FDA applicant
Maico Hearing Instruments, Inc.
FDA records 58 decisions for Maico Hearing Instruments, Inc. (Minneapolis, MN) from 1977 to 1996: 58 510(k) clearances. Most are in product codes ESD (Hearing Aid, Air-Conduction, Prescription) and EWO (Audiometer). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Maico Hearing Instruments, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Maico Hearing Instruments, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Maico Hearing Instruments, Inc.’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 “Maico”
FDA records each applicant name separately; these may or may not be the same firm.