Oticon Own SI Instructions For Use

Instructions for use
IIC - CIC
Oticon Own SI™
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.
Model overview
This booklet is valid for the following hearing aid models and styles:
Styles
 IIC
 CIC
Invisible-In-the-Canal
Completely-In-the-Canal
Battery
Size 10
1.0
 Oticon Own SI 1
 Oticon Own SI 2
 Oticon Own SI 3
 Oticon Own SI 4
GTIN: (01) 05714464139934
GTIN: (01) 05714464139927
GTIN: (01) 05714464139910
GTIN: (01) 05714464140039
Introduction to this booklet
This booklet guides you on how to use and maintain your new hearing aids.
Ensure you read the booklet carefully including the Warnings section. This
will help you get the most benefit of your new hearing aid.
Warnings
Text marked with a warning symbol must be read before using the device.
Your hearing care professional has adjusted the hearing aid 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 educated and has proven competency in professionally
assessing hearing, selecting, fitting, and delivering hearing instruments
and rehabilitation care to persons with hearing loss.
The education of the hearing care professional is in accordance with
national or regional regulations.
*The job title may vary from country to country.
For your convenience this booklet contains a navigation bar to help you
navigate easily through the different sections.
About Getting started Daily use Options Tinnitus Warnings More info
Intended use
Intended use
Indications for use
Intended user
Intended user group
Use environment
Contraindications
Clinical benefits
The hearing aid is intended to amplify and transmit sound to
the ear.
Bilateral or unilateral impaired hearing of sensorineural,
conductive, or mixed type ranging from a slight (16 dB HL*)
to severe (75 dB HL*) degree of hearing loss, with an
individual frequency configuration.
Person with hearing loss using a hearing aid and their
caregivers. Hearing care professional responsible for
adjusting the hearing aid.
Adults.
Indoor and outdoor.
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.
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.
**In accordance with current Pediatric Amplification guidelines, custom hearing aids are not typically considered
for children of any age. However, a hearing care professional may, in special circumstance and on a case-bycase basis, select them for children older than 36 months.
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.
Table of contents
About
Your hearing aid
Identify left and right hearing aid
MultiTool for handling batteries and cleaning
Getting started
Turn the hearing aid ON and OFF
Low battery indication
How to replace the battery
Daily use
Insert the hearing aid
Remove your hearing aid
Caring for your hearing aid
Filter replacement
Replace ProWax miniFit filter
Replace T-Cap filter
Change volume with push-button
Change programs
Options
Mute the hearing aid
Optional features and accessories
14
15
16
18
19
20
22
23
24
26
27
28
29
30
32
33
Tinnitus
Tinnitus SoundSupport™
Guidelines for Tinnitus SoundSupport users
Limitation on use time
Sound options and volume adjustments
Warnings related to Tinnitus
34
35
35
36
38
General warnings
39
Water & dust resistant (IP68)
Conditions of use
Cell phone
Technical information
International warranty
Your individual hearing aid settings
Sound indicators
Troubleshooting guide
Summary of relevant studies
Technical Data
43
44
46
48
55
56
58
60
62
64
Warnings
More info
Your hearing aid
(CIC shown)
What it is and does
Microphone inlet
Sound in
Push-button
(Optional - CIC only)
Mute, change
volume and
program
Battery drawer
Contains the
battery and
functions as
ON/OFF switch
Sound outlet
Sound out
Pull out string
Pull out the
hearing aid
Vent
Vent
Components may be positioned differently on your hearing aid.
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About Getting started Daily use Options Tinnitus Warnings More info
Identify left and right hearing aid
It is important to distinguish between the left and the right hearing aid as
they might be shaped and programmed differently.
A BLUE shell, dot or text
identifies the LEFT hearing aid
A RED shell, dot or text identifies
the RIGHT hearing aid
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MultiTool for handling batteries and cleaning
The MultiTool contains a magnet that makes it easier to replace the battery
in the hearing aid. It also contains a brush and a wire loop for cleaning and
removing earwax. If the vent is very small, a special tool may be required. If
you need a new tool please 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 magnetically sensitive devices.
