FDA applicant

Qualitone Hearing Aids and Audiometers

Minneapolis, MN1 decision1991–19910 recalls

FDA records 1 decision for Qualitone Hearing Aids and Audiometers (Minneapolis, MN) in 1991: 1 510(k) clearance. All are in product code EWO (Audiometer). 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 Qualitone Hearing Aids and Audiometers’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Qualitone Hearing Aids and Audiometers since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Qualitone Hearing Aids and Audiometers 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 40

Qualitone Hearing Aids and Audiometers

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Qualitone”