# K972346: Miracle-Ear Ite Digital

- Pathway: 510(k) (Traditional)
- Applicant: Miracle-Ear, Inc.
- Decided: Jul 23, 1997 after 29 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
Longest line of descent: 1 generation back to K964683 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964683: Digifocus Ite, Oticon, Inc. (1996) Summary page 1.

## Indications for use
The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies).

Source page: https://510kreport.com/device/K972346
Methodology: https://510kreport.com/methodology