Page 1
BTE (Behind-The-Ear)
Standard
Products
OPERATIONS MANUAL
Page 2
Table of Contents
Hearing Aid
Hearing Aid Controls
Push Button Controls p. 4
Rocker Switch Controls p. 6
Size 312 Battery - Brown Size 13 Battery - Orange
Overview
Push Button mini BTE 312 Overview . . . . . . . . . . . . . . . . . 4
Rocker Switch BTE 13 Overview . . . . . . . . . . . . . . . . . . . . 6
Preparation
Batteries/Battery Indicators . . . . . . . . . . . . . . . . . . . . . . . . 8
Insertion and Removal . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Operation
Power On & Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
User Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Volume Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Volume Control Indicators . . . . . . . . . . . . . . . . . . . . . . . . 20
Memory Change . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Mute . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
BiCROS Balance Control . . . . . . . . . . . . . . . . . . . . . . . . . 22
Multiflex Tinnitus Level Control . . . . . . . . . . . . . . . . . . . . 22
Directional Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Telephone Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
CROS/BiCROS Technology . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Multiflex Tinnitus Technology . . . . . . . . . . . . . . . . . . . . . . . . 27
Accessories
Wireless Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Hearing Aid Care
Hearing Aid Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Standard Tubing/Thin Tubing . . . . . . . . . . . . . . . . . . . . . 31
Service and Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Troubleshooting Guide . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Tips for Better Communication . . . . . . . . . . . . . . . . . . . . . . . 35
Regulatory Information
Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
FDA Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
FCC Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Page 3
Push Button mini BTE 312 Overview | 5 4 | Push Button mini BTE 312 Overview
8
9
10
00-000000
Serial Number
Features, Controls and Identification
Your hearing aid controls include:
1. Earhook
2. Microphones
3. Push button (user control)
4. Battery compartment (on/off control)
5. Location of left/right side indicator
RED is for right ear, BLUE is for left ear
Your hearing aid 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
1
2
3
4
5
7
6
Page 4
8
9
10
4
2
1
3
5
7
6
00-000000
Serial Number
Rocker Switch BTE 13 Overview | 7 6 | Rocker Switch BTE 13 Overview
Features, Controls and Identification
Your hearing aid controls include:
1. Earhook
2. Microphone
3. Rocker switch (user control)
4. Battery compartment (on/off control)
5. Location of left/right side indicator
RED is for right ear, BLUE is for left ear
Your hearing aid can be identified by:
6. Location of serial number
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
Page 5
Preparation | 9 8 | Preparation
Batteries
Your hearing aid 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 finger pick 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.
21
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5
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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
Preparation | 11 10 | Preparation
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
clinician is your best source for lifespan estimates
and verification that you are using the proper size
and type.
Page 7
Preparation | 13 12 | Preparation
Insertion and Removal
To insert the custom earmold and hearing aid:
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 aid and custom earmold:
Take the hearing aid 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.
21
4
3
5
Page 8
Preparation | 15 14 | 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.
To remove the hearing aid and
comfort earbud or custom eartip:
• Remove the lock from the
concha bowl of your ear.
• Remove the hearing aid from
behind your ear.
• Gently grasp the tubing at the
opening of the ear canal and
pull outward.
1
2
3
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 clinician.
• If an actual allergic reaction occurs, alternative
earmold materials are available; contact your
clinician.
• Severe swelling, discharge from the ear, excessive
wax or other unusual conditions warrant immediate
consultation with a physician.
Page 9
Operation | 17 16 | Operation
Power On & Off
To turn ON:
Insert a battery and completely close the battery
door. Your hearing aid has a power-on delay and
may require a few seconds to power on. You
may hear a tone indicating that your hearing aid
is fully powered on.
To turn OFF:
Open the battery door until the battery is no
longer touching the battery contacts.
User Controls
Your hearing aid’s user control may have been
customized by your clinician. Ask your clinician
how the user control on your hearing aid is set.
Available User Control
Functionality
The user control on your hearing
aid can respond differently
depending on how long you
activate (press) the button. Your
hearing aid 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 particular user control
is configured.
Page 10
Operation | 19 18 | Operation
Assigned User Control Settings
Volume Control
Power On Volume Level
Your hearing aid has been set to a specific volume
level by your clinician. If sounds are generally too
loud or too soft, please contact your clinician for
advice and adjustment.
Your hearing aid will always power-on to the same
volume setting (Volume Home) determined by
your clinician.
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 aid 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 aid 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 aid.
Some user controls can be set for the right hearing
aid to increase volume and the left hearing aid to
decrease volume.
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.
Volume
Control
Memory
Change
Mute
Multiflex
Tinnitus Level
Balance
Control
Short Press
(Press and Release)
Long Press
(Press and Hold)
Page 11
Operation | 21 20 | Operation
Volume Control Indicators
Your clinician 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 clinician depending on
hearing aid model options.
