FDA applicant

Phonak, Inc.

Naperville, IL39 decisions1990–20130 recalls

FDA records 39 decisions for Phonak, Inc. (Naperville, IL) from 1990 to 2013: 39 510(k) clearances. Most are in product codes ESD (Hearing Aid, Air-Conduction, Prescription) and EPF (Hearing Aid, Group And Auditory Trainer). Its devices cite 5 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Phonak, LLC”.

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 Phonak, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2013

2007high 2 (2013) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Phonak, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Phonak, Inc.’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

Phonak, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?