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About Getting started Daily use Options Tinnitus Warnings More info
Turn the hearing aid ON and OFF
The battery drawer is also used to switch the hearing aid ON and OFF. To
save battery life, make sure your hearing aid is switched OFF when you are
not wearing it. If you wish to return to the standard settings of the hearing
aid, simply open and then close the battery drawer (quick reset).
Turn ON
Close the
battery
drawer
with the
battery in
place.
Turn OFF
Open the
battery
drawer.
Note: Open the battery door fully to make sure the hearing aid does not drain the battery fully and to allow air to
circulate whenever you are not using your hearing instrument, especially at night or for longer periods of time.
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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.
The battery is running low
Three alternate tones
The battery has run out
Four descending tones
Voice Notification
(Optional for select languages)
Battery tip
To make sure the hearing aid is always working, bring spare batteries with
you, or replace the battery before you leave home.
19
How to replace the battery
1. Remove
2. Uncover
3. Insert
Fully open the battery
drawer. Remove the
battery.
Remove the sticky
label from the + side of
the new battery.
Insert the new battery
into the battery drawer.
Ensure that the + side of
the battery and battery
drawer align.
Tip:
Wait 2 minutes so that
the battery can draw
air, to ensure optimal
functioning.
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About Getting started Daily use Options Tinnitus Warnings More info
4. Close
Tip
MultiTool
Close the battery drawer. The hearing
aid will play a jingle.
Hold the hearing aid close to your ear
to hear the jingle.
The MultiTool can be used for battery
change. Use the magnetic end to
remove and insert batteries.
21
Insert the hearing aid
22
Step 1
Step 2
Place the tip of the hearing aid in your
ear canal.
Gently pull your ear outwards and
push the hearing aid into the ear canal,
twisting slightly if necessary. Follow
the natural contour of the ear canal.
Push the hearing aid to make sure it fits
comfortably in the ear.
About Getting started Daily use Options Tinnitus Warnings More info
Remove your hearing aid
Hold the hearing aid by the pull-out string (if available). Gently pull the
hearing aid from the ear canal.
If your hearing aid doesn’t have a pull-out string, you can remove it by
pulling on the edge of the hearing aid.
IMPORTANT NOTICE
DO NOT use the battery door as a handle to insert or remove your hearing aids,
as it is not designed for this purpose.
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Caring for your hearing aid
When handling your hearing aid, hold it over a soft surface to avoid damage
if you drop it.
Cleaning the hearing aid
Carefully brush away debris from the microphone inlets with a clean brush.
Gently brush the surface. Make sure that the filters do not fall off.
Microphone
inlet
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About Getting started Daily use Options Tinnitus Warnings More info
Clean the vent by pressing the brush
through the hole while twisting it slightly.
If the vent is very small, a
special tool may be required.
Please consult your hearing
care professional.
Vent
Vent
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
Filter replacement
The filters keep wax and debris from damaging the hearing aid.
If the filters become clogged, please replace the filters or contact your
hearing care professional.
• ProWax miniFit filters protect the sound outlet.
• T-cap filters protect the microphone inlet.
Please refer to the following pages for instructions on how to replace the
appropriate filters.
IMPORTANT NOTICE
Ensure you always use the same type of wax filter as was originally supplied
with the hearing aids.
If you are in doubt about the use or replacement of ProWax miniFit filters,
contact your hearing care professional.
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About Getting started Daily use Options Tinnitus Warnings More info
Replace ProWax miniFit filter
1. Tool
2. Remove
3. Insert
New
filter
New
filter
New filter
Old filter
Remove the tool from
the shell. The tool has
two pins, one empty
for removal and one
with the new ProWax
miniFit filter.
Push the empty pin
into the ProWax miniFit
filter in the hearing aid
and pull it out.
Old filter
Insert the new ProWax
miniFit filter using the
other pin, remove the
tool and throw it out.
27
Replace T-Cap filter
1. Tool
2. Remove
3. Insert
Push the tool fork
under the top edge of
the used T-Cap filter
and lift it out.
Insert the new T-Cap
filter and remove the
tool by twisting it
slightly. Throw the tool
out after use.
new filter
Remove the tool from
the packaging. The tool
has two ends, one for
removal and one with
the new T-Cap filter.
