510(k) Report

FDA applicant

Hearing Enhancement Center, Inc.

Rutland, VT1 decision1989–19890 recalls

FDA records 1 decision for Hearing Enhancement Center, Inc. (Rutland, VT) in 1989: 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 Hearing Enhancement Center, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hearing Enhancement Center, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Hearing Enhancement Center, 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, Prescription1decision

What has FDA decided for it lately?

  • K884997Ite Hearing Aid Parker/Technitone, Model PAHearing Enhancement Center, Inc. · 1989

The one decision as Hearing Enhancement Center, Inc. →

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 Express 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 Aids by Guy Horn 1