510(k) Report

FDA applicant

Hearing Aid Express

Bellaire, TX5 decisions1989–19940 recalls

FDA records 5 decisions for Hearing Aid Express (Bellaire, TX) from 1989 to 1994: 5 510(k) clearances. 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 Hearing Aid Express’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hearing Aid Express since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Hearing Aid Express 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, Prescription5decisions

What has FDA decided for it lately?

  • K942830HAE 3Hearing Aid Express · 1994
  • K942831HAE 2Hearing Aid Express · 1994
  • K942829HAE 1Hearing Aid Express · 1994
  • K894428Hearing Aid (in-the-Ear)Hearing Aid Express · 1989
  • K894414Hearing Aid (in-the-Canal)Hearing Aid Express · 1989

All 5 as Hearing Aid Express →

Other applicant names beginning “Hearing”

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

Hearing Tech, Inc. 11Hearing Solutions, Inc. 5Hearing Aid Co. 4Hearing Services, Inc. 3Hearing Innovations, Inc. 3Hearing Aid Crafters 2Hearing Health Group, Inc. 1Hearing Components, Inc. 1Hearing Improvement 1Hearing Care Products, Inc. 1Hearing Enhancement Center, Inc. 1Hearing Aids by Guy Horn 1