FDA applicant
Hearing Solutions, Inc.
FDA records 5 decisions for Hearing Solutions, Inc. (Paoli, PA) from 1995 to 1996: 5 510(k) clearances. All are in product code ESD (Hearing Aid, Air-Conduction, Prescription). 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 Hearing Solutions, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Hearing Solutions, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Hearing Solutions, 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 “Hearing”
FDA records each applicant name separately; these may or may not be the same firm.