FDA applicant

Zenith-Omni H.C., Inc.

New Haven, CT1 decision1992–19920 recalls

FDA records 1 decision for Zenith-Omni H.C., Inc. (New Haven, CT) in 1992: 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 Zenith-Omni H.C., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Zenith-Omni H.C., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Zenith-Omni H.C., Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Zenith-Omni H.C., 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 “Zenith-Omni”

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

Zenith Technical Innovations 5 Zenith Hearing Instrument Co. 1 Zenith/Omni Hearing Instruments, Inc. 1

Zenith-Omni H.C., Inc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Zenith-Omni”