Evaluation of safety and effectiveness the Nurotron CS-30A cochlear implant system in adults
Post-lingual severe-to-profound bilateral sensorineural hearing loss in adults
This is a prospective, multicentre, single-arm interventional study. Participants will undergo implantation with the Nurotron CS-30A Cochlear Implant System in the ear selected according to study inclusion criteria. The device consists of an implantable internal unit and an external speech processor that converts sound into electrical stimulation of the auditory nerve. Following baseline assessments (aided and unaided hearing thresholds, speech perception tests, and quality-of-life questionnaire), participants will undergo cochlear implantation surgery. The external speech processor will be activated approximately 1–6 weeks post-surgery, with device fitting, programming, and rehabilitation sessions provided using the NuroSound system. Outcomes will be assessed at follow-up visits at 1, 3, 6, and 12 months after activation. Primary efficacy endpoints include aided word and sentence recognition in quiet and in noise, and secondary endpoints include hearing-related quality of life. Safety is monitored through adverse event reporting, adjudicated by an independent Data Safety Monitoring Board and Clinical Event Committee.
1. 18 years or older 2. Post-lingual onset of severe sensory neural hearing loss (from 6 years old or older) 3. Local language proficiency 4. In the ipsilateral ear: unaided acoustic pure-tone thresholds of ≥ 50 dB HL at 500 Hz, ≥ 60 dB HL at 1000 Hz, ≥ 70 dB HL by 2000, 4000 and 8000 Hz; Marginal hearing aid benefit, defined as word recognition score of ≤ 50% in the best-aided condition at 65dB SPL without lip-reading; Duration & performance situation at base-line, sensory neural loss level ≥ 3 months stable (preferably ≥ 6 months) unless risk of imminent obliteration
1. Previous ear surgery that could compromise the inner ear 2. Indication of a central auditory lesion or compromised auditory nerve (ideally confirmed by preoperative MRI) 3. Cochlear malformation or obstruction that would preclude full insertion of electrode array 4. Presence of additional disabilities that would prevent or interfere with participation in the required study procedures; 5. Medical or physiological conditions that contraindicate surgery or impact the ability to manage an implanted device or the study related procedures (e.g. silicone allergy) 6. Presence of magnetically adjustable CSF shunts or any active implantable medical device in the study candidate at the time of informed consent signature