Ponto Evidence Doc-00063842-01 - PowerPoint Presentation

Slide1

Ponto Evidence

Doc-00063842-01

Slide2

Bone Conduction Devices and Transmission Methods

Doc-00063842-01

Slide3

Direct Sound Transmission

Vibrations directly to the bone

Skin Transmission

Vibrations through the skin

Bone Conduction Devices

References: Reinfeldt et al., 2015

Percutaneous

Transducer in external sound processor

Passive transcutaneous

Implanted magnet

Active transcutaneous

Transducer in implant

Non-surgical solutions

Slide4

Ponto is an effective and proven intervention

Doc-00063842-01

Slide5

Ponto is an Effective and Proven Intervention

Slide6

Objective, Hypothesis and Method

Objective: Evaluate auditory development in patients with bilateral microtia-atresia, fitted with a

softband via skin transmission as compared to normal hearing children. Hypothesis:

Using a Ponto via skin transmission will have a positive impact on auditory development

Method:

40 infants (median age 7 months) with grade III bilateral aural atresia. Infant-Toddler Meaning Auditory Integration Scale was conducted to evaluate auditory development, and compared to control

Slide7

Objective Hypothesis and Method (2)

Objective: Compare speech discrimination scores of patients with bilateral microtia-atresia (conductive loss) unaided, with Ponto via Skin transmission, and Ponto via Direct drive transmission

Hypothesis: Patients will obtain an improvement in speech discrimination scores via aided condition, and obtain best performance via Direct drive transmission

Method:

6 patients (average age 15 years) with grade III bilateral aural atresia tested in all 3 conditions.

Softband

worn for an average of 6 months before implantation. Tested using a

bisyllabic

test list in mandarin.

Slide8

Results

Total Infant-Toddler Meaning Auditory Integration Scale scores in the

softband group improved significantly and approached normal levels

Normal

Slide9

Results (2)

Speech discrimination scores improved with aiding, and best results were obtained via Direct sound transmission

Speech discrimination scores Unaided - 23%

Softband

- 77%

Implant -

97%

Normal

Slide10

Conclusions

Using softband bone-anchored hearing devices is effective for auditory development and hearing improvement in infants with bilateral microtia-atresia.

The best speech discrimination scores were obtained via Direct sound transmission

Slide11

Direct Sound Transmission

Vibrations directly to the bone

Skin Transmission

Vibrations through the skin

Bone Conduction Devices

References: Reinfeldt et al., 2015

Percutaneous

Transducer in external sound processor

Passive transcutaneous

Implanted magnet

Active transcutaneous

Transducer in implant

Non-surgical solutions

Slide12

Pediatric Case Study: Importance of Timely Transition

Verhagen et al (2008) The Baha Softband a new

treatment

for

young

children

with bilateral

congenital

aural atresia. International Journal of Pediatric Otorhinolaryngology 72, 1455-1459

Q score of 100 is normal.

Receptive language development

0

33696-03

Transition

Transition to Direct Sound Transmission was necessary to maintain normal language development

”Language development testing showed an accelerated improvement in speech development after implantation”

8

Slide13

Direct Sound Transmission

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Slide14

Basis of Direct Sound Transmission benefits

5.

Verstraeten

et al (2008) Comparison of the audiologic results obtained with the bone-anchored hearing aid attached to the headband, the

testband

and to the ‘snap’ abutment. Otology & Neurotology 30: 70-75

WDH HQ –

Oticon Medical, DK

By up to 10-20 dB in the mid to high frequency range.

5

compared to Direct Sound Transmission

The mid to high frequency range

contains the most important

information for speech understanding.

Sounds are attenuated in Skin Transmission solutions

Skin

Transmission

Direct Sound

Transmission

Maximum Force Output (MFO) level at 90 dB SPL input

Difference in hearing threshold obtain with headband vs. abutment

* MFO of Ponto 3 corrected by Skin Transmission dampening as measured in ref 5.

