Post-lingual severe-to-profound bilateral sensorineural hearing loss in adults Ear, Nose and Throat
Conditions
Interventions
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 incl
Sponsors
Nurotron Global SARL
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Word recognition in quiet measured using Percentage of words correctly understood in a validated monosyllabic word recognition test administered via loudspeaker at 65 db SPL at Baseline, 1 month, 3 months, and 6 months post-activation;Device-related serious adverse events measured using Accumulated incidence of device-related adverse events triggering surgical reintervention, adjudicated by independent DSMB and Clinical Event Committee at Baseline through 12 months post-implantation | — |
Secondary
| Measure | Time frame |
|---|---|
| Sentence recognition in quiet measured using Percentage of words correctly understood in validated sentence test lists, presented via loudspeaker at 65 dB SPL at Baseline, 1 month, 3 months, and 6 months post-activation;Sentence recognition in noise measured using Percentage of words correctly understood in sentence test lists in noise at +5/+10 dB SNR at Baseline, 1 month, 3 months, and 6 months post-activation;Pure-tone audiometry thresholds measured using Aided acoustic pure-tone thresholds (dB HL) in the implanted ear at Baseline, 1 month, 3 months, and 6 months post-activation;Hearing related quality of life measured using quality of life questionnaire at Baseline and 3 months post-activation;All adverse events measured using Number and percentage of participants reporting each adverse event, including onset, severity, duration, course of action, and resolution; summarized by type and incidence. at Baseline through 12 months post-implantation | — |
Countries
England, Germany, Poland, Spain, United Kingdom
Contacts
Public ContactDan Jiang
Outcome results
None listed