Hearing Aid Devices-Medical Devices Pipeline Assessment, 2017

Table of Contents

1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 6

1.2 List of Figures 7

2 Introduction 8

2.1 Hearing Aid Devices Overview 8

3 Products under Development 9

3.1 Hearing Aid Devices-Pipeline Products by Stage of Development 9

3.2 Hearing Aid Devices-Pipeline Products by Segment 10

3.3 Hearing Aid Devices-Pipeline Products by Territory 11

3.4 Hearing Aid Devices-Pipeline Products by Regulatory Path 12

3.5 Hearing Aid Devices-Pipeline Products by Estimated Approval Date 13

4 Hearing Aid Devices-Pipeline Products under Development by Companies 14

4.1 Hearing Aid Devices Companies-Pipeline Products by Stage of Development 14

4.2 Hearing Aid Devices-Pipeline Products by Stage of Development 15

5 Hearing Aid Devices Companies and Product Overview 16

5.1 ADTS Ltd Company Overview 16

5.1.1 ADTS Ltd Pipeline Products & Ongoing Clinical Trials Overview 16

5.2 Advanced Bionics LLC Company Overview 17

5.2.1 Advanced Bionics LLC Pipeline Products & Ongoing Clinical Trials Overview 17

5.3 Audiodontics, Inc. Company Overview 19

5.3.1 Audiodontics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 19

5.4 BatAndCat Corp Company Overview 20

5.4.1 BatAndCat Corp Pipeline Products & Ongoing Clinical Trials Overview 20

5.5 Cochlear Ltd Company Overview 21

5.5.1 Cochlear Ltd Pipeline Products & Ongoing Clinical Trials Overview 21

5.6 EarGear LLC Company Overview 23

5.6.1 EarGear LLC Pipeline Products & Ongoing Clinical Trials Overview 23

5.7 GN ReSound A/S Company Overview 24

5.7.1 GN ReSound A/S Pipeline Products & Ongoing Clinical Trials Overview 24

5.8 Hannover Medical School Company Overview 25

5.8.1 Hannover Medical School Pipeline Products & Ongoing Clinical Trials Overview 25

5.9 iHear Medical, Inc. Company Overview 27

5.9.1 iHear Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 27

5.10 Phonak AG Company Overview 29

5.10.1 Phonak AG Pipeline Products & Ongoing Clinical Trials Overview 29

5.11 Samsung Electronics Co., Ltd. Company Overview 33

5.11.1 Samsung Electronics Co., Ltd. Pipeline Products & Ongoing Clinical Trials Overview 33

5.12 Unitron Hearing Inc Company Overview 34

5.12.1 Unitron Hearing Inc Pipeline Products & Ongoing Clinical Trials Overview 34

5.13 University of California Irvine Company Overview 35

5.13.1 University of California Irvine Pipeline Products & Ongoing Clinical Trials Overview 35

5.14 University of Michigan Company Overview 36

5.14.1 University of Michigan Pipeline Products & Ongoing Clinical Trials Overview 36

5.15 University of Strathclyde Company Overview 37

5.15.1 University of Strathclyde Pipeline Products & Ongoing Clinical Trials Overview 37

5.16 Washington State University Company Overview 38

5.16.1 Washington State University Pipeline Products & Ongoing Clinical Trials Overview 38

6 Hearing Aid Devices- Recent Developments 39

6.1 Mar 13, 2017: Teladoc Adds Peter Nieves as Chief Revenue Officer 39

6.2 Mar 02, 2017: Teladoc Appoints Former CEO of Allina Health Ken Paulus to Board of Directors 39

6.3 Mar 01, 2017: Teladoc Announces Full-Year and Fourth Quarter 2016 Results 40

6.4 Feb 21, 2017: Phonak Continues to Break Ground With a New Lithium-ion Rechargeable Hearing Aid Bolero B-PR 41

6.5 Feb 21, 2017: Phonak Introduces New Titanium-made Custom Device Virto B -Titanium 42

6.6 Feb 21, 2017: Sonova continues to set new standards with innovative hearing solutions 43

6.7 Feb 16, 2017: Starkey Hearing Technologies' Halo 2 Named 2017 SXSW Interactive Innovation Awards and 2017 Edison Awards Finalist 44

