Oticon Intent Instructions For Use

Instructions for use
miniRITE
Oticon Intent™
WARNING: People younger than
18 should go to a doctor before
using this.
People younger than 18 years old
need specialized care, and using this
without a medical evaluation may
worsen impairment or disability.
A hearing aid user who is younger
than 18 should have a recent medical
evaluation from a doctor, preferably
an ear-nose-throat doctor (an ENT).
Before using this, a doctor should
determine that the use of a hearing
aid is appropriate.
WARNING to Hearing Aid Dispensers:
You should advise a prospective hearing
aid user to consult promptly with a doctor,
preferably an ear specialist such as an
ENT, before dispensing a hearing aid if
you determine 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:
• Visible deformity of the ear, either
congenital or traumatic
• Fluid, pus, or blood coming out of the ear
within the previous 6 months
• Pain or discomfort in the ear
• History of excessive ear wax or suspicion
that something is in the ear canal
• Dizziness, either recent or long-standing
• Sudden, quickly worsening, or fluctuating
hearing loss within the previous 6 months
• Hearing loss or ringing (tinnitus) only
in one ear or a noticeable difference in
hearing between ears
• Audiometric air-bone gap equal to or
greater than 15 dB at 500 Hz, 1000 Hz,
and 2000 Hz
WARNING to Hearing Aid Dispenser,
Outputs over 132 dB SPL:
You should exercise special care in selecting
and fitting a hearing aid with a maximum
output that exceeds 132 dB SPL because
it may impair the remaining hearing of the
hearing aid user.
Caution: This is not hearing protection.
You should remove this device if you
experience overly loud sounds, whether
short or long-lasting. If you’re in a loud
place, you should use the right kind of
hearing protection instead of wearing
this device. In general, if you would use
ear plugs in a loud place, you should
remove this device and use ear plugs.
Caution: The sound output should not
be uncomfortable or painful.
You should turn down the volume or
remove the device if the sound output
is uncomfortably loud or painful. If you
consistently need to turn the volume down,
you may need to further adjust your device.
Caution: You may need medical help if
a piece gets stuck in your ear.
If any part of your hearing aid, like the
eartip, gets stuck in your ear, and you
can’t easily remove it with your fingers,
get medical help as soon as possible. You
should not try to use tweezers or cotton
swabs because they can push the part
farther into your ear, injuring your eardrum
or ear canal, possibly seriously.
Note: What you can expect when you
start using a hearing aid
A hearing aid can benefit many people with
hearing loss. However, you should know
it will not restore normal hearing, and you
may still have some difficulty hearing over
noise. Further, a hearing aid will not prevent
or improve a medical condition that causes
hearing loss.
People who start using hearing aids
sometimes need a few weeks to get used
to them. Similarly, many people find that
training or counseling can help them get
more out of their devices.
If you have hearing loss in both ears, you
might get more out of using hearing aids
in both, especially in situations that make
you tired from listening —for example, noisy
environments.
Note: Tell FDA about any injuries,
malfunctions, or other adverse events.
To report a problem involving your hearing
aid, you should submit Information to FDA
as soon as possible after the problem. FDA
calls them “adverse events,” and they can
include: skin irritation in your ear, injury
from the device (like cuts or scratches, or
burns from an overheated battery), pieces
of the device getting stuck in your ear,
suddenly worsening hearing loss from using
the device, etc.
Instructions for reporting are available at
https://www.fda.gov/Safety/MedWatch,
or call 1-800-FDA-1088. You can also
download a form to mail to FDA.
Note: Hearing loss in people younger
than 18
• People younger than 18 should see a
doctor first, preferably an ear-nosethroat doctor (an ENT), because they
may have different needs than adults.
• The doctor will identify and treat medical
conditions as appropriate.
• The doctor may refer the person to an
audiologist for a separate test, a hearing
aid evaluation.
• The hearing aid evaluation will help the
audiologist select and fit the appropriate
hearing aid.
A person younger than 18 years old
with hearing loss should undergo medical
evaluation by a doctor, preferably an ENT,
before buying a hearing aid. The purpose of
a medical evaluation is to identify and treat
medical conditions that may affect hearing
but that a hearing aid won’t treat on its own.
Following the medical evaluation and if
it is appropriate, the doctor will provide a
written statement that the hearing loss
has been medically evaluated and the
person is a candidate for a hearing aid.
The doctor may refer the person to an
audiologist for a hearing aid evaluation,
which is different from the medical
evaluation and is intended to identify
the appropriate hearing aid.
The audiologist will conduct a hearing
aid evaluation to assess the person’s ability
to hear with and without a hearing aid.
This will enable the audiologist to select
and fit a hearing aid for the person’s
individual needs. An audiologist can also
provide evaluation and rehabilitation
since, for people younger than 18, hearing
loss may cause problems in language
development and educational and social
growth. An audiologist is qualified by
training and experience to assist in the
evaluation and rehabilitation of hearing
loss in people younger than 18.
Introduction to this booklet
This booklet guides you on how to use and maintain your new hearing
aids. Ensure you read this booklet carefully, including the Warnings
section. This will help you get the most benefit from your hearing aids.
Warnings
Text marked with a warning symbol must be read before using the device.
Your hearing care professional has adjusted the hearing aids to meet
your needs. If you have additional questions, contact your hearing care
professional.
A hearing care professional* (hearing aid professional, audiologist,
ENT (ear, nose and throat) doctor, and hearing aid dispenser) is a
person who is appropriately trained and has proven competency in
professionally assessing hearing, selecting, fitting, and delivering
hearing instruments and rehabilitation care to persons with hearing
loss. The hearing care professional has been trained in accordance
with national or regional regulations.
*The job title may vary from country to country.
Table of contents
About
Model overview
Intended use
Your hearing aid, speaker and earpiece
Getting started
Battery performance
Low battery indication
Turn hearing aids ON/OFF
Identify left and right hearing aids
Daily use
Put on hearing aid
Cleaning
Clean the hearing aid
Replace standard earpiece
Clean customized earpiece
ProWax miniFit filter
Replace ProWax miniFit filter
10
12
14
18
19
20
22
23
24
25
26
27
28
29
Continues on next page
Table of contents
Replace ProWax filter
Change volume
Change program
Store your hearing aids
30
31
32
34
Turn Bluetooth® ON/OFF
Mute/unmute your hearing aids
Use your hearing aids with digital devices
Pairing and compatibility
Call handling
Wireless accessories and other options
35
36
37
38
40
42
Tinnitus SoundSupport™ (optional)
Guidelines for Tinnitus SoundSupport users
Limitation on use time
Sound options and volume adjustments
Warnings related to tinnitus
44
45
46
47
49
Options
Tinnitus
Warnings
General warnings
50
Water and dust resistant (IP68)
Conditions of use
Technical information
Cell phone
Warranty
Your individual hearing aid settings
Sound and LED light indicators
Troubleshooting
Summary of relevant studies
Technical Data
56
57
58
64
70
71
74
80
84
86
More info
Model overview
This booklet is valid for the following hearing aid models:
10
FW 1.1
 Oticon Intent 1 miniRITE
 Oticon Intent 2 miniRITE
 Oticon Intent 3 miniRITE
 Oticon Intent 4 miniRITE
GTIN: (01) 05714464139699
GTIN: (01) 05714464139682
GTIN: (01) 05714464139675
GTIN: (01) 05714464140169
FW 1.0
 Oticon Intent 1 miniRITE
 Oticon Intent 2 miniRITE
 Oticon Intent 3 miniRITE
 Oticon Intent 4 miniRITE
GTIN: (01) 05714464133130
GTIN: (01) 05714464133147
GTIN: (01) 05714464133154
GTIN: (01) 05714464133161
About
Getting started
Daily use
Options
Tinnitus
Warnings
More info
The following speakers are available for the above models:
 miniFit Detect speaker 60
 miniFit Detect speaker 85
 miniFit Detect speaker 100
 MicroShell Detect 60
 MicroShell Detect 85
 MicroShell Detect 100
 MicroShell Detect 105
The packaging box contains the following elements:
• Hearing aids
• Multitool
• Soft cloth
11
Intended use
Intended use
The hearing aid is intended to amplify and transmit sound
to the ear.