28
About Getting started Daily use Options Tinnitus Warnings More info
Change volume with push-button
(Optional - CIC only)
The push-button allows you to adjust the volume.
You may hear a click when you turn the volume up or down.
MAXIMUM
A short press on the
RIGHT hearing aid
increases the volume
START-UP
VOLUME
A short press on the
LEFT hearing aid
decreases the volume
MINIMUM
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Change programs
(Optional - CIC only)
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.
Use a short press to switch between programs.
If Volume control is enabled, use a long press to
switch programs.
If you have two synchronized 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.
If your hearing aids work independently, you
must press the buttons on each hearing aid.
30
About Getting started Daily use Options Tinnitus Warnings More info
For information regarding tones, see the Sound 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.
31
Mute the hearing aid
Use the mute function if you need to silence the hearing aid. Only available
for hearing aids with push-button.
Press and hold the push-button
for two seconds to mute the
hearing aid.
To unmute, press the push-button.
NOTE: the mute function only mutes the microphone(s) on the hearing aids.
IMPORTANT NOTICE
Do not use the mute function as an off switch, as the hearing aids are still using
battery power in this mode.
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About Getting started Daily use Options Tinnitus Warnings More info
Optional features and accessories
The features and accessories described on the following pages are
optional. Please contact your hearing care professional to find out how your
hearing aid is programmed.
If you experience difficult listening situations, a special program may be
helpful. These are programmed by your hearing care professional.
Write down any hearing situations in which you may need help.
33
Tinnitus SoundSupport™
(Optional - CIC only)
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. Fitting
of Tinnitus SoundSupport must be done by a hearing care professional
participating in a tinnitus management program.
34
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.
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.
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.
35
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.
36
About Getting started Daily use Options Tinnitus Warnings More info
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.
37
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.
38
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 of your hearing loss.
About Getting started Daily use Options Tinnitus Warnings More info
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.
To achieve the full benefit from your
hearing aids, you should use them
frequently.
Usage of hearing aids
Hearing aids should only be used as
directed and adjusted by your hearing care
professional. Misuse can result in sudden
and permanent hearing loss.
Never allow others to wear your hearing
aid, as incorrect usage could cause
permanent damage to their hearing.
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.
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39
General warnings
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.
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.
Use of replaceable batteries
Only use batteries recommended by your
hearing care professional.
Batteries of low quality may leak and cause
bodily harm.
Never attempt to recharge your replaceable
batteries.
40
Never dispose of batteries by burning
them. There is a risk that the batteries will
explode. Follow local guidelines for proper
and safe disposal of batteries.
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
About Getting started Daily use Options Tinnitus Warnings More info
voltages into the human body defined
in the standards for human health
and coexistence with active medical
implants, such as pacemakers and heart
defibrillators.
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.
If you have an active brain implant, contact
the manufacturer of your implanted device
for information about the use with a
hearing aid.
Remove hearing aids before certain
medical procedures
Remove your hearing aid before medical
procedures such as X-ray examinations,
CT/MR/PET scans, electrotherapy,
surgery, etc. Your hearing aid may be
damaged if exposed to strong magnetic or
electromagnetic fields.
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.
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41
General warnings
Potential side effects
You may produce more earwax when using
hearing aids.
In rare cases, the non-allergenic materials
in the product may cause skin irritation or
other side effects. If you experience any
such side effects, consult your doctor.
Do not modify
Do not make any modifications to your
hearing aid not expressly approved by the
manufacturer. This will void the warranty.
Connection to external equipment
The safety of the hearing aids, when
connected to external equipment (with
an auxiliary input cable and/or with USB
cable and/or directly), is determined by the
external signal source. When the hearing
aid is connected to external equipment
which is plugged into a power socket, this
equipment must comply with IEC 62368-1
or equivalent safety standards.
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.
Use of third-party accessories
Only use accessories, cables or transducers
(for example, microphones) supplied by
the manufacturer. Non-original accessories
42
may result in reduced electromagnetic
compatibility (EMC) of your hearing aid.
About Getting started Daily use Options Tinnitus Warnings More info
Water & dust resistant (IP68)
Your hearing aid is dust-tight 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, gently wipe
off any water and let the hearing aid dry.
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.
