Hearing Implants Pipeline by Stages of Development, Segments, Region, Regulatory Path and Key Companies

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Hearing Implants Pipeline Market Report Overview

Hearing implants are electronic devices implanted into the ear of a deaf or hard-to-hear person. These devices transmit sound from the ear to the brain. Cochlear implants, bone-anchored hearing implants, and middle ear implants have been tracked under this category.

The hearing implants pipeline market research report provides comprehensive information about the hearing implants pipeline products with a comparative analysis of the products at various stages of development and information about the clinical trials that are in progress.

Key Segments ·        Cochlear Implants

·        Middle Ear Implants

·        Bone Anchored Hearing Implants

·        Multi-Channel Cochlear Implants

Key Territories ·        The US

·        Global

·        Europe

·        France

·        Australia

Key Regulatory Paths ·        PMA

·        510(k)

·        CE

·        MDL

·        UKCA

·        TGA

Leading Companies ·        Advanced Bionics AG

·        Advanced Bionics LLC

·        Auritec Pharmaceuticals Inc

·        Blackrock Neurotech

·        Ceragenix Pharmaceuticals, Inc. (Inactive)

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Hearing Implants Pipeline Market by Segments

The key segments in the hearing implants pipeline market are Cochlear Implants, Middle Ear Implants, Bone Anchored Hearing Implants, and Multi-Channel Cochlear Implants. As of October 2023, Cochlear Implants have the most pipeline products.

Hearing Implants Pipeline Market Analysis by Segments, 2023 (%)

Hearing Implants Pipeline Market Analysis by Segments, 2023 (%)

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Hearing Implants Pipeline Market Segmentation by Territories

Some of the key territories in the hearing implants market are the US, Global, Europe, France, and Australia among others. As of October 2023, the US has the highest number of pipeline products.

Hearing Implants Pipeline Market Analysis by Territories, 2023 (%)

Hearing Implants Pipeline Market Analysis by Territories, 2023 (%)

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Hearing Implants Pipeline Market Segmentation by Regulatory Paths

Some of the key regulatory paths in the hearing implants pipeline market are 510(k), CE, PMA, MDL, UKCA, and TGA. As of October 2023, PMA is the most followed pathway for pipeline products in the market.

Hearing Implants Pipeline Market Analysis by Regulatory Paths, 2023 (%)

Hearing Implants Pipeline Market Analysis by Regulatory Paths, 2023 (%)

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Hearing Implants Pipeline Market – Competitive Landscape

Some of the key companies in the hearing implants pipeline market are:

  • Advanced Bionics AG
  • Advanced Bionics LLC
  • Auritec Pharmaceuticals Inc
  • Blackrock Neurotech
  • Ceragenix Pharmaceuticals, Inc. (Inactive)

Advanced Bionics LLC (Advanced Bionics): Advanced Bionics, a subsidiary of Sonova Holding AG, is a medical device company that develops, manufactures, and markets cochlear implant systems. The company’s medical devices are used to restore the sense of hearing. It provides sound processors and accessories. Advanced Bionics offers products for audiology, surgical, library, product development, education and training and clinical research support. It provides a range of wireless technologies for streaming audio. The company has operations in Switzerland, Brazil, Australia, Belgium, Colombia, China, Denmark, France, Hong Kong, the US, India, and Italy, among others. Advanced Bionics is headquartered in Valencia, California, the US.

Hearing Implants Pipeline Market Analysis by Companies, 2023

Hearing Implants Pipeline Market Analysis by Companies, 2023

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Segments Covered in the Report

Hearing Implants Pipeline Market Segments Outlook

  • Cochlear Implants
  • Middle Ear Implants
  • Bone Anchored Hearing Implants
  • Multi-Channel Cochlear Implants

Hearing Implants Pipeline Market Territories Outlook

  • The US
  • Global
  • Europe
  • France
  • Australia

Hearing Implants Pipeline Market Regulatory Paths Outlook

  • 510(k)
  • CE
  • PMA
  • MDL
  • UKCA
  • TGA

Scope

This report provides:

  • Extensive coverage of the Hearing Implants under development.
  • Review details of major pipeline products which include product description, licensing and collaboration details, and other developmental activities.
  • Reviews of major players involved in pipeline product development and lists all their pipeline projects.
  • Coverage of pipeline products based on various stages of development ranging from early development to approved/issued stage.
  • Provides key clinical trial data related to ongoing clinical trials specific to pipeline products.
  • Recent developments in the segment/industry.