6.8 Feb 16, 2017: IntriCon Reports 2016 Fourth-Quarter Results 45

6.9 Feb 09, 2017: Smith & Nephew Fourth Quarter Trading and Full Year 2016 Results 47

6.10 Feb 09, 2017: Smith & Nephew: Directorate Change 52

6.11 Feb 09, 2017: GN Store Nord Annual Report 2016 52

6.12 Feb 07, 2017: Kerma expands HealthTrust supplier purchasing agreement to include TIDI eyewear offerings 54

6.13 Feb 06, 2017: Knowles Reports Q4 & Full Year 2016 Financial Results and Provides Outlook for Q1 2017 54

6.14 Feb 01, 2017: Jim Hagemann Snabe proposed as new Chairman of Siemens' Supervisory Board 55

6.15 Jan 31, 2017: Siemens: First Quarter Results FY 2017 56

6.16 Jan 30, 2017: World premiere: Innovative and Effective Tinnitus Therapy in Signia Hearing Aids 56

6.17 Jan 27, 2017: Knowles Appoints Helmut Vogler as Senior Vice President of Global Sales 58

6.18 Jan 19, 2017: iHear Medical Raises USD4 Million in Series C-2 Financing 58

6.19 Jan 17, 2017: TelaDoc to Raise Funds through Public Offering of Shares 58

6.20 Jan 12, 2017: Starkey Hearing Technologies to Launch Complete Ear Health Product Line 59

6.21 Jan 12, 2017: Confirmation of CFO leaving Smith & Nephew 60

6.22 Jan 09, 2017: Teladoc Completes Record Visit Volume in 2016; Provides Preliminary Unaudited 2016 Results and 2017 Financial Outlook 60

6.23 Jan 06, 2017: Teladoc Sets Industry Record, Surpassing 2 Million Telehealth Visit Milestone 60

6.24 Jan 04, 2017: Signia Named as CES 2017 Innovation Award Honoree For Cellion Primax 61

6.25 Dec 21, 2016: ReSound and Cochlear Bimodal Hearing Solutions Provide Life-Changing Outcomes 62

6.26 Dec 19, 2016: CES 2017: Oticon to Showcase Opn, the World's First Internet Connected Hearing Aid 62

6.27 Dec 19, 2016: Signia unveils a nearly invisible hearing aid that's ready to wear 63

6.28 Dec 14, 2016: iHEAR Partners with Ameritas to Deliver Lower-Cost, Innovative Hearing Solutions 64

6.29 Dec 09, 2016: FDA Makes the Right Move on Making Hearing Aids more Accessible, Says CTA 64

6.30 Dec 07, 2016: FDA takes steps to improve hearing aid accessibility 64

6.31 Dec 06, 2016: ReSound Launches ReSound Up Smart Pediatric Smart Hearing Aid in the United States 65

6.32 Nov 30, 2016: Graham Baker appointed Chief Financial Officer 66

6.33 Nov 29, 2016: Oticon Opn Family Expands with Enhanced Power Options and New Performance Levels to Benefit More People 67

6.34 Nov 14, 2016: Oticon Opn, the World's First Internet Connected Hearing Aid, Captures CES 2017 Innovation Awards in Two Categories 68

6.35 Nov 14, 2016: First Half Results 2016/17: Sonova with Strong Foundation for Further Growth 68

6.36 Nov 14, 2016: IntriCon Reports 2016 Third-Quarter Results 72

6.37 Nov 10, 2016: Siemens Healthcare Plans IPO of Shares 73

6.38 Nov 10, 2016: Siemens intends to further strengthen its healthcare business 73

6.39 Nov 10, 2016: iHEAR Announces EarPiNG-A New Telehealth Service to Remotely Customize Hearing Aids by Hearing Professionals 74

