Taking people in TürkiyeNo phase
Otoferlin Gene-mediated Hearing Loss Natural History Study
Key facts
- Who runs it
- Akouos, Inc.
- Where
- Ankara, TürkiyeSee the siteAlso in 6 other countries, 9 sites
- Trial code
- Status
- Recruiting
- People taking part
- 150 people, planned
- Started
- 14 Jul 2022
- Expected to end
- Feb 2029
- Type of study
- Observational, 2 groups
- Treatments tested
- Natural History Study
- Record updated
- 4 March 2026
Who can take part
- Age
- Up to 44 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- Clinical presentation of bilateral sensorineural hearing loss (SNHL), including auditory neuropathy (AN) / auditory neuropathy spectrum disorder (ANSD) phenotype or medical history of AN / ANSD phenotype earlier in life
- Mutation(s) in the otoferlin gene
- Able and willing to comply with all study requirements, as evidenced by successful completion of the informed consent (and assent, if applicable) process; Additional Criteria for Inclusion in the Prospective Phase:
- Presence of OAE / CM and absent / abnormal ABRs in at least one ear (that does not have a cochlear implant) within 12 months prior to or at the Month 0 visit
Who cannot take part
- Presence of bilateral cochlear implants at the time of record review or planned within the next 6 months
- Presence of middle ear or auditory brainstem implant(s) at the time of record review or planned within the next 6 months
- Any condition that would not allow the potential participant to complete follow-up assessments during the course of the study and/or, in the opinion of the Investigator, makes the potential participant unsuitable for the study; Note: Potential participants will not be excluded based on their sex, gender, race, or ethnicity
- Unwillingness or inability of the potential participant and/or legally authorized representative to comply with all protocol requirements
- Presence of cochlear nerve deficiency and/or cochlear nerve dysplasia; Additional Criteria for Exclusion from the Prospective Phase:
Where in Türkiye
Also in 6 other countries, 9 sites
- Ankara UniversityAnkara, TürkiyeContact: Akouos Clinical TrialsTaking people
About the trial
What the trial wants to find out
This is a retrospective and prospective longitudinal study in participants with Otoferlin Gene-Mediated Hearing Loss.
The 2 groups in the trial
- Retrospective
Treatment: Natural History Study
- Prospective
Treatment: Natural History Study
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Natural History Study in Individuals With Otoferlin Gene-mediated Hearing Loss
- Record updated
- 4 March 2026