We make the device. You make the miracle. Introducing The Cochlear Nucleus 6 System

Transcription

1 We make the device. You make the miracle. Introducing The Cochlear Nucleus 6 System

2 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 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. HISTORY OF INNOVATION 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 9 th 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

3 THE MOST CHOSEN, MOST TRUSTED COCHLEAR IMPLANT. A portfolio of electrodes designed For PERFORMANCE and PRESERVATION. The Most Reliable Cochlear Implant Ever 3-8 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: An industry best 99% reliability (CSR at eight years). 3 Up to 3X more reliable than other manufacturer s current implants. 3-5 Cochlear Nucleus Contour Advance The only perimodiolar electrode array With its unique perimodiolar placement, the Contour Advance provides the most precise and efficient stimulation for patients Over 100,000 patients implanted around the world, more than all other implants combined. 3-5 Up to 3x More reliable 3-5 Than anything else available today Learn more at KnowTheDifference.com Cochlear is the only manufacturer with a true portfolio of electrodes 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. Cochlear Nucleus Slim Straight 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. 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 Full Band Straight Cochlear Nucleus Double Array Cochlear Nucleus Auditory Brainstem Implant 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.

4 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. Powerful battery choices New features make the Cochlear Nucleus 6 easier to use Tactile buttons Auto FM Auto-on and auto-off 05 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 Choice of two different remotes Up to 60 hours of battery life with the High Power 675 zinc air batteries 06 Water protection Cochlear Nucleus 5 IP57 Rating * What does this mean for your patients? Splash in the tub Play in the pool Walk in the rain Sweat during sports Sit in the hot tub And much more Cochlear Nucleus 5 with Aqua Accessory IP68 Rating * What does this mean for your patients? Swim underwater 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.

5 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. Discreet color Options 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. The Cochlear Nucleus 6 Sound Processor comes in a variety of subtle colors designed to blend with hair and skin tones. REMOTE ASSISTANT Pocket-sized CR230 Remote Assistant gives them the control they want to manage their hearing effectively, yet easily, and troubleshoot if necessary. REMOTE CONTROL The keyring-sized CR210 Remote Control covers the essentials. It s compact and easy to use. 07 Carbon Maize Mocha Smoke 08 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. 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. Feature Control of volume or sensitivity and program changes Manual control of telecoil and audio streaming options 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 Remote Control

6 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. 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. 09 Wireless Connectivity Your patients will be able to connect to a wide range of 2.4 GHz wireless devices with a future software upgrade. Future Upgrades With 5X the processing power of the industry leading Nucleus 5, the new chip provides the platform for a vast array of future technologies. 10 Sometimes the biggest miracles are also the smallest.

7 SOME OF THE BEST PLACES ARE ALSO THE NOISIEST. SMARTSOUND Technology LETS YOUR PATIENTS BE PART OF THE CONVERSATION. 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. Front Omni Microphone Rear Omni Microphone SmartSound processing uses the Nucleus 6 dual microphones to create unique strategies to block out noise from all around your patient. Standard 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 11 Adaptive Beam 12 Sentences at at 60db 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. 100 Cochlear Implants are better than Hearing Aids in Noise 12 Average Average Percent Percent Accurate Accurate % 70% Hearing Aid Cochlear Implant Fixed zoom 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. 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

8 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. But that s just the beginning. 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. 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 13 Intuitive Design 14 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 off Air 9.8 hrs Time On Air Daily Average Speech 2.4 hrs On Air 9 hrs 2 power-ons Coil Off 2.8 hrs 3 coil-offs Clinical insights Industry s first data logging capability, with advanced hearing analysis Valuable insight on how patients use their devices every day hrs 9 4 On Air Easier to troubleshoot issues and challenges hrs 3 Speech 1 Mar 2 Jun 19 Oct 13 Feb 28 Today * Pending FDA approval.

