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.