A Randomized, Double-Blind, Placebo-Controlled Phase 1/2 Study of OTO-413 given as a Single Intratympanic Injection in Subjects with Speech-in-Noise Hearing Impairment

Eligibility: Participants must be 21-64 years old with complaints of trouble hearing in background noise.

Goal: To evaluate an investigational drug that is delivered directly in the ear through the eardrum. 

Contact Information: USF ARCT lab phone at 813-974-1262 or email us at; Mention the "OTO413 Study". 


Principal Investigator: Victoria Sanchez, Au.D., Ph.D., CCC-A 

External IRB Approved Study Number: 20192199 


Study Overview 

Researchers at the Auditory Rehabilitation and Clinical Trials Laboratory (ARCT Lab) within the Department of Otolaryngology are conducting a research study to evaluate an investigational drug that is delivered directly in the ear through the ear drum. The researchers are seeking participants who are 21-64 years of age with complaints of trouble hearing in background noise. The study takes place over a minimum of 7 visits across a 3-month period and includes one ear injection. Qualified candidates will be compensated for their participation in the study, and there will be no cost to the participant or the participant’s insurance company.