LIFE IS A JOURNEY. HEAR EVERY STEP.

Transcription

1 LIFE IS A JOURNEY. HEAR EVERY STEP. INTRODUCING NUCLEUS HYBRID HEARING

2 You hear the rumble of thunder but miss a bird s chirp. You hear a drumbeat but miss the guitar solo. You hear a loud shout but miss a baby s giggle. 02 You hear a joke but miss the punch line. You hear a little but miss a lot. IT S TIME TO GET BACK WHAT YOU VE BEEN MISSING.

3 HYBRID HEARING * : WHEN YOU NEED MORE THAN A HEARING AID. If you ve been diagnosed with hearing loss but hearing aids don t seem to be helping, our new hearing solution offers hope. Until now, hearing aids were the only choice for mild-to-moderately-severe hearing loss. But hearing aids alone are often not enough because they simply amplify sound making everything louder, including background noise. Cochlear Hybrid Hearing is the first and only FDA-approved hearing solution that gives you back access to the sounds you ve been missing while taking full advantage of the hearing you still have. Hearing loss can vary in degrees across the full spectrum of sound. You may be able to hear some sounds like car honks, but not high-pitched sounds like birds chirping and children s voices. For those missing the full spectrum of sound, speech is often difficult to understand, especially in noisy situations. New Cochlear Hybrid Hearing is the only hearing solution that combines the amplification of a hearing aid with cochlear implant technology to give you access to the full spectrum of sound in one device. So, whether you re on the phone, in a group, listening to music or out in nature, the Cochlear Nucleus Hybrid Implant System can help you hear better and more clearly than hearing aids alone especially in noisy environments. In fact, in an FDA-approved clinical study, Hybrid System recipients reported a tenfold increase in their overall satisfaction X INCREASE in their overall hearing satisfaction 1 10X 2X BETTER hearing in noise 1 INCREASE in music satisfaction 1 Along with better satisfaction and hearing ratings, Hybrid Hearing may be more affordable than hearing aids. Unlike hearing aids, hearing implants are covered by most private insurance plans, including Medicare and typically Medicaid. * Hybrid Hearing is approved only for use with the Nucleus Hybrid L24 Implant. The Nucleus Hybrid System may be classified as new technology by health plans and will be reviewed on a case-by-case basis until universal adoption. Cochlear is being proactive in working with insurance companies to expand consideration of coverage for the Nucleus Hybrid Implant System.

4 04 THIS EXPERIENCE HAS BEEN MIRACULOUS AND LIFE-CHANGING. Ellen D Nucleus Hybrid System recipient

5 EXPERIENCE EVERYTHING LIFE HAS TO OFFER. If you re struggling with hearing loss and are able to hear some sounds but not others, you re missing out on more than you might think. Having access to the full spectrum of sound provides you with a more complete hearing experience and can enable you to understand the sounds around you, especially in noisy situations. The full spectrum of sound includes both high- and low-frequency sounds that are critical to helping you distinguish words, hear the sounds of nature and enjoy music. Low frequency examples include a dog s bark and a lawn mower while high-frequency sounds include sounds of nature, children s voices and sirens. Only Cochlear Hybrid Hearing * can give you access to the sounds you re missing, while taking advantage of the hearing you have all in one convenient device. In fact, new Cochlear Hybrid Hearing is the first and only FDA-approved solution that uses the hearing you have and provides access to the hearing you re missing so you can enjoy a more complete hearing experience and a richer, fuller life. 05 Frequency [Hz] NORMAL 0-25 db HL 10 Hearing threshold (db HL) MILD db HL MODERATE db HL MODERATELY SEVERE db HL SEVERE db HL j z ng n e l o a r h g sh f s th COCHLEAR HYBRID HEARING ZONE TRADITIONAL COCHLEAR IMPLANTS PROFOUND 91 db HL Icons and letters represent the sounds you can typically hear at different volume and pitch levels. * Hybrid Hearing is approved only for use with the Nucleus Hybrid L24 Implant.

