IHS 2016: Cochlear Americas Expanded Indications and Meaningful Innovations

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1 Cochlear Americas The Cochlear Mission We help people hear and be heard. We empower people to connect with others and live a full life. We transform the way people understand and treat hearing loss. We innovate and bring to market a range of implantable hearing solutions that deliver a lifetime of hearing outcomes. Hearing Loss Over 5% of the world s population million people - has disabling hearing * loss (328 million adults and 32 million children). 1 Nearly 1 out of every 3 people over the age of 65 are affected by hearing loss. It affects communication and can contribute to social isolation, anxiety, depression and cognitive decline. 2 Market penetration 3 1. Who.int. WHO Deafness and hearing loss [Internet] Who.int. WHO 10 facts on deafness [Internet] Market penetration. This figure is a global estimate based on Cochlear sourced data. * Disabling hearing loss refers to hearing loss greater than 40 decibels (db) in the better hearing ear in adults and a hearing loss greater than 30 db in the better hearing ear in children. 1

2 1 BLANCHFIELD, B.B., ET. AL. (2001). THE SEVERELY TO PROFOUNDLY HEARING-IMPAIRED POPULATION IN THE UNITED STATES: PREVALENCE ESTIMATES AND DEMOGRAPHICS. JAAA. 12, COCHLEAR INTERNAL ESTIMATE, RECIPIENT S DATA. Less than 10 % of people who would benefit from an implantable hearing solution are aware of their options and seek treatment 1,2 What are the effects of untreated hearing loss? Stress & Fatigue 5,6 Emotional Distress 2 Loss of relationships 9 Cognitive Decline 1,8 Higher use and cost of healthcare 3 Social Isolation 2,8 Depression 4 Reduced Quality of Life 7 Increased risk of hospitalization Years of Hearing 2

3 Our Products Cochlear Nucleus Profile with Slim Modiolar Electrode (CI532) Cochlear Nucleus Implant Portfolio Uniquely Designed for Preservation, Performance and Preference Slim Modiolar Electrode The Thinnest and Flexible PERIMODIOLAR electrode 1 Contour Advance Electrode Profile CI512 is the stylet based Perimodiolar Electrode Slim Straight Electrode Profile CI522 is the THINNEST full length electrode 1 Hybrid L24 Electrode The industry's ONLY FDA-approved hearing PRESERVATION electrode Full-Band Straight Electrode Ideal for various types of abnormal cochlea Auditory Brainstem Implant The ONLY FDA-approved ABI electrode 3

4 Perimodiolar placement reduces current spread Scala Tympani Modiolus Larger spread of excitation with lateral wall placement Lateral wall placement Perimodiolar placement Smaller spread of excitation with modiolar wall placement Reliability Matters Breakthrough performance with the latest in microchip technology HYBRID HEARING Integrated signal path for delivering acoustic amplification and electrical stimulation in one device 4

5 Cochlear Nucleus 6 System Simply Smarter SmartSound iq* A range of technologies working together to meet user needs in every hearing situation Music Speech in Noise Quiet Speech Wind Noise Automatically adjusts to the hearing situation Industry first scene classifier (SCAN) Background noise reduction (SNR-NR) Wind noise reduction (WNR) SmartSound iq, SNR-NR, and Wind Noise Reduction are approved adults and children 6 yrs and older First and ONLY Hybrid Hearing Solution Every Nucleus 6 Sound Processor is Hybrid-Ready Easily configured in a few simple steps Instant fit disposable domes or customized earmolds Integrated programming to optimize the acoustic output Why Baha? Direct Bone Conduction: Works independently of ear canal and middle ear Direct transmission gives clear and natural sound Pre-operative testing is possible High wearing comfort Safe and straightforward surgery Predictable outcome 5

6 Osseointegration The process by which living bone tissue bonds with titanium Makes direct bone conduction possible Provides the basis of long-term predictability and success of the Baha system Proven to integrate with soft tissue Viable tissue completely covering the DermaLock surface. Soft tissue does not bind to the titanium surface, resulting in epidermal downgrowth and the formation of a deep pocket. Soft tissue binds with the DermaLock TM surface to create stability, prevent pocket formation and seal against bacteria. 1. van Hoof M, Wigren S, Duimel H, Savelkoul PH, Flynn M, Stokroos RJ. Can the Hydroxyapatite-Coated Skin-Penetrating Abutment for Bone Conduction Hearing Implants Integrate with the Surrounding Skin? Front Surg Sep 14;2:45 Components of the Baha System Sound Processor Abutment or magnet Implant 6

