Post Approval Study to Assure the ContInued saFety and effectIveness of Neuro Cochlear Implant System in Adult Users

Study Overview
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Brief Summary
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On June 23, 2021, the Oticon Medical Neuro Cochlear Implant System (NCIS) was granted premarket approval (PMA) in the US to treat individuals 18 years or older, with bilateral severe-to-profound sensorineural hearing loss, who obtain limited benefit from appropriately fitted hearing aid(s). To help assure the continued safety and effectiveness of an approved device, a post-approval study was required as a condition of approval under 21 CFR 814.82(a)(2). The purpose of this study is to provide longer-term data on the safety and effectiveness of the Neuro Cochlear Implant System under general conditions of use in the postmarket environment.

Detailed Description
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The post-approval study will be an open-label, prospective, multi-center, single-arm, non-randomized, self-controlled clinical trial in 10 clinical sites in the US. The purpose of this study is to provide longer-term data on the safety and effectiveness of the Neuro Cochlear Implant System under general conditions of use in the postmarket environment. This study will be conducted as a prospective, non-controlled, non-randomized study in 10 clinical sites. A total of 60 subjects, newly treated will be enrolled. Study subjects will be followed for 3 years post implantation of the device with a target follow-up rate of 80% at the end of the study The primary safety endpoint is the comparison of the type and frequency of adverse events and serious adverse events observed during the study period. The effectiveness endpoints will include the within-subject differences for sentence recognition as evaluated with the AzBio test. The study will include the following visits: baseline, 1-month post-surgery (activation date), 3 months, 6-months, 12-months, 18-months, 24-months, and 36-months post-activation. Each participant will serve as their own control with baseline measurements. The total estimated duration of the study is 60 months: 24 months of recruitment and 36 months of subject participation. The first patient is expected to be included within 6 months of study approval (obtained on August 19, 2021).

Official Title
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Post Approval Study to Assure the ContInued saFety and effectIveness of Neuro Cochlear Implant System in Adult Users

Conditions
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Sensorineural Hearing Loss, Bilateral, Sensorineural Hearing Loss, Severe, Sensorineural Hearing Loss, Profound

Intervention / Treatment
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* Device: Neuro Cochlear Implant system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals 18 years of age or older Obtain limited benefit from appropriately fitted hearing aids Bilateral severe-to-profound sensorineural hearing loss _ Severe-to-profound hearing loss is determined by a pure-tone average (PTA) superior or equal (≥) to 70 dB HL at 500, 1000 and 2000 Hz. Limited benefit from amplification is defined by scores of 50% or less on a validated sentence recognition test in quiet (AzBio sentences), in the best-aided listening condition _ Exclusion Criteria: Previous cochlear implantation Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array Active external or middle ear infections or tympanic membrane perforation in the ear to be implanted Presence of medical contraindications to middle-ear or inner-ear surgery or anesthesia as required Diagnosis of retro-cochlear pathology Diagnosis of auditory neuropathy Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and use of the prosthetic device Unwillingness or inability to comply with all investigational requirements Additional cognitive, medical, or social handicaps that would prevent completion of all study requirements

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Neuro Cochlear Implant system|Patients will be regular candidates for a cochlear implantation surgery, according to the indication criteria of the Neuro Cochlear Implant System and the device will be used according to its intended purpose|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stability of improvement of speech perception performance at 12- and 36-months post-activation with AzBio sentence scores. | Average scores for AzBio sentence tests will be recorded in Quiet at 12- and 36-months post-activation and compared to pre-operative (baseline) measures. The AzBio sentence test is a validated sentence recognition test in quiet and has a score range of 0-100% with higher values indicating better scores. | At 12- and 36-months post-activation (visit 9 and visit 11) | 
| Safety outcome | Occurrence and severity of all adverse events and serious adverse events occuring during the study period. All device failures (internal and external parts) will be documented. | From Visit 1(8- 12 weeks pre-surgery) to Visit 12 (36 Months post-activation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stability of improvement of speech perception performance at 12- and 36-months post-activation with CNC-words scores. | Consonant-Nucleus-Consonant (CNC) scores will be recorded in Quiet at 12- and 36-months post-activation and compared to pre-operative (baseline) measures. The CNC word test has a score range of 0-100% with higher values indicating better scores. | At 12- and 36-months post-activation (visit 9 & visit 12) | 
| Stability of outcomes over time using AzBio Sentence scores at 1 month in Quiet. | Scores for AzBio sentence tests will be recorded in Quiet at 1-month post-activation in quiet and compared to pre-operative (baseline) measures. The AzBio sentence test is a validated sentence recognition test in quiet and has a score range of 0-100% with higher values indicating better scores. | At 1 month post-activation (Visit 6) | 
| Stability of outcomes over time using AzBio sentences in Quiet and Noise at 3- ; 6- and 24-months post-activation | Average scores for AzBio sentence tests will be recorded in Quiet at 3- ; 6- and 24-months post-activation and compared to pre-operative (baseline) measures. The AzBio sentence test is a validated sentence recognition test and has a score range of 0-100% with higher values indicating better scores. | at 3 months(visit 7), 6 months (visit 9) and 24 months (visit 11) | 
| Stability of outcomes over time using CNC word scores at 3-, 6- and 24-months | Average scores for CNC word test will be recorded at 3-, 6- and 24 months post-activation and compared to pre-operative (baseline) measures. The Consonant-Nucleus-Consonant (CNC) word test has a score range of 0-100% with higher values indicating better scores. | At 3 months(visit 7), 6 months (visit 9) and 24 months (visit 11) | 
| Stability of outcomes over time for patients under a bimodal condition (i.e., patient wearing a contralateral hearing aid). | Average scores for AzBio sentence tests will be recorded in Noise (at +10dB SNR), at 3- and 12-months post-activation and compared to pre-operative (baseline) measures. The AzBio sentence test is a validated sentence recognition test and has a score range of 0-100% with higher values indicating better scores. | At 3-months post activation (visit 7) and 12 months (visit 9) | 
| Longitudinal measures of patient reported outcomes in a newly-implanted population | Patient reported outcome (PRO) measures including quality of life, listening effort and tinnitus at 6-,12-,24- and 36 months post-activation | At 6-,12-,24- and 36 months post-activation (Visits 8,9,11,12) | 
| Longitudinal measures of cognitive abilities in a newly implanted population | Scores on a cognitive assessment at 12-24 and 36 months post-activation | At 12-24 and 36 months post-activation (Visits 9,11,12) | 
| Longitudinal programming parameters (T- and C- levels) | T and C levels collected at all intervals | At activation (Visit 5), then from 3 months post-activation (V7) throught study completion (an average of 3 years post activation) | 
| Longitudinal device functionality measures (impedances) | Electrode impedances collected at all intervals | At activation (Visit 5), then from 3 months post-activation (V7) throught study completion (an average of 3 years post activation) | 
| Pedictors of outcomes: Electrode impedances collected at all intervals | Electrode impedances collected at all intervals | At surgery visit (Visit 3 baseline visit) then from activation, 1-month post surgery( visit 5) throught study completion (an average of 3 years post activation) | 
| Pedictors of outcomes: eCAP responses collected in the operating room | eCAP responses collected in the operating room | From activation (visit 5) throught study completion (an average of 3 years post activation) | 
| Proportion of major postsurgical complications and AEs over time | Surgeon perception of handling of the Neuro Zti and electrode array as well as information related to surgical technique | At surgery visit (i.e. visit 3, baseline visit, ) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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candidates for a cochlear implantation surgery, patients aged 18 years and older