Reasons to Buy

The report enables you to:

  • Formulate significant competitor information, analysis, and insights to improve R&D strategies.
  • Identify emerging players with potentially strong product portfolios and create effective counter strategies to gain a competitive advantage.
  • Identify and understand important and diverse types of Hearing implants under development.
  • Develop market-entry and market-expansion strategies.
  • Plan mergers and acquisitions effectively by identifying major players with the most promising pipeline.
  • In-depth analysis of the product’s current stage of development, territory, and estimated launch date.

Advanced Bionics AG
Advanced Bionics LLC
Auritec Pharmaceuticals Inc
Blackrock Neurotech
Ceragenix Pharmaceuticals, Inc. (Inactive)
Cochlear Ltd
Demant A/S
Desktop Health
Ecole Polytechnique Federale de Lausanne
Envoy Medical Corp
Hannover Medical School
Hemideina Solution
Huntington Medical Research Institutes
Labyrinth Devices
MED-EL Elektromedizinische Gerate Gesellschaft mbH
Naval Information Warfare Center Pacific
Northwestern University
Oticon Medical AB
OtoKinetics Inc
Ototronix, LLC
Sonova Holding AG
SpecialtyCare Inc
Tel Aviv Sourasky Medical Center
The University of Nottingham
Trinity College Dublin
University of Florida
University of Michigan Pediatric Device Consortium
University of Oklahoma
University of South Florida
University of Utah
University of Wisconsin Madison

