Small, Powerful, SMART - Why Baha® in 2018?

Charlene Cohen-DeRoy, Au.D

Clinical Territory Manager

Cochlear’s 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.

Agenda

• Foundations of Baha®

• Baha® Technology Today

• Baha® for your Patients

• Introducing the Baha®

SoundArc

• Reimbursement

considerations

• Q&A

Foundations of Baha® Technology

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

Baha® Foundations

• Invented and developed in the

1970’s by Professor Brånemark

and Dr. Tjellström

• Approved by the FDA in 1995 for

mixed and conductive hearing loss

and in 2002 for single-sided

deafness

• About 40,000 people in the United

States now hear with a Baha®

solution1

1 – Cochlear Internal Recipient Data, December 2017

Dr Tjellström and the first Baha recipient,

Mona Andersson (in 2012)

Evolution of Baha® Technology

User-friendly

ergonomic shape

Compatible with all

Baha Systems

Discreet streamlined

design

We left the box behind… Cochlear™ Baha® 5 Sound Processor

Power and connectivity

on the inside

New design language

CAM-MKTP-484

Surgical Options

Implant BI300 Implant provides a strong

foundation

Connection BIM400 Implant Magnet or

BA400 Abutment connect

recipients for a lifetime of

hearing

Processor Baha 5 suite of processors

attach for incredibly smart,

unbelievably powerful hearing

Proven Stability: 5 Years of Clinical Study

The Baha® BI300 Implant provides early access to sound as the

stable foundation for the Baha Connect and Attract Systems

1. ClinicalTrials.gov ID# NCT02092610. Long-term stability, survival and tolerability of a (novel) Baha® Implant System.

The long-term clinical performance of the BI300 is

proven through 5 years1 of continuous clinical study.

The wider 4.5 mm diameter and TiOblast™ surface

enhances primary and long-term stability.

Proven to Integrate with Soft Tissue

The industry’s broadest abutment portfolio.

27 mm

2.5 mm

Strong foundation for efficient

single-point sound

transmission and future

hearing options.

Sleek titanium casing

with rounded edges to

minimize soft tissue

irritation.

Established coupling to

facilitate removal of the implant

magnet for future upgrades

and possible MRI > 1.5 Tesla.

Smooth Magnet Attached to a Strong Foundation

A Proven Transition Path Between Systems

Good clinical outcomes can be expected

when transitioning from a skin-penetrating

to a magnetic system using the same

BI300 Implant, if the soft tissue in the

implant area is healthy and has sufficient

thickness. A pre-operative softband

evaluation is important to ensure correct

expectations and achieve patient

satisfaction.1

Clinical guidance on transition from a Baha®

Connect to Baha® Attract System.1-3

TRANSITION PATH

Supported by leading surgeons

1. Wigren S., Weber P. Clinical guidance and considerations for successful outcomes with the Cochlear Baha Attract System. Mölnlycke, Sweden: Cochlear Bone Anchored Solutions AB; 2014, Paper E83356A.

2. Wigren S., Considerations for transitioning from Baha Connect System to Baha Attract System. Mölnlycke, Sweden: Cochlear Bone Anchored Solutions AB; 2014, White Paper E83345.

3. Cristobal, R., Cochlear Baha Connect to Baha Attract System Transition Surgery. Mölnlycke, Sweden: Cochlear Bone Anchored Solutions AB; 2014, Paper E83358

4. Devèze A, Rossetto S, Meller R, Sanjuan Puchol M. Switching from a percutaneous to a transcutaneous bone anchored hearing system: the utility of the fascia temporalis superficialis pedicled flap in case of skin intolerance.

Eur Arch Otorhinolaryngol. 2015 Jan 30.

At-a-Glance

Baha® Attract Baha® Connect

The internal implant is completely

hidden beneath the skin

The direct connection maximizes the

hearing performance

The specially designed Baha®

SoftWear pad adapts comfortably to

the shape of the head

With DermaLock technology the hair and

skin around the abutment can be safely

preserved and abutment is barely visible

The Baha® Attract System’s internal

magnet can be MRI scanned safely

up to 1.5 Tesla

Only minor surgery is required and the

healing process is generally quick

Transition path for patients whose

hearing deteriorates

The implant and abutment can be MRI

scanned safely

A Portfolio to Fit Your Patient’s Hearing Needs

The

world’s

smallest

sound

processor*

The

world’s

smartest

power

device*

The world’s

most

powerful

head-worn

solution**

*Flynn MC. Smart and Small-Innovative technologies behind the Cochlear Baha 5 Sound Processor. Cochlear Bone Anchored Solutions AB, 629761, 2015.

