Bone Conduction Implants Recent Changes in Surgical Techniques, Hearing Technology & Implant Options

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1 A G B e l l L S L S y m p o s i u m Bone Conduction Implants Recent Changes in Surgical Techniques, Hearing Technology & Implant Options J u l y 1 0,

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3 The Oticon Medical company Part of William Demant Global leader in hearing health care Oticon Medical s core business is hearing implant solutions Bone anchored hearing systems Cochlear implant systems Headquarter in 3 sites Copenhagen, Denmark Close to WDH/Oticon headquarter Gothenburg, Sweden the cradle of bone anchored hearing Nice, France Technology park at Sophia Antipolis

4 Oticon Medical Global presence 2015 Sales Companies Distributors

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6 I love what we do

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9 These are exciting time to be involved in bone anchored hearing implants...

10 Osseointegration and Direct Bone Conduction Sound processor Abutment Implant/fixture

11 Osseointegration

12 Indications Conductive / Mixed Loss 5 years or older BC scores: > 45 db HL (.5, 1K, 2K & 3K) > 55dB HL (.5, 1K, 2K & 3K) Pro Power and Plus Power Single-sided deafness 5 years of age and older Normal hearing in better ear 20 < (.5, 1K, 2K & 3K)

13 The world of BAHS has changed Surgical advances New processor technology Happier patients

14 This is not case anymore!

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16 Surgical advances

17 Evolution of products and surgical technique Longer abutments More stable implants Less invasive techniques Wide ( 4.5mm) Ponto implant Earlier activation

18 Wide Ponto Implant OptiGrip Implant Geometry Improved stability enables longer abutments OptiGrip geometry Designed for improved stability Largest initial bone contact surface in the industry Wide ( 4.5mm) Ponto implant Ponto ( 3.75 mm) implant

19 Longer abutments Allow full tisue preservation for even more patients

20 Tissue Preservation surgery No thinning of the skin around abutment No removal of hair Quicker healing Better cosmetics Less numbness and pain Fully reversible

21 Data with Ponto abutments and tissue preservation Data series 40 adult patients Ongoing multi-center trials > 6 month data Skin status requiring no treatment (Holgers < 2) in 95% of visits No implant loss Holgers scores per visit 3.5% 1.7% 8.7% 86.1% Holgers 0 Holgers 1 Holgers 2 Holgers 3 Holgers 4 Banerjee et al. (CI 2014) Foghsgaard (2014)

22 Don t under estimate the abutment design OptiFit Designed for tissue preservation A smooth tissue interface without pockets and pathways for bacteria OptiFit Other system The skin-abutment interface

23 Percutaneous Bone-Anchored Hearing Implant Surgery Without Soft-Tissue Reduction: Up to 42 Months of Follow-up Reference: Singam, Williams, Saxby & Houlihan: Percutaneous Bone-Anchored Hearing Implant Surgery Without Soft-Tissue Reduction: Up to 42 Months of Followup Otol & Neurotol, 2014 (in press)

24 Key finding Abutment Choice 22 were Ponto patients A single Holgers 1 (mild redness around abutment) reported Easily treated by changing from 9 to 12mm abutment 38% of Cochlear patients needed tissue reduction

25 Conclusions Further evidence for the tissue preservation technique Authors conclusion: seems to be a safe technique with consistently good results, decreasing operating time and patient morbidity and avoiding some of the complications seen in traditional techniques using softtissue reduction. and Ponto abutments with OptiFit design is the preferred choice: We now predominantly use the new Oticon abutments, the shape of which seems ideally suited for softtissue preservation

26 Summary Soft tissue preservation technique is a big step forward for patients Better cosmetics Less numbness and pain Quicker surgery 100+ cases already published in peer-reviewed journals Complications at least as low with previous techniques Excellent results with Ponto abutments

27 Advances in sound processors for BAHS

28 Huge advances in patient benefits in recent years Less than 5 years since digital was introduced Dramatic improvement in feedback control Directional microphones Noise reduction Datalogging Wireless connectivity Durability Divino Ponto Power

29 And it s not just new products for the sake of it Better on every account

30 2 out of 3 patients prefer Ponto Systematic review of studies comparing Ponto to other sound processors 7 studies report patient preference 1,2,3,4,5,8,10 In every single study, a majority preferred Ponto All studies 1,2,3,4,5,8,10 N=100 Ponto 72% No preference 5% BAHA 23% Studies only comparing Ponto to BP100/BP110 1,4,5,8 N=57 Ponto Pro, Ponto Pro Power 67% No preference 9% BP100, BP110 24%

31 Putting the Plus in Ponto Everything you have come to know from Ponto Plus so much more More power from an updated transducer design New Inium sound processing platform Wireless capabilities

32 New transducer

33 What we have done Maximizing the magnetic field in the vibrator Same well-proven reliability Same small size Approx. 60% higher output for the same power consumption

34 The result A more powerful sound processor db Ponto Plus Series1 Plus Ponto Pro Ref: Oticon Medical tech sheet Output force level at 90dB SPL input at maximum gain.

