OTO-413 in Subjects With Speech-in-Noise Hearing Impairment

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety, tolerability, and exploratory efficacy of OTO-413 administered as an intratympanic injection for the treatment of speech-in-noise hearing impairment.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otonomy, Inc.

Criteria

Inclusion Criteria:

• Subject has audiometrically-defined normal hearing or up to moderately severe hearing impairment.

• Subject has self-reported difficulty hearing in noisy environments for at least 6 months prior to Screening.

• Subject exhibited a speech-in-noise hearing deficit in at least one ear.

Exclusion Criteria:

• Subject is pregnant or lactating.

• Subject has the following hearing disorders or any other hearing disorders that may impact the efficacy assessments or safety of the subject in the opinion of the Investigator: Meniere's disease, congenital hearing loss, or genetic sensorineural hearing loss.

• Subject has a cochlear implant or consistently uses a hearing aid.

• Subject has worked at least 5 years as a professional musician or has had at least 15 years of formal musical training.

• Subject self-reports bothersome, subjective tinnitus and is consistently aware of their tinnitus throughout much of the waking day.