Intracochlear Application of VSF1.01 for the Reduction of Cochlear Implant Surgery Related Trauma
Trial Parameters
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Men, women, inter/diverse aged ≥ 18 years * Women without childbearing potential defined as follows: * at least 6 weeks after surgical sterilization by bilateral tubal ligation or bilateral oophorectomy or * hysterectomy or uterine agenesis or * ≥ 50 years and in postmenopausal state \> 1 year or * Women of childbearing potential: * who are practicing sexual abstinence (periodic abstinence and withdrawal are not acceptable) or * who have sexual relationships with female partners only and/or with sterile male partners or * who are sexually active with fertile male partner, have a negative pregnancy test during screening and agree to use reliable methods of contraception from the time of screening until end of the clinical trial. * Signed written informed consent from subjects capable of understanding all information and to give full informed consent * Functional deaf patients (profound hearing loss with or without non-functional residual hearing in the low frequenc