|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P130016 / PAS001 |
| Date Original Protocol Accepted |
03/20/2014
|
| Date Current Protocol Accepted |
09/11/2014
|
| Study Name |
Extended f/u study
|
| Device Name |
NUCLEUS HYBRID L24 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 |
This is an extended follow-up of the premarket cohort. The purpose of the study is to evaluate the long term safety and effectiveness of the Nucleus Hybrid L24 Implant in implanted subjects out to 5 years post-activation. It is a prospective, multicenter, non-controlled, non-randomized study
|
| Study Population |
Subjects from the original pivotal study and
associated Continued Access study who remain implanted with Hybrid L24 Implant, enrolled in the study, and have not met their 5 year post-activation interval.
|
| Sample Size |
Up to 35 subjects.
|
| Key Study Endpoints |
The primary safety endpoint will be the comparison of the type
and frequency of adverse events and serious adverse events occurring over the course of this study up to the 5 year post- activation interval as compared to the pivotal clinical study for the Hybrid L24 implant.
The co-primary efficacy endpoints for this study will be the
assessment of statistical significance of the within-subject differences for two speech recognition tests (CNC test and AzBio test), measured in two conditions: the implant ear and both ears
|
| Follow-up Visits and Length of Follow-up |
5 years post-activation for each subject
2 years post-activation (if not yet completed), 3 years post- activation (if not yet completed), 4 years post-activation (if not yet completed), 5 years post-activation (if not yet completed)
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
35
|
| Actual Number of Sites Enrolled |
8
|
| Patient Follow-up Rate |
100% at 5 years*
The primary endpoint for this investigation is 5 years post-activation of the Hybrid L24 device.
As of March 18, 2019, all 35 enrolled subjects have reached this designated study phase.
|
| Final Safety Findings |
A total of eight (8) Adverse Events (AEs) occurred during this PAS.
Serious AEs in three (3) subjects were reported during the PAS, but only one (1) was related to the study
device. This included a significant decline in residual low frequency hearing thresholds that was
accommodated by explantation of the study device and replacement with a traditional cochlear implant
was accomplished electrode array. There were no unanticipated adverse device effects reported. In
general, the type and frequency of adverse events and serious adverse events occurring over the course
of this study up to 5 year post-activation interval as compared to the pivotal clinical study for the Hybrid
L24 implant
|
| Final Effect Findings |
Through the 5-year post-activation follow-up, the Hybrid
L24 improves overall mean CNC Word (words in quiet) and AzBio (sentences in noise at +5 dB SNR)
scores compared with pre-implant baseline unilateral and bilateral conditions. The device benefit is
sustainable over the five years of follow up.
|
| Study Strengths & Weaknesses |
This is a single arm study with no comparator; however, the subjects
served as their own control. It is a long-term study (up to 5 years post-implantation) with a high followup
rate.
|
| Recommendations for Labeling Changes |
Yes. A labeling update is recommended to reflect the findings of the study.
|
