FDA applicant

Phonic Ear, Inc.

Mill Valley, CA31 decisions1982–20040 recalls

FDA records 31 decisions for Phonic Ear, Inc. (Mill Valley, CA) from 1982 to 2004: 31 510(k) clearances. Most are in product codes ESD (Hearing Aid, Air-Conduction, Prescription) and EPF (Hearing Aid, Group And Auditory Trainer). Its devices cite 1 predicate, 1 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 Phonic Ear, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Phonic Ear, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Phonic Ear, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?