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|
| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P000025 S134/ PAS001 |
| Date Original Protocol Accepted |
01/23/2026
|
| Date Current Protocol Accepted |
01/23/2026
|
| Study Name |
MED-EL Cochlear Implant Pediatric PAS
|
| Device Name |
MED-EL CI System
|
| Clinical Trial Number(s) |
NCT03900897
|
| General Study Protocol Parameters |
| Study Design |
Retrospective Cohort Study
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
Device Subjects Serve as Own Control
|
| Analysis Type |
Analytical
|
| Study Population |
Infant: 29 days < 2 yrs,
Child: 2 yrs < 12 yrs,
Adolescent: 13-18 yrs
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Pediatric Expansion Post-Approval Study (PEPAS) in the MED-EL Cochlear Implant Population combines an extended follow-up
study and a new, prospectively designed, retrospective study to assess long-term safety and effectiveness of cochlear implantation up to a minimum of 2 years post-implantation in children aged 7 months to 18 years.
|
| Study Population |
The target study population will include approximately 100 children implanted at ages greater than or equal to 7 months to < 18 years. Cohort 1 will include approximately 26 children prospectively implanted at ages greater than or equal to 7 to < 12 months in IDE G180269. Cohort 2 will include 30 new retrospective participants implanted at ages greater than or equal to 1 to < 6 years. Cohort 3 will include 50 new retrospective participants implanted at ages greater than or equal to 6 to < 18 years. Study participants will include children with bilateral SNHL who received a MED-EL cochlear implant before January 1, 2024, and meet the expanded indications approved in PMA Supplement P000025/S134.
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| Sample Size |
Cohort 1 will consist of 26 subjects implanted at ages greater than or equal to 7 to < 12 months from pivotal study G180269.
Cohort 2 will include 30 new subjects implanted at ages greater than or equal to 1 to < 6 years.
Cohort 3 will include 50 new subjects implanted at ages greater than or equal to 6 to < 18 years.
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| Key Study Endpoints |
Primary effectiveness endpoint:
The primary effectiveness endpoint is to evaluate the performance of the cochlear implant on age-appropriate speech tests. Formal hypothesis tests are planned to establish superiority of the 24-month post-operative condition over the pre-operative condition. A within-subject analysis will be conducted on at least 75% of subjects who will demonstrate clinical success by 2 years post-activation on developmentally-appropriate measures of subjective benefit (e.g., improvement of greater than or equal to 25 percentage points on developmentally-appropriate parent questionnaires) or speech recognition (e.g., improvement of greater than or equal to 10 percentage points on the same developmentally-appropriate speech recognition test or non-zero score on a more difficult test in the speech recognition hierarchy) when compared to pre-implantation baseline or first available postoperative score.
Secondary Effectiveness endpoint:
1. Mean postoperative audibility, defined by aided thresholds at 125-8000 Hz in the cochlear implant ear(s) alone through 2 years post-activation, including functional gain in subjects with preoperative thresholds available for comparison.
2. Mean improvement on available outcome measures in subjects with preoperative and postoperative scores on the same test.
A descriptive analysis of change in audiometric thresholds and speech performance pre- to post-operatively will be conducted to demonstrate improving speech recognition.
Primary safety endpoint:
The primary safety endpoint will be summarized with the number and percentage of participants experiencing an adverse device effect (ADE) through 2 years.
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| Follow-up Visits and Length of Follow-up |
2 years post-implantation for each subject.
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