43
Conditions of use
Operating Conditions
Temperature: +1°C to +40°C (34°F to 104°F)
Humidity: 5% - 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:
Temperature: -25°C to + 60°C (-13°F to 140°F)
Humidity: 5% - 93% relative humidity, non-condensing
Atmospheric pressure: 700 hPa to 1060 hPa
44
About Getting started Daily use Options Tinnitus Warnings More info
45
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.
46
About Getting started Daily use Options Tinnitus Warnings More info
IMPORTANT NOTICE
The performance of individual hearing aids 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.”
Technical information
The hearing aids contain 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 –15 dBμA/m
at a distance of 10 meters (–4.6 dBμA/ft
at a distance of 33 feet).
Only use your hearing aids in areas where
wireless transmission is permitted.
The hearing aids comply 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:
48
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.
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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.
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
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.
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).
49
CIC
This device contains a radio module
(AM_AU5_KIT10) with the following
certification ID number:
FCC ID: 2ACAHAU5CIC
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.
50
About Getting started Daily use Options 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.
51
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 at
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
Kongebakken 9
DK-2765 Smørum
Denmark
52
Waste from electronic
equipment must be
handled according to
local regulations.
About Getting started 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 Regulation
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
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.
53
Description of symbols accompanying the product
Radio Frequency (RF) transmitter
Your device 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.
Firmware
Firmware version used in the device.
Keep dry
Indicates a medical device that needs to be protected from moisture.
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.
Unique device identifier
Indicates a carrier that contains unique device identifier information.
54
About Getting started Daily use Options Tinnitus Warnings More info
International warranty
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.
If you need service
Take your device to your hearing care
professional, who may be able to solve
minor problems and adjustments
immediately. Your hearing care
professional may charge a fee for their
services.
55
Your individual hearing aid settings
To be filled out by your hearing care professional.
Tinnitus SoundSupport: Limitation on use
n
n
n
n
n
56
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
About Getting started Daily use Options Tinnitus Warnings More info
Tinnitus SoundSupport settings overview for your hearing aid
Left
n Yes
Right
n No
Tinnitus SoundSupport
n Yes
n No
n A) How to change 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 change 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.
57
Sound indicators
Different sounds indicate the hearing aid status. The different indicators
are listed below.
Your hearing care professional can set sound indicators to match your
preferences.
58
Program
n Sound
1
1 tone
2
2 tones
3
3 tones
4
4 tones
Voice Notification
n Yes
When to use
n No
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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
Change 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.
59
Troubleshooting guide
Symptom
Possible causes
Worn-out battery
No sound
Clogged sound outlet
Clogged microphone inlet
Hearing aid microphone muted
Intermittent or
reduced sound
Squealing noise
Service
alert voice
notification
60
Clogged sound outlet
Moisture
Worn-out battery
Hearing aid not inserted properly
Ear wax accumulated in ear canal
Issue detected by hearing aid
About Getting started Daily use Options Tinnitus Warnings More info
Solutions
Replace the battery
Clean sound outlet* or replace the wax filter
Clean microphone inlet* or replace filter (T-Cap)
Unmute the hearing aid microphone
Clean sound outlet or replace the wax filter
Wipe battery and hearing aid with a dry cloth
Replace the battery
Re-insert the hearing aid
Have ear canal examined by your doctor
Contact your hearing care professional
If none of the above solutions work, consult your hearing care professional for assistance.
* According to guideline in this booklet
61
Summary of relevant studies
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.