Slide15

Benefits of Direct Sound Transmission

WDH HQ –

Oticon Medical, DK

Consequence of skin attenuation of speech phonemes

Skin

Transmission

Direct Sound

Transmission

33696-03

Slide16

Age at fitting of amplification is predictive for speech perception, speech production

, and spoken language skills. 9

Auditory system development, and particularly development of speech perception, is guided by access to relevant acoustic and linguistic information early in life.10

9) Sininger et al (2010) Auditory development in early amplified children: Factors influencing Auditory-based communication outcomes in children with hearing loss. Ear and Hearing 2010, 31(2), pp166-185

10) Kuhl, P. K. (2000). A new view of language acquisition. Proc Natl

Acad

Sci, 97, 11850–11857.

Whitton, J. P. and D. B.

Polley

(2011). "Evaluating the perceptual and pathophysiological consequences of auditory deprivation in early postnatal life: a comparison of basic and clinical studies." J Assoc Res

Otolaryngol 12(5): 535-547.

33696-03

The Importance of Providing Timely Amplification

Slide17

What does this all mean for the brain?

The choice of system

Direct Sound Transmission

Skin

Transmission

Slide18

Learn faster – A test of learning speed1

Doc-00063842-01

Slide19

Learn faster

Open Access

The first Auditory-Based Learning study on BAHS

Slide20

ObjectiveDetermine if the benefits that children receive from a BAHS - coupled to an implanted abutment rather than a

softband - occur for auditory tasks important for learning new information.

HypothesisPerformance with direct stimulation via an abutment will be better

for tasks involving the detection and

learning of unfamiliar words

as it is for the perception of familiar words.

Objective and hypothesis

Skin

Transmission

Direct Sound

Transmission

Slide21

Skull simulator measurements;reflect that more amplification was provided with Skin Transmission (softband).

Aided

sound-field threshold;

better

threshold

with Direct Sound Transmission

(

abutment).

Graphs &

pictures are from Pittman’s presentation at Oticon Medical Scientific Meeting 2018

Method - Verification

Slide22

Rapid Word Learning

How fast children can learn new words

Children select one of six images displayed on a computer screen after hearing each nonsense word.

They learn to associate the correct word with the correct image.

Example

of nonsense

word

Safin

Sentop

Doztul

Safins

SentopsDoztuls

Method: the Rapid Word Learning task

Slide23

2.5 times faster learning

with

Direct Sound Transmission

Results

Slide24

Word recognition alone is not sufficient to detect all benefits of a implanted device.

Results show that direct stimulation significantly improves word learning performance compared to transcutaneous stimulation.

It is important that professionals are aware of the benefits of Direct Sound Transmission when counselling

Conclusion

The choice of

System

will

Affect how fast a child will

learn

Slide25

Access to Sound and Auditory Development

Slide26

Effect of Temporary Losses

Listening in Spatialized Noise-Sentences Test (

LiSN-S)

Signal and noise from same direction

No difference in Speech Reception Thresholds between control and OME group

Tomlin, D. and G.

Rance

(2014). "Long-term hearing deficits after childhood middle ear disease."

Ear Hear

35

(6): e233-242.

Speech

Noise

Slide27

Listening in Spatialized Noise-Sentences Test (LiSN-S)

Signal and noise separated by 90 °

OME with CHL Speech Reception Thresholds worse than control

Tomlin, D. and G.

Rance

(2014). "Long-term hearing deficits after childhood middle ear disease."

Ear Hear

35

(6): e233-242.

Speech

Noise

Slide28

Possible Underlying Mechanisms

Whitton and Polley

2011, propose that “That a history of fluctuating hearing in early childhood may specifically affect the ability to combine inputs from the two ears”

The ability to effectively combine binaural inputs has a number of real-life consequences. E.g. locating a speaker, listening to speech in a classroom.

Whitton, J. P. and D. B.

Polley

(2011). "Evaluating the perceptual and pathophysiological consequences of auditory deprivation in early postnatal life: a comparison of basic and clinical studies."

J

Assoc

Res

Otolaryngol

12

(5): 535-547.

Slide29

Conclusions- a balanced approach

Implant loss occurs at a higher rate in children under 5, and this needs to be balanced against these positive results.

However the vast majority do not have an implant loss and benefit greatly from the increased access to high frequencies

Direct sound transmission delivers the most optimal sound quality, children need to transition as soon as deemed clinically appropriate in order to get the best outcomes

Chan. K et al., 2017. Complications and parent satisfaction in

pediatiric

osseintegrated

bone conduction hearing implants.

Larynyscope.