7 The gold standard in bone conduction Since its introduction in 2012, the Baha Connect System with DermaLock technology is the most widely used direct bone conduction implant system in the world. As of Sep 2015 Baha 5 Power Sound Processor Ardium Smart platform featuring SmartSound iq Cochlear True Wireless Made for iphone Bluetooth Smart +Smart App Powerful BCDrive transducer in a robust headworn design Excellent battery life also when streaming or using Wireless and FM Full featured, with user controls Program/Stream button Volume Rocker LED Integrated tamperproof battery door, battery size 675 Powered by Ardium Smart Baha 5 sound processors utilize the same Ardium Smart platform featuring: Made for iphone Bluetooth Smart Cochlear True Wireless SmartSound iq 7

8 Smart connectivity for direct-to-device communication With new Bluetooth technology designed by Apple, Baha 5 sound processors are the hearing implant industry s only Made for iphone Hearing Devices. Streamed phone calls, music and turn-by-turn navigation Live Listen and device control Cochlear Wireless Accessories Only Cochlear offers True Wireless technology that allows you to hear even better in challenging situations. 8

9 Nucleus Cochlear Implant Indications Cochlear Implant: Sentence Score no better than 50% in the ear to be implanted and no better than 60% in the best aided condition Medicare National Coverage Determination: Sentence Score no better than 40% (best aided) unless enrolled in a clinical trial Current opportunity: Evaluation of Revised Indications for Cochlear Implant Candidacy for the Adult CMS Population Hybrid L24: An Expanded Indication Ear to be Implanted Aided CNC word score between 10% and 60% correct, inclusively Normal to moderate SNHL in the low frequencies; PTA of 2k, 3k, 4k > 75 db HL Contralateral Ear Aided CNC word score better than ear to be implanted but less than 80% correct PTA of 2k, 3k, 4k, >60 db Adults aged 18 years and older unilateral implantation of poorer ear Hybrid Hearing is available for adult recipients (>18 years) who utilize the Hybrid L24 Implant System Nucleus Cochlear Implant Indication Pediatric: months Cochlear Implant 9

10 Nucleus Cochlear Implant Indication Pediatric: 2 17 years Cochlear Implant <30% MLNT or LNT in best aided condition FDA Indication for Implantation Mixed & Conductive Hearing Loss 5 years of age 65 db HL Bone Conduction PTA > PTA of 0.5, 1, 2 & 3 khz For bilateral fitting, symmetric bone conduction thresholds are defined as less than 10 db difference on average (0.5, 1, 2 & 3 khz) or less than 15 db at individual frequencies Conductive Hearing Loss Mixed Hearing Loss FDA Indication for Implantation Single-sided Deafness 5 years of age Normal Hearing in the contralateral ear > Defined as PTA Air Conduction thresholds equal to or better than 20 db at 0.5, 1, 2 & 3 khz Functions by transcranial routing of the signal Single-Sided Deafness (SSD) 10

11 Cochlear Baha Softband Early access to sound Softbands are proven solutions to give toddlers and young children early access to hearing. However, there are still some improvement opportunities. 1. The pressure from the connector can cause discomfort - resulting in shorter wearing time or the need to wear the sound processor in a suboptimal position for best hearing. 2. The limited contact surface area of the connector impacts the sound performance Based on our learnings from the Baha Attract System we developed a new Baha Softband designed to address these limitations and provide a better hearing experience for children and in counselling situations. Cochlear Baha Softband Baha Softband The Baha SoftWearPad s memory foam adapts to the contours of the skin, distributing pressure and maximizing the contact surface area to improve comfort and performance Connector with larger contact surface area, designed to reduce pressure Demonstrate Baha & test benefit Fit the processor on a softband or testband Informal or formal assessment with the device 11

