Evidence map›Paper›PMID 42479273›Full record

ArticleJournal of the Association for Research in Otolaryngology : JARO2026

Single Intratympanic Injection of Proprietary Brain-Derived Neurotrophic Factor (OTO-413) in Subjects with Speech-in-Noise Hearing Impairment: a Randomized, Dose Escalating, Double-Blind, Placebo-Controlled Phase 1/2 Study.

Alan C Foster, Jeffery J Anderson, David R Moore, Morgan Oktela Fuentes, Yiwei Wang, Peter G Volsky, K Paul Boyev, Victoria A Sanchez

Registry-linked trialAbstract read
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In one paragraph

Article in Journal of the Association for Research in Otolaryngology : JARO, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04129775 (A Randomized, Double-blind, Placebo-controlled Phase 1/2 Study of OTO-413 Given as a Single Intratympanic Injection in Subjects With Speech-in-noise Hearing Impairment), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04129775 phase1 / phase2completednot on this map

A Randomized, Double-blind, Placebo-controlled Phase 1/2 Study of OTO-413 Given as a Single Intratympanic Injection in Subjects With Speech-in-noise Hearing Impairment

TypeinterventionalSponsorOtonomy, Inc.Ran2019 to 2022Enrolled110ConditionsSensorineural Hearing LossArmsOTO-413, Placebo
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Alan C FosterJobral Consulting, San Diego, CA, USA.
Jeffery J AndersonOtonomy, Inc, San Diego, CA, USA.
David R MooreDivision of Patient Services Research and Department of Pediatrics, Cincinnati Children's Hospital, Cincinnati, OH, USA.
Morgan Oktela FuentesDepartment of Otolaryngology-Head & Neck Surgery, University of South Florida, Tampa, FL, USA.
Yiwei WangOtonomy, Inc, San Diego, CA, USA.
Peter G VolskyDepartment of Otolaryngology-Head and Neck Surgery, Eastern Virginia Medical School at Old Dominion University, Norfolk, VA, USA.ORCID http://orcid.org/0000-0002-5247-8562
K Paul BoyevDepartment of Otolaryngology-Head & Neck Surgery, University of South Florida, Tampa, FL, USA.
Victoria A SanchezDepartment of Otolaryngology-Head & Neck Surgery, University of South Florida, Tampa, FL, USA. vasanchez@usf.edu.ORCID http://orcid.org/0000-0001-5033-6643

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo evaluate the safety and tolerability and exploratory efficacy of OTO-413, an intratympanic-administered, sustained release formulation of brain-derived neurotrophic factor (BDNF) in a thermoreversible gel, in participants with speech-in-noise hearing difficulties.

methodsThis was a single dose, dose-ascending, randomized, double-blind, Placebo-controlled Phase 1/2 study conducted at 7 enrolling clinical sites in the U.S. 110 participants (56% female) enrolled had self-reported speech-in-noise (SIN) difficulties that were confirmed by a SIN test and were randomized to OTO-413 or Placebo. OTO-413 dose range was escalated from 0.01 mg to 1.5 mg within 7 Cohorts. Safety evaluations included monitoring for treatment-emergent adverse events, physical and audiological examinations, and monitoring for plasma BDNF and anti-BDNF antibodies. Exploratory efficacy outcomes included three SIN tests with the Digits-in-Noise Test (DIN), Words in Noise Test (WIN), and the American English Matrix Test (AEMT) and self-reported Patient Global Impression of Change (PGIC).

resultsThere were no study drug-related serious adverse events, and no audiometric safety concerns at any OTO-413 dose. Plasma levels of BDNF were comparable to endogenous levels of BDNF and anti-BDNF antibodies were not detected. An exploratory responder analysis indicated a numerical advantage for OTO-413 versus placebo over the three months of observation. Improvement was particularly evident with the WIN at the 0.3 mg dose. No improvement in PGIC was noted.

conclusionThis exploratory study demonstrated that a single intratympanic injection of OTO-413 was safe and well tolerated and provided evidence for a SIN hearing treatment benefit of 0.3 mg OTO-413.

trial registrationNCT04129775.

Indexed as

Clinical trialHearing lossHidden hearing lossIntratympanic injectionSpeech perceptionSynaptopathy

Identifiers

PMID42479273

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.