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

  • STATUS
    Recruiting
  • End date
    Jun 26, 2022
  • participants needed
    70
  • sponsor
    Otonomy, Inc.
Updated on 26 July 2021
hearing impairment
hard of hearing
audiogram

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.

Details
Condition Sensorineural hearing loss, Hearing Loss, Auditory Loss and Deafness, Hearing Impairment
Treatment Placebo, OTO-413
Clinical Study IdentifierNCT04129775
SponsorOtonomy, Inc.
Last Modified on26 July 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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