510(k) Report

FDA applicant

Segi Hearing Aid Co.

New York, NY1 decision1996–19960 recalls

FDA records 1 decision for Segi Hearing Aid Co. (New York, NY) in 1996: 1 510(k) clearance. All are in product code LRB (Face Plate Hearing Aid). Its devices cite 2 predicates, 0 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 Segi Hearing Aid Co.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Segi Hearing Aid Co. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Segi Hearing Aid Co.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • LRBFace Plate Hearing Aid1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K961593Intrastar Pre-Wired Faceplate for in-the-Ear Hearing AidsSegi Hearing Aid Co. · 1996

The one decision as Segi Hearing Aid Co. →