Cochlear Osia 2 User manual

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Cochlear™Osia®2
Sound Processor
User manual
EN-US English

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This guide is intended for recipients and caregivers
using the Cochlear™Osia®2 Sound Processor as part
of the Cochlear Osia System.
Intended use
The Cochlear Osia System uses bone conduction to transmit
sounds to the cochlea (inner ear) with the purpose of enhancing
hearing. The Osia Sound Processor is intended to be used as part
of the Cochlear Osia System to pick up surrounding sound and
transfer it to the implant through a digital inductive link.
Indications
The Osia System is intended for the following patients and
indications:
• Patients 12 years of age or older.
• Patients who have a conductive or mixed hearing loss and still
can benefit from sound amplification. The pure tone average
(PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2,
and 3 kHz) should be better than or equal to 55 dB HL.
• Bilateral fitting of the Osia System is intended for patients
having a symmetrically conductive or mixed hearing loss. The
difference between the left and right sides’ BC thresholds
should be less than 10 dB on average measured at 0.5, 1, 2, and
3 kHz, or less than 15 dB at individual frequencies.
• Patients who have profound sensorineural hearing loss in one
ear and normal hearing in the opposite ear (i.e., single-sided
deafness or “SSD”). The pure tone average air conduction
hearing thresholds of the hearing ear should be better than or
equal to 20 dB HL (measured at 0.5, 1, 2, and 3 kHz).
• The Osia System for SSD is also indicated for any patient who is
indicated for an air-conduction contralateral routing of signals
(AC CROS) hearing aid, but who for some reason cannot or will
not use an AC CROS.
• Prior to receiving the device, it is recommended that an
individual have experience with appropriately fitted air
conduction or bone conduction hearing aids
Contraindications
• Insufficient bone quality or quantity to support implantation of
both the BI300 Implant and the OSI200 Implant
• Chronic or non-revisable vestibular or balance disorders that
could prevent benefit from the device, as determined by good
clinical judgement
• Abnormally progressive hearing loss
• Evidence that hearing loss is bilateral retrocochlear or bilateral
central origin
• Evidence of conditions that would prevent good speech
recognition potential as determined by good clinical judgment
• Skin or scalp conditions that may preclude attachment of the
Sound processor or that may interfere with the use of the
Sound processor
NOTES
Refer to the Cautions and Warnings sections for safety advice
relating to the use of the Osia Sound Processor, batteries and
components. Please also refer to your Important Information
document for essential advice that applies to your implant system.
Symbols used in this guide
NOTE
Important information or advice.
TIP
Time saving hint.
CAUTION (no harm)
Special care to be taken to ensure safety and effectiveness.
Could cause damage to equipment.
WARNING (harmful)
Potential safety hazards and serious adverse reactions.
Could cause harm to person.

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Contents
Intended use............................................................................................................. 2
Indications................................................................................................................. 2
Contraindications.................................................................................................... 3
Symbols used in this guide................................................................................... 3
Overview ................................................................................................. 6
Use .............................................................................................................7
Turn on and off ........................................................................................................ 7
Change programs.................................................................................................... 7
Adjust volume..........................................................................................................8
Power........................................................................................................ 9
Batteries.....................................................................................................................9
Battery life................................................................................................................. 9
Change the battery...............................................................................................10
Lock and unlock the battery door.....................................................................11
Wear ........................................................................................................12
Wear your sound processor ............................................................................... 12
For users with two implants .............................................................................. 12
Attach a Cochlear SoftWear™Pad.................................................................... 13
Attach a Safety Line ............................................................................................. 14
Wear the headband.............................................................................................. 15
Change the cover ...................................................................................................17
Flight mode............................................................................................................. 18
Wireless accessories............................................................................................. 19
Made for iPhone.................................................................................................... 19
Care.........................................................................................................20
Regular care............................................................................................................20
Water, sand and dirt.............................................................................................20
Audio and visual indicators............................................................... 21
Audio signals........................................................................................................... 21
Visual signals..........................................................................................................23
Troubleshooting...................................................................................24
Cautions.................................................................................................26
Warnings................................................................................................26
For parents and caregivers .................................................................................26
Processors and parts............................................................................................27
Batteries...................................................................................................................29
Medical treatments............................................................................................. 30
Other information...............................................................................30
Physical configuration......................................................................................... 30
Batteries.................................................................................................................. 30
Materials.................................................................................................................. 31
Environmental conditions................................................................................... 31
Product dimensions (Typical values)............................................................... 31
Product weight ...................................................................................................... 31
Operating characteristics .................................................................32
Wireless communication link...........................................................33
Electromagnetic compatiblity (EMC).............................................34
Guidance and manufacturer’s declaration –
electromagnetic emissions.................................................................................34
Guidance and manufacturer’s declaration –
electromagnetic immunity ................................................................................35
Environmental protection................................................................. 37
Equipment classification and compliance .................................... 37
Privacy and the collection of personal information...................39
Legal statement...................................................................................39
Product order overview.....................................................................40
Key to symbols.....................................................................................42
Radio symbols......................................................................................43

