FDA applicant

Hear-O Inc. C/O L.P. Leale & Assoc.

Walnut Creek, CA1 decision1988–19880 recalls

FDA records 1 decision for Hear-O Inc. C/O L.P. Leale & Assoc. (Walnut Creek, CA) in 1988: 1 510(k) clearance. All are in product code ESD (Hearing Aid, Air-Conduction, Prescription). 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 Hear-O Inc. C/O L.P. Leale & Assoc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hear-O Inc. C/O L.P. Leale & Assoc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Hear-O Inc. C/O L.P. Leale & Assoc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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See the 510(k) Report

Other applicant names beginning “Hear-O”

FDA records each applicant name separately; these may or may not be the same firm.

Hear Co., Inc. 2 Hear-Right, Inc. 1 Hear-Well Technologies, Inc. 1 Hear Clear, Inc. 1

Hear-O Inc. C/O L.P. Leale & Assoc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Hear-O”