510(k) Report

FDA applicant

General Hearing Instruments, Inc.

Harahan, LA5 decisions1985–20060 recalls

FDA records 5 decisions for General Hearing Instruments, Inc. (Harahan, LA) from 1985 to 2006: 5 510(k) clearances. Most are in product codes ESD (Hearing Aid, Air-Conduction, Prescription) and KLW (Masker, Tinnitus). 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 General Hearing Instruments, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for General Hearing Instruments, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • ESDHearing Aid, Air-Conduction, Prescription4decisions
  • KLWMasker, Tinnitus1decision

Who builds on its devices?

Later devices cite its devices 5 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K974751Tranquil Tri-OE, Tranquil Tri-Coe, Tranquil Tri-CicGeneral Hearing Instruments, Inc. · 19983cite it
  • K850123IN-TH-Ear Hearing AidGeneral Hearing Instruments, Inc. · 19851cites it
  • K061459Tranquil Tri-BteGeneral Hearing Instruments, Inc. · 20061cites it

What has FDA decided for it lately?

  • K061459Tranquil Tri-BteGeneral Hearing Instruments, Inc. · 2006
  • K974751Tranquil Tri-OE, Tranquil Tri-Coe, Tranquil Tri-CicGeneral Hearing Instruments, Inc. · 1998
  • K971399Auris AE, Auris TL, Auris HS, Auris AC, Auris MM, Auris Coe, Auris CicGeneral Hearing Instruments, Inc. · 1997
  • K943144Auris CicGeneral Hearing Instruments, Inc. · 1994
  • K850123IN-TH-Ear Hearing AidGeneral Hearing Instruments, Inc. · 1985

All 5 as General Hearing Instruments, Inc. →