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Overview
Indicator
light
Control
button
Microphone
ports
Cover
Front
Battery
door
THIS WAY UP
Back
Attachment
holes for
Safety line
Use
Turn on and off
Turn on your sound processor by completely closing the battery
door. (A)
Turn off your sound processor by gently opening the battery door
until you feel the first “click.” (B)
A B
If enabled, and attached to the implant, audio signals will
let you know that the device is starting up.
Change programs
You can choose between programs to change the way your
sound processor deals with sound. You and your hearing care
professional will have selected up to four preset programs
for your sound processor.
Program 1 ....................................................................................................
Program 2 ....................................................................................................
Program 3 ....................................................................................................
Program 4 ....................................................................................................
These programs are suitable for different listening situations.
Ask your hearing care professional to fill in your specific programs
on the lines provided above.

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To change programs, press and release the button
on your sound processor.
If enabled, audio and visual signals will let you know
which program you are using.
• Program 1: 1 beep, 1 orange flash
• Program 2: 2 beeps, 2 orange flashes
• Program 3: 3 beeps, 3 orange flashes
• Program 4: 4 beeps, 4 orange flashes
NOTE
You will only hear the audio signal if you are wearing
your sound processor.
Adjust volume
Your hearing care professorial has set the volume level
for your sound processor.
You can adjust the volume level with a compatible Cochlear
remote control, Cochlear Wireless Phone Clip, iPhone, iPad
or iPod touch (see the Made for iPhone section on page 19).
Power
Batteries
The Osia 2 Sound Processor uses a high power 675 (PR44) zinc air
disposable battery designed for hearing implant use.
CAUTION
If a standard 675 battery is used the device will not function.
Battery life
Batteries should be replaced as needed, just as you would with
any other electronic device. Battery life varies according to your
implant type, the thickness of skin covering your implant, and
which programs you use each day.
Your sound processor has been designed to provide the majority
of users with a full day of battery life when using zinc air batteries.
It will automatically go into sleep mode after you remove it
from your head (~30 seconds). When it is attached again, it will
automatically turn on again within a few seconds. As sleep mode
will still consume some power, the device should be turned off
when not in use.

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Change the battery
1. Hold the sound processor with the front facing you.
2. Open the battery door until it is completely open. (A)
3. Remove the old battery. Dispose of the battery according
to local regulations. (B)
4. Remove the sticker on the + side of the new battery
and let it stand for a few seconds.
5. Insert the new battery with the + sign facing upwards in the
battery door. (C)
6. Gently close the battery door. (D)
A B
C D
Lock and unlock the battery door
You can lock the battery door to prevent it from opening
accidentally (tamper-proof). This is recommended when
the sound processor is being used by a child.
To lock the battery door, close the battery door and place
the Tamperproof tool into the battery door slot. Slide the
locking pin up into place.
To unlock the battery door, place the Tamperproof tool into the
battery door slot. Slide the locking pin down into place.
WARNING
Batteries can be harmful if swallowed. Be sure to keep your
batteries out of reach of small children and household pets. In
the event of a battery being swallowed, seek immediate medical
attention at the nearest emergency centre.

