Clinical data on PontoTM - the Bone Anchored Hearing System September 2013 Clinical data on PontoTM - the Bone Anchored Hearing System

Overview of results, Ponto sound processors Independent prospective studies1-10 have investigated the performance of the Ponto sound processors when compared to reference bone anchored sound processors.* The studies have reported better performance with Ponto in respect to: Speech understanding in quiet and noise when rated subjectively by the test persons1,2,3,5,7,8,9, 10 Speech recognition when measured objectively1,2,7 Better sound quality2,5,8 Less feedback2,4,5 Less annoyance caused by wind noise 1,2,5,10 Ease of handling (e.g. adjusting controls)1,5,10 *Reference BAHA: Cochlear BP100, Divino and Intenso 4 studies are published1-4 and additional 6 studies have been presented at International conferences.5,-10 Background information: Across 10 independent studies better performance has been reported with the Ponto sound processors as compared to Cochlear BAHA. In two studies4, 6 one did not find any significant differences between Ponto Pro and BP100 at any parameters. BP100/110 was found to have significant directional benefit (difference between omni and full dir mode) in 2 studies5, 6; these objective findings were not supported in the subjective data, as the patients did not report that it was easier to understand speech in daily life with the BP100/BP100. In study (4) patients reported it was easier to understand speech with Ponto Pro Power in daily life.

2 out of 3 patients prefer Ponto In seven of the independent studies1,2,3,4,5,8,10 patients were, at the end of the study, asked which sound processor they preferred or would continue to use. In every single study, a majority of the patients preferred the Ponto sound processors over the reference BAHA. In total, almost 3 of 4 patients preferred Ponto (72 %). Only including studies comparing Ponto to BP100/BP110,1,4,5,8 2 of 3 users prefer Ponto (67 %). In these studies both devices were new to all patients. Studies only comparing Ponto to BP100/BP1101,4,5,8 N=57 All studies1,2,3,4,5,8,10 N=100

Reference list: Studies including Ponto sound processors Published articles Olsen S et al (2011) Comparison of two bone anchored hearing instruments: BP100 and Ponto Pro. International Journal of Audiology. International Journal of Audiology, 2011; 50: 920-928. Bosman A et al (2013). Evaluation of a new powerful bone-anchored hearing system: a comparison study. Journal of the American Academy of Audiology. 2013 Jun; 24(6): 505-13. Oeding K, Valente M. (2013) The Effectiveness of the Directional Microphone in the Oticon Medical Ponto Pro. J Am Acad Audiol, vol. Accepted for publication, 2013. Hill-Feltham et al (2013). Digital processing technology for bone anchored hearing aids: a randomized comparison of two devices in listeners with a mixed / conductive hearing loss. Journal of Laryngology & Otology. Accepted for publication Presentations and posters at International conferences Busch S et al (2013) Audiological results and patient satisfaction with Baha BP 110 and Ponto Pro Power: Results of a prospective clinical study. Presentation at 4th International Symposium Bone Conduction Hearing – Craniofacial Osseointegration, Newcastle upon Tyne, UK, June 5th – 7th 2013. Soli et al (2012). Within-subject comparison of speech perception in quiet and in noise for patients with single-sided deafness fitted with the BP100 and Ponto osseointegrated implant speech processors. Presentation at 12th International Conference on Cochlear Implants and Other Implantable Auditory Technologies, Baltimore, USA, May 2nd– 5th, 2012. Bosman A et al (2011). Evaluation of Cochlear BP-100 and Oticon Ponto Pro Sound Processors. Poster at the 3’rd International Bone Conduction hearing – Craniofacial Osseointegration (Osseo) conference, Sarasota Florida; March 2011. Ortega C et al (2011). Performance of the Ponto Pro and BP 100 processors in patients with single sided deafness (SSD). Presentation at 3’rd International Bone Conduction hearing – Craniofacial Osseointegration (Osseo) conference, Sarasota Florida; March 2011 . Stenfelt S (2011). Comparing of two digital bone-conduction hearing aids in experienced users: a two-center study. Presentation at 3’rd International Bone Conduction hearing – Craniofacial Osseointegration (Osseo) conference, Sarasota Florida; March 2011. Olsen S et al (2010). Field test of a new bone anchored system. Poster at 22nd Annual Convention of the American Academy of Audiology (AAA) - Audiology Now, San Diego, USA, April 2010.

