2019 NHCA Annual Conference

For over 2 decades we have been hearing about pharmacologic otoprotective agents moving towards clinical use for noise- and drug-induced hearing loss. So why do we not yet have any FDA approved agents available? At what stage of development are we now? This lecture will discuss some of the issues in the approval process including clinical trials populations, clinical trials for temporary threshold shift versus permanent threshold shift, prophylaxis versus rescue, the use of FDA approved versus new agents in clinical trials, intellectual property issues, approval processes, drug delivery methods, safety and efficacy determinations and how advancements in one area can facilitate developments in other areas.  The purpose of this presentation is to update clinical audiologists on the bench to bedside process of otoprotective agent development and to help them understand how they may be able to assist in the process and how they can respond to inquiries from patients and physicians.  Once at least one of these agents is approved, this session should also help clinical audiologists understand how the area could further develop and expand for additional populations and applications.  Time will be allotted for questions.