510(k) Report

FDA applicant

Hearing Health Group, Inc.

Mchenry, IL1 decision1981–19810 recalls

FDA records 1 decision for Hearing Health Group, Inc. (Mchenry, IL) in 1981: 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 Health Group, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hearing Health Group, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

See the 510(k) Report

Which product codes does it file in?

  • ESDHearing Aid, Air-Conduction, Prescription1decision

What has FDA decided for it lately?

  • K811719Custom in-the-Ear Hearing AidHearing Health Group, Inc. · 1981

The one decision as Hearing Health Group, 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 Components, Inc. 1Hearing Improvement 1Hearing Care Products, Inc. 1Hearing Enhancement Center, Inc. 1Hearing Aids by Guy Horn 1