Memory Change
Your clinician may create multiple memories within
your hearing aid. These additional memories can
be accessed by activating the user control on your
hearing aid.
If your user control is configured for memory
changes, each time you activate the user control, the
memory of your hearing aid will increment through
the available memories.
Memory Indicators
Your clinician may enable an audible indicator, which
is presented while making a memory change. The
indicator defaults to a voice identifying which memory
your hearing aid is in.
Mute
Long Press Mute
If your hearing aid is configured with mute
functionality, a long press and hold of the user
control will mute your hearing aid. If enabled by
your clinician, you may hear an indicator prior to the
hearing aid muting. To unmute your hearing aid,
long press and hold the user control until audio is
restored.
My hearing aid is configured with the
following control:
Press and Release Volume Control.
Press and Hold Volume Control.
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 •
Page 12
Operation | 23 22 | Operation
BiCROS Balance Control
Your user control on the transmitter can also adjust
the balance between your hearing aid and transmitter.
Please refer to the section labeled CROS/BiCROS
Technology (page 26) for further information.
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 (page 27) for
further information.
Directional Settings
Your hearing aid may have a directional microphone
to help improve speech understanding in noisy
situations. Ask your clinician about your particular
directional settings.
Telephone Use
Your hearing aids can be customized with features to
help you effectively communicate on the telephone.
Ask your clinician about your telephone solution.
Automatic Telephone Memory
and Automatic Telecoil
These options activate the telephone memory
automatically when used with a hearing aid compatible
telephone. To use, place the telephone receiver on
your ear as you normally would and the hearing aid
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 aid will switch
back to the last used memory.
NOTE: Consult with your clinician if your hearing
aid does not switch to the telephone memory
automatically, if it is enabled.
My hearing aids have the following
telephone setting(s):
Automatic telephone memory and automatic
telecoil.
Manual telephone memory and manual telecoil.
See next page. (Memory # _________________ ).
None
Page 13
Operation | 25 24 | Operation
Manual Telephone Memory and Manual Telecoil
Manual access allows you to switch the hearing aids
into a telephone or telecoil memory, as needed. Ask
your clinician which memory you should access for
manual telephone use.
General Telephone Use
Some hearing aids 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 aids in the non-phone
ear (ear opposite the phone) may
switch to a telephone setting to
reduce background sounds. Your
clinician can provide instructions
and techniques for your
specific needs.
Ear-to-Ear Phone Streaming
The telephone memory in your hearing aid 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 aid to the opposite ear’s hearing aid.
This allows you to hear the telephone conversation
in both ears. Ask your clinician about your particular
telephone settings.
Page 14
Introduction
A Contralateral Routing of Signals (CROS) hearing
system is a type of hearing aid 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 only 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 aid 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.
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
the transmitter is streamed to your hearing aid.
When CROS streaming begins you may hear an
alert tone. If for any reason the CROS stream is
unexpectedly interrupted you may also hear an
alert tone. Please ask your clinician about your
particular settings.
Multiflex Tinnitus Technology | 27 26 | CROS/BiCROS 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 aid. The tinnitus stimulus is programmed
according to your hearing loss, and your clinician
can adjust the settings of the tinnitus stimulus to
meet your needs.
Sprinkler 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 aid 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.
Page 15
Accessories | 29
My hearing aid is configured with the
following control:
Press and Release Tinnitus Stimulus Control.
Press and Hold Tinnitus Stimulus Control.
28 | Multiflex Tinnitus Technology
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 aid 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 aid.
Some user controls can be set for the right hearing aid
to increase stimulus level and the left hearing aid to
decrease stimulus level.
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.
Wireless Accessories
*
There are several wireless accessories that allow you
to control and maximize the full potential of your
hearing aids. Available functionality includes:
• Ability to adjust your hearing aid using a remote
control.
• Ability to transmit television audio directly to your
hearing aids.
• Ability to transmit remote microphone audio
directly to your hearing aids.
• Ability to transmit your cell phone conversation
directly to your hearing aids.
Consult with your clinician to determine if your
hearing aids have wireless capabilities and which
accessories may be best for you.
* Wireless accessories are only compatible with hearing aids that have 900 MHz
wireless technology.
Page 16
Hearing Aid Care | 31 30 | Hearing Aid Care
Hearing Aid Care
Keep your hearing aid 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 hearing aid.
Your clinician can provide further information on
additional maintenance procedures for your hearing
aid, if needed.
My hearing aid has:
Standard Tubing. See next page.
Thin Tubing. See next page.
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 clinician can provide further information
on additional maintenance procedures for your
hearing aid, if needed.
Thin Tubing
1. Unscrew the tubing from
the tip of the hearing aid.
2. Thread cleaner through
the tubing, starting at the
end just removed from the
hearing aid, until it extends
from the other end of
the tubing.