12 Demonstrate Baha & test benefit Soundfield thresholds Speech perception testing Speech in noise testing for SSD 1 : Speech to deaf ear Noise to good ear Test with and without Baha Compare and quantify benefit with Baha Pre-op benefit will predict post-op benefit Deaf ear Normal Ear Cochlear Baha 5 System The widest and most powerful portfolio 1 Up to 45 db SNHL 1. Norrman, J, Review of fitting ranges. Cochlear Bone Anchored Solutions AB, D773528, Cochlear Baha 5 System The widest and most powerful portfolio 1 Up to 55 db SNHL 1. Norrman, J, Review of fitting ranges. Cochlear Bone Anchored Solutions AB, D773528,

13 Cochlear Baha 5 System The widest and most powerful portfolio 1 Up to 65 db SNHL 1. Norrman, J, Review of fitting ranges. Cochlear Bone Anchored Solutions AB, D773528, Hearing aids or Baha? As the air/bone gap increases, hearing aid performance decreases. Baha performance is not affected. Snik AF et al. (2005) Consensus Statements on the BAHA System: Where Do We Stand at Present? Annals of ORL 114(12S). 195:

14 *Hybrid Hearing is approved in the US only for use with the Nucleus Hybrid L24 Implant and adults ages 18 and older. IHS 2016: Cochlear Americas Expanded Designed to Work Together Industry s Smartest Hearing Implants compatible with the Industry s Smartest Hearing Aids Cochlear Hybrid Cochlear Nucleus 6 Cochlear Baha 4 Cochlear Baha 5 ReSound LiNX/LiNX 2 /LiNX TS ReSound LiNX 2 ReSound LiNX 2 ReSound ENZO/ENZO 2 61 RIC 62 RIC 77 BTE 98 SP BTE 14

15 Two Ears Are Better than One % Correct Sentence Recognition in Quiet Resound Linx Nucleus 6 Bimodal Up to 7% bimodal benefit 1 1 Wolfe, Jace, Morais, Mila, Schafer, Erin C. (In submission). Benefits of a Wireless Audio Streaming Accessory for Bimodal Cochlear Implant Users. Cochlear Implants International Maximize Your Hearing with Both Ears The industry s only 2.4 GHz wireless platform designed to maximize bimodal hearing potential. T.V. Streamer Phone Clip Mini Microphone SMARTstream Benefits Bimodal hearing results in better speech recognition than hearing with a cochlear implant or hearing aid alone 1 Bimodal users hear better in quiet and noise with the Mini Microphone 1 Bimodal users hear better on the telephone with the Phone Clip 1 1. Wolfe, Jace. "Why Two Are Better Than One." Presented at ACIA 2014, Nashville, TN. 15

16 Smart Hearing Alliance Benefit TM 2.4 GHz Wireless Technology Stronger, more stable connection than traditional neck worn devices Clear and secure audio streaming directly to device Low transmission latency Discreet and easy to use Cochlear True Wireless technology The evolution of wireless connectivity has incrementally improved the overall user experience (e.g. sound quality, ease of use) and reduced dependencies on extra equipment (cords, neck loops, etc.). DIRECT-TO-DEVICE WIRELESS INDIRECT WIRELESS WIRED 16

17 Smarter Connectivity True Wireless 2.4 GHz wireless technology streams stereo sound directly from a wireless accessory to the sound processor. WIRED DONGLE 2.4 GHz SMART Smarter Connectivity Bluetooth Smart Bluetooth Smart and Made for iphone technology that lets users stream audio and control their sound processor directly from an iphone. WIRED DONGLE 2.4 GHz SMART SMARTstream Wireless TV Streamer Mini Microphone 17

18 SMARTstream Hearing Benefit in Noise Sentence Recognition in Noise Mini Mic On Up to 21% bimodal benefit in noise with Mini Microphone 1 Percent Correct Resound Linx Nucleus 6 Bimodal 0 Quiet Wolfe, Jace, Morais, Mila, Schafer, Erin C. (In submission). Benefits of a Wireless Audio Streaming Accessory for Bimodal Cochlear Implant Users. Cochlear Implants International SMARTstream Wireless Mini Microphone Recipient Feedback Confirms Benefit For the first time since receiving my implant, I can sit back in my chair in the café with my daughter, rather than leaning forward to hear. Jones M. Use of Cochlear Wireless Accessories with Nucleus 6 Sound Processors CLTD Internal clinical trial data SMARTstream Wireless TV Streamer Recipient Feedback Confirms Benefit I was able to hear the TV in remarkable clarity being able to hear all the finer sound and background music. An advantage of the TV Streamer is that you control your own volume without the concerns of others watching. I find that I can recognize speech far better and have become less dependent on closed captioning. Jones M. Use of Cochlear Wireless Accessories with Nucleus 6 Sound Processors CLTD Internal clinical trial data 18