6 NEW COCHLEAR HYBRID HEARING * COMBINING THE BEST OF TWO TECHNOLOGIES. Cochlear Hybrid Hearing is a unique combination of two proven hearing technologies. It uses the amplification of a hearing aid that helps make the sounds you do hear louder, while providing access to the sounds you re missing through our most advanced cochlear implant technology. The unique combination of these two technologies can allow you to experience the full spectrum of sound. 06 Cochlear Implants Hearing Aids Cochlear Nucleus Hybrid Implant System Combining advanced cochlear implant technology with the amplification of a hearing aid. Cochlear Hybrid Hearing is the only FDA-approved hearing solution that uses the hearing you have while giving you access to the hearing you re missing. * Hybrid Hearing is approved only for use with the Nucleus Hybrid L24 Implant.

7 HOW IT WORKS IS AMAZING. HEARING WITH THE NUCLEUS SYSTEM 3 [ 1 ] Microphones on the Nucleus 6 Sound Processor pick up the sounds you re missing and convert them into digital information [ 2 ] At the same time, when using Hybrid Hearing *, the acoustic component amplifies the sounds you do hear and sends them through the ear canal in the normal pathway of hearing. [ 3 ] The missing sound information is transferred through the coil to the Nucleus Hybrid Implant just under the skin. 2 [ 4 ] The Nucleus Hybrid Implant sends electrical signals down the electrode into the cochlea. [ 5 ] The hearing nerve fibers in the cochlea pick up the signals, combine them with the amplified sounds and send them to the brain, which is translated as the sound you hear. 07 The Nucleus Hybrid Implant System Includes Two Components: The Nucleus 6 Sound Processor and the Nucleus Hybrid Implant SIMPLY SMARTER HEARING The Nucleus Hybrid System features our most powerful sound processor, the Nucleus 6. The Nucleus 6 Sound Processor includes a microchip that s 5 times more powerful than our previous sound processors, enabling advanced technologies like data logging and future upgrades. Nucleus 6 Sound Processor with Hybrid Hearing THE PERFECT IMPLANT FOR YOUR EAR Cochlear boasts the largest electrode portfolio, including the Nucleus Hybrid L24, which is designed to preserve the hearing you have and restore access to the hearing you re missing. Your doctor will choose the best implant for you. Nucleus Hybrid Implant * Hybrid Hearing is approved only for use with the Nucleus Hybrid L24 Implant.

8 08 SOMETIMES THE BIGGEST MIRACLES ARE ALSO THE SMALLEST.

9 THE SMALLEST SOUND PROCESSOR THE WORLD HAS EVER SEEN. The Nucleus 6 Sound Processor is the smallest * and smartest sound processor the world has ever seen. It s very light and comfortable and features a choice of rechargeable or disposable batteries. So you ll feel confident wearing it all day, every day. INDUSTRY S MOST COMPREHENSIVE WARRANTY We understand that things happen, and when they do, you won t have to worry because the Nucleus 6 Sound Processor and Remote Assistants come with a no-questions-asked 5-year warranty YEAR WARRANTY 2 ON SOUND PROCESSOR AND REMOTE ASSISTANT * Nucleus 6 Sound Processor with compact rechargeable battery.

10 10 RAINY DAYS ARE NOW SUNNIER THAN EVER.

11 COME ON IN THE WATER S FINE. Whether the sun is shining or the rain is falling, we ve got you covered. The Nucleus 6 Sound Processor is treated with an innovative nano-coating that repels water and is designed to keep working in any type of weather. With the Nucleus 6 Sound Processor, you can take a shower, play in the tub and splash in the pool to your heart s content. The sound processor also allows you to enjoy swimming underwater when used with the waterproof Aqua+. * Nucleus 6 Sound Processor R A I N BATH SWEAT NANO COATED 11 READY TO SWIM IN 30 SECONDS! Nucleus 6 Sound Processor with Aqua+ POOL SNORKEL OCEAN * The Aqua+ accessory is IP68 rated and is approved for use with rechargeable batteries and is not approved for use with the acoustic component. The Nucleus 6 sound processor is water-resistant with out the Aqua+ accessory to level of IP57 of the International Standard IEC60529.

