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User Manual | Users Manual | 1.66 MiB | August 24 2021 | |||
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1 | User Manual | Users Manual | 1.66 MiB | August 24 2021 |
Table of Contents
Hearing Aid
My hearing aid is a:
CIC (Completely-In-Canal)
Table of Contents
Overview
CIC Overview
Preparation
Insertion and Removal
Operation
Power On & Off
Auto On/Off
User Controls
Edge Mode
Volume Control
Volume Control Indicators
4
11
12
13
13
14
15
17
Table of Contents
Memory Change 18
18
19
19
19
Mute
Multiflex Tinnitus Level Control
Directional Settings
Telephone Use
Multiflex Tinnitus Technology
Fall Alert
Introduction
Auto Alert
Manual Alert
Alert Cancellation
Contacts
Auto Alert Sensitivity
Indicators
Mobile Phone Use
Pairing with an iOS Device
Pairing with an Android Device
Accessories
Accessories
Hearing Aid Care
Hearing Aid Care
Service and Repair
Troubleshooting Guide
Tips for Better Communication
Regulatory Information
Safety Information
FDA Information
FCC Information
23
25
25
25
26
26
27
28
29
30
32
33
34
38
39
42
44
46
51
4
Adjustment
6 | CIC Overview
Features, Controls and Identification
Your hearing aid 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 aid can be identified by:
7. Location of serial number:
RED is for right ear, BLUE is for left ear
7
1
2
3
5
4
6
CIC Battery Size: 312
7
6
4
8
1
2
3
5
Preparation | 11
Insertion and Removal
To insert the hearing aid:
1� Hold the hearing aid 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 hearing aid into your
ear canal and rotate the
hearing aid backward� Softly
press the hearing aid into
place with your fingertip�
To remove the hearing aid:
Grasp the hearing aid with your
thumb and forefinger; gently rotate
it as you pull outward�
1
2
For hearing aids with removal handle: grasp removal
handle and gently remove from ear�
12 | Preparation
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�
Power On & Off
ON - The hearing aids will power on automatically
after removing them from the charger� There is a
delay that allows you time to insert your hearing
aid into your ear�
ON - If the hearing aid is manually powered off,
pressing the push button will power it on� The
delay still exists, to give you time to insert the
hearing aid in your ear�
OFF - The hearing aids will power off automatically
when placed on the charging posts� Charging
will proceed�
OFF - The hearing aids can be powered off manually
by pressing the push button for three seconds�
Operation | 13
Auto On/Off
Your hearing aid may support the ability to
automatically go into a low-powered state to conserve
battery*� This control can be configured by your
hearing professional or via the Thrive Hearing Control
app� Place your hearing aid on a flat, stable surface
(e�g�, a table) with the tip facing upwards and it will
go into a low-powered state after about 15 minutes�
To resume normal hearing aid function, pick up your
hearing aid and place it in your ear� Your hearing aid
will detect this motion and switch back on again� You
may hear a tone indicating that your hearing aid is
powered on�
*Going into a low-powered state helps conserve
battery consumption when used with rechargeable
hearing aids that are charged on a daily basis�
User Controls
Your hearing aid’s user control may have been
customized by your hearing professional� Ask your
hearing professional 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
14 | Operation
Operation | 15
hold). The options selected on the next
page indicate how your user control is
configured.
Assigned User Control Settings
Short Press
(Press & Release)
Long Press
(Press & Hold)
Tap Gesture*
Tap Gesture
Your hearing aid may support an
additional user control. This control can be configured
by your hearing professional. Once configured,
while the hearing aid is in your ear simply double tap
directly on the device with one or two fingers.
Edge Mode
Your hearing aid may have an additional feature.
Edge Mode works to identify and create a temporary,
real-time adjustment tailored for challenging
environments, Upon activation, your hearing aids use
an environmental scan to bring comfort and clarity,
Ask your hearing professional for more information,
Volume Control
Memory Change
Mute
Multiflex Tinnitus Level
Start/Stop Accessory
Streaming
Accessory Volume
Thrive Assistant
Balance Control
Manual Alert
Edge Mode
*Hearing aid may support
Volume Control
Power On Volume Level
Your hearing aid has been set to a specific volume level
(Volume Home) determined by your hearing professional.