6.40 Nov 04, 2016: PAVmed Enters into Licensing Agreement with Tufts University, Massachusetts Eye and Ear Infirmary and Massachusetts General Hospital 74

6.41 Nov 03, 2016: Smith & Nephew Third Quarter 2016 Trading Report 75

6.42 Nov 02, 2016: Lak Ananth to head new next47 startup unit 76

6.43 Nov 01, 2016: Sound Pharmaceuticals announces two new executive hires to accelerate its Meniere's drug development program 77

6.44 Oct 27, 2016: Teladoc Announces Third Quarter 2016 Results 77

6.45 Oct 19, 2016: ReSound to Showcase the Most Advanced Hearing Solutions at 61st International Congress of Hearing Aid Acousticians (EUHA) in Hannover 78

6.46 Oct 17, 2016: Signia's New Rechargeable Hearing Aid Goes 24 Hours With Unlimited Streaming 79

6.47 Oct 11, 2016: Sonova announces appointment of Group Vice President Retail 80

6.48 Oct 03, 2016: Supply agreement between Miracle-Ear and Sivantos renewed 81

6.49 Sep 29, 2016: Oticon Names Gary Rosenblum as New President 81

6.50 Sep 29, 2016: Cochlear: Retirement Of Chief Financial Officer 81

6.51 Sep 28, 2016: Special Daymond John Apple Store Event Exhibits Accessibility of Halo 2 Technology 82

6.52 Sep 28, 2016: Teladoc Names Hirschhorn Chief Operating Officer 82

6.53 Sep 23, 2016: Siegfried Russwurm to resign by mutual agreement from the Siemens Management Board 83

6.54 Sep 22, 2016: Teladoc Appoints Former Pfizer Vice Chairman and CFO David Shedlarz to Board of Directors 83

6.55 Sep 13, 2016: iHear Medical Granted Key Patents for Innovative Online Hearing Solutions Platform 84

6.56 Sep 08, 2016: ReSound Strengthens Smart Hearing Portfolio with New Mini BTE 85

6.57 Sep 06, 2016: Cochlear unveils Kanso, a first-of-its-kind hearing technology to treat severe to profound hearing loss 85

6.58 Sep 06, 2016: Earlens Selects iBASEt to Support 3D Printing of Revolutionary Hearing Aid 87

6.59 Aug 31, 2016: Sonova announces changes to the Management Board 87

6.60 Aug 17, 2016: William Demant Holding: Interim Report 2016-full report 88

6.61 Aug 03, 2016: Teladoc announces second quarter 2016 results 89

6.62 Aug 02, 2016: IntriCon Reports 2016 Second-Quarter Results 90

6.63 Jul 28, 2016: Smith & Nephew Second Quarter Trading and First Half 2016 Results 91

6.64 Jul 28, 2016: Cochlear Announces Senior Executive Appointments 95

6.65 Jul 11, 2016: CFO to leave Smith & Nephew in early 2017 96

6.66 Jul 08, 2016: Town Health International Medical Group: Update On The Financial Performance For The Six Months Ended 30 June 2016 96

6.67 Jul 06, 2016: Oticon President Peer Lauritsen Announces Plans to Retire 97

6.68 Jun 30, 2016: Phonak's Audéo V10 Wins Prestigious Red Dot Design Award 97

6.69 Jun 30, 2016: Phonak's Roger Touchscreen Mic Wins Prestigious Red Dot Design Award 98

6.70 Jun 30, 2016: IntriCon Reports Preliminary Second-Quarter Results 99

6.71 Jun 24, 2016: Fynes Audiology Now Offering Widex ZEN Therapy for Tinnitus 99

6.72 Jun 23, 2016: Cochlear announces availability of Cochlear Baha 5 Power, new powerful bone conduction sound processor for those with higher degrees of hearing loss 100

6.73 Jun 23, 2016: Cochlear announces availability of Baha 5 SuperPower, new powerful bone conduction sound processor for those with higher degrees of hearing loss 102