12 12 CONVERSATIONS DON T HAVE TO STOP WHEN IT STARTS TO GET NOISY.

13 HEAR YOUR BEST EVEN IN THE NOISIEST ENVIRONMENTS. You never know where life s going to take you, and with Hybrid Hearing * your ears will be pleasantly surprised. The Nucleus Hybrid System boasts our most powerful sound processor yet the Nucleus 6 that adapts to new situations. That means you ll hear your best wherever you are, from a quiet street to a crowded stadium and everywhere in between. The Nucleus 6 Sound Processor has dual microphone zoom technology that focuses on the direction of sounds in your environment, so you can filter out what you don t want to hear and tune in to what you do. Then, its innovative SmartSound technology optimizes desired sound to enhance your hearing even in surroundings filled with background noise so you can understand speech more clearly. And if you want more control over your hearing, adjusting the sound processor or utilizing the remote assistant allows you to modify your hearing based on your particular location. SMARTSOUND PROGRAMS 13 HOME Hear clearer and crisper speech FOCUS Have a conversation in noisy surroundings NOISE Hear comfortably in noisy environments MUSIC Listen to the music you love 100% OF RECIPIENTS 3 SHOWED IMPROVED HEARING IN NOISE WITH DUAL MICROPHONE ZOOM TECHNOLOGY * Hybrid Hearing is approved only for use with the Nucleus Hybrid L24 Implant.

14 14 MUSIC IS THE SOUNDTRACK OF LIFE LET IT MOVE YOU.

15 YOUR LEVEL OF MUSIC ENJOYMENT IS RELATED TO OUR LEVEL OF TECHNOLOGY. Music is an important and soothing part of life, and hearing loss shouldn t get in the way of enjoying it. Whether it s listening to the philharmonic s greatest performance or your child s holiday program, we help make sure you won t miss a note. In fact, in a clinical study, Hybrid Hearing * recipients ability to distinguish pitch was similar to that observed for normal hearing individuals. 4 The Nucleus 6 Sound Processor has a special Music Program that is specifically designed to enhance your musical experience. The unique SmartSound Music Program is designed to filter out unwanted noise in the same way that natural hearing works. The result is an enhanced listening experience with less distracting background noise. 15 WITH HYBRID HEARING, MUSIC SATISFACTION INCREASED 10X1 * Hybrid Hearing is approved only for use with the Nucleus Hybrid L24 Implant.

16 16 WHEN IT COMES TO YOUR HEARING, THERE IS NO SUCH THING AS TOO MUCH INFORMATION.

17 A SOUND PROCESSOR SO SMART, IT CAN TELL YOU WHERE IT S BEEN. We know how difficult it is to remember the details of how you re using your sound processor. And with data logging, you don t have to. Data logging is a minute-by-minute journal of how your sound processor is being used that gives your audiologist key information to help identify trends and make necessary adjustments so you re always hearing your best. With data logging, questions that may have been difficult to answer in the past are now right at your audiologist s fingertips, including: Which program is being used most? What sound environments are you experiencing the most? How often is the volume default setting being used? What accessories are being used and how often? 17 Music 0.8 hrs Groups 4.4 hrs Program Usage Daily Average Café 8.8 hrs Home 10.0 hrs Noise 6.0 hrs Wind 0.9 hrs Music 2.0 hrs Speech in Noise 1.7 hrs Scenes Daily Average Speech 4.4 hrs dba 6% dba 25% >80 dba 4% Loudness Distribution <40 dba 8% dba 14% Quiet 9.0 hrs dba 43%

18 18 EVERYONE WANTS TO FEEL CONNECTED JUST NOT WITH WIRES.