Indications for use
Bilateral or unilateral impaired hearing of sensorineural,
conductive or mixed type ranging from a slight (16 dB HL*)
to profound (95 dB HL*) degree of hearing loss, with an
individual frequency configuration.
Intended user
Person with hearing loss using a hearing aid and their
caregivers. Hearing care professional responsible for
adjusting the hearing aid.
Intended user group
Adults and children older than 36 months.
Use environment
Indoor and outdoor.
Contraindications
Not suitable for infants below 36 months. Users of active
implants must pay special attention when using the hearing
aid. For more information read the Warnings section.
Clinical benefits
The hearing aid is designed to provide better speech
understanding to help ease communication with the aim
of improving quality of life.
*As specified by the American Speech-Language-Hearing Association, asha.org, using pure-tone average
of 0.5, 1 and 2 kHz.
12
About
Getting started
Daily use
Options
Tinnitus
Warnings
More info
IMPORTANT NOTICE
The hearing aid amplification is uniquely adjusted and optimized to your
personal hearing capabilities during the hearing aid fitting performed by
your hearing care professional.
13
Your hearing aid, speaker and earpiece
Microphones
LED light
Wax filter
Speaker
Push-button
14
About
Getting started
Daily use
Options
Tinnitus
Warnings
More info
Charge pads
15
The hearing aids use one of the following speakers:
miniFit Detect speakers
60
85
100
Customized speakers
60
85
100
105
MicroShell Detect
16
About
Getting started
Daily use
Options
Tinnitus
Warnings
More info
The speakers use one of the following earpieces:
Standard earpieces
Customized earpieces
 OpenBass dome
 LiteTip*
 Bass dome, double vent
 MicroMold*
 Power dome
 Grip Tip
Available in small and large, left and
right, with or without vent.
Dome sizes
5 mm* 6 mm
8 mm
10 mm
12 mm
*Only as OpenBass dome for miniFit Detect
speaker 60
*Can be made of different materials
Note
For details on replacing the dome, see the Replace
standard earpieces section.
17
Battery performance
Ensure you fully charge your hearing aids before first use and charge
them every night. In this way, you ensure that you start your day with
fully charged hearing aids.
Battery performance varies depending on your individual use and
hearing aid settings. Streaming sound from a TV, mobile phone or
connectivity devices can influence this performance.
If your hearing aids do not perform for a full day, contact your hearing
care professional.
For instructions on how to use your charger, see the charger’s
instructions for use.
IMPORTANT NOTICE
When charging in high ambient temperatures, your hearing aid may reach up
to 45°C (113°F).
18
About
Getting started
Daily use
Options
Tinnitus
Warnings
More info
Low battery indication
The low battery indication is repeated periodically until the battery runs
out. Your hearing care professional can set your hearing aids to match
your preferences.
After the notification, you have approximately two hours before the
hearing aid runs out of battery. At this point, you may continue to
stream audio for approximately one hour. To extend battery
performance, ensure you stop any audio streaming.
The battery is running low
Three alternate tones
The battery has run out
Four descending tones
Voice Notification
(Optional for select languages)
Hearing aid LED light
Continuous fast ORANGE blinks indicate low battery.
19
Turn hearing aids ON/OFF
Your hearing aids can be turned ON or OFF using either the charger or
the push-button.
ON
Charger
Push-button
Remove hearing
aids from
charger*
Press and hold
the push-button
for two seconds
Hearing aid LED light turns
GREEN.
Depending on your hearing aid
settings, you may also hear a
start-up jingle when they are
removed from the charger
Press and hold
the push-button
for approximately
three seconds
Hearing aid LED light turns
ORANGE. Four descending tones
are played
OFF
Indicator
For information regarding tones, see the Sound and LED light indicators section.
*If the charger is disconnected from power or runs out of battery while charging your hearing aids, your hearing
aids may turn OFF to save power. If your hearing aids do not automatically turn ON when removed from the
charger, turn them on manually using the push-button.
20
About
Getting started
Daily use
Options
Tinnitus
Warnings
More info
ON/OFF
IMPORTANT NOTICE
Ensure that your charger is powered or that the charger’s built-in battery
is charged when the hearing aid is seated in the charging port. For more
information, see your charger’s instructions for use.
21
Identify left and right hearing aids
It is important to distinguish between the left and the right hearing aid,
as they may be programmed differently.
Color indicators mark the left and right hearing aids. A RED indicator marks
the RIGHT hearing aid. A BLUE indicator marks the LEFT hearing aid.
Color indicators
22
About
Getting started
Daily use
Options
Tinnitus
Warnings
More info
Put on hearing aid
Step 1
Step 2
Step 3
Ear grip
(optional)
Place the hearing aid
behind your ear.
You should always use
the speaker with an
earpiece attached.
Use only parts
designed for your
hearing aid.
Hold the bend of the
speaker wire between
your thumb and index
finger.
The earpiece should
point towards the
opening of the ear
canal.
Gently push the
earpiece into your ear
canal until the speaker
wire sits close to your
head.
If the speaker has an
ear grip, place it in the
ear so it follows the
contour of the ear.
23
Cleaning
The MultiTool contains a brush and wire loop for cleaning and removing
earwax. If you need a new MultiTool, contact your hearing care
professional.
Magnet
Wire loop
Brush
IMPORTANT NOTICE
The MultiTool has a built-in magnet. Keep the MultiTool at least
30 centimeters (1 foot) away from credit cards and other magneticallysensitive devices.
24
About
Getting started
Daily use
Options
Tinnitus
Warnings
More info
Clean the hearing aid
When handling the hearing aid, hold it over a soft surface to avoid
damage in case you drop it.
Clean the microphone openings
Use the brush of the MultiTool to carefully brush
debris away from the openings and the surface
around the openings.
Microphone
openings
Ensure that you do not forcefully squeeze parts
of the MultiTool into the microphone openings.
This may damage the hearing aid.
Keep the charge pads clean to ensure optimal
charging. Clean the charge pads using a dry cloth.
IMPORTANT NOTICE
To clean the hearing aids, use a soft, dry cloth. The hearing aids must never
be washed or immersed in water or other liquids.
25
Replace standard earpiece
The standard earpiece (dome or Grip Tip) should not be cleaned.
If the earpiece is filled with earwax, replace it with a new one.
Grip Tips should be replaced at least once a month.
26
Step 1
Step 2
Step 3
Hold on to the speaker
and pull off the
earpiece.
Insert the speaker
exactly into the
middle of the earpiece
to get a secure fit.
Push firmly to ensure
that the earpiece is
securely fastened.
About
Getting started
Daily use
Options
Tinnitus
Warnings
More info
Clean customized earpiece
The customized earpiece should be cleaned
regularly.
The earpiece has a white wax filter* that keeps
earwax and debris from damaging the speaker.
Ensure you replace the filter when clogged, or
if the hearing aid does not sound normal.
Clean the vent by
inserting the brush
through the hole,
twisting it slightly.
Alternatively, contact your hearing care
professional.
Note
If you use a mold or LiteTip, your hearing care professional must replace
the wax filter in the speaker.
* Not all molds have a wax filter. Filter composition can vary by mold. For
more information contact your hearing care professional.
Vent
ProWax filter
IMPORTANT NOTICE
If the earpiece is not on the speaker when removed from the ear, the
earpiece may still be in the ear canal. For further instructions, consult your
hearing care professional.
27
ProWax miniFit filter
The speaker has a white wax filter
attached to the end where the earpiece
is attached. The wax filter keeps earwax
and debris from damaging the speaker.
ProWax
miniFit filter
Ensure you replace the filter when
clogged, or if the hearing aid does not
sound normal. Alternatively, contact
your hearing care professional. Ensure
you remove the earpiece from the speaker
before replacing the wax filter. To do
this, see the Replace standard earpiece
section.
IMPORTANT NOTICE
Ensure you always use the same type of wax filter as originally supplied
with the hearing aids. If you are in doubt about the use or replacement of
wax filters, contact your hearing care professional.