62
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 Getting started Daily use Options Tinnitus Warnings More info
Technical Data
IIC
Measured according to American National Standard ANSI S3.22-2014,
IEC 60118-0:2015 and IEC 60318-5:2006
Supply voltage: Zinc-Air
Oticon Own SI
1
0 dB SPL ref. 20 μPa
OSPL90
Full-on Gain
Peak
109 dB SPL
109 dB SPL
HF Average
104 dB SPL
104 dB SPL
Peak
42 dB
42 dB
HF Average
38 dB
38 dB
Reference Test Gain
26 dB
26 dB
Frequency Range
<100-8300 Hz
<100-7500 Hz
500 Hz
<2 %
<2 %
800 Hz
<2 %
<2 %
1600 Hz
<2 %
<2 %
(omni)
20 dB SPL
20 dB SPL
Total Harmonic
Distortion
Equivalent Input Noise
Level
64
Oticon Own SI
2,3,4
Attack Time
5 ms
5 ms
Release Time
26 ms
26 ms
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Oticon Own SI
1
Oticon Own SI
2,3,4
Typical
1.8 mA
1.8 mA
Quiescent
1.7 mA
1.7 mA
Hours
45-55
45-55
8,2 ms
8,2 ms
0 dB SPL ref. 20 μPa
Battery Consumption
Expected battery life
(bat. size 10)
Latency
65
Technical Data
IIC
Measured according to American National Standard ANSI S3.22-2014,
IEC 60118-0:2015 and IEC 60318-5:2006
Supply voltage: Zinc-Air
Oticon Own SI
1
Oticon Own SI
2,3,4
Peak
119 dB SPL
119 dB SPL
HF Average
116 dB SPL
116 dB SPL
0 dB SPL ref. 20 μPa
OSPL90
Full-on Gain
49 dB
49 dB
HF Average
48 dB
48 dB
Reference Test Gain
38 dB
38 dB
Frequency Range
<100-7700 Hz
<100-7500 Hz
500 Hz
<2 %
<2 %
800 Hz
<2 %
<2 %
1600 Hz
<2 %
<2 %
(omni)
20 dB SPL
20 dB SPL
Total Harmonic
Distortion
Equivalent Input Noise
Level
66
Peak
Attack Time
5 ms
5 ms
Release Time
20 ms
20 ms
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Oticon Own SI
1
Oticon Own SI
2,3,4
Typical
2.4 mA
2.4 mA
Quiescent
1.8 mA
1.8mA
Hours
40-55
40-55
8,2 ms
8,2 ms
0 dB SPL ref. 20 μPa
Battery Consumption
Expected battery life
(bat. size 10)
Latency
67
Technical Data
CIC
Measured according to American National Standard ANSI S3.22-2014,
IEC 60118-0:2015 and IEC 60318-5:2006
Supply voltage: Zinc-Air
Oticon Own SI
1
0 dB SPL ref. 20 μPa
OSPL90
Full-on Gain
Peak
109 dB SPL
109 dB SPL
HF Average
104 dB SPL
104 dB SPL
Peak
47 dB
47 dB
HF Average
42 dB
42 dB
Reference Test Gain
26 dB
26 dB
Frequency Range
<100-6900 Hz
<100-6900 Hz
500 Hz
<2 %
<2 %
800 Hz
<2 %
<2 %
1600 Hz
<2 %
<2 %
(omni)
19 dB SPL
19 dB SPL
Total Harmonic
Distortion
Equivalent Input Noise
Level
68
Oticon Own SI
2,3,4
Attack Time
5 ms
5 ms
Release Time
32 ms
32 ms
About Getting started Daily use Options Tinnitus Warnings More info
Oticon Own SI
1
0 dB SPL ref. 20 μPa
Battery Consumption
Expected battery life
(bat. size 10)
Latency
Oticon Own SI
2,3,4
Typical
1.7 mA
1.7 mA
Quiescent
1.6 mA
1.6 mA
Hours
50-55
50-55
8,2 ms
8,2 ms
69
Technical Data
CIC
Measured according to American National Standard ANSI S3.22-2014,
IEC 60118-0:2015 and IEC 60318-5:2006
Supply voltage: Zinc-Air
Oticon Own SI
1
Oticon Own SI
2,3,4
Peak
119 dB SPL
119 dB SPL
HF Average
116 dB SPL
116 dB SPL
0 dB SPL ref. 20 μPa
OSPL90
Full-on Gain
55 dB
55 dB
HF Average
52 dB
52 dB
Reference Test Gain
38 dB
38 dB
Frequency Range
<100-7500 Hz
<100-7500 Hz
500 Hz
<2 %
<2 %
800 Hz
<2 %
<2 %
1600 Hz
<2 %
<2 %
(omni)
19 dB SPL
19 dB SPL
Total Harmonic
Distortion
Equivalent Input Noise
Level