19 WIRELESS FREEDOM WITH NO STRINGS ATTACHED. Just being able to talk on the phone like everyone else is life-changing. That s why the Nucleus 6 Sound Processor features a telecoil so you can stay connected without having to plug into anything. But that s just the beginning. With a simple software upgrade that s under development, * your sound processor will directly connect to an incredibly wide range of 2.4 GHz wireless devices. That means you ll be able to use Bluetooth-enabled music players and some hearing aids without any wires, ear buds or additional accessories hanging around your neck. And the audio signals from your TV, stereo and GPS will broadcast right to your sound processor just like an extra speaker. So you can be a part of whatever the wireless future holds. 19 Hear the TV like everyone else when you stream directly into your sound processor. Stereo Bluetooth Smartphone MP3 Player Remote Assistant * Pending FDA approval for the Nucleus 6 Sound Processor.

20 20 TWO EARS ARE BETTER THAN ONE.

21 HYBRID HEARING * COMBINES THE BEST OF BOTH WORLDS AND EARS. Hearing with both ears offers a clear advantage, especially when it comes to distinguishing where sound is coming from and understanding speech in noisy environments. As a result, many people who suffer from hearing loss benefit from hearing aids in both ears (bilateral). But when hearing aids alone are not enough, a Cochlear implant in one ear and a hearing aid in the other ear (bimodal) can be very helpful. In fact, bimodal hearing is a good solution if you have some residual hearing in the ear opposite your Cochlear implant. And with Hybrid Hearing, you can continue to experience the benefits of bimodal hearing for years to come. Whether you use a hearing aid, other hearing technology or a combination of the two, Cochlear Hybrid Hearing can work with what you have into the future. Percent Correct CNC WORD RECOGNITION SCORES Average Scores 21 Pre Implant Post Implant 1 Hearing aid Hybrid Hearing 2 Hearing aids (bilateral) Hybrid Hearing plus hearing aid (bimodal) * Hybrid Hearing is approved only for use with the Nucleus Hybrid L24 Implant. The CNC word recognition test is a list of 50 single syllable words.

22 ACCESSORIES THAT LET YOU HEAR JUST THE WAY YOU WANT TO. From colors to covers and remote assistants to remote controls, our wide array of accessories makes sure your Nucleus 6 Sound Processor fits exactly who you are. The Cochlear Nucleus Hybrid System gives you the most robust standard package and the largest choice of accessories to customize your hearing experience. Standard features include: Choice of sound processors Remote control included 2.4 GHz wireless streamer built in Acoustic driver built in Built-in telecoil 5-Year warranty Choice of four accessories, including Plus One Disposable and rechargeable batteries 22 Nucleus 6 Sound Processor without accessory port Nucleus 6 Sound Processor with accessory port SIMPLE CONTROL Our discreet pocket-size remote control with a handy display screen allows you to adjust simple settings without touching your sound processor. ADVANCED MONITORING AND CONTROL The intuitive design of the full-featured remote assistant puts you in control of monitoring and managing your hearing. OPTIONAL ACCESSORY PORT Choose between a sound processor that has a built-in accessory port if you prefer to use plug-in accessories, or one without.

23 Mocha Carbon Maize Smoke A DIFFERENT LOOK EVERY DAY With a range of 12 sound processor and coil covers in bright colors and patterns, you can even choose one to match your outfit. SUBTLE SHADES OF COLOR The Nucleus 6 Sound Processor comes in a variety of colors designed to blend in with hair and skin tones. MAKE IT YOUR OWN From your favorite sports team to a picture of the family, Skinit can turn any design or image into a custom skin for your sound processor. PLUS ONE The Plus One Program allows you to live with your sound processor for up to a year before making your final accessory selection. 23 LONG BATTERY LIFE The Nucleus 6 Sound Processor comes with a choice of battery options to ensure you never go without hearing. The standard disposable battery can last up to three days or you can go green with rechargeable batteries that come in two sizes standard and compact. Compact and Standard Rechargeable Batteries Standard Disposable Batteries Battery life may vary by individual.