If sounds are generally too loud or too soft, please contact
your hearing professional for advice and adjustment.
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.
16 | Operation
Operation | 17
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. Ask your hearing professional if this
setting would benefit you.
Volume Control Indicators
Your hearing professional may enable audible
indicators, which highlight the current volume position.
Volume Home (Power-on volume level)
3 Beeps •••
Volume Level
Volume Max
Volume Step(s)
Volume Step(s)
Volume Min
Tone
5 Beeps •••••
Short Tone –
Short Tone –
Single Beep •
My hearing aid is configured with the following control:
Press and Release Volume Control
Press and Hold Volume Control
Battery Indicators
An indicator will sound when the battery voltage is
low� You have approximately 30 minutes* of battery life
remaining. 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 your use of the product.
18 | Operation
Memory Change
Your hearing professional
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 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 hearing aid is in.
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 hearing
professional, you may hear an indicator prior to the
hearing aid muting.
Operation | 19
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 23) for
further information.
Activity and Engagement
Your hearing aid may support a sensor that is capable
of tracking body and brain health and reporting it to
the Thrive app. You can easily view and manage your
health information and receive daily feedback on your
progress by viewing your Thrive Wellness Score.
Directional Settings
Your hearing aid 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 aids can be customized with features to
help you effectively communicate on the telephone.
Ask your hearing professional about your telephone
solution.
20 | Operation
Operation | 21
My hearing aids 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 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 hearing professional if your
hearing aid 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 aids into
a telephone or telecoil
memory, as needed. Ask
your hearing professional
which memory you should
access for manual telephone
use.
22 | Operation
Multiflex Tinnitus Technology | 23
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 aid 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�
Introduction
Multiflex Tinnitus Technology can be used as 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 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 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�
24 | Multiflex Tinnitus Technology
Fall Alert | 25
Up/Down Tinnitus Stimulus Control
Introduction
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� Ask your hearing
professional if this setting would benefit you�
Fall Alert can be used to notify others should you fall
or experience a non-fall-related event� This feature
can be configured to send an SMS text message to
predefined contacts� Fall Alert can be configured to
send automated and/or manually-initiated alerts�
Auto Alert
If Auto Alert has been activated in the Thrive app
on your smartphone, the sensors in your hearing
aid(s) will monitor your head movement to detect
a fall automatically� When a fall is detected, a text
message will be initiated by the Thrive app on your
smartphone� An SMS text message will be sent to
a maximum of three predefined contacts, notifying
them of the detected fall event� The SMS text
message will contain a link from which each contact
can confirm receipt of the message and view a map,
indicating your location�
WARNING: Auto Alert may not detect 100 percent
of falls�
Manual Alert
My hearing aid is configured with the following control:
Press and Release Tinnitus Stimulus Control
Press and Hold Tinnitus Stimulus Control
If the user control on your hearing aid(s) has been
configured for Manual Alert by your hearing
professional, and there is a confirmed contact in
the Thrive app, a long “press and hold” of the user
control will initiate an alert text message by the Thrive
26 | Fall Alert
Fall Alert | 27
app on your smartphone� An SMS text message will
be sent to a maximum of three predefined contacts,
notifying them of the alert� The SMS text message will
