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Biological Therapies of the Inner Ear: What Otologists Need to Consider.

Over the past 50 years, our understanding of the REGULATORY HURDLES molecular and cellular basis of hearing has grown immensely. While for decades it has been a dream to ‘‘regrow’’ portions of the inner ear to treat hearing loss, biological therapies for the protection and regeneration of the inner ear are now on the horizon; with an active pipeline of drug, gene, and cell therapies now moving toward clinical translation. This poses new challenges to clinicians and researchers in the hearing field. In this commentary, we share some of our experiences in developing and conducting early phase trials of novel hearing therapies and suggest a collaborative approach to ensure optimal enhanced benefits to our patients. Hearing loss and the regulation of hearing loss therapies have become a public priority for governments worldwide. Recent data show that approximately half a billion people have disabling hearing loss, roughly corresponding to 6 to 8% of the world’s population (1) with an estimated annual economic burden of 750 billion US Dollars. This impact is set to increase as the world’s population ages and consequently the number of people with age-related hearing loss grows (2,3). Importantly, adult onset hearing loss has recently been identified as a key risk factor for dementia (4). The life sciences industry too has realized that hearing health care is an area of unmet need and great potential profit. This is evidenced by the fact that financial investments in new hearing loss therapies have risen sharply with more than 30 biotechnology start-ups generated in the hearing field over the past several years (5). With these investments, new drugs, gene, and cellular therapies are being developed to prevent, alleviate, or restore hearing loss and tinnitus. Translating these discoveries to the clinical domain creates new opportunities for otologists and neurotologists, since expertise in hearing health care will be needed for both the development of these new interventions and approaches to the delivery of these therapies to the inner ear. Particular challenges faced at the early stages of translation can be roughly divided into the areas of regulatory and financial hurdles, limitations in our current understanding of hearing loss mechanisms, and the need to develop internationally accepted standards for efficacy and outcomes analyses.