Audiologists are likely to be familiar with medications that have ototoxic side effects but may be less familiar with investigational medicines being evaluated for possible prevention of hearing loss, or even hearing restoration. With increasing information available to the public, audiologists may receive questions from patients. This session will provide a tutorial on the regulatory process for review of new drug agents, including consideration of ototoxicity and otoprotection, and updates on agents of interest to audiologists. Clinical trial design and findings will be reviewed, including not only the audiogram but also hearing-in-noise difficulties and tinnitus.
- Describe the regulatory oversight and testing process for investigational new drug agents
- Summarize the current status of drug development for hearing indications
- Identify outcome measures of interest for studies on ototoxicity and otoprotection
