FDA applicant

Colorado Hearing Systems, Inc.

Denver, CO1 decision1989–19890 recalls

FDA records 1 decision for Colorado Hearing Systems, Inc. (Denver, CO) in 1989: 1 510(k) clearance. All are in product code LYN (Apparatus, Visual Reinforcement Audiometric). 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 Colorado Hearing Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Colorado Hearing Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Colorado”

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

Colorado Medical, Inc. 6 Colorado Medtech, Inc. 2 Colorado Therapeutics, LLC 2 Colorado Catheter Company, Inc. 1 Colorado Biomedical, Inc. 1

Colorado Hearing Systems, Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Colorado”