Actively Recruiting
Otoferlin Gene-mediated Hearing Loss Natural History Study
Led by Akouos, Inc. · Updated on 2026-03-04
150
Participants Needed
10
Research Sites
342 weeks
Total Duration
On this page
Sponsors
A
Akouos, Inc.
Lead Sponsor
E
Eli Lilly and Company
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a retrospective and prospective longitudinal study in participants with Otoferlin Gene-Mediated Hearing Loss.
CONDITIONS
Official Title
Otoferlin Gene-mediated Hearing Loss Natural History Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical presentation of bilateral sensorineural hearing loss, including auditory neuropathy spectrum disorder phenotype or history
- Mutation(s) in the otoferlin gene
- Able and willing to comply with all study requirements and complete informed consent
- For prospective phase: presence of otoacoustic emissions or cochlear microphonics and absent or abnormal auditory brainstem responses in at least one ear without cochlear implant within 12 months prior to or at Month 0 visit
You will not qualify if you...
- Unwillingness or inability to comply with all protocol requirements
- Presence of cochlear nerve deficiency or cochlear nerve dysplasia
- For prospective phase: bilateral cochlear implants at record review or planned within 6 months
- For prospective phase: presence of middle ear or auditory brainstem implants at record review or planned within 6 months
- Any condition preventing completion of follow-up assessments or making participant unsuitable in investigator's opinion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
2
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
3
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
4
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232-8605
Actively Recruiting
5
Murdoch Children's Research Institute
Parkville, Victoria, Australia, VIC 3052
Withdrawn
6
University Hospital in Tübingen
Tübingen, Germany, 72076
Actively Recruiting
7
Sant Joan de Déu Barcelona Hospital
Esplugues de Llobregat, Barcelona, Spain, 08950
Actively Recruiting
8
National Taiwan University Hospital
Taipei, Taiwan, 100
Actively Recruiting
9
Ankara University
Ankara, Turkey, Turkey (Türkiye), 06230
Actively Recruiting
10
University College London
London, United Kingdom, United Kingdom, NW1 2PG
Actively Recruiting
Research Team
A
Akouos Clinical Trials
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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