510(k) Report

FDA applicant

Comfortone America'S Value Hearing Aid Line

Wichita, KS1 decision1996–19960 recalls

FDA records 1 decision for Comfortone America'S Value Hearing Aid Line (Wichita, KS) in 1996: 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 Comfortone America'S Value Hearing Aid Line’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Comfortone America'S Value Hearing Aid Line since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Comfortone America'S Value Hearing Aid Line 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

What has FDA decided for it lately?

  • K960741Comfortone PHSComfortone America'S Value Hearing Aid Line · 1996

The one decision as Comfortone America'S Value Hearing Aid Line →