contain a link from which each contact can confirm
receipt of the message and view a map, indicating
your location�
Alert Cancellation
An Auto Alert or Manual Alert can be cancelled from
either your hearing aid(s) or your smartphone� To
cancel an SMS alert text message from your hearing
aid(s), press the user control on either hearing aid� Fall
Alert messages can be cancelled within the 60 or 90
second preselected cancellation time following alert
initiation� It may take up to 20 seconds for a fall alert
to be automatically initiated�
Contacts
You can identify up to three contacts to whom you
would like alert text messages sent� You must enter
the name and smartphone number for each contact
into the Thrive app on your smartphone� Each of your
contacts will receive an SMS text message prompting
them to confirm participation in your Fall Alert system�
Auto Alert Sensitivity
You can adjust your Auto Alert Sensitivity in the
Thrive app� Increasing the sensitivity may increase the
likelihood of detecting a fall� Decreasing the sensitivity
may help reduce the probability of false alerts�
WARNING: Decreasing the Auto Alert Sensitivity
may prevent some falls from being detected by your
Fall Alert system�
For example, Auto Alert may not detect a fall if:
• The Sensitivity setting is not appropriate for
the user�
a fall�
• The fall is very slow, or you slide down gradually�
• You get up and begin walking immediately after
As a reminder, you can initiate a Manual Alert if Auto
Alert does not detect a fall� Manual Alert must be
configured by your hearing professional before it can
be used�
WARNING: Auto Alert may initiate false alerts� To
prevent false-alert text messages from being sent to
your contact(s), you may cancel the alert from either
your smartphone or by pressing the user control on
either hearing aid�
Adjustment | 29
Mobile Phone Use
Your hearing aid is designed to work with a
smartphone� When the hearing aid is paired and
powered on, incoming phone calls will route
automatically to your hearing aid�
iOS allows you to select a preference for how audio
(call audio and media audio) is routed from your
smartphone to your hearing aids�
28 | Fall Alert
Indicators
Speech indicators will play through your hearing aid(s)
when:
• You have successfully initiated a Manual Alert�
• A fall has been automatically detected�
• At least one contact has confirmed receipt of the
alert text message�
• You have successfully cancelled an alert via the
user control on the hearing aid�
A tonal indicator will play through your hearing aid(s)
when:
• There has been a communication failure during
the transmission of an alert text message�
• There has been a communication failure during
the cancellation of an alert text message�
WARNING: To reduce Fall Alert communication
failures:
• Your hearing aid(s) need to be powered on,
paired and connected with your smartphone
using Bluetooth® connectivity�
• The mobile device must be powered on, with
the Thrive app open (in the foreground or
background)�
• The mobile device must have a connection to the
internet (via a cellular network or WiFi)�
30 | Adjustment
Adjustment | 31
Pairing Your Hearing Aid with an iOS Device
To adjust your hearing aid with your iOS device, you
must pair the two together so they can communicate�
Please follow the instructions to pair your iOS device
and your hearing aid�
1�
Ensure Bluetooth setting is enabled on your iOS
device� Within the Settings menu go to Bluetooth
and toggle to On�
select memory or use your iOS device as a remote
microphone�
Select Start Live Listen to stream the iOS device
microphone input directly into your hearing aid� Point
the iOS device microphone toward the audio source�
To minimize background noise and provide the best
signal, place the iOS device as close to the source
as possible�
2� Turn your hearing aids off and back on� This puts
the hearing aids in pairing mode�
Right Volume/Left Volume allows you to increase
and decrease volume for each hearing aid individually�
Turn off Adjust Independently to make changes to
both hearing aids simultaneously�
Normal indicates the name of a memory setting in
the hearing aid� You can select from any memories
shown in the list to change the hearing aid to that
memory setting�
3�
Within the Settings menu go to Accessibility >
Hearing Devices.