Table of Contents

1 Table of Contents 3

1.1 List of Tables 6

1.2 List of Figures 9

2 Introduction 10

2.1 Hearing Implants Overview 10

3 Products under Development 11

3.1 Hearing Implants – Pipeline Products by Stage of Development 11

3.2 Hearing Implants – Pipeline Products by Segment 12

3.3 Hearing Implants – Pipeline Products by Territory 13

3.4 Hearing Implants – Pipeline Products by Regulatory Path 14

3.5 Hearing Implants – Pipeline Products by Estimated Approval Date 15

3.6 Hearing Implants – Ongoing Clinical Trials 16

4 Hearing Implants – Pipeline Products under Development by Companies 17

4.1 Hearing Implants Companies – Pipeline Products by Stage of Development 17

4.2 Hearing Implants – Pipeline Products by Stage of Development 19

5 Hearing Implants Companies and Product Overview 20

5.1 Advanced Bionics AG Company Overview 20

5.1.1 Advanced Bionics AG Pipeline Products & Ongoing Clinical Trials Overview 20

5.2 Advanced Bionics LLC Company Overview 21

5.2.1 Advanced Bionics LLC Pipeline Products & Ongoing Clinical Trials Overview 21

5.3 Auritec Pharmaceuticals Inc Company Overview 22

5.3.1 Auritec Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 22

5.4 Blackrock Neurotech Company Overview 23

5.4.1 Blackrock Neurotech Pipeline Products & Ongoing Clinical Trials Overview 23

5.5 Ceragenix Pharmaceuticals, Inc. (Inactive) Company Overview 24

5.5.1 Ceragenix Pharmaceuticals, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 24

5.6 Cochlear Ltd Company Overview 25

5.6.1 Cochlear Ltd Pipeline Products & Ongoing Clinical Trials Overview 25

5.7 Demant A/S Company Overview 31

5.7.1 Demant A/S Pipeline Products & Ongoing Clinical Trials Overview 31

5.8 Desktop Health Company Overview 34

5.8.1 Desktop Health Pipeline Products & Ongoing Clinical Trials Overview 34

5.9 Ecole Polytechnique Federale de Lausanne Company Overview 35

5.9.1 Ecole Polytechnique Federale de Lausanne Pipeline Products & Ongoing Clinical Trials Overview 35

5.10 Envoy Medical Corp Company Overview 36

5.10.1 Envoy Medical Corp Pipeline Products & Ongoing Clinical Trials Overview 36

5.11 Hannover Medical School Company Overview 39

5.11.1 Hannover Medical School Pipeline Products & Ongoing Clinical Trials Overview 39

5.12 Hemideina Solution Company Overview 40

5.12.1 Hemideina Solution Pipeline Products & Ongoing Clinical Trials Overview 40

5.13 Huntington Medical Research Institutes Company Overview 41

5.13.1 Huntington Medical Research Institutes Pipeline Products & Ongoing Clinical Trials Overview 41

5.14 Labyrinth Devices Company Overview 42

5.14.1 Labyrinth Devices Pipeline Products & Ongoing Clinical Trials Overview 42

5.15 MED-EL Elektromedizinische Gerate Gesellschaft mbH Company Overview 45

5.15.1 MED-EL Elektromedizinische Gerate Gesellschaft mbH Pipeline Products & Ongoing Clinical Trials Overview 45

5.16 Naval Information Warfare Center Pacific Company Overview 46

5.16.1 Naval Information Warfare Center Pacific Pipeline Products & Ongoing Clinical Trials Overview 46

5.17 Northwestern University Company Overview 47

5.17.1 Northwestern University Pipeline Products & Ongoing Clinical Trials Overview 47

5.18 Oticon Medical AB Company Overview 48

5.18.1 Oticon Medical AB Pipeline Products & Ongoing Clinical Trials Overview 48

5.19 OtoKinetics Inc Company Overview 52

5.19.1 OtoKinetics Inc Pipeline Products & Ongoing Clinical Trials Overview 52

5.20 Ototronix, LLC Company Overview 53

5.20.1 Ototronix, LLC Pipeline Products & Ongoing Clinical Trials Overview 53

5.21 Sonova Holding AG Company Overview 54

5.21.1 Sonova Holding AG Pipeline Products & Ongoing Clinical Trials Overview 54

5.22 SpecialtyCare Inc Company Overview 55

5.22.1 SpecialtyCare Inc Pipeline Products & Ongoing Clinical Trials Overview 55

5.23 Tel Aviv Sourasky Medical Center Company Overview 56

5.23.1 Tel Aviv Sourasky Medical Center Pipeline Products & Ongoing Clinical Trials Overview 56

5.24 The University of Nottingham Company Overview 57

5.24.1 The University of Nottingham Pipeline Products & Ongoing Clinical Trials Overview 57

5.25 Trinity College Dublin Company Overview 58

5.25.1 Trinity College Dublin Pipeline Products & Ongoing Clinical Trials Overview 58

5.26 University of Florida Company Overview 59

5.26.1 University of Florida Pipeline Products & Ongoing Clinical Trials Overview 59

5.27 University of Michigan Pediatric Device Consortium Company Overview 60

5.27.1 University of Michigan Pediatric Device Consortium Pipeline Products & Ongoing Clinical Trials Overview 60

5.28 University of Oklahoma Company Overview 61

5.28.1 University of Oklahoma Pipeline Products & Ongoing Clinical Trials Overview 61

5.29 University of South Florida Company Overview 62

5.29.1 University of South Florida Pipeline Products & Ongoing Clinical Trials Overview 62

5.30 University of Utah Company Overview 63

5.30.1 University of Utah Pipeline Products & Ongoing Clinical Trials Overview 63