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Wear
Wear your sound processor
Place the processor on your implant with the button/light
facing up and battery door facing down.
CAUTION
It is important to position your processor correctly.
Correct positioning enables its best performance.
For users with two implants
Ask your hearing care professional to mark your sound processors
with coloured stickers (red for right, blue for left) to make
identifying left and right processors easier.
RL
CAUTION
If you have two implants, you must use the correct sound processor
for each implant.
NOTE
Your sound processor will be programmed to recognise the
implant’s iD, so it will not work on the wrong implant.
Attach a Cochlear SoftWear™Pad
The Cochlear SoftWear Pad is optional. If you experience
discomfort when wearing your processor, you can attach this
adhesive pad to the back of your processor.
NOTE
You may need a stronger magnet and new feedback calibration
measurement after attaching the Cochlear SoftWear Pad.
Please contact your hearing care professional if you experience
poor sound or magnet retention.
WARNING
If you experience tightness or pain at the implant site, or develop
significant skin irritation, stop using your sound processor and
contact your hearing care professional.
1. Remove any old pad from the processor
2. Peel off the single backing strip on the adhesive side
of the pad. (A).
3. Attach the pad to the back of the processor
– press down firmly (B, C)
4. Peel off the two semicircle backing covers
on the cushion side of the pad. (D)
5. Wear your processor as usual.
DA CB

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Attach a Safety Line
To reduce the risk of losing your processor, you can attach a Safety
Line that clips onto your clothing or hair:
1.
A B
Pinch the loop on the end of the line between
your finger and thumb. (A)
2. Pass the loop through the attachment hole
in the sound processor from front to back. (B)
3. Pass the clip through the loop and pull the line tight. (B)
4. Attach the clip to your clothing or hair depending
on the Safety Line design.
NOTE
If you have trouble attaching the safety line, you can remove
the sound processor cover (page 17).
To attach the Safety Line to your clothes
use the clip shown below.
1. Lift the tab to open the clip. (A)
2. Place the clip on your clothing and press down to close. (B)
3. Place the sound processor on your implant.
A B
To attach the Safety Line to your hair use the below clip.
1. Press up on the ends to open the clip. (A)
2. With the teeth facing up and against your hair, push the clip up
into your hair. (B)
3. Press down on the ends to close the clip. (C)
4. Place your processor on your implant.
A B C
Wear the headband
The Cochlear Headband is an optional accessory that holds the
processor in place on your implant. This accessory is useful for
children or when performing physical activities.
To fit the headband:
Choose an appropriate size.
Size Circumference Size Circumference
XXS 41-47 cm M52-58 cm
XS 47-53 cm L 54-62 cm
S49-55 cm
NOTE
The headband may affect your sound processor’s
performance.
If you notice any change, contact your
hearing care professional.

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LEFT
PROCESSOR
POCKET
RIGHT
PROCESSOR
POCKET
ANTI-SLIP
(for forehead)
VELCRO VELCRO
1. Open the headband and lay it flat on a table with the anti-slip
facing up and the pockets facing away from you.
2. Pull the pocket lining out. (A)
3. Insert your processor in the correct pocket. (B)
• Place the left processor in the left-side pocket, the right
processor in the right-side pocket.
• Ensure the top of the processor is at the top of the pocket.
• Ensure the side of the processor that fits onto your implant is
facing up towards you.
4. Fold the pocket lining back over the processor.
5. Pick up the ends of the headband and place the anti-slip
section against your forehead.
6. Join the ends behind your head. Adjust so the headband fits
firmly, with your processor over your implant. (C)
7. Press firmly on the ends to ensure they join together.
A CB
Change the cover
To remove the cover:
1. Open the battery door. (A)
2. Press and lift to remove the cover. (B)
To attach the cover:
1. Place the cover over the front part of the sound processor base
unit. The button should be aligned with the cover opening.
2. Press down on the cover around the button until you feel
a “click” on both sides of the button. (A)
3. Press down on the cover between microphone ports until
you feel a “click”. (B)
4. Close the battery door. (C)
A
C
B
Change the battery door
1. Open the battery door (A)
2. Pull the door out of its hinge (B)
3. Replace the door. Be sure to align the hinge clip to the metal
pin on the processor (C)
4. Close the battery door (D)
A B

