NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Device Facts
| Record ID | P970051 |
|---|---|
| Device Name | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM |
| Applicant | Cochlear Americas |
| Product Code | MCM · Ear, Nose, Throat |
| Decision Date | Jun 25, 1998 |
| Decision | APPR |
| Device Class | Class 3 |
| Attributes | Real-World Evidence |
Real-World Evidence
| Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags |
|---|---|---|---|---|---|
| P970051 · Jun 25, 1998 | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM | Cochlear Americas | Retrospective clinical data from two CI centers (n=32); Systematic literature review of peer-reviewed clinical studies | The applicant combined data from a prospective feasibility study (n=10) and retrospective RWD (n=32) to establish effectiveness for the SSD/UHL indication. A systematic literature review was used to provide supporting evidence for both safety and effectiveness in adult and pediatric populations. | Single-sided deafness; Unilateral hearing loss; Retrospective analysis; Systematic literature review; Bimodal listening condition |
Clinical Evidence
| Study Design | Population | Comparator | Key Endpoints |
|---|---|---|---|
| Combined Feasibility Study and Real-World Data Analysis; Prospective analysis of feasibility study data combined with retrospective real-world data; Follow-up/Duration: 6, 12, and 24 months postoperatively | Adults with single-sided deafness (SSD) or unilateral hearing loss (UHL); Sample Size: 42 (10 feasibility, 32 RWD); Number of Sites: 4 | Not applicable for this study | Improvement in sentence in noise scores (HINT/BKB-SIN) and localization ability (RMS error) |
| Systematic Literature Review; Systematic literature review (PRISMA guidelines); Follow-up/Duration: Not applicable; Study Period: 2015-2021 | Children and adults with SSD/UHL; Sample Size: 296 adults (17 articles); 105 children (10 articles); Number of Sites: Not applicable (multi-center literature) | Not applicable for this study | Speech understanding in noise, localization, and patient-reported outcomes |
