# Miracle-Ear, Inc.

- Location (FDA's records): Golden Valley, MN
- FDA decisions: 65 (1990–1997): 65 510(k) clearances
- Product codes: ESD (64), LYY (1)
- Predicates its devices cite: 12 (10 its own); citations of its devices by later devices: 10 (10 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Oticon Corp.: 2 (https://510kreport.com/company/oticon)

## Its most-cited devices
- K960804: Miracle Ear & Audiotone Model Ite/Itc/Cic (1996), cited by 2
- K954941: Miracle Ear and Audiotone (1995), cited by 2
- K901745: Audiotone Model a-52S Behind-the-Ear Hearing Inst. (1990), cited by 1
- K941122: Audiotone Model a-54SR (1994), cited by 1
- K941121: Audiotone Model a-54 (1994), cited by 1
- K935265: Miracle Ear Model Sharp II Canal (1993), cited by 1

## Recent decisions
- K972344: Miracle-Ear Digital Bte (Jul 23, 1997)
- K972346: Miracle-Ear Ite Digital (Jul 23, 1997)
- K972345: Dahlberg/Miracle-Ear (Jul 23, 1997)
- K970262: Multi-Channel Compression Bte (SD) (Mar 31, 1997)
- K964419: Miracle - Ear (Ite/Itc/Cic) (Feb 4, 1997)
- K965057: Audiotone (A554H) (Jan 27, 1997)
- K965049: Dahlberg (a-554) (Jan 27, 1997)
- K965063: Audiotone (a-552) (Jan 27, 1997)

Source page: https://510kreport.com/company/miracle-ear