FCC/IC NOTICE
This instrument complies with part 15 of the FCC rules and
with ISED Canada’s license-exempt RSS standard(s).
Operation is subject to the following two conditions: (1)
This instrument m ay not cause harmful interference, and
(2) this instrument must accept any interference received,
including interference that may cause undesired operation
of the instrument.
Note: The manufacturer is not responsible for any radio
or TV interference caused by unauthorized modifications
to this equipment. Such modifications could void the
user’s authority to operate the equipment.
Cet appareil est conforme à la partie 15 des règles de la
FCC et avec les normes RSS de licence d’Industrie
Canada. Le fonctionnement est soumis à deux
conditions: (1) Cet appareil ne doit pas causer
d’interférences nuisibles et (2) cet appareil doit accepter
toute interference reçue, y compris les interférences qui
peuvent causer des fonctionnements du dispositif
57
FCC Information
Note: Le manufacturier n’est pas responsable de
l’interférence créée par la modification de cet équipement
lors de l’écoute du téléviseur ou de la radio. De telles
modifications pourraient entrainer la révocation de l’autorité
de l’utilisateur à opérer cet équipement.
Hereby, Starkey Hearing Technologies declares that
the BTE is in compliance with the essential requirements
and other relevant provisions of Directive 2014/53/EU.
A copy of the Declaration of Conformity can be obtained from
the addresses on the following page or from
docs.starkeyhearingtechnologies.com
Starkey Hearing Technologies
6700 Washington Ave. South
Eden Prairie, MN 55344 USA
Wm. F. Austin House, Bramhall Technology Park
Pepper Road, Hazel Grove, Stockport SK7 5BX
United Kingdom
Waste from electronic equipment must be
handled according to local regulations
58
Notes
59
0086
© 2017 Starkey Hearing Technologies. All Rights Reserved.
85001-007 6/17 BKLT2847-02-EE-XX

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Family Name                     : Avenir LT Std, Avenir LT Std, Avenir LT Std, Avenir LT Std, Avenir LT Std, Mr Eaves XL San OT, Avenir LT Std, Wingdings
Face Name                       : 45 Book, 45 Book Oblique, 65 Medium, 85 Heavy, 95 Black, Reg, 55 Roman, Regular
Font Type                       : OpenTypeCFFFont, OpenTypeCFFFont, OpenTypeCFFFont, OpenTypeCFFFont, OpenTypeCFFFont, OpenTypeCFFFont, OpenTypeCFFFont, TrueType
Version String                  : OTF 1.029;PS 001.001;Core 1.0.33;makeotf.lib1.4.1585, OTF 1.029;PS 001.001;Core 1.0.33;makeotf.lib1.4.1585, Version 1.030;PS 001.001;Core 1.0.38;makeotf.lib1.6.6565, OTF 1.029;PS 001.002;Core 1.0.33;makeotf.lib1.4.1585, OTF 1.029;PS 001.001;Core 1.0.33;makeotf.lib1.4.1585, Version 1.000;PS 001.000;hotconv 1.0.57;makeotf.lib2.0.21895, OTF 1.029;PS 001.001;Core 1.0.33;makeotf.lib1.4.1585, Version 1.31
Composite                       : false, false, false, false, false, false, false, false
Page Count                      : 60
EXIF Metadata provided by EXIF.tools
FCC ID Filing: EOA-MUSEPOWER13

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