indications and meaningful innovations · indications and meaningful innovations 17 wired dongle...

IHS 2016: Cochlear Americas Expanded Indications and Meaningful Innovations

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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


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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


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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


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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


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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


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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


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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


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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.


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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


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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)


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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


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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.




Up to 55 dB SNHL


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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


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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.


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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


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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


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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


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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


“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.”



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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


“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.”



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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


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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


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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


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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


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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.

indications and meaningful innovations · indications and meaningful innovations 17 wired dongle...

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