FDA applicant
Siemens Hearing Instruments, Inc.
FDA records 42 decisions for Siemens Hearing Instruments, Inc. (Piscataway, NJ) from 1984 to 2007: 42 510(k) clearances. Most are in product codes ESD (Hearing Aid, Air-Conduction, Prescription) and KLW (Masker, Tinnitus). 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 Siemens Hearing Instruments, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2007
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Siemens 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) Report