28
About
Getting started
Daily use
Options
Tinnitus
Warnings
More info
Replace ProWax miniFit filter
1. Tool
2. Remove
New filter
New filter
Remove the tool from
the shell. The tool has
two pins: one empty
for removal and one
with the new wax
filter.
Empty
pin
Insert the empty pin
into the wax filter in
the speaker and pull
it out.
3. Insert
New
filter
Old filter
Final
Insert the new wax
filter using the other
pin. Remove the tool
and throw it out.
Note
If you use a mold or LiteTip, your hearing care professional must replace the wax filter in the speaker.
29
Replace ProWax filter
1. Tool
2. Remove
3. Insert
New filter
Empty
pin
Old filter
New
filter
Remove the tool from
the shell. The tool has
two pins: one empty
for removal and one
with the new wax
filter.
30
About
Getting started
New filter
Insert the empty pin
into the wax filter in
the earpiece and pull
it out.
Daily use
Options
Tinnitus
Insert the new wax
filter using the other
pin. Remove the tool,
and throw it out.
Warnings
More info
Adjust volume
The push-button allows you to adjust the volume. When you increase
or decrease the volume, you hear a beep.
For information regarding button press times, see the table General
settings overview for your hearing aid, in the Your individual
hearing aid settings section at the end of this booklet.
MAXIMUM
A short press on the
RIGHT hearing aid
increases the volume
A short press on the
LEFT hearing aid
decreases the volume
START-UP
VOLUME
MINIMUM
31
Change program
Your hearing aid can have up to four different programs.These are
programmed by your hearing care professional. You will hear one
to four tones when you change program depending on the program.
Press the push-button to switch between
programs.
If you have two hearing aids:
The RIGHT hearing aid switches one program
forward, for example program 1 to 2.
The LEFT hearing aid switches one program
backward, for example from program 4 to 3.
32
About
Getting started
Daily use
Options
Tinnitus
Warnings
More info
For information regarding tones, see the Sound and LED light
indicators section.
For information regarding button press times see the table General
settings overview for your hearing aid, in the Your individual hearing
aid settings section at the end of this booklet.
33
Store your hearing aids
When you are not using your hearing aids, the charger is the best place
to keep them.
To ensure the longest life of the rechargeable battery in your hearing
aids, do not expose them to excessive heat. For example, do not leave
your hearing aids in the sun in front of a window or in a car, even if they
are in the charger.
Long-term storage
Before you put away or store your hearing aids for a prolonged period of
time (more than three months), ensure you first fully charge them, and
then turn them OFF. This way the battery can be charged again.
Note
To protect the rechargeable battery, it is necessary that you fully charge the hearing aid every six months. If a
stored hearing aid is not charged within a six month period, the rechargeable battery may need to be replaced.
34
About
Getting started
Daily use
Options
Tinnitus
Warnings
More info
Turn Bluetooth® ON/OFF
Bluetooth connectivity can be turned ON/OFF on your hearing aids.
When Bluetooth is turned OFF the hearing aids are still turned ON and
functioning. Be aware that pressing the push-button on one hearing aid,
turns OFF bluetooth for both hearing aids. For information about sounds
and lights, see the Sound and LED light indicators section.
Your hearing aids use Bluetooth wireless technology. They can be used
on an aircraft as hearing aids are exempt from the rules applied to
portable electronic devices on an aircraft.
To activate and deactivate
Press and hold the push-button for
approximately seven seconds.
Four descending tones, a jingle and an
LED light pattern confirm your action.
The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such
marks by Demant is under license. Other trademarks and trade names are those of their respective owners.
35
Mute/unmute your hearing aids
You can mute and unmute your hearing aids by using the optional app
or select devices. Additionally you can unmute by applying a short press
to the push-button on your hearing aids. For more information, contact
your hearing care professional.
IMPORTANT NOTICE
Do not use the mute function as an OFF button, as the hearing aid is still
using battery power in this mode.
36
About
Getting started
Daily use
Options
Tinnitus
Warnings
More info
Use your hearing aids with digital devices
iPhone®, iPad® and Mac®
Your hearing aids are Made for iPhone hearing aids and allow for direct
streaming from your iPhone, iPad or Mac.*
Android devices
Your hearing aids support Audio Streaming for Hearing Aids (ASHA) and
allow for direct streaming from selected Android™ devices.*
Oticon Companion can be used to control your hearing aids from your
mobile device.*
Additionally, your hearing aids offer hands-free communication with
compatible Apple iOS and select Android devices.*
For assistance in using your hearing aids with any of these products,
contact your hearing care professional.
*For a list of compatible iPhone, iPad, Mac and Android devices, visit: www.oticon.com/support/compatibility.
Use of the Made for Apple badge means that an accessory has been designed to connect specifically to the Apple
product(s) identified in the badge, and has been certified by the developer to meet Apple performance standards.
Apple is not responsible for the operation of this device or its compliance with safety and regulatory standards.
37
Pairing and compatibility
For instructions on how to pair your hearing aids with iPhone, iPad, Mac
or Android devices, visit:
www.oticon.com/support
For a list of compatible iPhone, iPad, Mac and Android devices, visit:
www.oticon.com/support/compatibility
38
About
Getting started
Daily use
Options
Tinnitus
Warnings
More info
Call handling
You can accept, reject or end phone calls with the push-buttons on your
hearing aids. You can also use the tap control to answer or end phone calls.
To accept
Briefly press the push-button to accept
a phone call. A short tone confirms your
action.
To reject
Press and hold the push-button to reject
a phone call. Short, descending tones
confirm your action.
To end
Press and hold the push-button to end
a phone call. Short, descending tones
confirm your action.
40
About
Getting started
Daily use
Options
Tinnitus
Warnings
More info
To use the call handling functionality, your hearing aids must be paired
with a compatible mobile device.*
To accept
Double tap on your ear or hearing
aid to accept a phone call. A short
tone confirms your action.
To end
Double tap on your ear or hearing
aid to end a phone call. Short,
descending tones confirm your
action.
* For a list of compatible mobile devices, visit: www.oticon.com/support/compatibility.
41
Wireless accessories and other options
There are a range of accessories available as an enhancement to your
wireless hearing aids. These enable you to hear and communicate better
in everyday situations.
ConnectClip
A device that can be used as
remote microphone and handsfree headset when paired to your
mobile phone.
Phone Adapter 2.0
A device that when used together
with hearing aids and ConnectClip,
lets you communicate hands-free
via a landline phone.
42
About
Getting started
Daily use
Options
TV Adapter 3.0
A device that streams sound from
a TV or electronic audio device, to
your hearing aids.
Remote Control 3.0
A device that lets you change
program, adjust volume, or mute
your hearing aids.
Tinnitus
Warnings
More info
EduMic
A device that can be used as a
remote microphone in classrooms,
work environments, public places
(using Telecoil), and other
settings.
Oticon Companion
An application that gives you
wireless access to your hearing
aids through a mobile device for
control of functionality, and that
allows your hearing aids to be
updated remotely. For iPhone,
iPad and Android devices. Ensure
that you only download Oticon
Companion from the official app
stores.
Telecoil
Telecoil can help you
hear better when using a
phone with a built-in loop
or when in buildings with teleloop
systems such as theaters, places
of worship, or lecture rooms.
This symbol is shown wherever a
teleloop has been installed.
Apple, the Apple logo, iPhone, iPad, Mac and the Mac logo are trademarks of Apple, Inc., registered in the U.S.
and other countries. App Store is a service mark of Apple Inc. Android™, Google Play, and the Google Play logo are
trademarks of Google LLC.
43
Tinnitus SoundSupport™ (optional)
Intended use of Tinnitus SoundSupport
Tinnitus SoundSupport is a tool intended to generate sounds to provide
temporary relief for patients suffering from tinnitus as part of a tinnitus
management program.
The target population is the adult population over 18 years of age.