9 A PROCESSOR SO SMART, IT CAN TELL YOU WHERE IT HAS BEEN. What is the auditory environment? Understand how much time is spent in each scene. Wind 0.9 hrs Music 2.0 hrs Noise 6.0 hrs Scenes Daily Average Speech in Noise 1.7 hrs Speech 4.4 hrs % Trends Over over time Time Noise Quiet Speech Mar 2 Jun 19 Oct 13 Feb 28 Today Data logging, a first for the COCHLEAR IMPLANT industry, answers the questions your patients may not be able to. Quiet 9.0 hrs 15 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. Get ready to start a better conversation with Nucleus 6 and data logging. What programs are being used? Identify programs most used and fine-tune settings. Groups 4.4 hrs Café 8.8 hrs Music 0.8 hrs Program Usage Daily Average Home 10.0 hrs 16 >80 dba 4% <40 dba 8% Is the device being used? What loudness ranges Are being used? dba 6% dba 14% % Trends Over Time Loud Understand system usage and track changes over time. Speech 2.4 hrs Understand how much time your patients are spending in each loudness range dba 25% Loudness Distribution dba 43% Mar 2 Jun 19 Oct 13 Feb 28 Sep 29 Moderate Soft off Air 9.8 hrs On Air 9 hrs 2 power-ons hrs 9 Trends Over Time On Air 4 Time On Air Daily Average hrs 3 Speech Telecoil FM 1 Other Coil Off 2.8 hrs 3 coil-offs Mar 2 Jun 19 Oct 13 Feb 28 Today What ACCESSORIES are being used? Accessory Usage Daily Average Understand accessory usage in both standby and usage modes. In Use Standby Telecoil 8.3 hrs 1.7 hrs FM 17 hrs 14.5 hrs Other 6.7 hrs 7.7 hrs

10 TECHNOLOGY IS ALWAYS IMPROVING. YOUR PATIENTS WILL BE ABLE TO Upgrade to our newest technology. Graham Carrick hearing his daughter s voice shortly after receiving his Cochlear implant in 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 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 with his daughter Heather 30 years later. 17 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. Implants Compatible with Nucleus 6 18 Under Development for Future Release Compatible Now 86 CI22M 97 CI24M 00 CI24R (Contour ) 05 CI24RE (Freedom ) 09 CI512

11 YOUR PATIENTS ARE COVERED. 5 Year Warranty * Together, We ve been changing lives for over 30 years. 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. * Sound Partnership services, A partnership for better hearing. 19 The 5 year warranty covers your patient s Sound Processor Coil Coil-Cable Magnet Remotes Battery Holder & Cover Cosmetic, electrical, mechanical & water damage are all covered under the 5 Year Warranty 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. Audiology On Call Expert support for candidacy questions, product selection, programming troubleshooting, and clinical issues. Surgical Support Surgical experts there when you need it for pre-operative planning, intraoperative support or follow-up. 20 Training & Education Customer Service 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. 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 09/30/13 03/30/14 1 Opened 05/30/14 In-depth training through professional education programs offering continuing education units (CEUs) both online and in person. Pre-Surgery Implant Insurance Support Assistance with pre-surgical questions about commercial insurance, billing codes, denials, appeals, authorization and preauthorization approvals. Troubleshooting on the telephone or via web chat with direct repair services to maximize the time of both the clinician and recipient. Reimbursement Billing Insurance Support 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. 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.

12 Our mission REFERENCES [ 1 ] Cochlear Annual Report [ 2 ] Cochlear Limited Annual Report, 2012 [Internet] Sept [Cited 2013 July]. Available from: We help people hear and be heard. [ 3 ] Publication: Nucleus Reliability Report, Vol.11, February 2013 [ 4 ] Publication: Advanced Bionics 2012 Reliability Update, HiRes 90K Supplier A Post modifications, As of May 1st M Rev B We empower them to connect with others and live a full life. [ 5 ] MED-EL Website: 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 21 We help transform the way people understand and treat hearing loss. [ 7 ] Cullen RD, Fayad JN, Luxford WM, et al. Revision cochlear implant surgery in children. Otol Neurotol 2008;29(2): [ 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): We innovate and bring to market a range of implantable hearing solutions, and deliver a lifetime of hearing outcomes. [ 9 ] The Hearing Zone is approximately 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 : 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 Aug;115(8): [ 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 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

13 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. Cochlear Americas East Peakview Avenue Centennial, CO USA Telephone: Support: Cochlear Canada Inc Adelaide Street West Toronto, ON M5H 1T1 Canada Telephone: Fax: Cochlear Limited 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