70
Peak
Attack Time
4 ms
4 ms
Release Time
29 ms
29 ms
About Getting started Daily use Options Tinnitus Warnings More info
Oticon Own SI
1
Oticon Own SI
2,3,4
Typical
1.9 mA
1.9 mA
Quiescent
1.6 mA
1.6 mA
Hours
30-55
30-55
8,2 ms
8,2 ms
0 dB SPL ref. 20 μPa
Battery Consumption
Expected battery life
(bat. size 10)
Latency
71
Technical Data
IIC
Oticon Own SI
1
OSPL90 – Output Sound
Pressure Level (dB SPL)
Input: 90 dB SPL
Technical setting: A0
Oticon Own SI
2,3,4
140
140
130
130
120
120
110
110
100
100
90
90
80
70
100
Frequency
response (dB SPL)
Input: 60 dB SPL
Technical setting: N0
80
1k
10k Hz
130
130
120
120
110
110
100
100
90
90
80
80
70
70
50
100
1k
10k Hz
1k
10k Hz
60
60
72
70
100
1k
10k Hz
50
100
About Getting started Daily use Options Tinnitus Warnings More info
Oticon Own SI
1
Input-Output
Technical Setting: N0
Oticon Own SI
2,3,4
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 dB SPL
500 Hz
800 Hz
1600 Hz
2000 Hz
70
40
50
60
70
80
90
100 dB SPL
73
IIC
Technical Data
Oticon Own SI
1
OSPL90 – Output Sound
Pressure Level (dB SPL)
Input: 90 dB SPL
Technical setting: A0
Oticon Own SI
2,3,4
140
140
130
130
120
120
110
110
100
100
90
90
80
70
100
Frequency
response (dB SPL)
Input: 60 dB SPL
Technical setting: N0
80
1k
10k Hz
130
130
120
120
110
110
100
100
90
90
80
80
70
70
50
100
1k
10k Hz
1k
10k Hz
60
60
74
70
100
1k
10k Hz
50
100
About Getting started Daily use Options Tinnitus Warnings More info
Oticon Own SI
1
Input-Output
Technical Setting: N0
Oticon Own SI
2,3,4
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 dB SPL
500 Hz
800 Hz
1600 Hz
2000 Hz
80
40
50
60
70
80
90
100 dB SPL
75
Technical Data
CIC
Oticon Own SI
1
OSPL90 – Output Sound
Pressure Level (dB SPL)
Input: 90 dB SPL
Technical setting: A0
Oticon Own SI
2,3,4
140
140
130
130
120
120
110
110
100
100
90
90
80
70
100
Frequency
response (dB SPL)
Input: 60 dB SPL
Technical setting: N0
80
1k
10k Hz
130
130
120
120
110
110
100
100
90
90
80
80
70
70
50
100
1k
10k Hz
1k
10k Hz
60
60
76
70
100
1k
10k Hz
50
100
About Getting started Daily use Options Tinnitus Warnings More info
Oticon Own SI
1
Input-Output
Technical Setting: N0
Oticon Own SI
2,3,4
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 dB SPL
500 Hz
800 Hz
1600 Hz
2000 Hz
70
40
50
60
70
80
90
100 dB SPL
77
CIC
Technical Data
Oticon Own SI
1
OSPL90 – Output Sound
Pressure Level (dB SPL)
Input: 90 dB SPL
Technical setting: A0
Oticon Own SI
2,3,4
140
140
130
130
120
120
110
110
100
100
90
90
80
70
100
Frequency
response (dB SPL)
Input: 60 dB SPL
Technical setting: N0
80
1k
10k Hz
130
130
120
120
110
110
100
100
90
90
80
80
70
70
50
100
1k
10k Hz
1k
10k Hz
60
60
78
70
100
1k
10k Hz
50
100
About Getting started Daily use Options Tinnitus Warnings More info
Oticon Own SI
1
Input-Output
Technical Setting: N0
Oticon Own SI
2,3,4
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 dB SPL
500 Hz
800 Hz
1600 Hz
2000 Hz
80
40
50
60
70
80
90
100 dB SPL
79
280510US / 2025.01.13 / v1
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<
>
8,15 mm
<
9.0 mm
>
<
21 mm
Placeholder
for FSC logo
< 15 mm >
0000280510000001
280510US / 2025.01.13 / v1
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