We make the device. You make the miracle.

Transcription

We make the device. You make the miracle.
We make the device. You make the miracle.
Introducing The Cochlear ™ Nucleus ® 6 System
The journey to better hearing
starts with Cochlear and
lasts a lifetime.
The passion of our founders
is what continues to drive all
of us at Cochlear today.
MORE PEOPLE TRUST THEIR HEARING TO COCHLEAR THAN ALL THE OTHER IMPLANT
COMPANIES COMBINED.1,2
HISTORY OF INNOVATION
For 30 years, Cochlear has helped children and adults connect to a world of sound. The journey began
when Cochlear partnered with a physician, Dr. Graeme Clark, who was inspired to find a solution to
restore hearing after watching his own father struggle with hearing loss. In 1978, despite deep
skepticism from many colleagues in acoustic science and medicine, a multi-disciplinary team helped
Dr. Clark develop the first cochlear implant, and he successfully performed the first implantable
multi-channel “bionic ear” surgery.
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As a partner in the world’s first Hearing Hub campus, we work with over 2,000 of the top hearing
professionals around the world and have more than 100 active research partners in 20 different
countries to innovate and provide breakthroughs continuously to those with hearing loss.
Today over 250,000 people can hear what they couldn’t hear before, and the breakthroughs continue
with the Cochlear ™ Nucleus® 6 System.1 The Nucleus 6 is our 9th generation sound processor that takes
the best of everything we’ve learned from 30 years of industry-leading innovation and improves upon
it in one tiny processor.
When your patients choose Cochlear, they are not only receiving the most advanced technology
available, but also trusting in our promise that we will help them achieve their best hearing today,
tomorrow, and always. It’s our promise and we stand by it. Hear now. And always
Dr. Graeme Clark discovered
how to place the electrode in the inner
ear securely by experimenting with a
blade of grass and a small sea shell.
Cochlear’s global headquarters — Sydney, Australia
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THE MOST CHOSEN, MOST TRUSTED
COCHLEAR IMPLANT.
A portfolio of electrodes designed
For PERFORMANCE and PRESERVATION.
The Most Reliable Cochlear Implant Ever3-8
Cochlear is the only manufacturer with a true portfolio of electrodes
We understand that a lifetime commitment to our recipients
is a partnership built on trust, a trust initiated with implant
reliability. The Cochlear Nucleus 6 System Implant,
the CI24RE, leads with:
Up to 3-5
3x More reliable
Cochlear’s portfolio of electrodes favors variation of surgical preferences to address the widest
range of patient conditions. Each electrode is uniquely designed for preservation of the cochlea
and to deliver the best possible hearing performance and outcomes.
Than anything else
available today
An industry best 99% reliability
(CSR at eight years).3
Cochlear Nucleus Contour Advance®
Up to 3X more reliable than other
manufacturer’s current implants.3-5
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Over 100,000 patients implanted
around the world, more than all
other implants combined.3-5
Learn more at KnowTheDifference.com
Cochlear Nucleus Slim Straight
Cochlear Nucleus Full–Band Straight
Proven Track Record of Reliability
3-8
Our commitment to quality and reliability began with our
very first implant. It sets the bar with an unprecedented
reliability record of 92.5% after 26 years.3 That means almost
all of our first generation recipients continue to hear with
their original implants and receive benefits of several sound
processor upgrades over the past three decades.
The First Implant Approved
for MRI up to 1.5 Tesla
Our implant has been approved for the most common
scan level of 1.5 Tesla with the magnet removed for
optimal image quality and reduced artifact.
Cochlear Nucleus Double Array
Cochlear Nucleus Auditory Brainstem Implant
The only perimodiolar electrode array
With its unique perimodiolar placement, the
Contour Advance provides the most precise
and efficient stimulation for patients.9-11
The thinnest electrode array
A soft tip, apical flexibility, and smooth
lateral wall surface facilitates an easy single
stroke insertion designed to protect the
delicate cochlear structures.
