IHS 2016: Cochlear Americas Expanded Indications and Meaningful Innovations
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
1. Who.int. WHO | Deafness and hearing loss [Internet]. 20152. Who.int. WHO | 10 facts on deafness [Internet]. 2015. 3. 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.
Over 5% of the world’s population - 360 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 penetration3
IHS 2016: Cochlear Americas Expanded Indications and Meaningful Innovations
2
Less than 10%
1 BLANCHFIELD, B.B., ET. AL. (2001). THE SEVERELY TO PROFOUNDLY HEARING-IMPAIRED POPULATION IN THE UNITED STATES: PREVALENCE ESTIMATES AND DEMOGRAPHICS. JAAA. 12, 183-189. 2 COCHLEAR INTERNAL ESTIMATE, RECIPIENT’S DATA.
of people who would benefit from an implantable hearing solution are aware of their options and seek treatment1,2
Cognitive Decline1,8
Emotional Distress2
Social Isolation2,8
Reduced Quality of
Life7
Depression4Loss of
relationships9
Stress & Fatigue5,6
Higher use and cost of healthcare3
What are the effects of untreated hearing loss?
Increased risk of hospitalization10
35 Years of Hearing
IHS 2016: Cochlear Americas Expanded Indications and Meaningful Innovations
3
Our Products
Cochlear™ Nucleus® Profilewith Slim Modiolar Electrode (CI532)
Cochlear™ Nucleus® Implant Portfolio
Slim Modiolar Electrode – The Thinnest and Flexible PERIMODIOLAR electrode 1
Uniquely Designed for Preservation, Performance and Preference
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
IHS 2016: Cochlear Americas Expanded Indications and Meaningful Innovations
4
Perimodiolar placement reduces current spread
Lateral wallplacement
Perimodiolarplacement
Scala TympaniLarger spread of excitation with lateral wall placement
Smaller spread of excitation with modiolar wall placement
Modiolus
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
IHS 2016: Cochlear Americas Expanded Indications and Meaningful Innovations
5
Cochlear™ Nucleus® 6 System Simply Smarter
• Automatically adjusts to the hearing situation
• Industry first scene classifier (SCAN)
• Background noise reduction (SNR-NR)
• Wind noise reduction (WNR)
SmartSound iQ*A range of technologies working together to meet user needs in every hearing situation
Music
Quiet
Wind
Speech in Noise
Speech
Noise
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
IHS 2016: Cochlear Americas Expanded Indications and Meaningful Innovations
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 DermaLockTM 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. 2015 Sep 14;2:45
Components of the Baha® System
Implant
Abutment or magnet
Sound Processor
IHS 2016: Cochlear Americas Expanded Indications and Meaningful Innovations
7
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.
The gold standard in bone conduction
† As of Sep 2015
Baha 5 Power Sound Processor
Powerful BCDrive™ transducer in a robust headworn design
Ardium™ Smart platform featuring
• SmartSound® iQ• Cochlear™ True Wireless• Made for iPhone• Bluetooth Smart • +Smart App
Excellent battery life also when streaming or using Wireless and FM
• Program/Stream button• Volume Rocker• LED• Integrated tamperproof
battery door, battery size 675
Full featured, with user controls
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
IHS 2016: Cochlear Americas Expanded Indications and Meaningful Innovations
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.
Live Listenand device control
Streamed phone calls, music and turn-by-turn
navigation
Cochlear™ Wireless Accessories - 2016
Only Cochlear offers True Wireless™
technology that allows you to hear even better in challenging situations.
IHS 2016: Cochlear Americas Expanded Indications and Meaningful Innovations
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
https://clinicaltrials.gov/ct2/show/NCT02075229
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: 12 – 24 months Cochlear Implant
IHS 2016: Cochlear Americas Expanded Indications and Meaningful Innovations
10
Nucleus Cochlear Implant Indication
Pediatric: 2 – 17 yearsCochlear Implant
<30% MLNT or LNT in best aided condition
FDA Indication for Implantation
• ≥ 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
Mixed & Conductive Hearing Loss
Conductive Hearing Loss
Mixed Hearing Loss
FDA Indication for Implantation
• ≥ 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
Single-Sided Deafness (SSD)
IHS 2016: Cochlear Americas Expanded Indications and Meaningful Innovations
11
Early access to sound
Cochlear™ Baha® Softband
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.
Baha Softband
Connector with larger contact surface area, designed to reduce pressure
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
Cochlear™ Baha® Softband
Demonstrate Baha & test benefit
Fit the processor on a softband or testband
Informal or formal assessment with
the device
IHS 2016: Cochlear Americas Expanded Indications and Meaningful Innovations
12
Demonstrate Baha & test benefit
• Soundfield thresholds• Speech perception testing• Speech in noise testing for SSD1:
