510(k) Report

FDA applicant

Associated Hearing Instruments

Upper Darby, PA1 decision1993–19930 recalls

FDA records 1 decision for Associated Hearing Instruments (Upper Darby, PA) in 1993: 1 510(k) clearance. All are in product code KLW (Masker, Tinnitus). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ear, nose and throat panel, where it files most

How often FDA has decided Associated Hearing Instruments’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Associated Hearing Instruments since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Associated Hearing Instruments by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Associated”

FDA records each applicant name separately; these may or may not be the same firm.