# MCM: Implant, Cochlear

- Device class: 3; regulation: 21 CFR —; FDA's rule: PMA required
- FDA decisions: 8
- Recalls: 20 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2017: 31
- 2018: 20
- 2019: 35
- 2020: 25
- 2021: 20
- 2022: 24
- 2023: 18
- 2024: 17
- 2025: 17
- 2026: 13

## Most-cited predicates

Source page: https://510kreport.com/product-code/MCM
Data by year (CSV): https://510kreport.com/product-code/MCM.csv