FDA applicant

GN Hearing A/S

Ballerup, DK5 decisions2018–20260 recalls

FDA records 5 decisions for GN Hearing A/S (Ballerup, DK) from 2018 to 2026: 5 510(k) clearances. Most are in product codes KLW (Masker, Tinnitus) and QDD (Self-Fitting Air-Conduction Hearing Aid…). Its devices cite 5 predicates, 3 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 GN Hearing A/S’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2018high 2 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — GN Hearing A/S by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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GN Hearing A/S

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?