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A
DC
B
Flight mode
When boarding a flight, wireless functionality must be deactivated
because radio signals must not be transmitted during flights.
To activate flight mode:
1. Turn off your sound processor by opening the battery door.
2. Press the button and close the battery door at the same time.
3. If enabled, audio and visual signals will confirm that flight mode
is activated (see Audio and visual indicators, page 21).
To deactivate flight mode:
Turn the sound processor off and then on again (by opening and
closing the battery door).
Wireless accessories
You can use Cochlear Wireless accessories to enhance your
listening experience. To learn more about the options available,
ask your hearing care professional or visit www.cochlear.com.
To pair your sound processor to a wireless accessory:
1. Press the pairing button on your wireless accessory.
2. Turn off your sound processor by opening the battery door.
3. Turn on your sound processor by closing the battery door.
4. You will hear an audio signal in your sound processor as a
confirmation of a successful pairing.
To activate wireless audio streaming:
Press and hold the button on your sound processor until you
hear an audio signal (see Audio and visual indicators, page 21).
To deactivate wireless audio streaming:
Press and release the button on your sound processor.
The sound processor will return to the previously used program.
Made for iPhone
Your sound processor is a Made for iPhone (MFi) hearing device.
This allows you to control your sound processor and stream audio
directly from your iPhone, iPad or iPod touch.
For compatibility details and more visit www.cochlear.com.

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Care
Regular care
CAUTIONS
Do not use cleaning agents or alcohol to clean your processor.
Turn your processor off before cleaning or performing maintenance.
Your sound processor is a delicate electronic device. Follow these
guidelines to keep it in proper working order:
• Turn off and store the sound processor away from dust and dirt.
• Avoid exposing your sound processor to extreme temperatures.
• Remove your sound processor before applying any hair
conditioners, mosquito repellent or similar products.
• Secure your sound processor with a Safety Line or use the
headband during physical activities. If the physical activity
involves contact, Cochlear recommends removing the sound
processor during the activity.
• After exercise, wipe your processor with a soft cloth to remove
sweat or dirt.
• For long-term storage, remove the battery. Storage cases are
available from Cochlear.
Water, sand and dirt
Your sound processor is protected against failure from exposure
to water and dust. It has achieved an IP57 rating (excluding
battery cavity) and is water resistant, but not waterproof. With
the battery cavity included the sound processor achieves an IP52
rating.
Your sound processor is a delicate electronic device. You should
take the following precautions:
• Avoid exposing the sound processor to water (e.g. heavy rain)
and always remove it before swimming or bathing.
• If the sound processor gets wet or is exposed to a very humid
environment, dry it with a soft cloth, remove the battery and
let the processor dry out before inserting a new one.
• If sand or dirt enters the processor, try to remove it carefully.
Do not brush or wipe in the indents or holes of the casing.
Audio and visual indicators
Audio signals
Your hearing care professional can set up your processor
so you can hear the following audio signals. The beeps
and melodies are only audible to the recipient when the
processor is attached over the implant.
General signals
Beeps What it means
Start up
5 beeps
Start up in Flight Mode.
10 x dual beeps
Change program. Number
of beeps indicates the
number of the current
program.
1-4 beeps
Volume level increased/
decreased by one step.
1 beep
Volume limit reached.
1 long beep
Low battery warning.
4 beeps 4 times

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Wireless signals
Beeps and melodies What it means
Wireless Accessory pairing
confirmation.
Ripple tone in upward melody
Wireless streaming activated.
Ripple tone upward melody
End wireless streaming due
to low battery voltage and
return to program.
2 × ripple tone downward melody
MFi pairing confirmation.
6 beeps followed by ripple tone upward
melody (about 20 seconds after pairing)
Change from one wireless
accessory to another
Ripple tone upward melody
Visual signals
Your hearing care professional can set up your processor to show
the following light indications.
General signals
Light What it means
No implant or wrong implant
detected
Green flashes
When connection to implant
is successfull steady green
light will be seen for 5 s.
Steady green
Start up in Flight Mode.
4 x dual flashes
Change program. Number
of flashes indicates the
number of the current
program.
1-4 flashes
Volume level increased/
decreased by one step.
1 quick flash
Volume limit reached.
1 long flash
Low battery warning.
Rapid flashes for 2.5 seconds
Wireless signals
Light What it means
Wireless streaming activated.
1 long flash followed by 1 short flash