• You will see your hearing aid name (e�g� “Chris
Hearing Aids”) when the iOS device first
discovers your hearing aids�
• If your name does not appear in the “Devices”
list within 5–7 seconds, tap Accessibility in the
upper left corner, then tap Hearing Devices�
You are now ready to use your iOS device to adjust
your hearing aid� You can adjust either with the native
iOS controls or with the Thrive app�
To access the native iOS hearing aid controls, triple-
click the Home button (iPhone 8 or earlier) or the side
button (iPhone X and newer) on your iOS device� For
additional configuration options, please consult Apple
support� From this screen you can adjust the volume,
32 | Adjustment
Accessories | 33
Pairing Your Hearing Aid with an
Android Device
To adjust your hearing aid with your Android device,
you must use the Thrive app and pair the two
together so they can communicate� Please follow the
instructions to pair your device and your hearing aid�
Tap the Settings icon on your device�
Ensure Bluetooth is On�
1�
2�
3�
4� When the hearing aids are discovered, you
will see your first name followed by Hearing
Aid (“Michelle’s Hearing Aid”) under Available
Devices� You will see this for each device�
5� Tap the hearing aid name to connect each
hearing aid to the device�
Accessories
There are several accessories that allow you to control
and maximize the full potential of your hearing aids�
Available functionality includes:
• Ability to adjust your hearing aids using a remote
control
hearing aids
• Ability to transmit television audio directly to your
Consult with your hearing professional to determine
which accessories may be best for you�
Turn your hearing aids off and back on� This puts
the hearing aids in pairing mode�
• Ability to transmit remote microphone audio
directly to your hearing aids
34 | Hearing Aid Care
Hearing Aid Care | 35
Hearing Aid Care
Helpful Hints
Keep your hearing aid 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 and receiver�
• Never use water, solvents, cleaning fluids
or oil to clean your hearing aid�
Your hearing professional can provide further
information on additional maintenance procedures
for your hearing aid, if needed�
• Do not take apart your hearing aids or insert the
cleaning tools inside them�
• When not in use, place hearing aids in charging
case and store:
– In a dry, safe place
– Away from direct sunlight and heat to avoid
extreme temperatures
– Where you can easily find them
– Safely out of reach from children and pets
36 | Hearing Aid Care
Hearing Aid Care | 37
Hear Clear Receiver Wax Guards
The hearing aid integrates disposable Hear Clear
earwax protection� The innovative wax guards prevent
earwax accumulation in the hearing aid receiver�
When you need to replace your wax guards, please
follow the instructions below�
1�
Insert empty end of the application stick straight
into used wax guard in hearing aid�
2� Pull straight out (do not twist) on stick to remove
used wax guard�
3� Use opposite end of stick to firmly insert clean
wax guard straight into hearing aid�
4� Pull straight out (do not twist) to remove stick
and discard�
1
2
3
4
38 | Hearing Aid Care
Hearing Aid Care | 39
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.
Service & 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 hearing professional
for advice and assistance. Many common problems
may be solved in your hearing professional’s office or
clinic.
Troubleshooting Guide
SYMPTOM
SOLUTIONS
POSSIBLE
CAUSES
Blocked
microphone or
receiver
Clean or replace wax
guard as needed
Not Loud
Enough
Hearing change
Contact your hearing
professional
Inconsistent
Performance
Unclear,
Distorted
Performance
Dead
Debris buildup
Blocked
microphone or
receiver
Blocked
microphone or
receiver
Clean both microphone
and receiver with brush
Clean or replace wax
guard as needed
Clean or replace wax
guard as needed
Blocked vent
Clean vent
Defective
hearing aid
Contact your hearing
professional
Replace battery
Dead Battery
Blocked
microphone or
receiver
Clean or replace wax
guard as needed
42 | Tips for Better Communication
Tips for Better Communication | 43
For Your Family & 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
Your hearing professional 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
44 | Regulatory Information
Regulatory Information | 45
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 formally certified to operate in explosive atmospheres
that may be found in coal mines or certain chemical factories.
95% rH
10% rH
-10 C
45 C 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).
Any serious incident that has occurred in relation to your Starkey device should
be reported to your local Starkey Hearing Technologies representative and
the Competent Authority of the Member State in which you are established. A
serious incident is defined as any malfunction, deterioration in the characteristics
and/or performance of the device, or inadequacy in the device Operations
Manual/ labeling which could lead to the death or serious deterioration in the
state of health of the user, OR could do so upon recurrence.
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 devices on an aircraft.
International Use*
The optional wireless capabilities that may be featured in your hearing aids 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 aids.
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.
*Applies to wireless hearing aids only.
