# MCM · Implant, Cochlear

_ ·  · Class 3_

**Canonical URL:** https://fda-staging.innolitics.com/productcode/MCM

## Overview

- **Product Code:** MCM
- **Device Name:** Implant, Cochlear
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)
- **Implant:** yes

## Recent Cleared Devices (15 of 15)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P960058S167](/device/P960058S167.md) | HiResolution™ Bionic Ear System | Advanced Bionics | Jul 22, 2026 | APPR |
| [P000025S134](/device/P000025S134.md) | MED-EL CI System | Med-El Corp. | Nov 26, 2025 | APPR |
| [P000025S129](/device/P000025S129.md) | MED-EL CI System | Med-El Corp. | Oct 3, 2024 | APPR |
| [P970051S205](/device/P970051S205.md) | Nucleus 24 Cochlear Implant System | Cochlear Americas | Jan 10, 2022 | APPR |
| [P200021](/device/P200021.md) | Neuro Cochlear Implant System | Oticon Medical | Jun 23, 2021 | APWD |
| [P970051S172](/device/P970051S172.md) | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM | Cochlear Americas | Mar 17, 2020 | APPR |
| [P000025S104](/device/P000025S104.md) | MED-EL Cochlear Implant System | Med-El Corp. | Jul 19, 2019 | APPR |
| [P000025](/device/P000025.md) | COMBI 40+ COCHLEAR IMPLANT SYSTEM | Med-El Corp. | Aug 20, 2001 | APPR |
| [P970051](/device/P970051.md) | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM | Cochlear Americas | Jun 25, 1998 | APPR |
| [P960058](/device/P960058.md) | CLARION MULTI-STRATEGY COCHLEAR IMPLANT | Advanced Bionics | Jun 26, 1997 | APPR |
| [P940022](/device/P940022.md) | CLARION(TM) MULTI-STRATEGY COCHLEAR IMPLANT | Advanced Bionics Corp. | Mar 22, 1996 | APCB |
| [P840024S046](/device/P840024S046.md) | NUCLEUS 22 CHANNEL COCHLEAR | Cochlear Americas | Aug 21, 1995 | APPR |
| [P890027](/device/P890027.md) | NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYS /CHILDREN | Cochlear Americas | Jun 27, 1990 | APPR |
| [P840024](/device/P840024.md) | NUCLEUS MULTICHANNEL IMPLANTABLE HEARING PROSTHESI | Cochlear Americas | Oct 31, 1985 | APPR |
| [P830069](/device/P830069.md) | 3M BRAND COCHLEAR IMPLANT SYSTEM/HOUSE DESIGN | Cochlear Americas | Nov 26, 1984 | APWD |

## Top Applicants

- Cochlear Americas — 7 clearances
- Med-El Corp. — 4 clearances
- Advanced Bionics — 2 clearances
- Advanced Bionics Corp. — 1 clearance
- Oticon Medical — 1 clearance

---

**Source:** [https://fda-staging.innolitics.com/productcode/MCM](https://fda-staging.innolitics.com/productcode/MCM)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com