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OTO-413 for Sensorineural Hearing Loss

Phase 1 & 2
Waitlist Available
Research Sponsored by Otonomy, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 2 weeks (dependent on dose group), 4 weeks, 8 weeks and 12 weeks after dosing

Summary

This trial is testing a medication called OTO-413, which is injected into the ear, to help people who have trouble hearing speech in noisy environments. OTO-413 is a formulation of brain derived neurotrophic factor (BDNF) that has shown potential to improve hearing function.

Eligible Conditions
  • Sensorineural Hearing Loss

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 2 weeks (dependent on dose group), 4 weeks, 8 weeks and 12 weeks after dosing
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 2 weeks (dependent on dose group), 4 weeks, 8 weeks and 12 weeks after dosing for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Audiometry (Safety)
Otoscopic Examinations (Safety)
Treatment Emergent Adverse Events (Safety)
Other study objectives
Electrophysiological Endpoint (dependent on dose group)
Patient Global Impression of Change
Speech-in-noise Hearing Tests

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: OTO-413Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

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Who is running the clinical trial?

Otonomy, Inc.Lead Sponsor
21 Previous Clinical Trials
3,009 Total Patients Enrolled
~12 spots leftby Nov 2025
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