46 | Regulatory Information
Regulatory Information | 47
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�
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 the Product Card or Quick Start Guide
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�
48 | Regulatory Information
Regulatory Information | 49
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
iv� Acute or chronic dizziness�
90 days�
90 days�
v� Unilateral hearing loss of sudden or recent onset within the previous
CAUTION: If set to the maximum output level and worn for periods of time
exceeding the recommendations below, the patient’s exposure to sound energy has
the potential to exceed noise exposure limits� This device is intended for use for a
maximum of sixteen (16) hours a day when set at the maximum output level�
For the Patient
A tinnitus therapy device is an electronic device intended to generate noise of
sufficient intensity and bandwidth to treat ringing in the ears� It can also be used
as an aid in hearing external sounds and speech�
Multiflex Tinnitus Technology is a tool to generate sounds� It is recommended
that this tool be used with appropriate counseling and/or in a tinnitus
management program to relieve patients suffering from tinnitus�
TINNITUS THERAPY CONCEPTS AND BENEFITS
Multiflex Tinnitus Technology can be used as a part of a tinnitus treatment program�
Multiflex Tinnitus Technology plays a white noise through the hearing aid�
Multiflex Tinnitus Technology is programmed according to your hearing loss and
preference, and your hearing professional can adjust the settings of Multiflex
Tinnitus Technology to meet your needs�
Multiflex Tinnitus Technology may provide temporary relief of your tinnitus�
PRESCRIPTION USE ONLY
CAUTION: Federal law restricts this device to sale by or on the order
of a doctor, audiologist or other hearing care practitioner licensed to dispense
hearing aids in your state�
The use of any sound generating tinnitus therapy device should be only on the
advice and in consultation with your audiologist or hearing care practitioner� Your
hearing professional will properly diagnose and fit the device to your personal
needs and requirements� This should include its use in a prescribed tinnitus
treatment program�
Your hearing professional will also be able to offer the appropriate follow-up care�
It is important that you follow your hearing professional’s advice and direction
regarding such care�
WARNING: There are some potential concerns associated with the use
of any sound generating tinnitus therapy device� Among them are the potential
for worsening of tinnitus, a possible change in hearing thresholds and possible
skin irritation at the point of contact with the device�
Multiflex Tinnitus Technology has been designed to minimize these concerns�
However, should you experience or notice any of the above conditions or any
dizziness, nausea, headaches or heart palpitations, you should immediately
discontinue use of the device and seek a consultation with a medical, audiology
or other hearing professional�
50 | Regulatory Information
Regulatory Information | 51
REGULATORY NOTICES
FCC ID: EOA-24LIVIOCIC
IC: 6903A-24LIVIOCIC (Evolv AI CIC, Arc AI CIC, Envy AI CIC, Savant AI CIC, AGXs evolv AI CIC)
FCC NOTICE
This device 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 device may not cause harmful interference, and (2) this
device must accept any interference received, including interference that
may cause undesired operation of the device.
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 règlements de la FCC ainsi qu’aux cahiers des
charges sur les normes radioélectriques relativement aux appareils exempts de licence
d’ISDE Canada. Son fonctionnement est assujetti aux deux conditions suivant es : (1) cet
appareil ne doit pas causer d’interférence nuisible, et (2) cet appareil doit accepter toute
interférence reçue, y compris celles pouvant générer un fonctionnement indésirable.
Remarque : Le fabricant n’est responsable d’aucune interférence radiophonique ou
télévisuelle qui pourrait se produire si des modifications non autorisées sont effectuées sur
cet équipement. De telles modifications risquent d’annuler le droit de l’utilisateur à se
servir de cet équipement.
Hereby, Starkey Hearing Technologies declares that the Custom hearing aid
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
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.
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.
TINNITUS 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 contain a radio transceiver utilizing Bluetooth Low Energy
wireless technology operating in the 2.4-2.4835 GHz frequency band with
a maximum effective radiated power of 0 dBm using GFSK transmission
modulation. The receiver section of the radio has a bandwidth of 1.5 MHz.
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
and proximity magnetic fields as stated in Table 11 of IEC 60601-1-2.
