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 ligationor 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 withdrawalare not acceptable) or

• who have sexual relationships with female partners only and/or withsterile male partners or

• who are sexually active with fertile male partner, have a negativepregnancy test during screening and agree to use reliable methods ofcontraception from the time of screening until end of the clinical trial.

• Signed written informed consent from subjects capable of understanding allinformation and to give full informed consent

• Functional deaf patients (profound hearing loss with or without non-functionalresidual 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 arecandidates 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: creatinine >1.5x above upper limit ofnormal (ULN), eGFR or creatinine clearance 59 mL/min/1.73 m2 (grade ≥2, CTCAE v5.0)

• Liver disease with elevated blood values: bilirubin >1.5x ULN, AST/ALT >3.0x ULN,ALP and y-GT >2.5x ULN, LDH >ULN, international normalized ratio (INR) >1.5-2.5xbaseline if on anticoagulation, albumin <3 g/dL (grade ≥2, CTCAE v5.0)

• Suspected or verified pregnancy or breastfeeding

• Hypersensitivity to any of the components of the medications used (such as Ringer'sLactate (excipient); any residuals from cell culture or raw materials used forpharmaceutical upstream and downstream processing to generate VSF1.01 (i.e.alpha-Modified Eagle Medium (αMEM), Dulbecco's MEM (DMEM), pooled human plateletlysate (pHPL), human serum albumin (HSA), Dipeptiven, phosphate buffered saline (PBS), animal origin free recombinant enzyme (TrypLETM Select))

• Participation in another clinical trial (other investigational drugs or devices atthe time of enrolment or within 30 days prior to enrolment)