|
|
| General |
| Study Status |
Hold |
Application Number /
Requirement Number |
P200021 / PAS001 |
| Date Original Protocol Accepted |
08/20/2021
|
| Date Current Protocol Accepted |
05/27/2022
|
| Study Name |
New Enrollment Study
|
| Device Name |
Neuro Cochlear Implant System
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Device Subjects Serve as Own Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The Neuro Cochlear Implant System Post Approval Study (PAS) 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 up to a minimum of 3 years post-implantation in adult population (aged 18 yrs and older). It is a prospective multi-center, one arm, non-randomized,
open label, repeated measures clinical study.
|
| Study Population |
60 adult subjects meeting the inclusion criteria
|
| Sample Size |
60
|
| Key Study Endpoints |
Primary effectiveness endpoint:
The primary effectiveness measures will be the within-subject
differences between AzBio scores obtained in Quiet at 12- and 36-months post-surgery with their cochlear implant alone and preoperative, best-aided scores.
Secondary Effectiveness endpoints:
Within-subject difference between CNC scores obtained in Quiet at 12- and 36-months post-surgery with their cochlear implant alone and pre-operative, best-aided scores.
AzBio Sentence scores at 1 month in Quiet
Az Bio sentences (Quiet and Noise) and CNC word scores at 3 months, 6 months and 24 months
AzBio sentences +10dB SNR and 5dB SNR at 3 months and 12 months (bimodal)
Patient reported outcome (PRO) measures including quality of life, listening effort and tinnitus at 6-,12-,24- and 36 months postactivation
Scores on a cognitive assessment at 12-24 and 36 months postactivation
T and C levels collected at all intervals
Electrode impedances collected at all intervals
eCAP responses collected in the operating room
Surgeon perception of handling of the Neuro Zti and electrode array as well as information related to surgical technique
Primary safety endpoint:
The primary safety endpoint is the description of the type and frequency of all adverse events and serious adverse events occurring during the study period. All device failures (internal and external parts) will be documented and reported according to the AAMI C186 reporting standard
|
| Follow-up Visits and Length of Follow-up |
36 months post-implantation for each subject
|