Slide30

BAHS and Binaural Integration

Slide31

BAHS and Binaural Integration

 ”In all tests, the participants revealed a benefit of bilateral BC stimulation indicating use of binaural cues. In the speech based tests, the binaural benefit for BC stimulation was approximately half that with AC stimulation”

Spatial Release of Masking

Bin. Masking

Lvl

. Diff.

Bin. Intelligibility

Lvl

. Diff.

Stenfelt

, S. and M.

Zeitooni

(2013). "Binaural hearing ability with mastoid applied bilateral bone conduction stimulation in normal hearing subjects."

The Journal of the Acoustical Society of America

134

(1): 481-493.

Slide32

Ponto 4

Open Sound. Open Life

Slide33

Ponto 4 – Join the open sound revolution

* Data on file at Oticon Medical

The world’s smallest bone anchored sound processor

Truly wireless – now and in the future

Velox S™ platform and OpenSound Navigator

™

27%

smaller

than

Ponto3

Combining

discretion

,

performance

&

reliability

The world’s first bone anchored sound processor to be connected to the Internet – using IFTTT and the Oticon ON App.

Pending FDA clearance.

Extremly fast and powerful

Unique technology for 360 degree access to sound

Slide34

World’s smallest bone anchored sound processor

*Baha 5 height (from coupling) is 16.94 mm, Ponto 4 is 15.25 mm

Unnoticeable wear

Low profile*

Slim design

Unbroken lines with no user controls

Discreet design available in six colours

Matching colour palette of other Demant technology

Pending FDA clearance.

Slide35

World’s smallest bone anchored sound processor Ponto 4 is appealing to all

LED option*

Ponto design element – the round dome

Tamper resistant drawer option

Upholding our legacy on reliability and durability

*Unique for the small sound processors

Black back shell and coupling for shadow-effect on the head and discretion of wear

Non-side specific

Pending FDA clearance.

Slide36

Join the future of connected hearing

Apple, the Apple logo, iPhone, 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. Android, Google Play, and the Google Play

logo are trademarks of Google LLC.

Made for iPhone®

Direct streaming from any smartphone

The first truly connected bone anchored sound processor

Ponto 4 connects directly to the iPhone for direct streaming of phone calls, music, changing program, volume etc.

Via

ConnectClip

To access user controls -

volume control, program change, IFU, “find my hearing aid” and much more using the App

Endless options with IFTTT

Unique Oticon cloud solution, enables connection and control to an endless range of devices used in

everyday life.

Pending FDA clearance.

Slide37

Endless options with IFTTT

Connect to you smart devices

Connect to your car

Connect to your security system

Connect to your TV,

radio and game console

Connect to

kitchen devices

Connect to electricity and

thermostat controllers

Pending FDA clearance.

Slide38

If This Then That - connected whereverAt home and at work, for patients and caregivers

Need to know when your child’s battery is out of power?

Send a text message or email to a caregiver when the hearing aid battery is low.

Want to know how long your child is wearing their Ponto 4?

Get a calendar notification every time the Ponto 4 is switched on and switched off in the day

Need to find a lost Ponto 4?

Get email of last location connection with app stopped

Pending FDA clearance.

Slide39

Velox S™ - the platform with unprecedented processing power

Velox S is built from the bottom up by Oticon – custom made for hearing technology, launched by Oticon February 2019

It offers extreme speed and precisionPonto 4 features the strongest audiology on the hearing instrument market from Oticon Opn™ and Oticon

Opn

S™

Sound processing has never been this current in bone anchored technology

Pending FDA clearance.

Slide40

OpenSound Navigator™ - 360◦ sound

OpenSound Navigator is opening up and balancing the sound environmentEnabled by Multi Speaker Access Technology – making directionality as we know it a thing of the past

Very High setting New for Velox S™- as OpenSound

Booster in the Oticon ON App

-

in Genie Medical BAHS

Pending FDA clearance.

Slide41

OpenSound Navigator™

Fast and seamless

Balance

Analyse

Noise removal

Pending FDA clearance.

Slide42

Ponto 4 is safe

Tamper resistant option

Tamper resistant option included in the sales packEase to change the battery door – instruction and tool are right by

Safe solution with no

nailgrip

and need for pin tool to open the door

Pending FDA clearance.