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

Summary

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.

Timeline

Start

2024-11-18

Primary completion

2026-10-28

Completion

2026-10-28

Drugs

Indications