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Troubleshooting
Contact your hearing care professional if you have any concerns
regarding the operation or safety of your sound processor.
Processor will not turn on
1. Try turning the processor on again. See Turn on and off, page 7.
2. Replace the battery. See Change the battery, page 10.
3. If you have two implants, check that you are wearing the correct
sound processor on each implant, see page 12.
4. If the problem continues, contact your hearing care professional.
The processor switches off
1. Restart the processor by opening and closing the battery door.
2. Replace the battery. See Change the battery, page 10.
3. Check so that the correct battery-type is used.
See requirements for battery on page 32.
4. Ensure that the sound processor is placed correctly, see page 12.
5. If the problems continue, contact your hearing care professional.
You experience tightness, discomfort or develop a skin
irritation at your implant site
1. Try using an adhesive Cochlear SoftWear pad. See Attach a Cochlear
SoftWear™ Pad, page 13.
2. If you are using a retention aid, such as a headband, this may be
placing pressure on your processor. Adjust your retention aid, or try
a different aid.
3. Your processor magnet may be too strong. Ask your hearing care
professional to change to a weaker magnet (and use a retention
aid such as the Safety Line if required).
4. If the problem continues, contact your hearing care professional.
You do not hear sound or sound is intermittent
1. Try a different program. See Change programs, page 7.
2. Replace the battery. See Change the battery, page 10.
3. Make sure the sound processor is properly oriented on your head, see
Wear your sound processor, page 12.
4. If the problem continues, contact your hearing care professional.
Sound is too loud or uncomfortable
1. If turning down the volume does not work,
contact you hearing care professional.
Sound is too quiet or muffled
1. If turning up the volume does not work,
contact your hearing care professional.
You experience feedback (whistling)
1. Check to ensure that the sound processor is not
in contact with items such as glasses or a hat.
2. Check that the battery door is closed.
3. Check that there is no external damage to the sound processor.
4. Check that the cover is attached correctly, see page 17.
5. If the problem continues, contact your hearing care professional.

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Cautions
Young children who are developing motor skills are at greater
risk of an impact to the head from a hard object (e.g. table or
chair). Impact to the sound processor may cause damage to
the processor or its parts. Impact to the head in the area of the
implant could damage the implant and result in its failure.
Warnings
For parents and caregivers
• Removable parts of the system (batteries, magnets,
battery door, safety line) can be lost or may be a choking or
strangulation hazard. Keep out of reach of children or lock the
battery door.
• Caregivers must routinely check the device for signs of
overheating and for signs of discomfort or skin irritation at
the implant site. Remove the processor immediately if there is
any discomfort or pain (e.g. if device becomes hot or sound is
uncomfortably loud) and inform your hearing care professional.
• Caregivers must monitor for signs of discomfort or skin
irritation if a retention aid (e.g. headband) is used that applies
pressure to the sound processor. Remove the aid immediately
if there is any discomfort or pain, and inform your hearing
care professional.
• Dispose of used batteries promptly and carefully, in accordance
with local regulations. Keep the battery away from children.
• Do not allow children to replace batteries without adult
supervision.
Processors and parts
• Each processor is programmed specifically for each implant.
Never wear another person’s processor or lend yours to another
person.
• Use your Osia System only with approved devices and
accessories.
• If you experience a significant change in performance, remove
your processor and contact your hearing care professional.
• Your processor and other parts of the system contain complex
electronic parts. These parts are durable but must be treated
with care.
• Do not subject your sound processor to water or heavy rain as
it might degrade the performance of the device.
• No modification of this equipment is allowed. Warranty will be
void if modified.
• If you experience tightness or pain at the implant site, or
develop significant skin irritation, stop using your sound
processor and contact your hearing care professional.
• Do not apply continued pressure to the processor when in
contact with the skin (e.g. sleeping while lying on processor, or
using tight fitting headwear).
• If you need to adjust the program often or if adjusting
the program ever causes discomfort, consult your hearing
care professional.
• Do not place the processor or parts in any household devices
(e.g. microwave oven, dryer).
• The magnetic attachment of your sound processor to your
implant may be affected by other magnetic sources.
• Store spare magnets safely and away from cards that may have
a magnetic strip (e.g. credit cards, bus tickets).
• Your device contains magnets that should be kept away
from life supporting devices (e.g. cardiac pacemakers and
ICDs (implantable cardioverter defibrillators) and magnetic
ventricular shunts), as the magnets may affect the function of
these devices. Keep your processor at least 15 cm (6 in) from
such devices. Contact the manufacturer of the specific device
to find out more.