Tinnitus SoundSupport is targeted to licensed hearing care
professionals (audiologists, hearing aid specialists, or otolaryngologists)
who are familiar with the evaluation and treatment of tinnitus and
hearing loss. Tinnitus SoundSupport must be fitted by a hearing care
professional participating in a tinnitus management program.
44
About
Getting started
Daily use
Options
Tinnitus
Warnings
More info
Guidelines for Tinnitus SoundSupport users
Your hearing care professional will be able to offer the appropriate
follow-up care. It is important to follow his/her advice and directions
regarding such care.
Prescription use only
Good health practice requires that a person reporting tinnitus have
a medical evaluation by a licensed ear physician before using a sound
generator. The purpose of such an evaluation is to ensure that any
medically treatable condition that may cause tinnitus is identified
and treated prior to using a sound generator.
45
Limitation on use time
Daily use
The volume levels of Tinnitus SoundSupport can be set to a level
which could lead to permanent hearing damage when used for a
prolonged period of time. Your hearing care professional will advise
you of the maximum amount of time per day you should use Tinnitus
SoundSupport. It should never be used at uncomfortable levels.
See the table Tinnitus SoundSupport: Limitation on use in the Your
individual hearing aid settings section at the end of this booklet to
learn how many hours per day you can safely use the relief sound in
your hearing aid.
46
About
Getting started
Daily use
Options
Tinnitus
Warnings
More info
Sound options and volume adjustments
Tinnitus SoundSupport is programmed by your hearing care professional
to match your hearing loss and preferences for tinnitus relief.
Tinnitus SoundSupport programs
The sound generator can be activated in up to four different programs.
Mute
If you are in a program for which Tinnitus SoundSupport is activated,
the mute functionality only mutes the environmental sounds, and not
the sound from Tinnitus SoundSupport. For information on how to mute
your hearing aids, see the Mute your hearing aids section.
47
Volume adjustments with Tinnitus SoundSupport
Your hearing care professional can set the volume control for a hearing
aid program for which Tinnitus SoundSupport is activated.
For more information about volume adjustments with Tinnitus
SoundSupport, see the table Tinnitus SoundSupport settings
overview for your hearing aid in the Your individual hearing aid
settings section at the end of this booklet.
48
About
Getting started
Daily use
Options
Tinnitus
Warnings
More info
Warnings related to tinnitus
If your hearing care professional has
activated the sound generator Tinnitus
SoundSupport, please pay attention to the
following warnings.
There are some potential concerns
associated with the use of any sound
generated by a tinnitus management
device. Among them are the potential
worsening of tinnitus, and/or a possible
change in hearing thresholds.
Should you experience or notice a change
in hearing or tinnitus, or any dizziness,
nausea, headaches, heart palpitations,
or possible skin irritation at the point
of contact with the device, you should
immediately discontinue use of the device
and consult a medical, audiology, or other
hearing care professional.
As with any device, misuse of the sound
generator feature may cause potentially
harmful effects. Care should be taken to
prevent unauthorized use and to keep the
device out of reach of children and pets.
Maximum wearing time
Always follow the maximum wearing time
per day of the Tinnitus SoundSupport
advised by your hearing care professional.
Prolonged use may lead to worsening of
your tinnitus or to hearing loss.
49
General warnings
For your personal safety and to ensure
correct usage, you should familiarize
yourself fully with the following general
warnings before using your hearing aids.
Consult your hearing care professional
if your hearing aids exhibit unexpected
behavior or you encounter serious
incidents with your hearing aids. Your
hearing care professional will support
you with issue handling and, if relevant,
reporting to the manufacturer and/or the
national authorities.
Note that hearing aids do not restore
normal hearing and do not prevent or
improve hearing impairment resulting
from natural processes such as aging or
sickness.
Hearing aids are only a part of hearing
habilitation and may need to be
supplemented by auditory training and
instruction in lipreading.
50
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To achieve the full benefit from your
hearing aids, you should use them
frequently.
Only charge the hearing aids with a
designated charger. Other chargers risk
damaging the hearing aids and batteries.
This hearing aid is supported by a nonremovable rechargeable lithium-ion
battery cell. Please ensure that you charge
the hearing aid and familiarize yourself
with the safety and handling information
related to rechargeable hearing aids.
Usage of hearing aids
Hearing aids should only be used as
directed by your hearing care professional.
Misuse can result in sudden and permanent
hearing loss. Never allow others to wear
your hearing aids. Unauthorized use could
cause permanent damage to their hearing.
Tinnitus
Warnings
More info
Choking hazards of swallowing small
parts
Keep all small parts (for example, hearing
aids, earpieces, batteries, etc.) out of reach
and sight of children and others who might
swallow these items. Seek emergency
medical treatment immediately if someone
is choking on small parts or batteries are
swallowed.
If a battery, hearing aid or small part is
swallowed, see a doctor immediately
and contact the National Poison Center
at 1-800-222-1222 or National Battery
Ingestion Hotline at 1-800-498-8666.
Keep away from environments with risk
of explosions
Your hearing aids are safe to use under
normal usage conditions. The hearing
aid has not been tested for compliance
with international standards concerning
explosive environments.
Do not use the hearing aid in environments
with danger of explosions such as mines,
oil fields, oxygen rich environments or
areas where flammable anesthetics are
handled.
Fatality hazards of swallowing batteries
Never swallow batteries. Doing so can lead
to serious injury or death within hours.
Swallowed batteries can cause burns that
may perforate inner organs. Keep the
batteries out of reach and sight of children
and others who might swallow them.
Batteries have occasionally been mistaken
for pills. Therefore, check your medicine
carefully before swallowing any pills. Seek
emergency medical treatment immediately
if a battery is swallowed.
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51
General warnings
Risk of placing batteries in ear or nose
Never place batteries in the ear or the
nose. This can lead to permanent damage
due to burns. Contact a doctor immediately
if a battery is placed in the ear or nose.
Never attempt to replace rechargeable
batteries
Do not attempt to open your hearing aids
as it may damage the battery.
Never attempt to replace the battery. If
battery replacement is needed, return your
device to the supplier. The warranty is void
if there are signs of tampering.
Beware of battery leakage
Do not touch your hearing aids if the
battery appears to be leaking as the acids
may cause skin irritation. If you have been
in contact with battery acids, wipe it off
using a wet cloth. If you experience skin
irritation, consult your doctor. In the event
of battery leakage contact your hearing
care professional for further instructions.
52
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Beware of sudden dysfunction
Your hearing aids may stop working
without notice. For example, if they run
out of battery or if the tubing is blocked.
Keep this in mind especially in situations
where you depend on warning sounds (for
example when in traffic).
Use with active medical implants
Your hearing aids have been thoroughly
tested and developed for human health
according to international standards for
human exposure (Specific Absorption Ratio
– SAR), induced electromagnetic power and
voltages into the human body.
The exposure values are well below
international accepted safety limits for
SAR, induced electromagnetic power and
voltages into the human body defined
in the standards for human health
and coexistence with active medical
implants, such as pacemakers and heart
defibrillators.
Tinnitus
Warnings
More info
If you have an active brain implant, contact
the manufacturer of your implanted device
for information about the use with a
hearing aid.
Accessories with built-in magnets (for
example the Autophone magnet and
the MultiTool) should be kept at least 30
centimeters (12 inches) away from any
implanted medical device. Follow the
guidelines from the manufacturer of your
implanted medical device regarding their
use with magnets.
Use with cochlear implants
If you are using a cochlear implant (CI) on
one ear and a hearing aid on the other ear,
make sure to always keep your CI at least
1 centimeter (0.4 inches) away from your
hearing aid. The magnetic field from the CI
may permanently damage the speaker unit
in your hearing aid. Never place the devices
close together on a table (for example,
when cleaning or changing batteries).
Do not carry the CI and the hearing aid
together in the same box.
Detached earpiece in ear canal
Ensure that the earpiece is still connected
to the speaker when removing the hearing
aid from your ear. If the earpiece is not on
the speaker, the earpiece may still be in
the ear canal. Consult your hearing care
professional.
