FDA applicant

Tuned, Ltd.

Gan Yoshiya, IL2 decisions2023–20250 recalls

FDA records 2 decisions for Tuned, Ltd. (Gan Yoshiya, IL) from 2023 to 2025: 2 510(k) clearances. Most are in product codes QUH (Self-Fitting Air-Conduction Hearing Aid, Over…) and SCR (Air-Conduction Hearing Aid Software). Its devices cite 2 predicates, 0 of them its own earlier devices. 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 Tuned, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2023high 1 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Tuned, Ltd. by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Tuned, Ltd.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?