Status:
COMPLETED
OTO-413 in Subjects With Speech-in-Noise Hearing Impairment
Lead Sponsor:
Otonomy, Inc.
Conditions:
Sensorineural Hearing Loss
Eligibility:
All Genders
21-64 years
Phase:
PHASE1
PHASE2
Brief 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 impairmen...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 5 2022
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT04129775
Start Date
October 1 2019
End Date
September 5 2022
Last Update
October 27 2022
Active Locations (8)
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1
Colorado Otolaryngology Associates LLC dba Colorado ENT & Allergy
Colorado Springs, Colorado, United States, 80923
2
Research Centers of America
Hollywood, Florida, United States, 33024
3
South Florida ENT Associates or Research Centers of America
Miami, Florida, United States, 33156
4
University of South Florida
Tampa, Florida, United States, 33612