**Norman, J, Review of fitting ranges. Cochlear Bone Anchored Solutions AB, D773528, 2015.

Baha® 5 Portfolio

Baha® 5 Sound Processor Cochlear™ Baha® 5 System

312 Battery

Program/streaming

The incredibly small and unbelievably

smart Cochlear Baha ® 5 Sound

Processor is packed full of features and

is ideal for patients who need full

features in a small package.

Baha® 5 Power Sound Processor Cochlear™ Baha® 5 System

LED visual indicator

New volume rocker

Built-in tamperproof

battery door

Program/streaming

The smart Cochlear Baha 5 Power

Sound Processor is packed full of

features and is ideal for patients who

need more power, longer battery life and

on-device control.

Baha® 5 Power Sound Processor Cochlear™ Baha® 5 System

The revolutionary Cochlear Baha ® 5

SuperPower Sound Processor utilises

Baha ® and Nucleus® technology to

make it the only head-worn sound

processor for up to 65 dB SNHL. Baha and Nucleus

technology Ear-level

microphones

Decoupled

transducer

Rechargeable

battery

BCDrive™ Technology

CAM-MKTP-484

Powered by BCDrive™ Transducer Technology

Conventional transducer BCDrive transducer

1. Gustafsson J. BCDrive performance vs. conv. bone conduction transducer. Cochlear Bone Anchored Solutions AB, 629908, 2015.

2. BCDrive reliability vs. conv. bone conduction transducer. Cochlear Bone Anchored Solutions AB, D844105, 2016.

3. Flynn MC. Smart and Small – innovative technologies behind the Cochlear Baha 5 Sound Processor. Cochlear Bone Anchored

Solutions AB, 629761, 2015.

Less distortion1

More reliable2

Twice as efficient3

BCDrive™ Transducer

Designed for Clearer Sound

In the BCDrive transducer, the spring and magnet forces are

symmetrical. This produces a clearer signal compared to a

traditional asymmetrical transducer design1.

1. Flynn, MC. Smart and Small – innovative technologies behind the Cochlear Baha 5 Sound Processor. Cochlear Bone Anchored Solutions AB, 629761, 2015.

Asymmetric transducer: (conventional design)

Magnet against

spring

Output force:

Symmetric transducer: (BCDrive design)

Magnet against

magnet and

spring against spring

Using Efficiency to Meet the Unique Needs of Patients

The different applications of BCDrive technology deliver

patient benefits across the entire Baha® 5 portfolio.

1. Battery life comparison: BP110 Power vs Baha 5 Power. Cochlear Bone Anchored Solutions AB. D829312. 2015.

2. OFL90 measured on skull simulator TU1000.

MINIMUM SIZE MAXIMUM POWER

Smaller size and

smaller battery

without losing power

Smoother power across

the entire frequency

range and a 30%

increase in battery life1

Baha 5 Power vs BP110 Power on Baha Connect System2

Baha 5 Power

BP110 Power

Maximum power

across the entire

frequency range with a

rechargeable battery

The SuperPower Challenge

• At very high power levels,

sound waves will propagate

across the entire skull

• This prevents some

SuperPower patients from

reaching sufficient gain

• Addressed by moving the

microphones away from

the hard bone

Acoustic Radiation

Addressing Acoustic Radiation

Hard skull bone

Soft tissue

Two Positions

UTE Increases Available Gain by 7-10dB

BTE

UTE Less

chance of

feedback

Directionality is Maintained

Back microphone

Front microphone

The first and only smart sound processor Ardium™ Smart

Ardium™ Smart platform

SMARTEST

• SmartSound® iQ

• Smart Connectivity

• Smart App

CAM-MKTP-484

SmartSound® iQ

CAM-MKTP-484

SmartSound® iQ Signal Processing

The Scene Classifier II in SmartSound® iQ

measures the input sound level and signal-

to-noise ratio to define and categorise the

patient’s acoustic environment.

It selects the best signal processing strategy

utilising:

Active Gain

Active Balanced Directionality

Noise Manager II

Active Gain

Using the information from Scene

Classifier II, Active Gain automatically

adjusts the amplification levels to

match the patient needs across

different listening situations.

Unlike conventional compression

where gain is determined based

solely on the input level, Active Gain

will further individualise the settings to

better match your patients’ listening

preference.

In Baha Fitting Software, you can also adjust the gain settings

in each acoustic scene to match the patient’s individual needs.

Controlled by Scene Classifier II

Active Balanced Directionality

Controlled by Scene Classifier II

Adaptive Beamwidth

actively adapts to the

listening situation.

Balanced Directionality

seamlessly blends the omni

and directional settings.

Noise Manager II

Controlled by Scene Classifier II

Noise Manager II reduces noise while actively

maintaining important speech information.

Using spectral subtraction, the noise signal is

identified and reduced before amplification.

