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

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 frequencies i.e. 125 Hz: 45 dB - 95 dB; 250 Hz: 50 dB - 105 dB; 500 Hz: 55 dB - 110 dB; 750 Hz and higher: 65 dB or below) that are candidates for cochlear implantation Exclusion Criteria: * Patients with prior ear surgery * Patients with inner ear malformations * Patients with acute or chronic otitis media * Patients with keloid disorder * Comorbidities concerning the central nervous system * Malignancies of any type * Kidney disease with elevated blood values: creatin…