• Immunity to ESD levels of +/- 8 kV conducted discharge and +/- 15 kV
air discharge.
52 | Regulatory Information
Notes
Starkey Hearing Technologies
6700 Washington Ave. South
Eden Prairie, MN 55344 USA
Starkey Laboratories (Germany) GmbH
Weg beim Jäger 218-222
22335 Hamburg
Germany
Class II Device
Waste from electronic equipment must be
handled according to local regulations
Consult Operations Manual
Keep dry
INSTRUCTIONS FOR DISPOSAL OF OLD ELECTRONICS
Starkey Hearing Technologies encourages, the EU requires, and your local
community laws may require, that your hearing aids be disposed of via your local
electronics recycling/disposal process.
Starkey, Starkey Hearing Technologies, Thrive and Just Talk are trademarks of
Starkey Laboratories, Inc�
Apple and iPhone are trademarks of Apple Inc� registered in the U�S� and other
countries�
The Bluetooth® word mark and logos are registered trademarks owned by
Bluetooth SI, Inc� and any use of such marks by Starkey is under license�
iOS is a trademark or registered trademark of Cisco in the U�S� and other
countries and is used under license� Android is a trademark of Google LLC�
©2021 Starkey� All Rights Reserved� 86374-007 3/21 BKLT3088-03-EE-XX
1 | ID Label | ID Label/Location Info | 355.56 KiB | August 24 2021 |
6600 Washington Avenue S. Sta rkey. Eden Prairie, Minnesota 55344 Hearing Technologies T: 1.800.328.8602 www.starkey.com July 7, 2021 Federal Communications Commission 45 L Street, NE Washington, DC 20554 Subject: FCC ID labeling on EOA-24LIVIOCIC wireless hearing aids Re: Response to Inquiry to FCC (Tracking Number 775017) To whom it may concern, Consistent to the direction provided on a previous similar product via your July 12, 2010 Response to Inquiry to FCC (Tracking Number 775017) concerning approval by the FCC for alternate labeling to our hearing aid under CFR 2.925(f), we are placing the FCC ID label for the EOA-24LIVIOCIC wireless hearing aids in the User Manual. Consistent to the direction provided on the earlier product, we are including the following documents with our submission for certification of Starkeys wireless hearing aids having an FCC ID of EOA-24LIVIOCIC. The FCC Response to Inquiry to FCC (Tracking Number 775017) Supporting documents similar to those associated with that Inquiry Figure 1 below showing curved nature, relative size, and available printed area and FCC ID of EOA-24LIVIOCIC hearing aids. The relevant page from the User Manual showing the alternate FCC ID marking location and other Part 15 required wording. If you have any questions or comments, please do not hesitate to contact me. Sincerely, William J. Mitchell, PE Principal Regulatory Affairs Engineer 952-918-5683 bill_mitchell@starkey.com FCC ID: EOA-24LIVIOCIC Figure 1 (scale in inches and mm)
1 | Antenna Info | Operational Description | 229.51 KiB | August 24 2021 |
Evolv AI Custom CIC Antenna Description The Bluetooth 2.4 GHz antenna is a center fed monopole. The peak gain of the antenna in the assembled DUT is -4.6 dBi. Figure 1 2.4 GHz Antenna (scale in mm) Antenna shown on faceplate before hearing aid is removed from excess plastic around faceplate and custom case molded to patient ear canal is placed on it. Half of antenna shown above faceplate in photo, other half is wire below faceplate. Antenna pattern
1 | Cover letter | Cover Letter(s) | 388.45 KiB | August 24 2021 |
6600 Washington Avenue S. Sta rkey. Eden Prairie, Minnesota 55544 Hearing Technologies T: 800.328.8602 www.starkey.com July 2, 2021 Federal Communications Commission 45 L Street, NE Washington, DC 20554 Attention: Application Examiner Reference: Certification: | Part 15.247 Intentional Radiator Applicant: Starkey Laboratories, Inc. Equipment: Low Power Device (2400-2483.5 MHz) Model #: Livio Custom Left Hearing Aid FCC ID: EOA-24LIVIOCIC Dear Sir/Madam:
Enclosed please find an FCC EOA-24LIVIOCIC certification application. The device is a wireless hearing aid intended for use by the hearing impaired. The wireless features are used during the initial fitting of a hearing aid to program the hearing aid, and used during normal usage to communicate control information and digital audio to and from any properly configured Bluetooth Low Energy compliant accessory and between a binaural pair of Evolv AI hearing aids. Further details and supporting documents are attached. Should you have any questions, please feel free to contact the undersigned. William J. Mitchell, PE Principal Regulatory Affairs Engineer 952-918-5683 bill_mitchell@starkey.com