• 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
The widest and most powerful portfolio1
Cochlear™ Baha® 5 System
Up to 45 dB SNHL
1. Norrman, J, Review of fitting ranges. Cochlear Bone Anchored Solutions AB, D773528, 2015.
The widest and most powerful portfolio1
Cochlear™ Baha® 5 System
1. Norrman, J, Review of fitting ranges. Cochlear Bone Anchored Solutions AB, D773528, 2015.
Up to 55 dB SNHL
IHS 2016: Cochlear Americas Expanded Indications and Meaningful Innovations
13
The widest and most powerful portfolio1
Cochlear™ Baha® 5 System
1. Norrman, J, Review of fitting ranges. Cochlear Bone Anchored Solutions AB, D773528, 2015.
Up to 65 dB SNHL
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). 195:1-12
IHS 2016: Cochlear Americas Expanded Indications and Meaningful Innovations
14
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/LiNX2/LiNX TS™
61 RICReSound LiNX2
62 RIC
ReSound LiNX2
77 BTE
ReSound ENZO/ENZO2
98 SP BTE
*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 Indications and Meaningful Innovations
15
0
10
20
30
40
50
60
70
80
90
100
Resound Linx Nucleus 6 Bimodal
% C
orre
ct
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
Up to 7% bimodal benefit1
Up to 7% bimodal benefit1
Sentence Recognition in Quiet
Two Ears Are Better than One
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 alone1
1. Wolfe, Jace. "Why Two Are Better Than One." Presented at ACIA 2014, Nashville, TN.
Bimodal users hear better in quiet and noise with the Mini Microphone1
Bimodal users hear better on the telephone with the Phone Clip1
IHS 2016: Cochlear Americas Expanded Indications and Meaningful Innovations
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™ technologyThe 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.).
WIRED
INDIRECTWIRELESS
DIRECT-TO-DEVICEWIRELESS
IHS 2016: Cochlear Americas Expanded Indications and Meaningful Innovations
17
2.4 GHzWIRED DONGLE SMART
Smarter Connectivity – True Wireless™
2.4 GHz wireless technology streams stereo sound directly from a wireless accessory to the sound processor.
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.
SMARTWIRED DONGLE 2.4 GHz
SMARTstream™ WirelessMini Microphone
TV Streamer
IHS 2016: Cochlear Americas Expanded Indications and Meaningful Innovations
18
0
10
20
30
40
50
60
70
80
90
100
Quiet 55 60 65 70 75
Resound Linx
Nucleus 6
Bimodal
SMARTstream™ Hearing Benefit in Noise
Sentence Recognition in Noise – Mini Mic On
Up to 21% bimodal benefit in noise with Mini Microphone1
Up to 21% bimodal benefit in noise with Mini Microphone1
Percent Correct
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
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. 2015. CLTD 5546. 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. 2015. CLTD 5546. Internal clinical trial data
IHS 2016: Cochlear Americas Expanded Indications and Meaningful Innovations
19
SMARTstream™ Wireless
Phone Clip
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.
Up to 24% bimodal benefit with Phone Clip1
Up to 24% bimodal benefit with Phone Clip1
Word Recognition in Quiet and Noise with Phone Clip
SMARTstream™ Benefit On the Phone
SMARTstream™ Wireless Phone Clip
Recipient Feedback Confirms Benefit
“All of the tasks (making phone calls, listening to music and movies on iPad, doing SkypeTM) would not have been possible for me without the Phone Clip.”
Jones M. Use of Cochlear™ Wireless Accessories with Nucleus® 6 Sound Processors. 2015. CLTD 5546. Internal clinical trial data
IHS 2016: Cochlear Americas Expanded Indications and Meaningful Innovations
20
Cochlear Implant Performance
Average Percent Accurate
89% of users reported satisfaction
with their ability to hear
89% of users reported satisfaction
with their ability to hear
Hearing in Noise at 60db
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. 2008 Mar;138(3): 357‐362.
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 connectivityOptimized for both one-to-oneand group communication.
1 Compared to Cochlear Wireless Mini Microphone* Clear line of sight
longer batterylife1
the range1
connectivity
• 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
IHS 2016: Cochlear Americas Expanded Indications and Meaningful Innovations
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 discreetOptimized for personal,one-to-one communication.
1. Compared to Cochlear Wireless Mini Microphone2. Refers to total footprint compared with Cochlear Wireless Mini Microphone* Clear line of sight
longer batterylife1
the range1
smaller than theprevious generation2
• 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
Dual-Mic Directional
When worn as a lapel/lavalier microphone
IHS 2016: Cochlear Americas Expanded Indications and Meaningful Innovations
22
Mini Mic 2+ Results
% C
orre
ct
n = 15Wolfe et al., in prep.
Electric only recipients
Mini Mic 2+ Results
Bimodal recipients
Wolfe et al., in prep. n = 7
% C
orre
ct
Smart connectivity for direct communication
Live ListenTM
and device control
Streamed phone calls, music and turn-by-turn
navigation
IHS 2016: Cochlear Americas Expanded Indications and Meaningful Innovations
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
NEW! Smart App for AndroidTM:• Samsung® S6, S7• Lollipop &
Marshmallow OS
Control and customize programs
Adjust volume and mute
Locate your device
Receive assistance and support
Smart App
Focus on AndroidTM
• Pairing to Android device is managed from within app
• Same features & languages as iOS version– except GeoTagging of Program+
• Requires latest Firmware (5.4.4.3) in sound processor
IHS 2016: Cochlear Americas Expanded Indications and Meaningful Innovations
24
Transforming Hearing Outcomes and Lifestyle with True Wireless technology
MiniMic 2
MiniMic 2+Nucleus 6True Wireless accessories
Nucleus 6 Sound Processor
Baha 5Sound
Processor
Music
Control
Status
Phone
Innovation for a Lifetime of Hearing
Cochlear™ Nucleus®
Cochlear Implant System
Cochlear™ Nucleus®
Hybrid™ Cochlear Implant System
Cochlear™
True Wireless
myCochlear™ ServicesCochlear™ Nucleus®
ABI System
Bimodal System
Smart Hearing Alliance
Cochlear™ Baha®
Systems
©Cochlear Limited 2016. 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.