24 24 LIVING PROOF OF OUR LIFETIME COMMITMENT TO YOU. Holly M, Cochlear Implant recipient since 1987

25 WITH BACKWARDS COMPATIBILITY, YOU LL ALWAYS BE READY FOR THE FUTURE. Holly lost her hearing to meningitis when she was four. Soon after, Holly s mom learned about the amazing results of Cochlear Implants and arranged for her daughter s surgery shortly before she turned five. Holly attended mainstream schools and graduated high school in the top 2% of her state. During her schooling, she upgraded her sound processors several times the last was the same year she graduated from law school with honors. Thirty years and five sound processor upgrades later, one of our first patients is living proof of our commitment to innovation and support. Processors will become more and more powerful, their size will get smaller and smaller, and with backward compatibility and continual access to new technology, you ll be able to take advantage of breakthroughs for years to come. That s the promise we make when we say, Hear now. And always. 25 We re proud to say we were with her every step of the way. And we ll be there with you too. With an implant, Holly attended her neighborhood schools. She graduated in the top 2% of her state.

26 26 TRUST IS SOMETHING YOU HAVE TO EARN.

27 IT S MORE RELIABLE SO YOU CAN WORRY LESS. THE BEST LONG-TERM RELIABILITY RECORD 5-10 Cochlear s Nucleus CI24RE Implant * has improved the hearing of nearly 100,000 people worldwide with a remarkable 99% reliability rating at ten years. 5 And because it s so reliable, 9 out of 10 surgeons surveyed chose the Nucleus System. 11 And you should, too. OVER TIME THE DIFFERENCE IS CLEAR 100% Current Devices Cumulative Survival Rate (CSR) 99% 99.0% 27 98% Months Cochlear Nucleus CI24RE Advanced Bionics HiRes 90K Med-El Concert UP TO 2X MORE RELIABLE THAN ANYTHING ELSE AVAILABLE TODAY 8-10 * The Nucleus Hybrid L24 is identical to the CI24RE Implant, using a shorter and thinner electrode.

28 THERE ARE STEPS TO HEARING, BUT THEY RE SHORT STEPS. For over thirty years we ve helped people hear better, and no one s ever said, I wish I would have waited. In fact, the opposite is true. And once you make this life-changing decision, we ll be with you every step of the way to ensure your hearing is the best it can be for life HEARING EVALUATION After a Hearing Implant Specialist determines you re a candidate, you ll talk with a surgeon about the procedure. Unlike hearing aids, cochlear implants are covered by most insurance plans, Medicare and typically Medicaid. To find a Hearing Implant Specialist in your area, visit Cochlear.com/US/Appointment ACTIVATION DAY This is the moment you ve been waiting for. Shortly after your implant procedure, you ll be ready for your processor to be turned on. And your life will change at the flick of a switch IMPLANT PROCEDURE This outpatient surgery is usually done under general anesthesia and lasts only a couple of hours. In a few days, most people are back to their normal activities. GETTING THE MOST OUT OF YOUR HEARING IMPLANT Before long, you ll be hearing better than you ever thought possible. Our Customer Support Services can help make sure of it.

29 MORE PEOPLE TRUST THEIR HEARING TO COCHLEAR THAN ALL THE OTHER HEARING IMPLANT COMPANIES COMBINED.12,13 We know firsthand what a wonderful, life-changing decision you re about to make. Many of us have Cochlear Implants ourselves. And it would be our honor to help you on your journey to hear. There s never been a better time to get back the sounds you ve been missing. COCHLEAR CONCIERGE This is a unique group of people who often have first hand experience, either as an audiologist or implant recipient or parent. You can ask them anything. Here s how: COCHLEAR COMMUNITY It s the largest community of its kind. Read story after story from people who faced a turning point just like you and made this life-changing decision. Cochlear.com/US/Community 29 Concierge@Cochlear.com Chat Cochlear.com/US/Concierge Call 1 (800) INSURANCE COVERAGE Cochlear implants are covered by most insurance plans, Medicare and typically Medicaid. * Our Insurance Support Team will help you seek insurance coverage or help you navigate through the appeals process if you have been denied. 1 (800) Cochlear.com/US/MyInsurance * The Nucleus Hybrid System may be classified as new technology by health plans and will be reviewed on a case-by-case basis until universal adoption. Cochlear is being proactive in working with insurance companies to expand consideration of coverage for the Nucleus Hybrid Implant System.