1 | Request for Confidentiality | Cover Letter(s) | 431.11 KiB | August 24 2021 |
6600 Washington Avenue S. Sta rkey. Eden Prairie, Minnesota 55344 Hearing Technologies T: 1.800.328.8602 www.starkey.com August 24, 2021 Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, Maryland 21046 Re: Request for confidentiality Applicant: Starkey Laboratories, Inc. DBA Starkey Hearing Technologies FCC ID: EOA-24LIVIOCIC To whom it may concern, Permanent Confidentiality Request is hereby submitted by Starkey Laboratories, Inc. DBA Starkey Hearing Technologies to withhold permanently from public review certain portions of the application for equipment certification for the referenced FCC identifiers. This request for confidentiality is made pursuant to 47 CFR 0.457(d) and 0.459 of the FCC Rules. In particular, the following sections of the application are to be kept permanently confidential:
e Schematics e Detailed Block diagrams e Detailed Operational/Functional Description Rationale for request for confidentiality:
Starkey Laboratories, Inc. DBA Starkey Hearing Technologies has invested considerable time and materials in research and development to produce the referenced product. Disclosure of the permanently confidential portions of this application to competitors would not only give them significant competitive advantages in developing similar products, but would also disclose successful implementation of unpublished, leading edge technology developed by us. Disclosure of the short-term confidential portions of this application during the period of importation and/or distribution would reveal key aspects of proprietary technology to competitors and diminish the value of our investment in research and development. Sincerely, Spite Qucrkiy William J. Mitchell, PE Principal Regulatory Affairs Engineer Starkey Laboratories, Inc. 952-918-5683 bill_mitchell@starkey.com
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2021-08-24 | 2402 ~ 2480 | DTS - Digital Transmission System | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2021-08-24
|
||||
1 | Applicant's complete, legal business name |
Starkey Laboratories Inc
|
||||
1 | FCC Registration Number (FRN) |
0015964463
|
||||
1 | Physical Address |
6700 Washington Avenue So
|
||||
1 |
Eden Prairie, MN
|
|||||
1 |
United States
|
|||||
app s | TCB Information | |||||
1 | TCB Application Email Address |
r******@element.com
|
||||
1 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
||||
app s | FCC ID | |||||
1 | Grantee Code |
EOA
|
||||
1 | Equipment Product Code |
24LIVIOCIC
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
W******** J****** M****
|
||||
1 | Title |
Principal Regulatory Affairs Engineer
|
||||
1 | Telephone Number |
952-9********
|
||||
1 | Fax Number |
952 8********
|
||||
1 |
b******@starkey.com
|
|||||
app s | Technical Contact | |||||
n/a | ||||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | No | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | DTS - Digital Transmission System | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Livio | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 | Modular Equipment Type | Does not apply | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 | Grant Comments | Output power listed is conducted. The antenna(s) used for the transmitter must not be collocated or operating in conjunction with any other antenna or transmitter, except in accordance with FCC multi-transmitter product procedures. | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 | Firm Name |
Element Materials Technology Minneapolis
|
||||
1 | Name |
R****** W******
|
||||
1 | Telephone Number |
503-8******** Extension:
|
||||
1 | Fax Number |
503-8********
|
||||
1 |
r******@element.com
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 2402.00000000 | 2480.00000000 | 0.0020000 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC