FDA applicant
Cochlear Americas
FDA records 27 decisions for Cochlear Americas (Centennial, CO) from 1984 to 2026: 21 510(k) clearances and 6 original PMA approvals. Most are in product codes LXB (Hearing Aid, Bone Conduction) and PFO (Active Implantable Bone Conduction Hearing…). Since 2016 its 510(k)s took a median of 114 days from receipt to decision, against 110 for FDA’s reviews in the same codes and years. Its devices cite 30 predicates, 20 of them its own earlier devices. 5 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Cochlear Americas’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
1in 2018
Class I Class II/III not classified
Planning a device like Cochlear Americas’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Cochlear”
FDA records each applicant name separately; these may or may not be the same firm.