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

Otonomy

Status and phase

Completed

Phase 2

Phase 1

Conditions

Sensorineural Hearing Loss

Treatments

Drug: OTO-413

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT04129775

413-201901

Details and patient eligibility

About

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.

Enrollment

110 patients

Sex

All

Ages

21 to 64 years old

Volunteers

No Healthy Volunteers

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.