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. 01 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 02 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 03 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. 04 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 05 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. 06 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. 07 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 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. 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 Remote Control 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. 09 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. 10 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 11 12 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. 20 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 13 14 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. 15 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 16 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 29 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. 17 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 19 Battery Holder & Cover 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. 20 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. 21 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 22 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