CompletedPhase 1/2

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

United States110 participantsStarted 2019-10-01

Plain-language 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.

Who can participate

Age range

21 Years – 64 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Treatment Emergent Adverse Events (Safety)

Timeframe: Reported or observed during or after dosing (Day 1) up to the end of study (Day 85 - 12 weeks after dosing)

Otoscopic Examinations (Safety)

Timeframe: After dosing (Day 1) up to end of study (Day 85 - 12 weeks after dosing)

Audiometry (Safety)

Timeframe: After dosing (Day 1) up to end of study (Day 85 - 12 weeks after dosing)

Trial details

NCT IDNCT04129775

SponsorOtonomy, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-09-05

View on ClinicalTrials.gov More Sensorineural Hearing Loss trials

Who can participate

Age range

21 Years – 64 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Treatment Emergent Adverse Events (Safety)

Timeframe: Reported or observed during or after dosing (Day 1) up to the end of study (Day 85 - 12 weeks after dosing)

Otoscopic Examinations (Safety)

Timeframe: After dosing (Day 1) up to end of study (Day 85 - 12 weeks after dosing)

Audiometry (Safety)

Timeframe: After dosing (Day 1) up to end of study (Day 85 - 12 weeks after dosing)