Ideal for malformed or abnormal cochleas
Full-Banded contacts and electrode length
provide maximum stimulation to ensure
optimal outcomes.
Ideal for ossified cochleas
For patients with ossified cochlea where intracochlear electrode insertion is still possible but
a full insertion is not expected.
The only FDA approved auditory
brainstem implant
Clinically proven treatment for patients with
conditions including bilateral acoustic
neuroma, cochlear nerve avulsion or
complete cochlear ossification.
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THE Cochlear
NUCLEUS 5 System.
Introducing The Cochlear
Nucleus 6 System.
The Nucleus 5 System features the industry’s smallest processor
configuration powered by a choice of batteries. The fit is comfortable
and discreet – yet tough enough for any situation.
Everything we’ve learned over 30 years makes
this processor simply smarter.
New features make the Cochlear
Nucleus 6 easier to use
Powerful battery choices
Tactile buttons
Auto FM
Auto-on and auto-off
Choice of two different remotes
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Up to 60 hours of battery life with
Standard Disposable
up to 3 days of battery life
Standard Rechargeable
up to 2 days of battery life
Compact Rechargeable
up to 18 hours of battery life
the High Power 675 zinc air batteries
Water protection
Cochlear Nucleus 5 — IP57 Rating*
Cochlear Nucleus 5 with Aqua Accessory — IP68 Rating*
What does this mean for your patients?
What does this mean for your patients?
Splash in the tub
Swim underwater
Play in the pool
Walk in the rain
Sweat during sports
Sit in the hot tub
And much more
New Chip makes the Cochlear
Nucleus 6 the smartest
processor on the market
5x more powerful than
industry leading Nucleus 5
Data logging
Capacity for upgrades in future
technological advances
2.4 GHz wireless ready
* When used with rechargeable battery.
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CHOICES AS UNIQUE AS YOUR PATIENTS.
The Nucleus 6 System comes with two processor options to best fit your patients’ lifestyles. With the
CP910 Sound Processor, your patients can plug in to a variety of accessories, while the CP920 Sound
Processor without an accessory port provides a smaller configuration.
your patients can choose how
to manage their own hearing.
With the Nucleus 6 your patients can choose a wireless, hand-held remote that gives them the option
of adjusting their hearing themselves.
Discreet color Options
The Cochlear Nucleus 6 Sound Processor comes in a variety of subtle colors designed
to blend with hair and skin tones.
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Carbon
Maize
Mocha
REMOTE ASSISTANT
REMOTE CONTROL
Pocket-sized CR230 Remote
Assistant gives them the
control they want to manage
their hearing effectively, yet
easily, and troubleshoot
if necessary.
The keyring-sized CR210 Remote
Control covers the essentials.
It’s compact and easy to use.
Smoke
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STYLE IT
The Nucleus 6 Sound Processors are compatible with 12 different covers for both the processor
and the coil. Whether Nucleus 6 recipients want to wear their processor discreetly or style
it up with a fun color, Cochlear has more than enough options to match any mood or outfit.
Feature
Control of volume or sensitivity
and program changes
Manual control of telecoil and audio
streaming options
If patients can’t find what they’re looking for with one of Cochlear’s colors, Skinit.com
offers an infinite number of designs and colors to style up their processor.
Bilateral control from the one device
Changes made manually on the
processor are shown on the remote
Monitor system status with one click
Enable parents/teachers/caregivers
to confirm system operations
Built-in USB post for future
data exchange
Remote Assistant
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Remote Control
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BREAKTHROUGH PERFORMANCE WITH
THE LATEST IN MICROCHIP TECHNOLOGY.
There has never been a sound processor this powerful. Or this smart. It is a small miracle in every
sense of the word. And you’re going to be able to put all that to good use for your patients.
Now and in the future.
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S o m e t i m e s t h e b i g g e s t m i r a c l e s a r e a l s o t h e s m a l l e s t.