Remove hearing aids before certain
medical procedures
Remove your hearing aids before medical
procedures such as X-ray examinations,
CT/MR/PET scans, electrotherapy,
surgery, etc. Your hearing aids may be
damaged if exposed to strong magnetic or
electromagnetic fields.
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53
General warnings
Keep away from extreme heat
Never expose your hearing aids to extreme
heat. For example, do not leave your
hearing aids inside a parked car in the sun.
Never use an external heating device to dry
your hearing aids. For example, do not dry
your hearing aids using a hair dryer or in an
oven such as a microwave.
Keep away from chemicals
Remove your hearing aids before applying
products that contain certain chemicals
that can damage your hearing aids. For
example, cosmetics, hairspray, perfume,
aftershave lotion, suntan lotion and insect
repellent. Allow the products time to dry
before putting on your hearing aids.
54
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Connecting the charger to external
equipment
If you connect your hearing aid charger
using a USB connector other than the
one originally supplied with your charger,
the USB connector must comply with IEC
62368-1 or equivalent safety standards.
Potential side effects
You may produce more earwax when
using hearing aids. In rare cases, the nonallergenic materials in the product may
cause skin irritation or other side effects.
If you experience any such side effects,
consult your doctor.
Use of third-party accessories
Only use accessories, cables or transducers
(for example, microphones) supplied by
the manufacturer. Non-original accessories
may result in reduced electromagnetic
compatibility (EMC) of your hearing aids.
Tinnitus
Warnings
More info
Do not modify hearing aids
Do not make any modifications to your
hearing aids not expressly approved by the
manufacturer. This will void the warranty.
Use in fields with electromagnetic
interference
Your hearing aids have been thoroughly
tested for interference according
to the most stringent international
standards, including EN/IEC 60601-1-2
and its amendments. Electromagnetic
interference may occur in the vicinity of
equipment that can affect the performance
of your hearing aids such as mobile phones,
Wi-Fi routers or other equipment with the
displayed symbol. If your hearing aids are
affected by interference, move away from
the source.
55
Water and dust resistant (IP68)
Your hearing aid is dust resistant and
protected against ingress of water,
which means it is designed to be worn
in all daily life situations. Therefore, you
do not have to worry about humidity
or getting wet in the rain. Should your
hearing aid come into contact with water
and stop working, please follow these
guidelines.
Before charging the hearing aid, make
sure to wipe off any moisture.
IMPORTANT NOTICE
Do not wear your hearing aid while showering or participating in water
activities. Do not immerse your hearing aid in water or other liquids.
56
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Tinnitus
Warnings
More info
Operating conditions
Operating
conditions
Temperature: +5°C to +40°C (41°F to 104°F)
Humidity: 5% to 93% relative humidity, non-condensing
Atmospheric pressure: 700 hPa to 1060 hPa
Charging
conditions
Temperature: +5°C to +40°C (41°F to 104°F)
Humidity: 5% to 93% relative humidity, non-condensing
Atmospheric pressure: 700 hPa to 1060 hPa
Transportation
and storage
conditions
Temperature and humidity shall not exceed the below limits
for extended periods during transportation and storage:
Transportation:
Temperature: -20°C to +60°C (-4°F to 140°F)
Humidity: 5% to 93% relative humidity, non-condensing
Atmospheric pressure: 700 hPa to 1060 hPa
Storage:
Temperature: -20°C to +30°C (-4°F to 86°F)
Humidity: 5% to 93% relative humidity, non-condensing
Atmospheric pressure: 700 hPa to 1060 hPa
Note
For more information about the charger’s conditions of use, see your charger’s instructions for use.
57
Technical information
The hearing aid contains the following
two radio technologies:
The hearing aid contains a radio
transceiver using short range magnetic
induction technology operating at
3.84 MHz. The magnetic field strength
of the transmitter is very weak and
always below 15 nW (typically below
–40 dBμA/m (–12.20 dBμA/ft) at
10 meters (33 feet) distance).
The hearing aid also contains a radio
transceiver using Bluetooth Low Energy
technology and a proprietary shortrange radio technology, both operating
at ISM band 2.4 GHz.
58
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The radio transmitter is weak and
always below 2.5 mW equal to 4 dBm
in total radiated power.
Only use your hearing aids in areas
where wireless transmission is
permitted.
The hearing aid complies with
international standards concerning
radio transmitters, electromagnetic
compatibility, and human exposure.
The hearing instrument is designed
to operate in public and residential
environments. It has passed the
following applicable emissions and
immunity tests:
Tinnitus
Warnings
More info
Radiated emissions requirements for a
CISPR 11 Group 1 Class B device as stated
in table 2 of IEC 60601-1-2.
Radiated emission for communication
devices operating in the ISM 2.4 GHz
band as stated in 47 CFR Part 15,
subpart C, RSS-247 and EN 300 328
(only for products with Bluetooth).
Radiated emission for near field
magnetic induction communication
operating at 3.84 MHz as stated in
47 CFR Part 15, subpart C, RSS-210 and
EN 300 330.
RF radiated immunity at a field level of
10 V/m between 80 MHz and 2.7 GHz
as stated in table 4 of IEC 60601-1-2
and, 3 V/m between 2.7 and 6.0 GHz as
stated in CISPR 32.
RF radiated immunity at a field level of
up to 28 V/m for selected RF wireless
communication bands between 380 MHz
and 5.8 GHz as stated in table 9 of
IEC 60601-1-2.
RF radiated immunity at a field level
of up to 65 A/m for selected proximity
magnetic fields at 30 kHz, 134.2 kHz
and 13.56 MHz as stated in table 11 of
IEC 60601-1-2 AM1.
RF radiated immunity field levels at
selected bands stated in IEC 60118-13
between 25 V/m and 60 V/m and, for
proximity-fields from communication
devices held to the ear, stated in
ANSI C63.19.
59
Immunity to power frequency magnetic
fields at a field level of 30 A/m as stated
in table 4 of IEC 60601-1-2 (only for
products with telecoil).
Immunity to ESD levels of +/- 2, 4 and
8 kV conducted discharge and +/- 2, 4, 8
and 15 kV air discharge as stated in table
4 of IEC 60601-1-2.
Due to the limited space available on the
hearing aid, relevant approval markings
can be found in this booklet.
Additional information can be found in
the Technical data document on www.
oticon.com
60
About
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Tinnitus
Warnings
More info
miniRITE only
This device contains a radio module with
the following certification ID number:
FCC ID: 2ACAHAU5MNRR
Radio frequency radiation
exposure information
This device complies with FCC RF
exposure limits set forth for an
uncontrolled environment and has
been tested for portable use.
The device must not be co-located or used
in conjunction with any other antenna or
transmitter.
Use of other accessories not verified
by the manufacturer may not ensure
compliance with FCC RF exposure
guidelines.
62
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Tinnitus
Warnings
More info
Note: This device has been
tested and found to comply
with the limits for a Class B digital
device, pursuant to part 15 of the
FCC Rules. These limits are designed
to provide reasonable protection
against harmful interference in a
residential installation. This device
generates, uses and can radiate
radio frequency energy and, if not
installed and used in accordance with
the instructions, may cause harmful
interference to radio communications.
However, there is no guarantee that
interference will not occur in a particular
installation. If this device does cause
harmful interference to radio or
television reception, which can be
determined by turning the equipment
off and on, the user is encouraged to
try to correct the interference by one
or more of the following measures:
- Reorient or relocate the receiving
antenna.
- Increase the separation distance
between the equipment and receiver.
- Connect the equipment into an outlet
on a circuit different from that to which
the receiver is connected.
- Consult the manufacturer or an
experienced radio/TV technician
for help.
Changes or modifications not expressly
approved by the party responsible
for compliance could void the user’s
authority to operate the equipment.
63
Cell phone
Some hearing aid users have reported
a buzzing sound in their hearing aid
when using cell phones, indicating that
the cell phone and hearing aid may not
be compatible.
The hearing aid is compliant with
ANSI C63.19 in both microphone
and telecoil mode.
The ANSI C63.19 standard determines
the prediction of compatibility between
a specific hearing aid and a cell phone,
thus hearing aid compliance is tested
according to this standard. However,
demonstrating compliance according to
this standard cannot guarantee that all
users will be satisfied.
