510(k) Report

FDA applicant

United Hearing Systems, Inc.

Plainfield, CT3 decisions1989–20050 recalls

FDA records 3 decisions for United Hearing Systems, Inc. (Plainfield, CT) from 1989 to 2005: 3 510(k) clearances. Most are in product codes ESD (Hearing Aid, Air-Conduction, Prescription) and LXB (Hearing Aid, Bone Conduction). Its devices cite 5 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 United Hearing Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — United Hearing Systems, 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, Prescription2decisions
  • LXBHearing Aid, Bone Conduction1decision

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K050653Transear Bone Conduction Hearing AidUnited Hearing Systems, Inc. · 20051cites it

What has FDA decided for it lately?

  • K050653Transear Bone Conduction Hearing AidUnited Hearing Systems, Inc. · 2005
  • K970828Uhs Micronet Programmable Hearing Aids Models 901,902,903,906,909/ProgrammerUnited Hearing Systems, Inc. · 1997
  • K892803Phonic Ear Ite/Itc HRNG Aid 901, 902, 903, 906,911United Hearing Systems, Inc. · 1989

All 3 as United Hearing Systems, Inc. →