30 30 THEY SAID NOTHING COULD BE DONE ABOUT HEARING LOSS. GOOD THING HE DIDN T LISTEN.

31 DR. CLARK HAS BEEN PASSIONATELY PROVING THEM WRONG FOR OVER 30 YEARS. Over thirty years ago, Dr. Graeme Clark invented the world s first multichannel cochlear implant. He grew up in Australia with a dream of fixing ears. His father was deaf, so he was determined to help him and others hear. Today, Dr. Clark s passion has brought hearing to over 250,000 people worldwide. Now you can be one of them too. 31 REFERENCES [ 1 ] FDA Panel Sponsor Executive Summary, Nucleus Hybrid L24 Implant System. November 8, CommitteesMeetingMaterials/MedicalDevices/ MedicalDevicesAdvisoryCommittee/ EarNoseandThroatDevicesPanel/UCM pdf [ 2 ] Terms and conditions apply for the 5-year warranty. See our website for details at Cochlear.com/US. [ 3 ] Wolfe, J., Parkinson, A., Schafer, E., Gilden, J., Rehwinkel, K., Mansanares, K., Coughlan, J. et al. Benefits of a Commercially Available Cochlear Implant Processor with Dual-Microphone Beamforming: A Multi-Center Study. Otology & Neurotology, Vol 33(4): , 2012 June. [ 4 ] Kang, S.Y., Nimmons, G.L., Drennan, W., Longnion, J., Ruffin, C., Nie, K., Won, J.H., Worman, T., Yueh, B., Rubinstein, J. (2009). Development and validation of the University of Washington clinical assessment of music perception test. Ear Hear, 30(4), [ 5 ] Publication: Nucleus Reliability Report, vol.12, February [ 7 ] MED-EL Website: Concert, July [ 8 ] 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): [ 9 ] Cullen RD, Fayad JN, Luxford WM, et al. Revision cochlear implant surgery in children, Otol Neurotol 2008;29(2): [ 10 ] 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): [ 11 ] Cochlear surgeons preference survey: Internal reliability preferences. [Data on file] Cochlear Americas: 2010 June. [ 12 ] Cochlear Americas [Data on file] 2012 March. [ 13 ] Cochlear Annual Report, 2012 September. Income statement. [Cited 2013 July] [Internet: pdf document, 80 p.] Available at [ 6 ] Publication: Advanced Bionics 2012 Reliability Update, HiRes 90K Supplier A Post-2005 modifications, as of May 1st M Rev B.

32 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. * As your partner in hearing for life, Cochlear believes it is important that you understand not only the benefits, but also the potential risks associated with any cochlear implant or hybrid implant. You should talk to your hearing healthcare provider about who is a candidate for a cochlear implant or a hybrid implant. Before any surgery, it is important to talk to your doctor about CDC guidelines for pre-surgical vaccinations. Cochlear implants and hybrid Implants are contraindicated for patients with lesions of the auditory nerve, active ear infections or active disease of the middle ear. Cochlear implantation and hybrid implantation are surgical procedures, and carry with them the risks typical of surgery. You 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 or hybrid implant. For complete information about risks and benefits of cochlear implantation, please refer to the Nucleus Package Insert available at *Cochlear Americas [Data on file] 2012 March. Follow us on 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. The names of actual companies and products mentioned herein may be the trademarks of their respective owners. FUN2105 ISS1 APR14