Sensorineural Hearing Loss
Conditions
Keywords
hearing loss, speech-in-noise, synaptopathy, hearing impairment, hidden hearing loss
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 impairment.
Interventions
DRUGOTO-413
Single intratympanic injection of Brain-Derived Neurotrophic Factor (BDNF)
DRUGPlacebo
Single intratympanic injection of placebo
Sponsors
Otonomy, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 64 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Emergent Adverse Events (Safety) | Reported or observed during or after dosing (Day 1) up to the end of study (Day 85 - 12 weeks after dosing) | An adverse event (AE) is any unfavorable and unintended diagnosis, symptom, sign, syndrome or disease which occurs during the study, having been absent at baseline, or if present at baseline, appears to worsen. |
| Otoscopic Examinations (Safety) | After dosing (Day 1) up to end of study (Day 85 - 12 weeks after dosing) | Clinically significant change form Baseline |
| Audiometry (Safety) | After dosing (Day 1) up to end of study (Day 85 - 12 weeks after dosing) | Clinically significant change from Baseline |
Other
| Measure | Time frame | Description |
|---|---|---|
| Speech-in-noise Hearing Tests | Screening, Baseline, 2 weeks (dependent on dose group), 4 weeks, 8 weeks and 12 weeks after dosing | Ability to hear over noise |
| Electrophysiological Endpoint (dependent on dose group) | At Screening, 4 weeks, 8 weeks and 12 weeks after dosing | Electrophysiological test of auditory brainstem response to auditory stimuli |
| Patient Global Impression of Change | At 2 weeks (dependent on dose group), 4 weeks, 8 weeks and 12 weeks after dosing | Change in overall hearing status, ranging from very much worse (-3) to very much improved (+3) |
Countries
United States
Outcome results
None listed