Whereas all hearing aids have acoustic
coupling, only the larger hearing aids
have the physical space for telecoil
(inductive) coupling.
64
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Tinnitus
Warnings
More info
IMPORTANT NOTICE
The performance of an individual hearing aid may vary with individual cell
phones. Therefore, ensure you try this hearing aid with your cell phone or,
if you are purchasing a new phone, be sure to try it with your hearing aid
prior to purchase. For additional guidance, please ask your cell phone
provider for the booklet entitled “Hearing Aid Compatibility with Digital
Wireless Cell Phones”.
65
The manufacturer declares that this
hearing aid is in compliance with the
essential requirements and other
relevant provisions of Directive
2014/53/EU.
This medical device complies with
Medical Device Regulation (EU)
2017/745.
Declaration of Conformity is available
from the headquarters.
Oticon A/S
Kongebakken 9
DK-2765 Smørum
Denmark
www.oticon.global/doc
Should your hearing aid require service or replacement, contact your hearing care
professional for assistance. Many repair needs can be handled on-site at your
local hearing care professional’s office, and they will arrange for service with the
manufacturer if required. You can also contact us at:
580 Howard Ave., Somerset, NJ 08873.
SBO Hearing A/S
Denmark
66
About
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Waste from electronic
equipment must be
handled according to
local regulations.
Daily use
Options
Tinnitus
Warnings
More info
Description of symbols accompanying the product
Warnings
Text marked with a warning symbol must be read before using the device.
Manufacturer
The device is produced by the manufacturer whose name and address are stated next
to the symbol. Indicates the medical device manufacturer, as defined in EU Regulations
2017/745.
CE mark
The device complies with all required EU regulations and directives.
The four digit number indicates the identification of the notified body.
Electronic waste (WEEE)
Recycle hearing aids, accessories or batteries according to local regulations.
Hearing aid users can also return electronic waste to their hearing care professional for
disposal. Electronic equipment covered by Directive 2012/19/EU on waste and electrical
equipment (WEEE).
Regulatory Compliance Mark (RCM)
The device complies with electrical safety, EMC and radio spectrum requirements for
devices supplied to the Australian or New Zealand markets.
IP code
Indicates the class of protections against harmful ingress of water and particulate matter
according to EN 60529. IP6X indicates total dust protection. IPX8 indicates the protection
against the effects of continuous immersion in water.
Bluetooth logo
Registered trademark of Bluetooth SIG, Inc. where any use of such requires a license.
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67
Description of symbols accompanying the product
Made for Apple badges
Indicates that the device is compatible with iPhone and iPad.
Mac badge
Indicates that the device is compatible with Mac.
Apple AirPlay badge
The AirPlay button can be used to disconnect and connect hearing aids from a Mac.
Android badge
Indicates that the device is compatible with Android.
Hearing loop
This logo incorporates the universal symbol for hearing assistance.
The “T” signifies that a hearing loop is installed.
Radio Frequency (RF) transmitter
Your hearing aid contains an RF transmitter.
GTIN
Global Trade Item Number
A globally unique 14-digit number used to identify medical device products including
medical device software. GTIN in this booklet is related to medical device firmware (FW).
GTIN on regulatory packaging label is related to medical device hardware.
FW
Firmware version used in the device.
Keep dry
Indicates a medical device that needs to be protected from moisture.
68
About
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Daily use
Options
Tinnitus
Warnings
More info
Description of symbols accompanying the product
Catalog number
Indicates the manufacturer’s catalog number so that the medical device can be
identified.
Serial number
Indicates the manufacturer’s serial number so that a specific medical device can be
identified.
Medical Device
The device is a medical device.
Battery recycling symbol
Li-ion battery recycling symbol.
Temperature limit
Indicates the temperature limits to which the medical device can be safely exposed.
Humidity limitation
Indicates the range of humidity to which the medical device can be safely exposed.
Unique device identifier
Indicates a carrier that contains unique device identifier information
69
International warranty
70
Your device is covered by an
international warranty issued by the
manufacturer. This international
warranty covers manufacturing
and material defects in the device
itself, but not in accessories such as
batteries, tubing, speakers, earpieces
and filters, etc. Problems arising from
improper/incorrect handling or care,
excessive use, accidents, repairs made
by an unauthorized party, exposure to
corrosive conditions, physical changes
in your ear, damage due to foreign
objects entering the device, or incorrect
adjustments are NOT covered by the
international warranty and may void
it. The above international warranty
does not affect any legal rights that you
might have under applicable national
legislation governing the sale of
consumer goods in the country where
you have bought your device. Your
hearing care professional may also have
issued a warranty that goes beyond the
clauses of this international warranty.
Please consult him/her for further
information.
About
Tinnitus
Getting started
Daily use
Options
If you need service
Take your device to your hearing care
professional, who may be able to sort
out minor problems and adjustments
immediately. Your hearing care
professional may charge a fee for their
services.
Warnings
More info
Your individual hearing aid settings
To be filled out by your hearing care professional.
Tinnitus SoundSupport: Limitation on use
n
n
n
n
n
No limitation on use
Program
Start-up volume (Tinnitus)
Max volume (Tinnitus)
1
Max _______ hours per day
Max _______ hours per day
2
Max _______ hours per day
Max _______ hours per day
3
Max _______ hours per day
Max _______ hours per day
4
Max _______ hours per day
Max _______ hours per day
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71
Tinnitus SoundSupport settings overview for your hearing aid
Left
n Yes
Right
n No
Tinnitus SoundSupport
n Yes
n No
n A) How to adjust Tinnitus SoundSupport volume in each ear separately
To increase or decrease the volume (on one hearing aid only), use a short
press on the push-button repeatedly until you reach your desired level.
n B) How to adjust Tinnitus SoundSupport volume in both ears
simultaneously
You can use one hearing aid to increase the volume and the other hearing aid
to decrease the volume.
To increase the volume, use a short press on the push-button repeatedly on
the RIGHT hearing aid.
To decrease the volume, use a short press on the push-button repeatedly on
the LEFT hearing aid.
To be filled out by your hearing care professional.
72
About
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Daily use
Options
Tinnitus
Warnings
More info
General settings overview for your hearing aid
Left
Right
n Yes n No
n Short press
n Long press
Change program
n Yes n No
n Short press
n Long press
n Yes
Adjust volume
n Yes
n No
n On
n On
n On
n Off
n Off
n Off
n On
n Off
n No
Volume control indicators
n On
n On
n On
n Off
n Off
n Off
Beeps at min/max volume
Beeps when changing volume
Beeps at start-up volume
Battery indicators
n On
n Off
Low battery warning
To be filled out by your hearing care professional.
73
Sound and LED light indicators
Different sounds and light patterns indicate the hearing aid status. The
different indicators are listed on the following pages. For light indicators
on your charger, see the charger’s instructions for use.
Your hearing care professional can set sound and LED light indicators to
match your preferences.
Program
n Sound
1
1 tone
2
2 tones
3
3 tones
4
4 tones
n LED light*
When to use
Short GREEN blink
*LED light blinks continuously or is repeated three times with short pauses.
74
About
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Options
Tinnitus
Warnings
More info
ON/OFF
Sound
LED light
ON
n Jingle
n
OFF
n 4 descending tones
n
Volume
Sound
LED light
Start-up volume
n 2 beeps
n
Minimum/maximum
volume
n 3 beeps
n
Volume up/down
n 1 beep
n
Mute
Long GREEN blink
n
Short GREEN blink
Long ORANGE blink
LED light comments
Shown once
Continuous or
repeated three times
Short ORANGE blink
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Accessories
n Sound
TV Adapter 3.0
2 different tones
EduMic
2 different tones
ConnectClip
2 different tones
Bluetooth
n Sound
Bluetooth ON
4 descending tones
+ short jingle
Bluetooth OFF
4 descending tones
+ short jingle
Long GREEN blink
76
About
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n LED light
Continuous or
repeated three times
n LED light
Short GREEN blink
Daily use
LED light comments
Options
Only available when
three-time repetition
is selected
Long ORANGE blink
Tinnitus
Warnings
Short ORANGE blink
More info
Warnings
Sound
LED light
n 3 alternate
Low battery
tones
n Voice
LED light
comments
n
Continuously
blinking
n
Repeated four
times. See
the Troubleshooting section
Turned OFF
See the Troubleshooting section
Notification
Battery shut down
Microphone cleaning
or service needed
The hearing aid LED
light does not turn
ON when the hearing
aid is placed in the
charger
4 descending
tones
8 beeps
repeated 4 times
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77
Warnings
Sound
LED light
LED light
comments
The hearing aid LED
light blinks ORANGE
when the hearing
aid is placed in the
charger
Long GREEN blink
78
About
Getting started
Continuously
blinking. See the
Troubleshooting
section.