6.74 Jun 21, 2016: Christian Stein hands over ASTP-Proton presidency to Marta Catarino 103

6.75 Jun 15, 2016: Siemens Healthcare Becomes Siemens Healthineers 104

6.76 Jun 01, 2016: Oticon Opn with BrainHearing Technology Helps People with Hearing Loss Hear Better, with Less Effort and Better Recall 104

6.77 Jun 01, 2016: Elos Medtech appoints Jan Wahlström as new President and CEO as of 1 July 2016 106

6.78 May 30, 2016: PAI Europe VI to Acquire Atos Medical from EQT 106

6.79 May 24, 2016: LaVoieHealthScience Launches PR for Breakthrough Hearing Aids: Oticon Opn 107

6.80 May 18, 2016: Sonova announces full year results 2015/16 107

6.81 May 17, 2016: Beltone Legend Selected as Stevie Award Winner in 2016 American Business Awards 112

6.82 May 12, 2016: IntriCon Raises USD4.2 Million in Public Offering of Shares 112

6.83 May 11, 2016: Clarissa Haller new head of communications at Siemens 113

6.84 May 10, 2016: Teladoc Announces First Quarter 2016 Results 113

6.85 May 10, 2016: William Demant Holding: Interim information 114

6.86 May 09, 2016: Audiology Management Group and Tinnitus Treatment Solutions Create Clinical Partnership to Benefit More Individuals With Ringing in Ears 116

6.87 May 04, 2016: Earnings Release and Financial Results Q2 FY 2016: Continuing growth in orders, revenue and profitability 117

6.88 May 03, 2016: Siemens Mrosik appointed CEO of Digital Factory Division 117

6.89 Apr 26, 2016: IntriCon Reports 2016 First-Quarter Results 118

6.90 Apr 26, 2016: Elos Medtech Interim report, 1 January-31 March 2016 119

6.91 Apr 25, 2016: Siemens Healthcare Enables the Exchange of Health Data with ELGA 120

6.92 Apr 25, 2016: Beltone Announces KAM Hearing as Exclusive Distributor for Hong Kong, Macau and Guangdong 121

6.93 Apr 12, 2016: Compulink Announces Audiology Advantag at AudiologyNOW! 2016 121

6.94 Apr 11, 2016: Preliminary Data From Turtle Beach's Latest Clinical Study Suggests HyperSound Clear Has Potential To Alleviate Tinnitus 121

6.95 Apr 05, 2016: Oticon Names Douglas Beck, AuD, Director of Academic Sciences and Thomas Lawrence, Director of Sales 123

6.96 Mar 31, 2016: Sonova announces changes to the Management Board 123

7 Appendix 125

7.1 Methodology 125

7.2 About GlobalData 128

7.3 Contact Us 128

7.4 Disclaimer 128

List of Figure

1.2 List of Figures

Figure 1: Hearing Aid Devices-Pipeline Products by Stage of Development 9

Figure 2: Hearing Aid Devices-Pipeline Products by Segment 10

Figure 3: Hearing Aid Devices-Pipeline Products by Territory 11

Figure 4: Hearing Aid Devices-Pipeline Products by Regulatory Path 12

Figure 5: Hearing Aid Devices-Pipeline Products by Estimated Approval Date 13

List of Table

1.1 List of Tables

Table 1: Hearing Aid Devices-Pipeline Products by Stage of Development 9

Table 2: Hearing Aid Devices-Pipeline Products by Segment 10

Table 3: Hearing Aid Devices-Pipeline Products by Territory 11

Table 4: Hearing Aid Devices-Pipeline Products by Regulatory Path 12

Table 5: Hearing Aid Devices-Pipeline Products by Estimated Approval Date 13

Table 6: Hearing Aid Devices Companies-Pipeline Products by Stage of Development 14

Table 7: Hearing Aid Devices-Pipeline Products by Stage of Development 15

Table 8: ADTS Ltd Pipeline Products & Ongoing Clinical Trials Overview 16

Table 9: Auditory Training System-Product Status 16

Table 10: Auditory Training System-Product Description 16

Table 11: Advanced Bionics LLC Pipeline Products & Ongoing Clinical Trials Overview 17

