510(k) Report

FDA applicant

Hearing Innovations, Inc.

Washington, D.C., DC3 decisions1995–20020 recalls

FDA records 3 decisions for Hearing Innovations, Inc. (Washington, D.C., DC) from 1995 to 2002: 3 510(k) clearances. Most are in product codes ESD (Hearing Aid, Air-Conduction, Prescription) and KLW (Masker, Tinnitus). Its devices cite 8 predicates, 1 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 Hearing Innovations, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Hearing Innovations, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

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Which product codes does it file in?

  • ESDHearing Aid, Air-Conduction, Prescription1decision
  • KLWMasker, Tinnitus1decision
  • LXBHearing Aid, Bone Conduction1decision

Whose devices does it build on?

Its devices cite 8 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K013253Hisonic-TRD Tinnitus Relief DeviceHearing Innovations, Inc. · 20021cites it
  • K951678HI Sonic 2000 Digital Hearing InstrumentHearing Innovations, Inc. · 19951cites it

What has FDA decided for it lately?

  • K013253Hisonic-TRD Tinnitus Relief DeviceHearing Innovations, Inc. · 2002
  • K963745Model WMR Bte Hearing Instrument (Model WMR)Hearing Innovations, Inc. · 1996
  • K951678HI Sonic 2000 Digital Hearing InstrumentHearing Innovations, Inc. · 1995

All 3 as Hearing Innovations, 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 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