SmartSound ® Technology
Data Logging and Analysis
Ensure your patients are hearing their best
in every situation with the industry leading
SmartSound® technology.
When you know exactly how your patients
are using their processor, you can give them
the best treatment possible.
Wireless Connectivity
Future Upgrades
Your patients will be able to connect to
a wide range of 2.4 GHz wireless devices
with a future software upgrade.
With 5X the processing power of the industry
leading Nucleus 5, the new chip provides the
platform for a vast array of future technologies.
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SOME OF THE BEST PLACES
ARE ALSO THE NOISIEST.
SMARTSOUND Technology LETS YOUR
PATIENTS BE PART OF THE CONVERSATION.
®
Front Omni Microphone
The new Cochlear Nucleus 6 Sound Processor includes
synchronized microphones that provide a suite of directionality
and input processing options fundamental to realizing
improved hearing capabilities across many different listening
situations. SmartSound technology integrates advanced
input processing algorithms from Cochlear including Adaptive
Dynamic Range Optimization (ADRO ®), Autosensitivity™
(ASC), Beam® and Zoom technology.
SmartSound processing uses the Nucleus 6 dual microphones to create unique strategies to
block out noise from all around your patient.
Standard
Rear Omni Microphone
A standard, fixed directional microphone is sensitive to sounds from all around, but there is
a small amount (about 5 dB) of attenuation for sounds from behind the listener. This means that
sounds originating from the direction the listener is facing are amplified more than sounds from
behind or in other directions (more like normal hearing listeners). This setting is good for quiet,
music or windy environments.
Cochlear Impants vs. Hearing Aids In Noise
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Adaptive Beam
HEARING IN NOISE
Adaptive Beam reduces competing noise from several different sources in the area. It is ideal
for a situation in which the noise source, or cochlear recipient, is in motion.
Sentences
atat
60db
Sentences
60db
Cochlear Implants
are better than
Hearing Aids
in Noise 12
Average
Percent
Accurate
Average
Percent
Accurate
100
90
Fixed zoom
80
70
70%
60
50
Hearing Aid
Cochlear Implant
Implant
40
30
A fixed super-directional microphone setting constantly blocks sound from behind and to the
sides of the listener, allowing for easier understanding in noisy environments. This setting is good
for situations when the desired signal is relatively stationary and remains in front of the recipient
and noise is behind the listener and is not moving.
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10
0
18%
Customized Smartsound programs
Customized SmartSound programs let you give your patients their best hearing performance.
Home
Hear clearer and
crisper speech
Groups
Have a conversation
in noisy surroundings
Café
Hear comfortably in
noisy environments
Music
Listen to the
music you love
The world is going 2.4 GHz
wireless. And the Nucleus 6
is going right along with it.
Custom Sound 4.0 software
is your most sophisticated
programming tool.
Just being able to use the phone like everyone else is life changing. That’s why the Nucleus 6 comes
with a telecoil so recipients can talk on the phone without plugging anything else in.
Custom Sound® has always been designed as the industry’s most sophisticated programming software.
The revolutionary enhancements in Custom Sound 4.0 build upon this ability, giving you more control,
more flexibility, and more insight.
®
But that’s just the beginning.
In the future a simple software upgrade will connect the Nucleus 6 Sound Processor directly to an
incredibly wide range of wireless devices.* A new world will open up to Nucleus 6 recipients with
the use of Bluetooth® enabled music players and some hearing aids without any wires, ear buds or
additional accessories hanging around the neck. The audio signals from TV, stereo and GPS devices
will be broadcast right to the sound processor.
Smart Programming
Up to four customized programs
for patients with specific needs
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Intuitive Design
Easier to counsel with new custom
program icons
Stereo
Bluetooth
Smartphone
GPS
MP3 Player
Remote Assistant
Telecoil
Improved user interface
for directionality
Saves time with many clinical
parameters set to common
default options
Speech 2.4 hrs
Off Air 9.8 hrs
On Air 9 hrs
2 power-ons
Clinical insights
Industry’s first data logging capability,
with advanced hearing analysis
Time On Air
Daily Average
Coil Off 2.8 hrs
3 coil-offs
their devices every day
Easier to troubleshoot issues
hrs 9
On Air
4
hrs 3
Speech
1
Mar
2
* Pending FDA approval.