Short GREEN blink
Daily use
Options
Long ORANGE blink
Tinnitus
Warnings
Short ORANGE blink
More info
Troubleshooting
Symptom
Possible causes
Hearing aid is out of power
Dead battery
No sound
Incompatable receiver
Clogged earpieces (dome, Grip Tip, or mold)
Hearing aid microphone muted
Intermittent or reduced
sound
Squealing noise
Beeping
Pairing issue with
smartphone
Connectivity issues with
Mac
80
About
Getting started
Clogged sound outlet
Moisture
Hearing aid earpiece incorrectly inserted
Earwax accumulated in ear canal
If your hearing aid plays eight beeps, four times consecutively,
your hearing aid may need a microphone service check.
Bluetooth connection failed
Only one hearing aid is paired
Audio problems
Daily use
Options
Tinnitus
Warnings
More info
Solutions
Charge the hearing aid
Contact your hearing care professional
Contact your hearing care professional
Clean mold
Replace wax filter, dome, or Grip Tip
Unmute the hearing aid microphone
Clean mold or replace wax filter, dome, or Grip Tip
Gently wipe the hearing aid and let it dry
Re-insert the earpiece
Have ear canal examined by your doctor
First, try to clean the microphone with the cleaning tool.
If the beep persists, contact your service center.
1) Unpair your hearing aid. 2) On your phone, turn Bluetooth OFF and ON again.
3) Turn the hearing aid OFF and then turn it back ON. 4) Pair your hearing aid again (for guidance,
visit: www.oticon.com/support)
1) Open the Control Center on Mac. 2) Under Sound, click the AirPlay button OFF. 3) Turn your
hearing aids OFF, then ON again. 4) In the Control Center under Sound, click the AirPlay button ON
Note
If none of the above solutions work, consult your hearing care professional.
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Troubleshooting
To troubleshoot the charger, see your charger’s instructions for use.
Symptom
Possible causes
The charger is turned OFF
The hearing aid LED light
remains turned OFF when
the hearing aid is placed
in the charger
The hearing aid or charger’s temperature is either too warm or too
cold
Charging is incomplete. The charger has stopped charging to
protect the battery.
The hearing aid is incorrectly seated in the charger
The hearing aid charge pins are dirty
82
The hearing aid LED light
pulses ORANGE when the
hearing aid is placed in
the charger but does not
power ON when removed
from the charger
Battery is very low and insufficient to power ON hearing aids
The hearing aid LED light
blinks ORANGE when the
hearing aid is placed in
the charger
System error
About
Getting started
Daily use
Options
Tinnitus
Warnings
More info
Solutions
Verify that the charger’s power plug is correctly connected or the power bank has enough battery
Move the charger and hearing aid to a location with a temperature between +5°C and +40°C
(+41°F and +104°F)
Reinsert the hearing aid into the charger. This completes the charging within approximately
15 minutes.
Check the charging ports for foreign objects
Clean the contacts using a dry cloth
The hearing aids are charging. Ensure you leave the hearing aids in the charger during this process
Contact your hearing care professional
Note
If none of the above solutions work, consult your hearing care professional.
83
Summary of relevant studies
84
Clinical evaluations conducted by or
for the manufacturer provide evidence
to support the intended use and clinical
benefits outlined in the IFU and demonstrate
regulatory conformity. Clinical data is
collected, assessed, and analyzed to
support the performance of the hearing
aids by validating that they provide
sufficient audibility and hearing loss
compensation based on best-practice
prescriptive fitting rationales. The clinical
data also demonstrate improved speech
understanding and success with hearing
aids using validated questionnaires and
surveys.
Non-clinical data supporting the overall
performance of the hearing aids includes
software verification, electroacoustic
verification, electrical and mechanical
safety evaluation, electromagnetic
compatibility (EMC) evaluation, and
documentation of radio properties and
performance. Additional information can
be found in section Technical Information.
About
Tinnitus
Getting started
Daily use
Options
Warnings
More info
Technical Data
miniRITE
Measured according to American National Standard ANSI S3.22-2014, IEC 60118-0:2015
and IEC 60318-5:2006
Supply voltage: Lithium-ion
0 dB SPL ref. 20 μPa
OSPL90
Full-on Gain
Oticon Intent 1
Oticon Intent 2, 3 & 4
Peak
109 dB SPL
109 dB SPL
HF Average
105 dB SPL
105 dB SPL
Peak
34 dB
34 dB
HF Average
31 dB
31 dB
27 dB
27 dB
<100-8400 Hz
<100-7500 Hz
87/87 dB SPL
87/87 dB SPL
Reference Test Gain
Frequency Range
Telecoil output
Total Harmonic
Distortion
Equivalent Input Noise
Level
86
HF Average SPLITS (left/right ear)
500 Hz
<2 %
<2 %
800 Hz
<2 %
<2 %
1600 Hz
<2 %
<2 %
(omni/dir)
18/30 dB SPL
18/30 dB SPL
Attack Time
6 ms
6 ms
Release Time
30 ms
30 ms
About
Getting started
Daily use
Options
Tinnitus
Warnings
More info
0 dB SPL ref. 20 μPa
Oticon Intent 1
Oticon Intent 2, 3 & 4
Expected operating time* Hours
24 hrs
24 hrs
Latency
8.1 ms
8.1 ms
Maximum Induction Coil
Sensitivity
Measured output at 1 mA/m
60 dB SPL
60 dB SPL
Measured output at 10 mA/m
80 dB SPL
80 dB SPL
Measured output at 31.6 mA/m
90 dB SPL
90 dB SPL
*Expected operating time for rechargeable battery depends on use pattern, active feature set, hearing loss, sound
environment, battery age and use of wireless accessories.
87
Technical Data
miniRITE
Measured according to American National Standard ANSI S3.22-2014, IEC 60118-0:2015
and IEC 60318-5:2006
Supply voltage: Lithium-ion
0 dB SPL ref. 20 μPa
OSPL90
Full-on Gain
Oticon Intent 2, 3 & 4
116 dB SPL
116 dB SPL
HF Average
113 dB SPL
113 dB SPL
Peak
55 dB
55 dB
HF Average
47 dB
47 dB
Reference Test Gain
36 dB
36 dB
Frequency Range
<100-8500 Hz
<100-7500 Hz
96/96 dB SPL
96/96 dB SPL
Telecoil output
Total Harmonic
Distortion
Equivalent Input Noise
Level
88
Oticon Intent 1
Peak
HF Average SPLITS (left/right ear)
500 Hz
<2%
<2%
800 Hz
<2%
<2%
1600 Hz
<2%
<2%
(omni/dir)
19/30 dB SPL
19/30 dB SPL
Attack Time
5 ms
5 ms
Release Time
26 ms
26 ms
About
Getting started
Daily use
Options
Tinnitus
Warnings
More info
0 dB SPL ref. 20 μPa
Oticon Intent 1
Oticon Intent 2, 3 & 4
Expected operating time* Hours
24 hrs
24 hrs
Latency
8.1 ms
8.1 ms
Maximum Induction Coil
Sensitivity
Measured output at 1 mA/m
75 dB SPL
75 dB SPL
Measured output at 10 mA/m
95 dB SPL
95 dB SPL
Measured output at 31.6 mA/m
105 dB SPL
105 dB SPL
*Expected operating time for rechargeable battery depends on use pattern, active feature set, hearing loss, sound
environment, battery age and use of wireless accessories.
