510(k) Report

FDA applicant

Int'L Hearing Aids, Inc.

Hopkins, MN21 decisions1978–19870 recalls

FDA records 21 decisions for Int'L Hearing Aids, Inc. (Hopkins, MN) from 1978 to 1987: 21 510(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 Int'L Hearing Aids, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Int'L Hearing Aids, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Int'L Hearing Aids, 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, Prescription21decisions

What has FDA decided for it lately?

  • K873800International Model XM Behind-the-EarInt'L Hearing Aids, Inc. · 1987
  • K873799International Model XL Behind-the-EarInt'L Hearing Aids, Inc. · 1987
  • K873798International Model XP Behind-the-EarInt'L Hearing Aids, Inc. · 1987
  • K872647International Model at 8185 Custom-in-the-EarInt'L Hearing Aids, Inc. · 1987
  • K864028Model AQ8181 Custom-Canal-in-the Ear Hearing AidInt'L Hearing Aids, Inc. · 1986
  • K864031Model AK 8184 Custom-Low-Profile Hearing AidInt'L Hearing Aids, Inc. · 1986
  • K864029AY8182 Custom-Semi Canal-in-the-Ear Hearing AidInt'L Hearing Aids, Inc. · 1986
  • K864030Model AJ8183 Custom-in-the-Ear Hearing AidInt'L Hearing Aids, Inc. · 1986

All 21 as Int'L Hearing Aids, Inc. →