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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P970051 S172/ PAS001 |
| Date Original Protocol Accepted |
05/15/2020
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| Date Current Protocol Accepted |
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| Study Name |
Nucleus 24 Pediatric Post-Approval Study
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| Device Name |
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
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| General Study Protocol Parameters |
| Study Design |
Retrospective Cohort Study
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| Data Source |
Sponsor Registry
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| Comparison Group |
Device Subjects Serve as Own Control
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| Analysis Type |
Descriptive
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| Study Population |
Infant: 29 days-2 yrs
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| Detailed Study Protocol Parameters |
| Study Objectives |
The Nucleus 24 Cochlear Implant Pediatric Post Approval Study (PAS) combines an extended follow-up study (Cohort 1) and a new, prospectively-designed, retrospective study (Cohort 2) to assess long-term safety and effectiveness of cochlear implantation up to a minimum of 2 years post-implantation in children aged 9-12 months. It is a retrospective, non-controlled, non-randomized, multicenter study.
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| Study Population |
All available 84 subjects who were enrolled in the pre-market, prospectively-designed, retrospective study for the extended follow-up study (Cohort 1) and a minimum of 50 subjects implanted at age of 9-12 months for the new, prospectively-designed, retrospective study (Cohort 2).
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| Sample Size |
Cohort 1 will consist of 84 subjects from the original study. Cohort 2 will include at least 50 new subjects.
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| Key Study Endpoints |
Primary effectiveness endpoint:
To evaluate the performance of the cochlear implant on parental questionnaires. 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 a minimum of 80% of subjects who have the same pre- to post-operative parental questionnaire available for comparison. Additional statistical hypothesis tests will be based on t-tests with a one-sided 0.025 alpha level. The formal statistical analysis plan will include a non-parametric test to be used in the event the conditions of normality are not met.
Results will be compared to the existing body of literature regarding the administration of these metrics in both typical-hearing and hearing-impaired populations.
Secondary Effectiveness endpoint:
To evaluate the performance of the implant on audiometric thresholds. A descriptive analysis of change in audiometric thresholds pre- to post-operatively will be conducted to demonstrate the effectiveness of the device in providing access to sound.
Primary safety endpoint:
To demonstrate the rate of adverse events gathered in Cohort 2 and in the extension of Cohort 1 is qualitatively similar to the events reported in the original RWE dataset.
At a minimum, adverse events will be sorted into the following categories:
temperature regulation issues and/or instances of arrhythmia during surgery
post-operative complications
facial nerve injuries
swelling/irritation related to the device(s)
ear-related infections/conditions
CSF leak
device migration/extrusion due to skull growth (in young children)
readmissions to the hospital within 30 days of surgery
skin flap breakdown
extrusions
Rate of device-/procedure-/otologic-related events will be classified using the criteria outlined in Cohen and Hoffman (1991) and compared to the published literature.
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| Follow-up Visits and Length of Follow-up |
2 years post-implantation for each subject.
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| Interim or Final Data Summary |
| Interim Results |
N/A
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| Actual Number of Patients Enrolled |
84 (Cohort 1); 51 (Cohort 2)
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| Actual Number of Sites Enrolled |
5
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| Patient Follow-up Rate |
N/A
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| Final Safety Findings |
Sites were asked to collect any untoward medical occurrences documented in the EHR for the specified time frame. The sponsor reports that a total of 16 events (ear-related infections/conditions) in 13 subjects (13/134 = 9.7%) were reported in the combined dataset. Four (4) events were reported for Cohort 1 (data collected between 6 months and 2 years post-operatively), and 12 events were reported for Cohort 2 (data collected out to two years post-operatively). Out of the 16 separate events that were reported, 8 were device/procedure-related (“definitely related”) or “possibly related”) (2 for Cohort 1 and 6 for Cohort 2) and 5 (1 for Cohort 1 and 4 for Cohort 2) met Medical Device Reporting (MDR) criteria due to their relationship to the device/procedure and requirement of surgical or antibiotic intervention. All resolved.
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| Final Effect Findings |
Primary Effectiveness Endpoint: The primary effectiveness endpoint of this amendment (PAS) was to evaluate the performance of the cochlear implant on parental questionnaires. The sponsor concludes that the results of Cohort 1 and Cohort 2 compared to the existing body of literature regarding the administration of these metrics in both typical-hearing and hearing-impaired populations show that this data are qualitatively similar to the available published data for both the IT-MAIS (Robbins et al., 2004; Waltzman & Roland, 2005; Zimmerman-Phillips, Robbins, & Osberger, 2000) and LittlEARS (Connix et al., 2019; May-Mederake et al., 2010) questionnaires. Overall, the sponsor concludes that subjects within this data set demonstrated significant improvement in auditory skill development as demonstrated through administration of parental questionnaires pre- versus post-operatively. See below for assessment. Secondary Effectiveness Endpoint: The secondary effectiveness endpoint of this was to evaluate the performance of the implant on aided audiometric thresholds. The sponsor reports that data collected through this amendment demonstrate a significant improvement in audiometric threshold following cochlear implantation, demonstrating that the use of the device provides improved access to auditory information.
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| Study Strengths & Weaknesses |
N/A
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| Recommendations for Labeling Changes |
Yes
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