Smart Connectivity

CAM-MKTP-484

Technology has come a long way

WIRED 2.4 GHz DONGLE SMART

Smart Connectivity

CAM-MKTP-484

Less advanced dongle systems

WIRED 2.4 GHz DONGLE SMART

Less advanced dongle

systems stream sound

to and from bulky neck-

worn hardware.

Smart Connectivity

CAM-MKTP-484

2.4 GHz

True wireless technology

WIRED DONGLE SMART

Smart Connectivity

DIRECT-TO-DEVICE

Cochlear 2.4 GHz wireless

technology streams stereo

sound directly from a

wireless accessory to the

sound processor.

CAM-MKTP-484

SMART

True wireless technology

WIRED DONGLE 2.4 GHz

Smart Connectivity

DIRECT-TO-DEVICE

The first bone conduction

platform to utilize

Bluetooth® Smart and

Made for iPhone

technology that lets users

stream audio and control

their sound processor

directly from an iPhone.

CAM-MKTP-484

Smart Connectivity for Direct-to-Device Communication

With Bluetooth® technology designed

by Apple, Baha® 5 sound processors

are the hearing implant industry’s only

Made for iPhone® Hearing Devices. Live Listen

and device control

Streamed phone calls, music

and turn-by-turn navigation

The First Smart App for Bone Conduction

Advanced control of sound processor

and wireless accessories,

personalisation and support –

directly from iPhone®, iPad®, iPod

touch® and also AndroidTM

smartphones.

Cochlear™ Wireless

TV Streamer

Cochlear™

Wireless

Phone Clip

Cochlear™ Wireless

Mini Microphone 2

Cochlear™ Wireless

Mini Microphone 2+

True Wireless™ Accessories

Treating Patients with the Baha® System

Why Baha® Technology?

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

Baha® Indications

Single-Sided Deafness

Normal hearing in the

good ear

Conductive & Mixed Hearing

Loss

Candidacy is based on bone

conduction thresholds

Bilateral fitting requires

symmetric bone conduction

thresholds

Defined as Air Conduction

PTA equal to or better than

20 dB at 0.5, 1, 2 & 3 kHz

Bone Conduction PTA equal

to or better than 65 dB at

0.5, 1, 2 & 3 kHz

Less than 10 dB on average

(0.5, 1, 2 & 3) or less than 15

dB at individual frequencies

Surgery can be

considered for children 5

years of age or older

Baha® for Conductive & Mixed Hearing Loss (CMHL)

Conductive & Mixed Hearing Loss (CMHL)

• Direct bone conduction bypasses the outer and middle ear

• Baha® solutions treat conductive & mixed hearing loss – Atresia

– Chronic middle ear disease

– Cholesteatoma

– Congenital abnormalities

• Baha® devices do not have to overcome conductive component, only amplify for any sensorineural component

Treatment Options for CMHL: Hearing Aids

Hearing Aid

• The greater the air-bone gap, the

more a Baha® system will

outperform hearing aids2

• Hearing aid prescriptions for

conductive and mixed hearing

loss require more gain and

receive less clinical research than

for sensorineural hearing loss3

• Hearing aid fitting can be difficult if

there is drainage from the ear, ear

pain or a mastoid cavity present

after mastoidectomy4

1 - 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

2 – Mylanus EAM, van der Pouq K, Snik M (1998) Intraindividual comparison of the bone-anchored hearing aid and air-conduction hearing aids. Arch Otolaryngol Head Neck Surg, 124(3):271-276

3 - Johnson EE. (2013) Prescriptive amplification recommendations for hearing losses with a conductive component and their impact on the required maximum power output: An update with accompanying clinical explanation. J Am Acad Audiol,

24(6):452-60.

4 - Gluth MB, Friedman AB, Atcherson SR, Dornhoffer JL. (2013) Hearing aid tolerance after revision and obliteration of canal wall down mastoidectomy cavities. Otology & Neurotology, 34(4):711-4.

1

Baha® for CMHL

Nothing worn on the external ear, which is helpful in cases

where ear drainage is present1

Baha® does not need to be re-adjusted if the air conduction

thresholds fluctuate because gain is only required for the bone

conduction thresholds

Pre-operative testing can be used to predict post-operative

benefit2

Use of Baha® is associated with high user satisfaction and good

long-term benefit3,4

1 - Bouhabel S, Arcand P, Saliba I. (2012) Congenital aural atresia: bone-anchored hearing aid vs. external auditory canal reconstruction. Int J Pediat Otorhinolaryngol. 76(2):272-7.

