510(k) Report

FDA applicant

Hearing Components, Inc.

Maplewood, MN1 decision1992–19920 recalls

FDA records 1 decision for Hearing Components, Inc. (Maplewood, MN) in 1992: 1 510(k) clearance. 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, last Nov 3, 2026

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

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

FDA decisions per year

No FDA decision for Hearing Components, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • ESDHearing Aid, Air-Conduction, Prescription1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K915794AD-HearHearing Components, Inc. · 19921cites it

What has FDA decided for it lately?

  • K915794AD-HearHearing Components, Inc. · 1992

The one decision as Hearing Components, Inc. →

Other applicant names beginning “Hearing”

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

Hearing Tech, Inc. 11Hearing Solutions, Inc. 5Hearing Aid Express 5Hearing Aid Co. 4Hearing Services, Inc. 3Hearing Innovations, Inc. 3Hearing Aid Crafters 2Hearing Health Group, Inc. 1Hearing Improvement 1Hearing Care Products, Inc. 1Hearing Enhancement Center, Inc. 1Hearing Aids by Guy Horn 1