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|
| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P970051 S205/ PAS001 |
| Date Original Protocol Accepted |
03/11/2022
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| Date Current Protocol Accepted |
06/08/2023
|
| Study Name |
Cochlear New Enrollment SSD/UHL Study
|
| Device Name |
Nucleus 24 Cochlear Implant System
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
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| Comparison Group |
Device Subjects Serve as Own Control
|
| Analysis Type |
Analytical
|
| Study Population |
Child: 2-12 yrs,
Adolescent: 13-18 yrs,
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
This clinical study will be conducted as a prospective, nonrandomized, single-arm multicenter investigation in which each participant serves as his/her own control.
|
| Study Population |
Individuals 18 years or older (Group A) and children 5 years to 17 years 11 months (Group B)
|
| Sample Size |
60 subjects at 15 sites
30 subjects aged 18 and above
20 subjects aged 5-11 years; 11 months
10 subjects aged 12-17 years; 11 months
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| Key Study Endpoints |
Primary Effectiveness Endpoints:
1. The improvement in sentences in noise scores obtained at the 12 months post-activation interval in the bimodal (CI + NH) listening condition compared to scores obtained preoperatively in the best listening condition (normal hearing alone or normal hearing + hearing aid) when the speech is presented from the front and noise is presented to the normal hearing ear (SONNH).
2. The improvement in sentences in noise scores obtained at the 12 months post-activation interval in the bimodal (CI + NH) listening condition compared to scores obtained preoperatively in the best listening condition (normal hearing alone or normal hearing + hearing aid) when the speech is presented from the front and noise is presented to the normal hearing ear (SONCI).
3. The improvement in sentences in noise scores obtained at the 12 months post-activation interval in the bimodal (CI + NH) listening condition compared to scores obtained preoperatively in the best listening condition (normal hearing alone or normal hearing + hearing aid) when the speech is presented from the front and noise is presented to the normal hearing ear (SON0).
Primary Safety Endpoint
1. Incidence of procedural and device related adverse events reported through the duration of the study
Secondary Effectiveness Endpoints
1. Mean improvement in word recognition at 12 months in the CI alone condition compared to preoperative aided performance in the poorer hearing ear alone.
2. Improvement in patient reported spatial hearing at 12 months post-activation compared to the reported outcome preoperatively.
Additionally, longitudinal hearing performance, 12-months to 36 months will be analyzed.
|
| Follow-up Visits and Length of Follow-up |
36 months
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| Interim or Final Data Summary |
| Interim Results |
N/A
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| Actual Number of Patients Enrolled |
4 subjects, 0 subjects implanted
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| Actual Number of Sites Enrolled |
8
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| Patient Follow-up Rate |
N/A
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