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• Your sound processor radiates electromagnetic energy
that may interfere with life supporting devices (e.g. cardiac
pacemakers and ICDs). Keep your processor at least 15 cm (6
in) from such devices. Contact the manufacturer of the specific
device to find out more.
• Do not place the device or accessories inside any part of your
body (e.g. nose, mouth).
• Seek medical advice before entering any environment that
may adversely affect the operation of your Cochlear implant,
including areas protected by a warning notice preventing entry
by patients fitted with a pacemaker.
• Some types of digital mobile telephones (e.g. Global System
for Mobile communications (GSM) as used in some countries),
may interfere with the operation of your external equipment.
You may hear distorted sound when close, 1-4 m (~3-12 ft), to a
digital mobile telephone in use.
• Remove the processor before engaging in activities that create
extreme electrostatic discharge, such as playing on plastic
slides. In rare cases, a discharge of static electricity can damage
the electrical components of the Cochlear Osia system or
cause your sound processor to shut down.If static electricity
is present (for example when removing or putting on clothes
over your head, or getting out of a vehicle), before the Cochlear
Osia system contacts any object or person you should touch
something conductive, such as a metal door handle.If you stop
hearing and suspect your sound processor received a discharge
of static electricity, turn it off and then on again. If the problem
continues, contact your clinician or a Cochlear representative.
• Magnetic fields that are very close to an Osia implant can
affect the operation of the implant. These magnetic fields can
be created by magnets that are stronger than the Osia Sound
Processor coil magnets.If you stop hearing and suspect that
you have a strong magnetic field close to the location of the
Osia implant, move away from the source of the magnetic field.
Hearing will then return. If the problem continues, contact your
clinician or a Cochlear representative.
• Devices such as airport metal detectors and commercial theft
detection systems produce strong electromagnetic fields. You
could experience a distorted sound sensation when passing
through or near one of these devices. The materials used in
your Osia implant may activate metal detection systems. Turn
off your processor if near or passing through a theft and metal
detection system.
• Interference from nearby electrical devices can sometimes
disrupt audio streaming from a wireless accessory. If streaming
is disrupted, try moving away from any device that might be
causing this interference and reactivate the wireless audio
streaming program. If the problem continues, contact your
clinician or a Cochlear representative.
Batteries
• Use only Cochlear supplied or recommended high power
675 (PR44) zinc air battery designed for hearing implant use.
• Insert the battery in the correct orientation.
• Do not short-circuit batteries (e.g. do not let terminals of
batteries contact each other, do not place batteries loose in
pockets, etc.).
• Do not disassemble, deform, immerse in water or dispose of
batteries in fire.
• Store unused batteries in original packaging, in a clean and dry
place.
• When processor is not in use, remove the battery and store
separately in a clean and dry place.
• Do not expose batteries to heat (e.g. never leave batteries in
sunlight, behind a window or in a car).
• Do not use damaged or deformed batteries. If skin or eyes
come into contact with battery fluid or liquid, wash out with
water and seek medical attention immediately.
• Never put batteries in mouth. If swallowed, contact your
physician or local poison information service.