5.31 University of Wisconsin Madison Company Overview 64

5.31.1 University of Wisconsin Madison Pipeline Products & Ongoing Clinical Trials Overview 64

6 Hearing Implants- Recent Developments 65

6.1 Oct 03, 2023: Olympus Names Dr. John de Csepel as Chief Medical Officer 65

6.2 Aug 24, 2023: Envoy Medical Appoints David R. Wells as Chief Financial Officer 65

6.3 Jul 14, 2023: Elos Medtech Announces Interim Report January 1 – June 30, 2023 66

6.4 Jun 30, 2023: Brinter Joins Winston Starts Accelerator, Poised for Accelerated Growth 66

6.5 Jun 21, 2023: Brinter Collaboration with SRM AP University in India 67

6.6 Jun 10, 2023: Brinter Takes BIO 2023 by Storm with its Bio-Implants 67

6.7 Jun 05, 2023: Brinter Opens a New Boston/MIT Showroom Office 68

6.8 Jun 02, 2023: Brinter Makes New Steps to Heal U.S. Military with the Help of MTEC 68

6.9 May 16, 2023: Knowles appoints Erania Brackett to its board of directors 68

6.10 May 12, 2023: Olympus announces consolidated financial results for the fiscal year ended March 31, 2023 69

6.11 May 03, 2023: Resolutions from annual general meeting of Elos Medtech AB 69

6.12 May 03, 2023: Brinter Makes Waves at MedInvest Conference 2023 70

6.13 Apr 27, 2023: Knowles announces results for quarter ended March 31, 2023 71

6.14 Apr 26, 2023: Elos Medtech announces interim report for January 1 – March 31, 2023 72

6.15 Apr 19, 2023: Insights Into the TERMIS-AM Conference in Boston, USA, April 11-14, 2023 72

6.16 Apr 10, 2023: Insights Into the TERMIS European Chapter, at Manchester, UK, March 28-31, 2023 72

6.17 Apr 07, 2023: Meet With Brinter at TERMIS-BOSTON 2023 and See Our LIVE 3D Bioprinting Demo April 11-14, 2023 73

6.18 Apr 04, 2023: Elos Medtech Notice to attend the Annual General Meeting 73

6.19 Mar 24, 2023: Insights Into the Prestigious LSI 2023, Dana Point Conference, and Brinter’s Live Demos 80

6.20 Mar 02, 2023: Katya Kruglova to join Sonova’s Management Board as GVP Human Resources & Communications 80

6.21 Mar 01, 2023: Insight Into 11th Annual UCLA MedTech Partnering Conference 81

6.22 Feb 15, 2023: Brinter Approved as BIO Member to Advance Future of Life Science 81

6.23 Feb 10, 2023: Olympus Announces Consolidated Financial Results for the Third Quarter and Full-year Forecasts for Fiscal 2023 82

6.24 Jan 26, 2023: Brinter Attending Inflames Corporate Corner – Immunoprofiling and Immunodrug Development 82

6.25 Jan 20, 2023: Brinter Has Been Approved for Biocom California Membership on January 20, 2023. 83

6.26 Dec 20, 2022: Advanced Bionics to pay over $12 million for alleged false claims for cochlear implant processors 83

6.27 Dec 20, 2022: Advanced Bionics to pay over $12 million for alleged false claims for cochlear implant processors 85

6.28 Dec 06, 2022: Use of hearing aids and cochlear implants associated with a decreased risk of developing dementia 87

6.29 Nov 14, 2022: Sonova Holding First half results 2022/23 87

6.30 Nov 11, 2022: Olympus Consolidated Financial Results for the Six Months of the Fiscal Year Ending March 31, 2023 90

6.31 Nov 11, 2022: Olympus Announces Consolidated Financial Results for the Six Months of the Fiscal Year Ending March 31, 2023 92

6.32 Oct 21, 2022: Olympus Announces Leadership Succession Plan 92

6.33 Oct 21, 2022: Elos Medtech Interim Report January 1 – September 30, 2022 92

6.34 Oct 21, 2022: Olympus Corp Notice Concerning Changes of Representative Executive Officer and Management Team 93

6.35 Oct 14, 2022: Elos Medtech Nomination Committee appointed for the 2023 Annual General Meeting 93

7 Appendix 95

7.1 Methodology 95

7.2 About GlobalData 98

7.3 Contact Us 98

7.4 Disclaimer 98

Table

Hearing Implants – Pipeline Products by Stage of Development 11

Hearing Implants – Pipeline Products by Segment 12

Hearing Implants – Pipeline Products by Territory 13

Hearing Implants – Pipeline Products by Regulatory Path 14

Hearing Implants – Pipeline Products by Estimated Approval Date 15

Hearing Implants – Ongoing Clinical Trials 16

Hearing Implants Companies – Pipeline Products by Stage of Development 17

Hearing Implants – Pipeline Products by Stage of Development 19

Advanced Bionics AG Pipeline Products & Ongoing Clinical Trials Overview 20

Naida CI Marvel Sound Processor – Product Status 20

Naida CI Marvel Sound Processor – Product Description 20

Advanced Bionics LLC Pipeline Products & Ongoing Clinical Trials Overview 21

Hires Fidelity 120 Pediatrics – Product Status 21

Hires Fidelity 120 Pediatrics – Product Description 21

Auritec Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 22

Steroid Eluting Cochlear Implant – Product Status 22

Steroid Eluting Cochlear Implant – Product Description 22

Blackrock Neurotech Pipeline Products & Ongoing Clinical Trials Overview 23

ANI Device – Product Status 23

ANI Device – Product Description 23

Ceragenix Pharmaceuticals, Inc. (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 24

Cerashield Coated Cochlear Inner Ear Implant – Product Status 24

Cerashield Coated Cochlear Inner Ear Implant – Product Description 24

Cochlear Ltd Pipeline Products & Ongoing Clinical Trials Overview 25

Cochlear Osia OSI300 Implant – Product Status 25

Cochlear Osia OSI300 Implant – Product Description 26

Nucleus 7 Sound Processor For Nucleus 22 Implant – Product Status 26

Nucleus 7 Sound Processor For Nucleus 22 Implant – Product Description 26

Nucleus Kanso 2 Sound Processor – Product Status 27

Nucleus Kanso 2 Sound Processor – Product Description 27

Nucleus Profile Plus – Product Status 27

Nucleus Profile Plus – Product Description 28

Cochlear Ltd – Ongoing Clinical Trials Overview 29

Nucleus Kanso 2 Sound Processor – A Pre-market, Open-label, Within Subject Study, of Acceptance and Performance of the CP1170 Sound Processor in Experienced Adult Cochlear Implant Recipients Compared With the CP1150 Sound Processor and Their Current Sound Processor. 30

Demant A/S Pipeline Products & Ongoing Clinical Trials Overview 31

Neuro 2 – Product Status 31

Neuro 2 – Product Description 31

Demant A/S – Ongoing Clinical Trials Overview 32

Neuro 2 – Pupillometry Techniques Usage to Quantify the Programming Parameters Effect in the Auditory Effort in Zti Opticon Cochlear Implant Adult Users 33

Desktop Health Pipeline Products & Ongoing Clinical Trials Overview 34

PhonoGraft – Product Status 34

PhonoGraft – Product Description 34

Ecole Polytechnique Federale de Lausanne Pipeline Products & Ongoing Clinical Trials Overview 35

Soft Auditory Brainstem Implant – Product Status 35

Soft Auditory Brainstem Implant – Product Description 35

Envoy Medical Corp Pipeline Products & Ongoing Clinical Trials Overview 36

Acclaim Cochlear Implant – Product Status 36

Acclaim Cochlear Implant – Product Description 36

Envoy Medical Corp – Ongoing Clinical Trials Overview 37

Acclaim Cochlear Implant – Study to Assess the Safety and Efficacy of Acclaim Cochlear Implant 38

Hannover Medical School Pipeline Products & Ongoing Clinical Trials Overview 39

Optical Cochlea Stimulator – Product Status 39

Optical Cochlea Stimulator – Product Description 39

Hemideina Solution Pipeline Products & Ongoing Clinical Trials Overview 40

Hera Wireless Implant – Product Status 40

Hera Wireless Implant – Product Description 40

Huntington Medical Research Institutes Pipeline Products & Ongoing Clinical Trials Overview 41

Multisite Device – Product Status 41

Multisite Device – Product Description 41

Labyrinth Devices Pipeline Products & Ongoing Clinical Trials Overview 42

MVI Vestibular Implant System – Product Status 42

MVI Vestibular Implant System – Product Description 42

Labyrinth Devices – Ongoing Clinical Trials Overview 43

MVI Vestibular Implant System – First-in-human Early Feasibility Study of Safety, Tolerability and Efficacy for a Multichannel Vestibular Implant in Individuals with Bilateral Severe-to-profound Loss of Vestibular Sensation 44

MVI Vestibular Implant System – Vestibular Implantation in Older Adults 44

MVI Vestibular Implant System – Vestibular Implantation to Treat Adult-Onset Bilateral Vestibular Hypofunction 44