35 Latest generation platform with Feedback Shield

36 Competitor Power Ponto Plus Power Ponto Pro Power The result Even less feedback and fewer artefacts 10 min sequence known to trigger feedback and artifacts in anti-feedback systems Well-controlled lab test supports comparisons 35% 1% 0 min 10 min Time 0% 50% 100%

37 Ponto Streamer & ConnectLine

38 Ponto Streamer Wireless communication possibilities Built in telecoil Remote control function Contact for FM Bluetooth/ audio jack connection

39 ConnectLine and accessories Extending the communication possibilities ConnectLine TV adapter ConnectLine Microphone ConnectLine Phone adapter FM Office Phone

40 Durable, reliable & easy to operate Made for living Designed and tested for an active lifestyle. With IP57 classification against moisture and dirt the highest in its class* User friendly push button for easy operating Metal spring coupling for durability and ease of use Water resistant nano coating Easy to access Volume control Hole for safety line Tamper resistant battery door & Low battery warning system IP 57 classification* * Please note, Ponto Plus is not waterproof. Users should always remove their sound processor while showering or bathing

41 Summary Ponto Plus Best sound processors we have ever made And that s even before Ponto Streamer is added Ponto Streamer opens up a world of communication Wireless sound controlled by Ponto Streamer

42 Clinical data 2 out of 3 patients prefer Ponto Plus Clinical study comparing Ponto Plus to Ponto Pro Radboud University Medical Center Nijmegen Cross-over design with 19 patients; mixed and conductive hearing loss 5% PONTO PRO 26% NO PREFERENCE 69% PONTO PLUS Bosman et al. (2014)

43 What do patients think

44 There are also exciting times ahead.

45 It used to be a one-technology market Middle ear implants Sensorineural + Mixed conduct. Soundbridge Esteem Other non-implantable SSD and cond. Soundbite TransEar Bone-anchored hearing system Cond., mixed and SSD Oticon Medical Cochlear Passive transcutaneous Cond., mixed and SSD Sophono Cochlear Attract Active transcutaneous Cond., mixed and SSD BCI, Håkansson Bonebridge

46 and in some sense it still is Bone-anchored hearing system Cond., mixed and SSD Oticon Medical Cochlear

47 The very basic principle We completely bypass the middle ear Mastoid as new middle ear The Exception -Middle ear implants Applies vibrations directly to round window (or other structure) Theretically more appealing since less mass to vibrate Drawbacks Complexity and risk of surgery Device costs Device reliability

48 Surgical aspects Audiological aspects Patient

49 Surgical aspects Audiological aspects Complexity and risk Implant loss Skin reactions Patient

50 Surgical aspects Audibility More gain More MFO Audiological aspects Complexity and risk Implant loss Skin reactions Patient

51 ? Surgical aspects Audibility More gain More MFO Audiological aspects Complexity and risk Implant loss Skin reactions Is there a transcutaneous solution? Cosmetics Patient

52 Overview of bone conduction devices Bone Conduction Devices Direct Drive In mouth Skin Drive Transcutaneous Implanted Transducer Percutaneous Headband Eye glass Implant with External Magnet BCI, Bonebridge Ponto Family BAHA SoundBite Sophono BAHA Attract Active transcutaneous Passive transcutaneous Bo Håkansson (2013)

53 Active Trancutaneous Solution No abutment Active implanted traducer Directly vibrating the mastoid

54 Active Transcutaneous solutions * Compared to percutaneous solutions: Up to 70% of the energy transferred will be lost in the inductive link Design freedom: Vibrator can be moved from sound processor Move from Pos A to Pos B (Håkansson, 2009) Increased sensitivity for ipsilateral cochlea in MF/HF Pos B Pos A *Med El Bonebridge and BCI Products are Not available in the US

55 Active Transcutaneous solutions Other factors Price is higher than transcutaneous. But less aftercare(?) Size of transducer could be limiting (careful surgical planning) MRI could be an issue *Med El Bonebridge and BCI Products are Not available in the US

56 Passive Transcutaneous solution No abutment Transducer worn externally Vibrations pass through skin before reaching the implant and mastiod

57 db Passive Transcutaneous solutions transcutaneous vs. percutaneous (skin dampening) + Working point of vibrator (resonance) Skin dampening = In-situ audiometry including change of vibrator working point transcutaneous vs. percutaneous: Frequency [Hz]

58 Maximum Force Output (db) Direct bone conduction provides more audibility Skin dampening is a physical fact Severely hampers high-frequency audibility Frequency (Hz) * The MFO curve from the BAHA 4 Connect official data sheet was corrected by the effect of skin dampening (Verstraeten et al., Otol & Neurotol; 2008:30)

59 On the importance of bandwidth Stelmachowicz et al. (2001) Recognition of high-frequency consonants Difference between speakers

60 On the Importance of bandwith for children Pittman (2008) Learning of new words Children (NH and HI) required 3 times as many exposures to learn each new word with 5kHz bandwidth compared to 10kHz

61 Passive transcutaneous solutions Other factors Price same as percutaneous Less aftercare? Studies suggest not (e.g. O Niel et al, 2014) Critical holding force of the sound processor MRI could be an issue Skin dampening

62 A rough benchmark trans- vers. percutaneous Percutaneous Transcutaneous Active Passive Ipsilateral Contralateral??? < 45 db HL < 55 db HL?? SSD < 20 db HL

63 Surgical aspects Audibility More gain More MFO Audiological aspects Implant loss Skin reactions A price is paid in audibility Cosmetics Patient

64 Where are we headed?

65 Our commitment to innovation We believe in direct drive Implantable solution based on direct bone contact Strong low- and high frequency transducer Excellent audiological results Safe & fast surgery and we collaborate with Bo Håkansson on BCI Eeg-Olofsson: 6 months data to be published soon Right now: Ponto brings the best compromise and will continue to be the solution for many patients

66 Summary Exciting times new possibilities but the basic physics hasn t changed and passive transcutaneous solutions are no different from old bone conduction hearing aids Percutaneous BAHS continues to be the gold standard delivering the most audiologic benefit We will bring new solutions when we believe in them and have tested them thoroughly New solutions means a lifelong commitment for patients, surgeons and companies

67 Thank you!!