Ref. Sound processors Indication (hearing loss) Nbr of patients Subjective outcome measures Objective (lab-based) measures Preference/choice Olsen (1) Ponto Pro/BP100 (both devices were new to patients) cond. & SSD 12 NSH GHABP Aided thresholds ANL Dantale II Ponto Pro: 8 BP100: 4 Bosman (2) Ponto Pro Power/ Intenso Mix 18 APHAB SSQ (Speech & Q subscales) Form factors Aided thresholds Dutch CVC Plomp (Dutch HINT) Ponto Pro Power: 18 Intenso: 0 Oeding (3) Ponto Pro SSD 15 APHAB HINT Ponto Pro: 8 BAHA: 7 Hill- Feltham (4) Ponto Pro/ BP100 (both devices were new to patients) Cond. & mix 14 Yes, but no published/standardized BKB sentences Ponto Pro: 9 BP100: 5 Busch (5) Ponto Pro Power/BP110 (both devices were new to patients) Mixed 11 APHAB SSQ-C Form factors Oldenburg sentence test Freiburg monosyllable in quiet Ponto Pro Power: 9 BP110: 2 Soli (6) HA device satisfaction APHAB; HDSS SSQ (Spatial) ; IOI Speech in noise test N/A Bosman (7) cond. 9 Ortega (8) Ponto Pro/ BP100 20 HHIA-s (modified HHIA) HDSS Preference quest. CNC Words HINT Quick SIN Ponto Pro: 12 No preference: 5 BP100: 3 Stenfelt (9) 6 Olsen (10) Ponto / BAHA 10 Dantale II Ponto: 8 BAHA: 2

Ponto Implant Studies

Summary of results, Ponto implants A number of studies have investigated the clinical outcomes of the Ponto implants11,12,16,17,18 or included Ponto implants in investigations of tissue preserving surgical techniques.13,14,15 In total, data on 211 Ponto implants is available. Results Reported implant loss rates are very low Highest reported loss in adults so far is 3.2% (1 case)11 Skin reactions with Ponto are at least as low as reported in the literature Adverse skin reactions (Holgers ≥2) rates between 0%- 4.3% for adults.

Reference list: Studies including Ponto implants Published articles Nelissen et al (2013a) A new bone-anchored hearing implant, short-term retrospective data on implant survival and subjective benefit. European Arch Otorhinolaryngol, E-published ahead of print. Babu et al (2012). The Ponto bone anchored implant system: A survey of clinical outcomes. Oticon Medical white paper, February 2012 Hultcrantz (2011). Outcome of the Bone-Anchored Hearing Aid Procedure Without Skin Thinning: A Prospective Clinical Trial. Otology & Neurotology, 32:1134-1139. Lanis and Hultcrantz (2013). Percutaneous osseointegrated implant surgery without skin thinning in children: A retrospective case review. Otology & Neurotology, E-published ahead of print. Goldman et al. (2013). The Punch Method for Bone-Anchored Hearing Aid Placement. Otolaryngology – Head and Neck Surgery, E-published ahead of print. Presentations (in selection) Nelissen, Hol and Mylanus (2013). A prospective comparison between the new wide and conventional Ponto implants: 6-months data in first 20 patients. Presentation at 4th International Symposium Bone Conduction Hearing – Craniofacial Osseointegration, Newcastle, UK, June 2013. Foghsgaard (2013). Ponto wide implant: A 12-month prospective study of stability, skin reaction and implant loss. New Ponto Wide Implant, Preliminary Results. Presentation at 4th International Symposium Bone Conduction Hearing – Craniofacial Osseointegration, Newcastle, UK, June 2013. Daugherty et al. (2013). A Clinical Study of Early Loading of the Oticon Medical Ponto 4.5mm Wide Implant. Presentation at 4th International Symposium Bone Conduction Hearing – Craniofacial Osseointegration, Newcastle, UK, June 2013.

Overview, Ponto Implant studies Study #Nbr of patients (with Ponto implants) Follow-up time Implant lost Skin reactions (Holger scores where possible) Nelissen et al. (2013a) 31 16.9 months (range 12–25 months) 1 Holgers ≥ 2: 4.3% Babu et al. (2012) 98 5.3 months 15% moderate skin reactions Goldman et al. (2013) 15 (10 with Ponto) 14.8 months (range 9-20 months) Holgers ≥ 2: 0% Lanis and Hultcrantz (2013) 10 (8 with Ponto) Pediatric patients 1.3 years (range 0.6-2 years) 1 implant loss + 1 failed osseointegr. “Severe infection”: 11% (1 case) Foghsgaard (2013) 24 10.3 months (range 2-16 months) Holgers ≥ 2: 2.8% Nelissen et al. (2013b) 20 6 months Daugherty et al. (2013) 3 weeks – 6 months Holgers ≥ 2: 1.4% 1 Both implants were electively removed, in one case because of revision mastoid surgery