MED-EL Elektromedizinische Gerate Gesellschaft mbH Pipeline Products & Ongoing Clinical Trials Overview 45

Totally Implantable Cochlear Implant (TICI) – Product Status 45

Totally Implantable Cochlear Implant (TICI) – Product Description 45

Naval Information Warfare Center Pacific Pipeline Products & Ongoing Clinical Trials Overview 46

Bionic Cochlea Implant – Product Status 46

Bionic Cochlea Implant – Product Description 46

Northwestern University Pipeline Products & Ongoing Clinical Trials Overview 47

Cochlear Implant – Product Status 47

Cochlear Implant – Product Description 47

Oticon Medical AB Pipeline Products & Ongoing Clinical Trials Overview 48

Next Generation Transcutaneous Bone Conduction Device – Product Status 48

Next Generation Transcutaneous Bone Conduction Device – Product Description 48

Sentio System – Product Status 49

Sentio System – Product Description 49

Oticon Medical AB – Ongoing Clinical Trials Overview 50

Sentio System – A Prospective, Multi-center, Single-arm, Clinical Investigation of the Safety and Performance of the Sentio System in Users with Mixed/Conductive Hearing Losses and Single Sided Deafness 51

Sentio System – Evaluation of a Sound Processor for a Transcutaneous System 51

OtoKinetics Inc Pipeline Products & Ongoing Clinical Trials Overview 52

Krescendo I – Product Status 52

Krescendo I – Product Description 52

Ototronix, LLC Pipeline Products & Ongoing Clinical Trials Overview 53

Dalhousie Hearing Device – Product Status 53

Dalhousie Hearing Device – Product Description 53

Sonova Holding AG Pipeline Products & Ongoing Clinical Trials Overview 54

Next Generation Cochlear Implant – Product Status 54

Next Generation Cochlear Implant – Product Description 54

SpecialtyCare Inc Pipeline Products & Ongoing Clinical Trials Overview 55

Miniature Middle Ear Implant – Product Status 55

Miniature Middle Ear Implant – Product Description 55

Tel Aviv Sourasky Medical Center Pipeline Products & Ongoing Clinical Trials Overview 56

Implant Electrode Extender – Product Status 56

Implant Electrode Extender – Product Description 56

The University of Nottingham Pipeline Products & Ongoing Clinical Trials Overview 57

Antibiotic Pellet – Product Status 57

Antibiotic Pellet – Product Description 57

Trinity College Dublin Pipeline Products & Ongoing Clinical Trials Overview 58

Closed-loop Cochlear Implant – Product Status 58

Closed-loop Cochlear Implant – Product Description 58

University of Florida Pipeline Products & Ongoing Clinical Trials Overview 59

Adjustable Middle Ear Prosthesis Device – Product Status 59

Adjustable Middle Ear Prosthesis Device – Product Description 59

University of Michigan Pediatric Device Consortium Pipeline Products & Ongoing Clinical Trials Overview 60

Enhanced Cochlear Implant Device – Product Status 60

Enhanced Cochlear Implant Device – Product Description 60

University of Oklahoma Pipeline Products & Ongoing Clinical Trials Overview 61

Totally Implantable Hearing System – Product Status 61

Totally Implantable Hearing System – Product Description 61

University of South Florida Pipeline Products & Ongoing Clinical Trials Overview 62

Promontory Anchored Incus Replacement Prosthesis – Product Status 62

Promontory Anchored Incus Replacement Prosthesis – Product Description 62

University of Utah Pipeline Products & Ongoing Clinical Trials Overview 63

Microphone Cochlear Implant – Product Status 63

Microphone Cochlear Implant – Product Description 63

University of Wisconsin Madison Pipeline Products & Ongoing Clinical Trials Overview 64

Cochlear Implant – Product Status 64

Cochlear Implant – Product Description 64

Glossary 97

Figures

Hearing Implants – Pipeline Products by Stage of Development 11

Hearing Implants – Pipeline Products by Segment 12

Hearing Implants – Pipeline Products by Territory 13

Hearing Implants – Pipeline Products by Regulatory Path 14

Hearing Implants – Pipeline Products by Estimated Approval Date 15

Hearing Implants – Ongoing Clinical Trials 16

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