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

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).

• Stability of improvement of speech perception performance at 12- and 36-months post-activation with CNC-words scores. [Срок оценки: 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. [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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). [Срок оценки: At 3-months post activation (visit 7) and 12 months (visit 9)]
• Longitudinal measures of patient reported outcomes in a newly-implanted population [Срок оценки: At 6-,12-,24- and 36 months post-activation (Visits 8,9,11,12)]
• Longitudinal measures of cognitive abilities in a newly implanted population [Срок оценки: At 12-24 and 36 months post-activation (Visits 9,11,12)]
• Longitudinal programming parameters (T- and C- levels) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: From activation (visit 5) throught study completion (an average of 3 years post activation)]
• Proportion of major postsurgical complications and AEs over time [Срок оценки: At surgery visit (i.e. visit 3, baseline visit, )]