30 31
Medical treatments
MR
Magnetic Resonance Imaging (MRI)
• The Osia 2 Sound Processor, remote and related accessories are
MR Unsafe.
• The Osia implant is MR Conditional. For full MRI safety
information refer to the information supplied with the system,
or contact your regional Cochlear office (contact numbers
available at the end of this document).
• If the patient is implanted with other implants, consult the
manufacturer’s instructions before performing MRI.
Other information
Physical configuration
The processing unit comprises:
• Two microphones for receiving sounds.
• Custom integrated circuits with digital signal processing (DSP).
• A visual indication.
• A button allowing user control of key features.
• A battery providing power to the sound processor, which
transfers energy and data to the implant
Batteries
Check the battery manufacturer’s recommended operating
conditions for disposable batteries used in your processor.
Materials
• Sound processor enclosure: PA12 (Polyamide 12)
• Magnet housing: PA12 (Polyamide 12)
• Magnets: Gold coated
Environmental conditions
Condition Minimum Maximum
Storage & transport
temperature
-10°C (14°F) +55°C (131°F)
Storage & transport humidity 0% RH 90% RH
Operating temperature +5°C (41°F) +40°C (104°F)
Operating relative humidity 0% RH 90% RH
Operating pressure 700 hPa 1060 hPa
Product dimensions (Typical values)
Component Length Width Depth
Osia 2 processing unit 36 mm
(1.4 in)
32 mm
(1.3 in)
10.4 mm
(0.409 in)
Product weight
Sound Processor Weight
Osia 2 processing unit (no batteries or magnet) 6.2 g
Osia 2 processing unit (including Magnet 1) 7.8 g
Osia 2 processing unit (including Magnet 1 and a
zinc air battery)
9.4 g

32 33
Operating characteristics
Characteristic Value/Range
Sound input frequency range 100 Hz to 7 kHz
Sound output frequency range 400 Hz to 7 kHz
Wireless technology Proprietary low power bidirectional
wireless link (wireless accessories)
Published commercial wireless
protocol (Bluetooth Low Energy)
Operating frequency
communication to implant
5 MHz
Operating frequency RF
(radio frequency) transmission
2.4 GHz
Max. RF output power -3.85 dBm
Operating voltage 1.05 V to 1.45 V
Power consumption 10 mW to 25 mW
Button functions Change program, activate streaming,
activate flight mode
Battery door functions Turn processor on and off, activate
flight mode
Battery One PR44 (zinc air) button cell
battery, 1.4V (nominal)
Only high power 675 zinc air
batteries designed for cochlear
implants should be used
Wireless communication link
The wireless communication link operates in the 2.4 GHz ISM
band using GFSK (Gaussian frequency-shift keying), and a
proprietary bidirectional communication protocol. It continuously
switches between channels to avoid interference on any specific
channel.
Bluetooth Low Energy also operates in the 2.4 GHz ISM band,
using frequency hopping over 37 channels to combat interference.

34 35
Electromagnetic compatiblity (EMC)
Guidance and manufacturer’s declaration –
electromagnetic emissions
The Osia 2 Sound Processor is intended for use in the
electromagnetic environment specified below. The customer or
the user of the Osia 2 Sound Processor should assure that it is
used in such an environment.
Emission test Compliance Electromagnetic
environment – Guidance
RF emissions
CISPR 11
Group 1
The Osia 2 Sound Processor
uses RF energy only for
its internal function. The
RF emissions are very low
and not likely to cause
any interference in nearby
electronic equipment.
Class B
The Osia 2 Sound Processor
is suitable for use in all
establishments, including
domestic establishments
and those directly
connected to public
low-voltage power supply
network that supplies
buildings used for domestic
purposes.
Harmonic emissions
IEC 61000-3-2 Not applicable
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Not applicable
Guidance and manufacturer’s declaration –
electromagnetic immunity
The Osia 2 Sound Processor is intended for use in the
electromagnetic environment specified below. The customer or
the user of the Osia 2 Sound Processor should assure that it is
used in such an environment
Immunity test Compliance
level
Electromagnetic
environment – Guidance
Electrostatic discharge
(ESD)
IEC 61000-4-2
The functionality is
assessed by monitoring
the stimulation
sinusoidal audio signal.
+/- 8 kV
contact
+/-15 kV air
Floors should be wood,
concrete or ceramic tile.
If floors are covered with
synthetic material, the
relative humidity should be
at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
Not
applicable
Not applicable
Surge
IEC 61000-4-5
Not
applicable
Not applicable
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines
IEC 61000-4-11
Not
applicable
Not applicable
Power frequency
(50/60 Hz) magnetic
field
IEC 61000-4-8
The functionality is
assessed by monitoring
the stimulation
sinusoidal audio signal.
30 A/m Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment

36 37
Electromagnetic environment – Guidance
Portable and mobile RF communications equipment should be used no
closer to any part of the Osia 2 Sound Processor, including cables, than
the recommended separation distance calculated from the equation
applicable to the frequency of the transmitter.
IMMUNITY TEST: Conducted RF IEC 61000-4-6
COMPLIANCE LEVEL: 3 Vrms 0.15 to 80 MHz; 6 Vrms in ISM 0.15 to
80 MHz
Recommended separation distance d=1.2√P
IMMUNITY TEST: Radiated RF IEC 61000-4-3
COMPLIANCE LEVEL:
3 V/m 80 MHz to 2.7 GHz (programming mode)
10 V/m 80 MHz to 2.7 GHz (stand-alone mode)
d=0.35√P 80 MHz to 800 MHz
d=0.70√P 800 MHz to 2.7 GHz
where P is the maximum output power rating of the transmitter in
watts (W) according to the transmitter manufacturer and d is the
recommended separation distance in metres (m).
Field strengths from fixed RF transmitters, as determined by an
electromagnetic site survey, should be less than the compliance level in
each frequency range.
Interference may occur in the vicinity of equipment marked
with the following symbol:
IMMUNITY TEST: Proximity fields from RF wireless communications
equipment IEC 61000-4-3
COMPLIANCE LEVEL: 385 MHz (27 V/m); 450, 810, 870, 930, 1720,
1845, 1970, 2450 MHz (28 V/m); 710, 745, 780, 5240, 5500, 5785 MHz
(9 V/m)
WARNING
Portable RF communications equipment (including peripherals
such as antenna cables and external antennas) should be used
no closer than 30 cm (12 in.) to any part of your Osia 2 Sound
Processor, including cables specified by the manufacturer.
Otherwise, degradation of the performance of this equipment
could result.
WARNING
Use of accessories, transducers and cables other than those
specified or provided by Cochlear could result in increased
electromagnetic emissions or decreased electromagnetic
immunity of this equipment and result in improper operation.
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption and reflection
from structures, objects and people.
NOTE 3: If abnormal performance is observed, additional measures
may be necessary, such as reorienting or relocating the Osia 2 Sound
Processor.
Radio Frequency Identification (RFID)
RFID uses electromagnetic fields to automatically identify and
track tags attached to objects. Interference may occur in the
vicinity of equipment that uses RFID.
Environmental protection
Your sound processor contains electronic components subject
to the Directive 2002/96/EC on waste electrical and electronic
equipment.
Help protect the environment by not disposing of your sound
processor or batteries with your unsorted household waste. Please
recycle your sound processor according to your local regulations.
Equipment classification and compliance
Your sound processor is internally powered equipment Type B
applied part as described in the international standard IEC 60601-
1:2005/A1:2012, Medical Electrical Equipment– Part 1: General
Requirements for Basic Safety and Essential Performance.
This device complies with part 15 of the FCC (Federal
Communications Commission) Rules and with RSS-210 of ISED
(Innovation, Science and Economic Development) Canada.
Operation is subject to the following two conditions:
• This device may not cause harmful interference.
• This device must accept any interference received, including
interference that may cause undesired operation.

38 39
Changes or modifications made to this equipment not expressly
approved by Cochlear Limited may void the FCC authorization to
operate this equipment.
This equipment 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 equipment 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 equipment 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 between the equipment and receiver.
• Connect the equipment into an outlet or a circuit different
from that to which the receiver is connected.
• Consult the dealer or an experienced radio/TV technician for
help.
FCC ID: QZ3OSIA2
IC: 8039C-OSIA2
CAN ICES-3 (B)/NMB-3(B)
HVIN: OSIA2
PMN: Cochlear Osia 2 Sound Processor
The model is a radio transmitter and receiver. It is designed not to
exceed the emission limits for exposure to radio frequency (RF)
energy set by the FCC and ISED.
Privacy and the collection of personal
information
During the process of receiving a Cochlear device, personal
information about the user/recipient or their parent, guardian,
carer and hearing health professional will be collected for use by
Cochlear and others involved in care with regard to the device.
For more information please read Cochlear’s Privacy Policy on
www.cochlear.com/privacy or request a copy from Cochlear at the
address nearest you.
Legal statement
The statements made in this guide are believed to be true and
correct as of the date of publication. However, specifications are
subject to change without notice.
© Cochlear Limited 2019