← Product Code [MCM](/productcode/MCM) · P970051

# NUCLEUS 24 COCHLEAR IMPLANT SYSTEM (P970051)

_Cochlear Americas · MCM · Jun 25, 1998 · Ear, Nose, Throat · APPR_

**Canonical URL:** https://fda-staging.innolitics.com/device/P970051

## Device Facts

- **Applicant:** Cochlear Americas
- **Product Code:** [MCM](/productcode/MCM.md)
- **Decision Date:** Jun 25, 1998
- **Decision:** APPR
- **Device Class:** Class 3
- **Review Panel:** Ear, Nose, Throat
- **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 |

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**Source:** [https://fda-staging.innolitics.com/device/P970051](https://fda-staging.innolitics.com/device/P970051)

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