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Hearing Protection, Restoration, and Regeneration

An Overview of Emerging Therapeutics for Inner Ear and Central Hearing Disorders

Schilder, Anne G. M.*,†; Su, Matthew P.*,†; Blackshaw, Helen*,†; Lustig, Lawrence; Staecker, Hinrich§; Lenarz, Thomas||,¶; Safieddine, Saaid#,**; Gomes-Santos, Carina S.††; Holme, Ralph††; Warnecke, Athanasia||,¶

doi: 10.1097/MAO.0000000000002194

Objective: To provide an overview of biotechnology and pharmaceutical companies active in the field of inner ear and central hearing disorders and their therapeutic approaches.

Methods: Scientific and grey literature was searched using broad search terms to identify companies and their hearing-related therapeutic approaches. For each approach its lead indication, product, therapeutic modality, target, mechanism of action and current phase of clinical development was collated.

Results: A total of 43 biotechnology and pharmaceutical companies have been identified that are developing therapeutics for inner ear and central hearing disorders. Their therapeutics include drug-, cell- and gene-based approaches to prevent hearing loss or its progression, restore hearing, and regenerate the inner ear. Their therapeutic targets and specific mechanisms of action are wide-ranging, reflecting the complexity of the hearing pathways and the diversity of mechanisms underlying inner ear disorders. While none of the novel products under investigation have yet made it to the clinical market, and a large proportion are still at preclinical phase, many therapeutics have already entered clinical testing with more expected to do so in the next few years.

Conclusion: A wide range of novel therapeutics targeting different hearing, balance and tinnitus pathways, and patient populations are approaching the clinical domain. It is important that clinicians involved in the care of patients with hearing loss prepare for what may become a radically different approach to the management of hearing disorders, and develop a true understanding of the new therapies’ mechanisms of action, applications, and indications.

*evidENT, Ear Institute, University College London, Royal National Throat Nose and Ear Hospital

National Institute of Health Research University College London Hospitals Biomedical Research Centre, London, UK

Department of Otolaryngology Head and Neck Surgery, Columbia University, New York

§Department of Otolaryngology Head and Neck Surgery, University of Kansas Medical Center, Kansas City, Kansas

||Department of Otolaryngology Head and Neck Surgery, Hannover Medical School, Hannover

Cluster of Excellence “Hearing for all”, German Research Foundation, Germany

#Genetics and Physiology of Hearing, Pasteur Institute

**Sorbonne University, Pierre and Marie Curie University Paris, Paris, France

††Action on Hearing Loss, London, UK

Address correspondence and reprint requests to Anne G. M. Schilder, M.D., Ph.D., evidENT, Ear Institute, University College London, Royal National Throat Nose and Ear Hospital, 330 Gray's Inn Road, London, WC1X 8DA UK; E-mail:

This research was co-funded by the NIHR UCLH BRC Deafness and Hearing Problems Theme.

The authors disclose no conflicts of interest.

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Copyright © 2019 by Otology & Neurotology, Inc. Image copyright © 2010 Wolters Kluwer Health/Anatomical Chart Company