Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list International Hearing Aids with 21 510(k) clearances. The most recent is a 510(k) clearance dated Oct 20, 1987: INTERNATIONAL MODEL XM BEHIND-THE-EAR.
| Oct 20, 1987 | INTERNATIONAL MODEL XM BEHIND-THE-EARK873800 · ESD | 510(k) clearances |
| Oct 20, 1987 | INTERNATIONAL MODEL XP BEHIND-THE-EARK873798 · ESD | 510(k) clearances |
| Oct 20, 1987 | INTERNATIONAL MODEL XL BEHIND-THE-EARK873799 · ESD | 510(k) clearances |
| Aug 26, 1987 | INTERNATIONAL MODEL AT 8185 CUSTOM-IN-THE-EARK872647 · ESD | 510(k) clearances |
| Nov 13, 1986 | MODEL AK 8184 CUSTOM-LOW-PROFILE HEARING AIDK864031 · ESD | 510(k) clearances |
| Nov 13, 1986 | MODEL AJ8183 CUSTOM-IN-THE-EAR HEARING AIDK864030 · ESD | 510(k) clearances |
| Nov 13, 1986 | MODEL AQ8181 CUSTOM-CANAL-IN-THE EAR HEARING AIDK864028 · ESD | 510(k) clearances |
| Nov 13, 1986 | AY8182 CUSTOM-SEMI CANAL-IN-THE-EAR HEARING AIDK864029 · ESD | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