2 - Monini S, Filippi C, Atturo F, Biagini M, Lazzarino AI, Barbara M. (2015) Individualised headband simulation test for predicting outcome after percutaneous bone conduction implantation. Acta

Otorhinolaryngol Ital. 35(4):258-64

3 - Gardell ISK, Andresen K, Faber CE, Wanscher JH. (2015) Bone-anchored hearing aids are effective and associated with a high degree of satisfaction. Danish Medical Journal, 62(7):A5108

4 - Rasmussen J, Olsen S, Nielsen LH. (2012) Evaluation of long-term patient satisfaction and experience with the Baha bone conduction implant. Int J Audiol. 51(3):194-9.

Baha® for Single-Sided Deafness (SSD)

Two Ears

1. Help overcome the head shadow effect

2. Help understanding of speech in background noise

3. Help in the location of sound

Impact of SSD

1. Survey contained in ”Hear the other side” — A report on single-sided deafness. More information can be found at www.singlesideddeafness.com: A report by the advisory board for single

sided deafness. Available from Cochlear — article E80414A.

Common Treatments for SSD

• Patient remains untreated*

• CROS Hearing Aids (HAs)

• Steroids

• Medical intervention - surgery

• Bone Conduction Devices -

Baha® System

*Patient or physician choice

How Does Baha® treat SSD?

Sound travels via direct bone

conduction to stimulate the

better hearing cochlea

Baha® vs CROS Aids

1 – Phonak CROS II wireless compatibility, downloaded from: https://www.phonakpro.com/us/en/support/product-support/hearing-aids/cros-ii/compatibility-cros-ii.html December, 2017

2 - Gustafsson J. BCDrive performance vs. conventional bone conduction transducer. Cochlear Bone Anchored Solutions AB, 629908, 2015

3 - Niparko JK, Cox KM, Lustig LR. Comparison of the bone-anchored hearing aid implantable hearing device with contralateral routing of offside signal amplification in the rehabilitation

of unilateral deafness. Otology & Neurotology, 2003 Jan;24(1):73-78

4 - Hol MKS, Bosman AJ, Snik AFM, Mylanus EAM, Cremers CWRJ. "Bone anchored hearing aids in unilateral inner ear deafness: an evaluation of audiometric and patient outcome

measurements." Otol Neurotol (2005:26 ): 999-1006.

The Baha® system is a discreet solution worn on one side,

while CROS hearing aids require users to wear devices on both

ears

Baha® allows wireless streaming to be mixed with

environmental mic from the bad side while CROS aids require

turning off the bad side in order to stream1

Baha® 5 sound processors are the only Made for iPhone

solutions for individuals with SSD

The Baha® System bypasses outer and middle ear and sends

clearer, more crisp sound directly to the inner ear2

Studies show that the Baha® System provides better speech

understanding in noise than CROS hearing aids3-4

Cochlear™ Baha® SoundArc

Introducing the

Demo technology has not moved on

Testband Headband

They work well but they are not always:

• Comfortable

• Discreet

• Easy to use

• The Baha® Softband is a good solution for small

children

• But for older children there is an opportunity to

provide an alternative option

A need for an alternative choice

Cochlear™ Baha® SoundArc

Comfortable - Stylish - Effective

Non-Surgical Candidates

Non-surgical Options for Baha®

Baha® SoundArc

Good performance,

comfortable, stylish and

discreet

Baha® Softband

Good performance,

comfortable, optimal for

young children

Candidates for a Non-Surgical Option

• Children under the age of 5

• Children over 5 who are not

yet surgical candidates

• Medically compromised

patient

• Patient preference

• May be a “gateway” to

surgery

A Lifetime of Innovation

1995

FDA approves

the Baha®

system for use

in the US

(approved for

SSD in 2002)

2010

Baha® 3

systems set

new

standards for

implant

stability

2012

Cochlear’s

DermaLockTM

abutment is

designed to

further improve

patient outcomes

and surgical

procedure

2013

Cochlear

introduces the

Baha® Attract

2014

True wireless

is introduced to

Baha®

recipients with

the innovative

Baha® 4

2015

Baha® 5 is

introduced –

incredibly small,

unbelievably

smart

1970’s

Researchers at the

University of

Gothenberg

discover

osseointegration

and create the

Baha® System

TODAY

Baha® 5

Systems

expanded to

offer more

power and

more choices

Apps & True Wireless™ Baha® Fitting Software

Baha® Attract System

Baha® Connect System

Baha® 5 sound processors

Baha® BI300 Implant

One smart solution. The power to choose.

Baha® SoundArc

& Softband

D1179120-1

Baha® Reimbursement Brandy Harvey

Area Manager

Questions?

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registered in the U.S. and other countries.

Made for iPhone: Apple Inc. Use Made for iPhone hearing aids [Internet]. Apple support. 2017 [cited 24 February 2017]. Available from: https://support.apple.com/en-au/HT201466 (Subject to change)