Otoferlin Gene-mediated Hearing Loss Natural History Study
Key facts
- Where
- Taipei, TaiwanSee the site
Where in Taiwan
- National Taiwan University HospitalTaipei, TaiwanContact: Akouos Clinical TrialsTaking people
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 doctorTrial details
- Who runs it
- Akouos, Inc.
- Trial code
- NCT05572073
- Record updated
- 4 March 2026
- Original description
This is a retrospective and prospective longitudinal study in participants with Otoferlin Gene-Mediated Hearing Loss.Read full original descriptionShow less
A Natural History Study in Individuals With Otoferlin Gene-mediated Hearing Loss
This is a retrospective and prospective longitudinal study in participants with Otoferlin Gene-Mediated Hearing Loss.
Inclusion: 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.
Exclusion: 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:.