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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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New Enrollment Study


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General
Study Status Study Pending
Application Number P200021 / PAS001
Date Current Protocol Accepted  
Study Name New Enrollment Study
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 Design Description 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 Description 60 adult subjects meeting the inclusion criteria
Sample Size 60
Data Collection 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


New Enrollment Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 12/22/2021    
1 year report 06/23/2022    
18 month report 12/22/2022    
2 year report 06/23/2023    
3 year report 06/22/2024    
4 year report 06/22/2025    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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