Table 12: ClearVoice-Pediatric Use-Product Status 17

Table 13: ClearVoice-Pediatric Use-Product Description 17

Table 14: Sound Processor Third Generation-Product Status 18

Table 15: Sound Processor Third Generation-Product Description 18

Table 16: Audiodontics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 19

Table 17: Tooth Phone Auditory Device-Product Status 19

Table 18: Tooth Phone Auditory Device-Product Description 19

Table 19: BatAndCat Corp Pipeline Products & Ongoing Clinical Trials Overview 20

Table 20: Wearable Hearing Aid Device-Product Status 20

Table 21: Wearable Hearing Aid Device-Product Description 20

Table 22: Cochlear Ltd Pipeline Products & Ongoing Clinical Trials Overview 21

Table 23: Kanso Sound Processor-Product Status 21

Table 24: Kanso Sound Processor-Product Description 22

Table 25: EarGear LLC Pipeline Products & Ongoing Clinical Trials Overview 23

Table 26: EarGear System-Product Status 23

Table 27: EarGear System-Product Description 23

Table 28: GN ReSound A/S Pipeline Products & Ongoing Clinical Trials Overview 24

Table 29: ReSound 5th Generation 2.4 GHz Wireless Hearing Device-Product Status 24

Table 30: ReSound 5th Generation 2.4 GHz Wireless Hearing Device-Product Description 24

Table 31: Hannover Medical School Pipeline Products & Ongoing Clinical Trials Overview 25

Table 32: In-Ear Bone Conduction Hearing Aid-Product Status 25

Table 33: In-Ear Bone Conduction Hearing Aid-Product Description 25

Table 34: Laser Hearing Aid-Product Status 26

Table 35: Laser Hearing Aid-Product Description 26

Table 36: iHear Medical, Inc. Pipeline Products & Ongoing Clinical Trials Overview 27

Table 37: iHEARHD-Product Status 27

Table 38: iHEARHD-Product Description 27

Table 39: iHEARMAX-Product Status 28

Table 40: iHEARMAX-Product Description 28

Table 41: Phonak AG Pipeline Products & Ongoing Clinical Trials Overview 29

Table 42: Bolero B-M-Product Status 29

Table 43: Bolero B-M-Product Description 29

Table 44: Bolero B-P-Product Status 30

Table 45: Bolero B-P-Product Description 30

Table 46: Bolero B-PR-Product Status 30

Table 47: Bolero B-PR-Product Description 31

Table 48: Bolero B-SP-Product Status 31

Table 49: Bolero B-SP-Product Description 31

Table 50: Virto B-Titanium-Product Status 32

Table 51: Virto B-Titanium-Product Description 32

Table 52: Samsung Electronics Co., Ltd. Pipeline Products & Ongoing Clinical Trials Overview 33

Table 53: SM-R790-Product Status 33

Table 54: SM-R790-Product Description 33

Table 55: Unitron Hearing Inc Pipeline Products & Ongoing Clinical Trials Overview 34

Table 56: Moxi Fit R-Product Status 34

Table 57: Moxi Fit R-Product Description 34

Table 58: University of California Irvine Pipeline Products & Ongoing Clinical Trials Overview 35

Table 59: Hearing Aid-Product Status 35

Table 60: Hearing Aid-Product Description 35

Table 61: University of Michigan Pipeline Products & Ongoing Clinical Trials Overview 36

Table 62: Cochlear Analog Transducer-Product Status 36

Table 63: Cochlear Analog Transducer-Product Description 36

Table 64: University of Strathclyde Pipeline Products & Ongoing Clinical Trials Overview 37

Table 65: Insect-Inspired Microphone-Product Status 37

Table 66: Insect-Inspired Microphone-Product Description 37

Table 67: Washington State University Pipeline Products & Ongoing Clinical Trials Overview 38

Table 68: Remote Controlled Earplug System-Product Status 38

Table 69: Remote Controlled Earplug System-Product Description 38

Table 70: Glossary 127