OTO-413 in Subjects With Speech-in-Noise Hearing Impairment
Completed · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Sensorineural Hearing Loss
In brief
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.
Key facts
- Study ID
- NCT04129775
- Run by
- Otonomy, Inc.
- People needed
- 110
- Starts
- 2019-10-01
- Expected to finish
- 2022-09-05
- Last updated by the study team
- 2022-10-27
Who can join
Age: 21 and older, up to 64. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Colorado Otolaryngology Associates LLC dba Colorado ENT & Allergy — Colorado Springs, Colorado, United States
- Research Centers of America — Hollywood, Florida, United States
- South Florida ENT Associates or Research Centers of America — Miami, Florida, United States
- University of South Florida — Tampa, Florida, United States
- Advanced ENT and Allergy, PLLC — Louisville, Kentucky, United States
- Piedmont Ear, Nose & Throat Associates — Winston-Salem, North Carolina, United States
- JBR Clinical Research — Salt Lake City, Utah, United States
- Eastern Virginia Medical School, Department of Otolaryngology — Norfolk, Virginia, United States
Full record on ClinicalTrials.gov
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