FDA applicant

Hear Co., Inc.

Mchenry, IL2 decisions1980–19830 recalls

FDA records 2 decisions for Hear Co., Inc. (Mchenry, IL) from 1980 to 1983: 2 510(k) clearances. Most are in product codes ESD (Hearing Aid, Air-Conduction, Prescription) and EWO (Audiometer). 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 Co., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hear Co., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Hear Co., 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

Other applicant names beginning “Hear”

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

Hear-Right, Inc. 1 Hear-Well Technologies, Inc. 1 Hear Clear, Inc. 1 Hear-O Inc. C/O L.P. Leale & Assoc. 1

Hear Co., Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Hear”