Valuable insight on how patients use
Jun
19
Oct
13
Feb
28
Today
and challenges
A PROCESSOR SO SMART,
IT CAN TELL YOU WHERE IT HAS BEEN.
Speech in Noise 1.7 hrs
Noise 6.0 hrs
Speech 4.4 hrs
What is the auditory
environment?
Understand how much time
is spent in each scene.
Trends
Time
TrendsOver
over time
% 100
Scenes
Wind 0.9 hrs
Noise
80
60
Daily Average
Quiet
40
Music 2.0 hrs
Speech
0
Mar
2
Data logging, a first for the COCHLEAR IMPLANT industry, answers
the questions your patients may not be able to.
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Jun
19
Oct
13
Feb
28
Today
Quiet 9.0 hrs
To date, cochlear implant fittings have been completed in the clinic and then after a period of realworld use, the recipient returns for re-fitting. At that time, you rely on feedback from the recipient
on how, where and when the device was used. There is only so much that can be learned by asking
a recipient about his/her hearing experience. It can often be difficult for someone to remember their
experiences day to day and over an extended period of several months. Even “good reporters” often
fail to note many of the pertinent details that are needed to improve their experience. To address
this issue, Cochlear has incorporated data logging into the Nucleus 6 System. Imagine how your
counseling discussions could improve with data logging and trending reports that can be analyzed
in many different ways.
Music 0.8 hrs
Groups 4.4 hrs
What programs are
being used?
Program Usage
Identify programs most used
and fine-tune settings.
Daily Average
Café 8.8 hrs
Home 10.0 hrs
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Get ready to start a better conversation with Nucleus 6 and data logging.
<40 dBA 8%
>80 dBA 4%
What loudness ranges
Are being used?
Is the device being used?
Understand system usage and track changes over time.
Understand how much time
your patients are spending in
each loudness range.
Speech 2.4 hrs
Off Air 9.8 hrs
On Air 9 hrs
2 power-ons
70-80 dBA 6%
% 100
60-70 dBA 25%
Loudness
60
Distribution
50-60 dBA 43%
Trends Over Time
hrs 3
Telecoil
Speech
FM
Other
1
Mar
2
Jun
19
Oct
13
Feb
28
Today
What ACCESSORIES are
being used?
Soft
0
Mar
2
On Air
Coil Off 2.8 hrs
3 coil-offs
Moderate
40
hrs 9
Daily Average
Loud
80
4
Time On Air
Trends Over Time
40-50 dBA 14%
Accessory Usage
Daily Average
Understand accessory usage
in both standby and usage modes.
Telecoil
FM
Other
In Use
8.3 hrs
17 hrs
6.7 hrs
Standby
1.7 hrs
14.5 hrs
7.7 hrs
Jun
19
Oct
13
Feb
28
Sep
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TECHNOLOGY IS ALWAYS IMPROVING.
YOUR PATIENTS WILL BE ABLE TO
Upgrade to our newest technology.
30 years and five sound processor upgrades later, one of our first patients is living proof of our lifetime
commitment to hearing. Graham Carrick is profoundly deaf. And yet he can hear, thanks to the cochlear
implant he got in 1982. Since that remarkable day when he heard his daughter’s voice for the very first
time, Graham’s life has never been the same. Everything is so much better than he ever dreamed.
We’re proud to say we were with him every step of the way.
Graham Carrick hearing his daughter’s voice
shortly after receiving his Cochlear implant in 1982.
G r a h a m w i t h h i s d a u g h t e r H e at h e r 3 0 y e a r s l at e r .
We’ll be there with your patients, too.
