Intracochlear Application of VSF1.01 for the Reduction of Cochlear Implant Surgery Related Trauma

The goal of this clinical trial is to assess the safety of intracochlear application of VSF1.01 for the reduction of cochlear implant surgery related trauma in patients with profound hearing loss with or without non-functional residual hearing in low frequencies and cochlear implantation. The main questions it aims to answer are: Primary objective: Safety of intracochlear application of VSF1.01 in patients receiving cochlear implantation Secondary objectives: Effectiveness on 1. neural responses of auditory nerve 2. speech understanding 3. hearing thresholds 4. electrode impedances During cochlear implant operation, patients receive as adjuvant treatment intracochlear VSF1.01 prior to insertion of the electrode array. Cochlear implantation is conducted according to the clinical standard at the investigational site.

NCT Number	NCT06545175
Lead Sponsor	Hannover Medical School
Conditions	Hearing Loss
Enrollment	10 participants
Start Date	2024-11-18
Primary Completion	2026-10-28 (estimated)
Study Completion	2026-10-28 (estimated)
Updated on ClinicalTrials.gov	2026-07-16