1
2
1
Page 17
Hearing Aid Care | 33 32 | Hearing Aid Care
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 it to dry
overnight.
6. When completely dry, reassemble the thin tubing
to the hearing aid.
Helpful Hints
• Make sure the custom earmold/earbud/
eartip and tubing are completely dry before
reconnecting to your hearing aid earhook.
• When not wearing your hearing aid, open the
battery door to allow any moisture to evaporate.
• Do not take apart your hearing aids or insert the
cleaning tools inside them.
• When not in use, remove the batteries
completely; place your hearing aid 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 children and pets
Service and Repair
If, for any reason, your hearing aid 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 aid fail or perform poorly, check
the guide on the next page for possible solutions. If
problems continue, contact your clinician for advice
and assistance. Many common problems may be
solved right in your clinician’s office or clinic.
Page 18
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 clinician
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
Hearing aid
needs repair/
maintenance
Contact your clinician
Dead
Low battery Replace battery
Blocked
earmold/tubing
Clean or replace wax
guard as needed
Crimped tubing Contact your clinician
Tips for Better Communication | 35 34 | Hearing Aid Care
Your clinician will recommend an appropriate
schedule to help you adapt to your new hearing
aid. It will take practice, time and patience for your
brain to adapt to the new sounds that your hearing
aid 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 aids can and cannot do
• Better hearing with hearing aids is a learned skill
combining desire, practice and patience
Page 19
*Applies to wireless hearing aids only.
Regulatory Information | 37 36 | 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
• 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 aid is a wearable sound-
amplifying device intended to compensate for impaired hearing. Hearing aids
are available in multiple gain/output levels appropriate to treat hearing losses
ranging from mild-to-profound.
Your hearing aids 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 aids 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 aids should not be worn during an MRI procedure or in a hyperbaric
chamber.
Your hearing aids are classified as a Type B applied part under the IEC 60601-1
medical device standard.
Your hearing aids are not fully certified to operate in explosive atmospheres that
may be found in coal mines or certain chemical factories.
Your hearing aids should be stored within the temperature and humidity ranges
of -40°C (-40°F) to +60°C (140°F) and 10%-95% rH.
Your hearing aids are designed to operate beyond the range of temperatures
comfortable to you, from very cold up to 50°C (122°F).
Use on Aircrafts
*
The optional wireless capabilities that may be featured in your hearing aids can be
used on an aircraft as hearing aids are exempt from the rules applied to other
personal electronic instruments on an aircraft.
International Use
*
Your hearing aids 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 aids.
Page 20
Regulatory Information | 39 38 | Regulatory Information
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 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.
Required Hearing Aid 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. The physician will refer you to an
audiologist or hearing aid dispenser, as appropriate, for a hearing aid evaluation.
Page 21
Regulatory Information | 41 40 | Regulatory Information
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 aids 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.
Some hearing aid users have reported a buzzing sound in their hearing aid
when they are using mobile phones, indicating that the mobile phone and
hearing aid 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 aid and mobile phone can be
predicted by adding the rating for the hearing aid immunity to the rating for
the mobile phone emissions. For example, the sum of a hearing aid 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 your Quick Start
Guide or the Product Card included with your hearing aid for the exact M/T
rating of your hearing aid.
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.
For Clinicians
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
clinician 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 clinician 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 clinician 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 clinician.
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.
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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 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 clinician 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 instrument 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 clinician 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 clinician will also be able to offer the appropriate follow-up care. It is
important that you follow your clinician’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 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 instrument and seek a consultation with a medical,
audiology or other clinician.
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 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 clinician has set the
instrument at levels that exceed your comfort level.
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 300 kHz.
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.
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Regulatory Information | 45 44 | Regulatory Information
• 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 communication 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.
REGULATORY NOTICES
BTE 312 and BTE 13
FCC ID: EOA-EXPSTANDARD
IC: 6903A-EXPSTANDARD
Power Plus BTE 13
FCC ID: EOA-MUSEPOWER13
IC: 6903A-MUSEPOWER13
FCC NOTICE
This hearing aid complies with part 15 of the FCC rules and with ISED
Canada license-exempt RSS standards. Operation is subject to the following
two conditions: (1) This hearing aid may not cause harmful interference, and (2)
this hearing aid must accept any interference received, including interference
that may cause undesired operation of the hearing aid.
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.
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
page 45 or from docs.starkeyhearingtechnologies.com
Waste from electronic equipment
must be handled according to
local regulations
Consult Operations Manual
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
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NotesNotes
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© 2018 Starkey. All Rights Reserved. 86136 -600 4/18 BKLT2990-00-EE-GS
www.starkey.com
6700 Washington Ave. S.
Eden Prairie, MN 55344
1.800.328.8602
*For technical support of hearing devices with wireless connectivity
Veteran technical support line*:
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