Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of AmplifonLabelled 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 13, 2026, FDA's public records list Miracle-Ear with 65 510(k) clearances. The most recent is a 510(k) clearance dated Jul 23, 1997: MIRACLE-EAR DIGITAL BTE.
| Date | Record | Source |
|---|---|---|
| Jul 23, 1997 | MIRACLE-EAR DIGITAL BTEK972344 · ESD | 510(k) clearances |
| Jul 23, 1997 | MIRACLE-EAR ITE DIGITALK972346 · ESD | 510(k) clearances |
| Jul 23, 1997 | DAHLBERG/MIRACLE-EARK972345 · ESD | 510(k) clearances |
| Mar 31, 1997 | MULTI-CHANNEL COMPRESSION BTE (SD)K970262 · ESD | 510(k) clearances |
| Feb 4, 1997 | MIRACLE - EAR (ITE/ITC/CIC)K964419 · ESD | 510(k) clearances |
| Jan 27, 1997 | DAHLBERG (A-554)K965049 · ESD | 510(k) clearances |
| Jan 27, 1997 | AUDIOTONE (A554H)K965057 · ESD | 510(k) clearances |
| Jan 27, 1997 | AUDIOTONE (A-552)K965063 · 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
