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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?
©Cochlear Limited 2017. 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
Apple, the Apple logo, Made for iPhone logo, iPhone, iPad Pro, iPad Air, iPad mini, iPad and iPod touch are trademarks of Apple Inc., registered in the U.S. and other countries. App Store is a service mark of Apple Inc.,
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)