# K954941: Miracle Ear and Audiotone

- Pathway: 510(k) (Traditional)
- Applicant: Miracle-Ear, Inc.
- Decided: Dec 22, 1995 after 53 days
- Product code: ESD (Hearing Aid, Air-Conduction, Prescription)
- Device class: 1
- Regulation: 21 CFR 874.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K960804: Miracle Ear & Audiotone Model Ite/Itc/Cic (1996), 3 descendants of its own
- K964530: Dahlberg Hearing Aid with Multi-Channel Compression Circuit (1996), 1 descendant of its own
- K972345: Dahlberg/Miracle-Ear (1997), 0 descendants of its own
- K970262: Multi-Channel Compression Bte (SD) (1997), 0 descendants of its own
- K964794: Dahlberg K-Amp Bte (1996), 0 descendants of its own

Source page: https://510kreport.com/device/K954941
Methodology: https://510kreport.com/methodology