89
Technical Data
miniRITE
Measured according to American National Standard ANSI S3.22-2014, IEC 60118-0:2015
and IEC 60318-5:2006
Supply voltage: Lithium-ion
0 dB SPL ref. 20 μPa
OSPL90
Full-on Gain
Oticon Intent 1
Oticon Intent 2, 3 & 4
Peak
123 dB SPL
123 dB SPL
HF Average
121 dB SPL
121 dB SPL
Peak
59 dB
59 dB
HF Average
57 dB
57 dB
43 dB
43 dB
Reference Test Gain
Frequency Range
<100-7100 Hz
103/103 dB SPL
HF Average SPLITS (left/right ear)
Total Harmonic
Distortion
500 Hz
<2%
<2%
800 Hz
<2%
<2%
1600 Hz
<2%
<2%
(omni/dir)
16/29 dB SPL
16/29 dB SPL
Equivalent Input Noise
Level
90
<100-7100 Hz
103/103 dB SPL
Telecoil output
Attack Time
13 ms
13 ms
Release Time
19 ms
19 ms
About
Getting started
Daily use
Options
Tinnitus
Warnings
More info
0 dB SPL ref. 20 μPa
Oticon Intent 1
Oticon Intent 2, 3 & 4
Expected operating time* Hours
24 hrs
24 hrs
Latency
8.1 ms
8.1 ms
Maximum Induction Coil
Sensitivity
Measured output at 1 mA/m
86 dB SPL
86 dB SPL
Measured output at 10 mA/m
106 dB SPL
106 dB SPL
Measured output at 31.6 mA/m
116 dB SPL
116dB SPL
*Expected operating time for rechargeable battery depends on use pattern, active feature set, hearing loss, sound
environment, battery age and use of wireless accessories.
91
Technical Data
miniRITE
Measured according to American National Standard ANSI S3.22-2014, IEC 60118-0:2015
and IEC 60318-5:2006
Supply voltage: Lithium-ion
0 dB SPL ref. 20 μPa
OSPL90
Full-on Gain
Oticon Intent 1
Oticon Intent 2, 3 & 4
Peak
126 dB SPL
126 dB SPL
HF Average
123 dB SPL
123dB SPL
Peak
63 dB
63 dB
HF Average
57 dB
57 dB
45 dB
45 dB
Reference Test Gain
Frequency Range
<100-7500 Hz
105/105 dB SPL
HF Average SPLITS (left/right ear)
Total Harmonic
Distortion
500 Hz
<2%
<2%
800 Hz
<2%
<2%
1600 Hz
<2%
<2%
(omni/dir)
17/29 dB SPL
17/29 dB SPL
Equivalent Input Noise
Level
92
<100-8200 Hz
105/105 dB SPL
Telecoil output
Attack Time
8 ms
8 ms
Release Time
19 ms
19 ms
About
Getting started
Daily use
Options
Tinnitus
Warnings
More info
0 dB SPL ref. 20 μPa
Oticon Intent 1
Oticon Intent 2, 3 & 4
Expected operating time* Hours
24 hrs
24 hrs
Latency
8.1 ms
8.1 ms
Maximum Induction Coil
Sensitivity
Measured output at 1 mA/m
86 dB SPL
86 dB SPL
Measured output at 10 mA/m
106 dB SPL
106 dB SPL
Measured output at 31.6 mA/m
116 dB SPL
116 dB SPL
*Expected operating time for rechargeable battery depends on use pattern, active feature set, hearing loss, sound
environment, battery age and use of wireless accessories.
93
Technical Data
miniRITE
Oticon Intent 1
OSPL90 – Output
Sound Pressure Level
Input: 90 dB SPL
Technical setting: A0
Oticon Intent 2, 3 & 4
dB SPL
dB SPL
110
110
100
100
90
90
80
80
100
Frequency Response
Input:
60 dB SPL (Acoustic)
31.6 mA/m (Magnetic)
Technical setting: N0
Acoustic input
Magnetic input
Input-Output
Technical Setting: N0
200
500
1000
2000
5000 10000 Hz
100
100
90
90
80
80
500
1000
2000
5000 10000 Hz
500
1000
2000
5000 10000 Hz
70
70
100
200
dB SPL
dB SPL
200
500
1000
2000
5000 10000 Hz
100
200
dB SPL
dB SPL
110
110
100
100
90
90
80
80
500 Hz
800 Hz
1600 Hz
2000 Hz
70
40
94
100
50
60
70
80
90
100
500 Hz
800 Hz
1600 Hz
2000 Hz
70
40
50
60
70
80
90
100
Technical Data
miniRITE
Oticon Intent 1
OSPL90 – Output
Sound Pressure Level
Input: 90 dB SPL
Technical setting: A0
Oticon Intent 2, 3 & 4
dB SPL
dB SPL
120
120
110
110
100
100
90
90
100
Frequency Response
Input:
60 dB SPL (Acoustic)
31.6 mA/m (Magnetic)
Technical setting: N0
Acoustic input
Magnetic input
Input-Output
Technical Setting: N0
200
500
1000
2000
5000 10000 Hz
100
dB SPL
500
1000
2000
5000 10000 Hz
500
1000
2000
5000 10000 Hz
dB SPL
110
110
100
100
90
90
80
100
200
80
200
500
1000
2000
5000 10000 Hz
100
200
dB SPL
dB SPL
110
110
100
100
90
90
80
80
500 Hz
800 Hz
1600 Hz
2000 Hz
70
40
50
60
70
80
90
100
500 Hz
800 Hz
1600 Hz
2000 Hz
70
40
50
60
70
80
90
100
95
Technical Data
miniRITE
Oticon Intent 1
OSPL90 – Output
Sound Pressure Level
Input: 90 dB SPL
Technical setting: A0
Oticon Intent 2, 3 & 4
dB SPL
dB SPL
130
130
120
120
110
110
100
100
100
Frequency Response
Input:
60 dB SPL (Acoustic)
31.6 mA/m (Magnetic)
Technical setting: N0
Acoustic input
Magnetic input
Input-Output
Technical Setting: N0
200
500
1000
2000
5000 10000 Hz
dB SPL
120
120
110
110
100
100
90
100
200
500
1000
2000
5000 10000 Hz
500
1000
2000
5000 10000 Hz
dB SPL
90
200
500
1000
2000
5000 10000 Hz
100
200
dB SPL
dB SPL
120
120
110
110
100
100
90
90
500 Hz
800 Hz
1600 Hz
2000 Hz
80
40
96
100
50
60
70
80
90
100
500 Hz
800 Hz
1600 Hz
2000 Hz
80
40
50
60
70
80
90
100
Technical Data
miniRITE
Oticon Intent 1
OSPL90 – Output
Sound Pressure Level
Input: 90 dB SPL
Technical setting: A0
Oticon Intent 2, 3 & 4
dB SPL
dB SPL
130
130
120
120
110
110
100
100
100
Frequency Response
Input:
60 dB SPL (Acoustic)
31.6 mA/m (Magnetic)
Technical setting: N0
Acoustic input
Magnetic input
Input-Output
Technical Setting: N0
200
500
1000
2000
5000 10000 Hz
100
dB SPL
500
1000
2000
5000 10000 Hz
500
1000
2000
5000 10000 Hz
dB SPL
120
120
110
110
100
100
90
100
200
90
200
500
1000
2000
5000 10000 Hz
100
200
dB SPL
dB SPL
120
120
110
110
100
100
90
90
500 Hz
800 Hz
1600 Hz
2000 Hz
80
40
50
60
70
80
90
100
500 Hz
800 Hz
1600 Hz
2000 Hz
80
40
50
60
70
80
90
100
97
276032US / 2024.05.24 / v1
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9.0 mm
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Placeholder
for FSC logo
21 mm
>
<>
8,15 mm
< 15 mm >
0000276032000001
276032US / 2024.05.24 / v1
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