# Earlens Corporation

- Location (FDA's records): Menlo Park, CA
- FDA decisions: 3 (2015–2019): 2 510(k) clearances and 1 De Novo grant
- Product codes: PLK (3)
- Predicates its devices cite: 1 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Its most-cited devices
- K153634: Wireless Earlens Light Driven Hearing Aid (2016), cited by 1

## Recent decisions
- K182480: Earlens Contact Hearing Aid (Jan 25, 2019)
- K153634: Wireless Earlens Light Driven Hearing Aid (Apr 6, 2016)
- DEN150002: EarLens Contact Hearing Device (Sep 29, 2015)

Source page: https://510kreport.com/company/earlens