With the Nucleus 6 we continue the tradition of ensuring that upgradeability is built into every
implant and sound processor.
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18
Implants Compatible with Nucleus 6
Under Development for Future Release
Compatible Now
‘86
CI22M
‘05
CI24RE (Freedom™)
‘97
CI24M
‘00
CI24R (Contour™)
‘09
CI512
YOUR PATIENTS ARE COVERED.
Together, We’ve been changing
lives for over 30 years.
5 Year Warranty*
Your patients can worry less with the most comprehensive warranty out there. In keeping with our promise
to Hear now. And always, the Nucleus 6 System comes with a no questions asked 5 year warranty.*
The 5 year warranty covers your patient’s
Sound Processor
Coil
Coil-Cable
Magnet
Remotes
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Battery Holder & Cover
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Sound Partnership services, A partnership for better hearing.
Cochlear is more than just an implant and sound processor; we go beyond the tangible and strive for
the intangible. That’s why we’ve developed sound partnership services. It’s about making life easier and
creating streamlined access to hearing and support. Whether in person, online, or over the phone,
we’re committed to bringing you support whenever needed.
Cosmetic,
electrical,
mechanical &
water damage
Audiology On Call
Surgical Support
are all covered
Expert support for candidacy questions,
product selection, programming
troubleshooting, and clinical issues.
Surgical experts there when you need
it for pre-operative planning, intraoperative
support or follow-up.
under the
5 Year Warranty
Give your patients peace of mind with the Technology Exchange Program
With the Technology Exchange Program, Cochlear will ensure that all new Nucleus 5 recipients have
the ability to access the latest technology.
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Training & Education
Customer Service
In-depth training through professional
education programs offering continuing
education units (CEUs) both online
and in person.
Troubleshooting on the telephone or
via web chat with direct repair services
to maximize the time of both the
clinician and recipient.
Pre-Surgery Implant
Insurance Support
Reimbursement Billing
Insurance Support
Assistance with pre-surgical questions
about commercial insurance, billing
codes, denials, appeals, authorization
and preauthorization approvals.
Guidance through the purchase of parts and
accessories for those recipients with Medicare,
many state Medicaids, Tricare and Kaiser.
Helpful information and tips about private
insurance coverage for replacement parts,
accessories, repairs and upgrades.
Dual Sound Processor Systems**
Surgery Date
Number of Cochlear
Nucleus 5 Sound Processors
Eligible to Exchange
Opened
or Unopened
Exchange
by Date
04/01/13 – 08/04/13
1
Unopened
05/30/14
08/05/13 – 09/29/13 2
Unopened
11/30/13
Opened 05/30/14
Opened
05/30/14
09/30/13 – 03/30/14
1
Single Sound Processor Systems**
Surgery Date
Exchange Opened Nucleus 5 for Nucleus 6 Sound Processor On or Before
04/01/13 – 08/04/13
05/30/14
08/05/13 – 09/29/13 05/30/14
09/30/13 – 03/30/14
NA
* 5 year warranty for new recipients only. ** Technology Exchange Program Expires 03/30/14.
Ou r m i ss i o n
REFERENCES
[ 1 ] Cochlear Annual Report
[ 2 ] Cochlear Limited Annual Report, 2012 [Internet]. 2012 Sept [Cited 2013 July]. Available from: www.cochlear.com
[ 3 ] Publication: Nucleus Reliability Report, Vol.11, February 2013
We help people hear and be heard.
We empower them to connect with
others and live a full life.
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We help transform the way people
understand and treat hearing loss.
We innovate and bring to market
a range of implantable hearing
solutions, and deliver a lifetime of
hearing outcomes.
