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.
Men, women, inter/diverse aged ≥ 18 years
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
Patients with prior ear surgery
Patients with inner ear malformations
Patients with acute or chronic otitis media
Patients with keloid disorder