FDA applicant

Earlens Corporation

Menlo Park, CA3 decisions2015–20190 recalls

FDA records 3 decisions for Earlens Corporation (Menlo Park, CA) from 2015 to 2019: 2 510(k) clearances and 1 De Novo grant. All are in product code PLK (Tympanic Membrane Direct Contact Hearing Aid). 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 Earlens Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2015high 1 (2015) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Earlens Corporation by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Earlens Corporation

Which product codes does it file in?

Which of its devices are cited most?

What has FDA decided for it lately?