by Michael Naimark, Director of Business Development, CBSET, Inc. and Marie-Pierre Pasdelou, PharmD, founder and the Chief Development Officer, CILcare

Hearing research and development aims to prevent hearing loss, halt its progression, or reverse deficits through a range of approaches. Unfortunately progress to date has been limited and the FDA has yet to recognize any efficacious therapy for these indications. However, advances in this area including regenerative medicine coupled with novel drug delivery approaches give hope for the emergence of truly protective and restorative therapies in the near future.

This article provides a brief overview of this emerging field and highlights key regulatory guidance and recommendations for preclinical assessment.