FDA applicant

Qualitone

Minneapolis, MN40 decisions1976–19960 recalls

FDA records 40 decisions for Qualitone (Minneapolis, MN) from 1976 to 1996: 40 510(k) clearances. Most are in product codes ESD (Hearing Aid, Air-Conduction, Prescription) and EWO (Audiometer). No recall is linked to its devices.

FDA’s records also spell it “Qualitone, Inc.”.

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 Qualitone’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Qualitone since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Qualitone”

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

Qualitone Hearing Aids and Audiometers 1

Qualitone

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Qualitone”