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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P130016 / PAS002 |
| Date Original Protocol Accepted |
03/20/2014
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| Date Current Protocol Accepted |
06/16/2022
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| Study Name |
New Enrollment Study
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| Device Name |
NUCLEUS HYBRID L24 COCHLEAR IMPLANT SYSTEM
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| General Study Protocol Parameters |
| Study Design |
Prospective & Retrospective Study
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| Data Source |
New Data Collection
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| Comparison Group |
Device Subjects Serve as Own Control
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| Analysis Type |
Analytical
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| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
This is a new enrollment study.
The Nucleus Hybrid L24 Implant System New Enrollment Study will be conducted as a repeated-measures single-subject experiment.
Additional data will come from subjects in the Hybrid Extended Duration Study as well as real world evidence (RWE) from a retrospective study of patients at the University of Iowa. Data from the Hybrid Extended Duration study will be pooled with the New Enrollment study for analysis of effectiveness. Data from both the Hybrid Extended Duration study and the RWE study at the University of Iowa will be pooled with the New Enrollment study for analysis of safety.
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| Study Population |
Subjects will include a minimum of 50 newly implanted individuals, 18 years of age and older, who will be implanted with the Hybrid L24 cochlear implant from up to 25 investigational centers.
Data collected from two additional sources, including the Nucleus Hybrid Extended Duration post approval study and/or a retrospective review of standard of care clinical records will be included for a total population of up to 85 subjects for effectiveness analysis and 150 individuals for safety analysis.
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| Sample Size |
A total of 150 subjects would provide a precision (defined as the halfwidth of a two-sided 95% confidence interval) of approximately 11.9% or smaller. The three sources of data include:
1) A minimum of 50 subjects from this New Enrollment post approval study
2) Up to 35 subjects in continued follow-up in the Hybrid Extended Duration post approval study
3) A minimum of 65 subjects who were implanted outside of this New Enrollment post approval study following device approval and commercial availability using standard of care techniques.
This calculation is based on an exact binomial confidence interval.
Additionally, speech performance will be characterized in a total of 85 target subjects (range: 50-100 subjects, precision 4.7% - 8.2%).
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| Key Study Endpoints |
The primary effectiveness endpoint for this study will include the within- subject differences for a monosyllabic word recognition test, measured in two conditions: the implant ear alone and when using both ears together through 3 years post-activation
• Word recognition in quiet as evaluated with the Consonant Nucleus- Consonant (CNC) test
The secondary effectiveness endpoint for this study will include the within- subject differences for
a sentence recognition test:
• Sentence recognition in noise) best unilateral condition as evaluated with the AzBio test
The primary and secondary safety endpoints are the same as previous protocol.
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| Follow-up Visits and Length of Follow-up |
3 years post-activation for each subject.
Preoperative candidacy assessment/ Baseline evaluation Surgery, Initial activation, 3 months post-activation, 6 months post-activation, 12 months post-activation, Annual evaluation thereafter to 3 years post-activation
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
52 subjects were implanted in the New Enrollment Study. Forty-eight subjects completed the 1-year post-activation interval, and 38 subjects completed the 3-year post-activation interval.
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| Actual Number of Sites Enrolled |
19 sites
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| Patient Follow-up Rate |
At the 1-year timepoint, the rate was 92%.
At the 3-year timepoint, the rate was 73%.
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| Final Safety Findings |
A total of 223 Adverse Events (AEs) occurred during the New Enrollment Study, 99 of which were device and/or procedure-related. Twenty-five serious AEs were reported in 13 subjects during the PAS, but only one was related to the study device. These AEs included a significant decline in the residual low frequency pure-tone averages (PTA). When account for subject attrition, 36% of subjects at 3 years post-activation and 55% of subjects at 5 years post-activation had a total/profound ( > 90db HL) loss of residual hearing in the New Enrollment Study. The real-world data (RWD) safety data shows similar rates of decline in low-frequency PTAs. 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 3-year post-activation interval is similar to that observed in the previous Extended Duration study.
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| Final Effect Findings |
Through the 3-year post-activation follow-up, the Hybrid L24 improves overall mean CNC Word (in quiet) and AzBio (sentences in noise at +5 and/or +10 dB SNR) scores compared with pre-implant baseline unilateral and bilateral conditions. The device benefit is sustainable over the three years of follow up. Subjective hearing benefit improved over the baseline.
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| 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 follow-up rate. The New Enrollment Study is supplemented with RWD, which provides an additional source of safety data.
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| Recommendations for Labeling Changes |
Yes, labeling changes were recommended
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