Safety, Tolerability, Efficacy of EA0010 in OTOF Patients With CI

This study will evaluate the safety, tolerability, and efficacy of EA0010 injection in patients with OTOF-related hearing loss who have already undergone cochlear implantation. Conventional gene therapy generally excludes cochlear implant recipients, based on the concern that the electrode array may compromise the reparative potential of inner ear cells. To further address this clinical issue, the present study is designed to enroll cochlear implant users and administer a single intratympanic injection of EA0010 through the stapes annular ligament into the implanted cochlea. One subject is planned to be enrolled, and post-administration assessments of both safety and efficacy will be performed.

NCT Number	NCT07752888
Lead Sponsor	Shanghai EmayGene Technology Co., Ltd Collaborators: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Conditions	DFNB9, Cochlear Implantation
Enrollment	1 participants
Start Date	2026-05-23
Primary Completion	2027-05-31 (estimated)
Study Completion	2027-07-31 (estimated)
Updated on ClinicalTrials.gov	2026-08-12