19 SMARTstream Wireless Phone Clip SMARTstream Benefit On the Phone Word Recognition in Quiet and Noise with Phone Clip Up to 24% bimodal benefit with Phone Clip 1 1 Wolfe, Jace, Morais, Mila, Schafer, Erin. (Accepted, in press). Speech recognition of bimodal cochlear implant recipients using a wireless audio streaming accessory for the telephone. Otology and Neurotology. SMARTstream Wireless Phone Clip Recipient Feedback Confirms Benefit All of the tasks (making phone calls, listening to music and movies on ipad, doing Skype TM ) would not have been possible for me without the Phone Clip. Jones M. Use of Cochlear Wireless Accessories with Nucleus 6 Sound Processors CLTD Internal clinical trial data 19

20 Cochlear Implant Performance Hearing in Noise at 60db Average Percent Accurate 89% of users reported satisfaction with their ability to hear 1. Hirschfelder A, Gräbel S, Olze H. The impact of cochlear implantation on quality of life: The role of audiologic performance and variables. Otolaryngol Head Neck Surg Mar;138(3): Significant Improvement in Performance Wolfe, J., et al (2015). The Benefits of Adaptive Signal Processing in a Commercially Available Cochlear Implant Sound Processor, Otology & Neurotology. (In press) Mini Mic 2+: Ultimate performance with full connectivity Optimized for both one-to-one and group communication. FM compatibility Built-in Telecoil Line-in connector Range up to 82 feet (25 meters)* Up to 11 hours battery life Directional microphones Table Mic Mode Drop detection mute feature Volume lock and volume indicators Battery status indicator Swivel clip the range 1 connectivity longer battery life 1 1 Compared to Cochlear Wireless Mini Microphone * Clear line of sight 20

21 FM capabilities with the Mini Mic 2+ Mini Microphone can be placed anywhere within range and clear line of sight. Mini Mic 2: Small and discreet Optimized for personal, one-to-one communication. Simplified handling Range up to 82 feet (25 meters)* Up to 10 hours battery life Directional microphones Drop detection mute feature Volume lock and volume indicators Swivel clip the range 1 longer battery life 1 smaller than the previous generation 2 1. Compared to Cochlear Wireless Mini Microphone 2. Refers to total footprint compared with Cochlear Wireless Mini Microphone * Clear line of sight Dual-Mic Directional When worn as a lapel/lavalier microphone 21

22 Mini Mic 2+ Results Electric only recipients % Correct Wolfe et al., in prep. n = 15 Mini Mic 2+ Results Bimodal recipients % Correct Wolfe et al., in prep. n = 7 Smart connectivity for direct communication Streamed phone calls, music and turn-by-turn navigation Live Listen TM and device control 22

23 Focus on MFi MFi (Made for iphone) are features only available on iphone MFi features include Receive incoming phone calls and FaceTime Stream music directly to sound processor Live Listen (allows iphone to function as remote microphone) Basic remote control Baha 5 Smart App ONLY iphone has full MFi functionality Smart App Control and customize programs Adjust volume and mute Locate your device Receive assistance and support NEW! Smart App for Android TM : Samsung S6, S7 Lollipop & Marshmallow OS Focus on Android TM Pairing to Android device is managed from within app Same features & languages as ios version except GeoTagging of Program+ Requires latest Firmware ( ) in sound processor 23

24 Transforming Hearing Outcomes and Lifestyle with True Wireless technology Phone Music Nucleus 6 Sound Processor Control Status Baha 5 Sound Processor MiniMic 2+ Nucleus 6 True Wireless accessories MiniMic 2 Innovation for a Lifetime of Hearing Cochlear Nucleus Cochlear Implant System Cochlear Nucleus Hybrid Cochlear Implant System Cochlear Nucleus ABI System mycochlear Services Cochlear Baha Systems Cochlear True Wireless Bimodal System Smart Hearing Alliance 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. 24