[ 4 ] Publication: Advanced Bionics 2012 Reliability Update, HiRes 90K Supplier A Post- 2005 modifications,
As of May 1st 2012. 028-M107-03-Rev B
[ 5 ] MED-EL Website: www.medel.com/reliability. Concert, June 2013
[ 6 ] Battmer RD, O’Donoghue GM, Lenarz T. A multicenter study of device failure in European cochlear
implant centres. Ear Hear 2007 Apr;28(2 Suppl):95S-99S
[ 7 ] Cullen RD, Fayad JN, Luxford WM, et al. Revision cochlear implant surgery in children. Otol Neurotol 2008;29(2):214-20
[ 8 ] Battmer RD, Linz B, Lenarz T. A review of device failure in more than 23 years of clinical experience of a cochlear
implant program with more than 3,400 implantees. Otol Neurotol 2009 Jun;30(4):455-63
[ 9 ] The Hearing Zone is approximately 400-450 degrees into the cochlear, which has been determined from peer
review articles. Stakhovskaya O, Bonham BH, Sridhar D, Leake P. Frequency Map for the Human Cochlear Spiral
Ganglion. JARO. 2007 8:220-223 and Ariyasu L, Galey FR, Hilsinger R, Jr., Byl FM. Computer-generated three
dimensional reconstruction of the cochlea. Otolaryngology Head Neck Surgery. 1989; 100(2):87-91
[ 10 ] J. Thomas Roland Jr. MD. A model for cochlear implant electrode insertion and force evaluation: results with a new
electrode design and insertion technique. Laryngoscope. 2005 Aug;115(8):1325-39
[ 11 ] Wolfe, J., Parkinson, A., Schafer, E.C., Gilden, J., Rehwinkel, K., Mansanares, J., Coughlan, E., Wright, J., Torres, J.,
& Cunningham, S. (2011). Benefit of a commercially available cochlear implant processor with dual-microphone
beamforming: A Multi-Center Study, Otology & Neurotology, In Press
[ 12 ] The Nucleus Freedom Cochlear Implant System: Adult Post Market Surveillance Trial Results. 2008 June
As your patient’s partner in hearing for life, Cochlear believes it is important to convey not only the benefits, but also the potential
risks associated with any cochlear implant.
Not everyone with hearing loss is a candidate for cochlear implantation. Before any cochlear implant surgery, please review the
CDC recommendations regarding vaccination with your patient. Cochlear implants are contraindicated for patients with lesions of
the auditory nerve, absent cochlear development, active ear infections or active disease of the middle ear.
Cochlear implantation is a surgical procedure, and carries with it the risks typical for surgery. Patients may lose residual hearing
in the implanted ear. Electrical stimulation may result in some side effects, including ringing in the ear, stimulation of the facial
nerve; in rare cases this may cause pain. Though rare, it is possible that additional surgery may be required at some point to resolve
complications with a cochlear implant. For complete information regarding indications, warnings and adverse effects, please refer
to the Nucleus Package Insert available at www.Cochlear.com/US/NucleusIndications
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As the leading global expert in implantable hearing solutions,
Cochlear is dedicated to bringing the gift of sound to people
all over the world. For thirty years, Cochlear has pioneered this
technology, helping more than a quarter of a million people
reconnect to their families and friends.
Along with the industry’s largest investment in research
and development, we continue to partner with leading
international researchers and hearing professionals, ensuring
that we are at the forefront of hearing science.
For our customers, that means access to our latest
technologies throughout their lives, and the ongoing support
they need.
That is why seven out of ten people worldwide who choose
a cochlear implant choose Cochlear as their hearing partner.
www.Cochlear.com/US
Cochlear Americas
13059 East Peakview Avenue Centennial, CO 80111 USA
Telephone: 1 303 790 9010
Support: 1 800 483 3123
Cochlear Canada Inc.
2500-120 Adelaide Street West Toronto, ON M5H 1T1 Canada
Telephone: 1 416 972 5082
Fax: 1 416 972 5083
©Cochlear Limited 2013. All rights reserved. Hear Now And Always and other
trademarks and registered trademarks are the property of Cochlear Limited or
Cochlear Bone Anchored Solutions AB. The names of actual companies and
products mentioned herein may be the trademarks of their respective owners.
FUN1870 ISS1 SEP13