# K964683: Digifocus Ite

- Pathway: 510(k) (Traditional)
- Applicant: Oticon, Inc.
- Decided: Dec 12, 1996 after 20 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K972346: Miracle-Ear Ite Digital (1997), 0 descendants of its own

## Indications for use
To amplify and deliver sound to the ear

Source page: https://510kreport.com/device/K964683
Methodology: https://510kreport.com/methodology