FDA applicant

Sonova AG

Zurich, CH2 decisions2023–20240 recalls

FDA records 2 decisions for Sonova AG (Zurich, CH) from 2023 to 2024: 2 510(k) clearances. Most are in product codes QUH (Self-Fitting Air-Conduction Hearing Aid, Over…) and ESD (Hearing Aid, Air-Conduction, Prescription). 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 Sonova AG’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2023high 1 (2023) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

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

Planning a device like Sonova AG’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Sonova AG

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?