510(k) Report

FDA applicant

National Hearing Aid Dist., Inc.

Scarborough, ME3 decisions1994–19970 recalls

FDA records 3 decisions for National Hearing Aid Dist., Inc. (Scarborough, ME) from 1994 to 1997: 3 510(k) clearances. Most are in product codes ESD (Hearing Aid, Air-Conduction, Prescription) and LZI (Device, Assistive Listening). 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 National Hearing Aid Dist., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for National Hearing Aid Dist., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — National Hearing Aid Dist., 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
  • LZIDevice, Assistive Listening1decision

What has FDA decided for it lately?

  • K971296Tondi, Models U-03, U-2M1, U-2M4, KA-01, KA-02, KA-03, KA-03A, KA-04, KA-04A, KA-05National Hearing Aid Dist., Inc. · 1997
  • K952057Listenaider IINational Hearing Aid Dist., Inc. · 1995
  • K935458Audiphon, Model H-11National Hearing Aid Dist., Inc. · 1994

All 3 as National Hearing Aid Dist., Inc. →