# K951678: HI Sonic 2000 Digital Hearing Instrument

- Pathway: 510(k) (Traditional)
- Applicant: Hearing Innovations, Inc.
- Decided: Jun 7, 1995 after 57 days
- Product code: LXB (Hearing Aid, Bone Conduction)
- Device class: 2
- Regulation: 21 CFR 874.3302
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 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
- K013253: Hisonic-TRD Tinnitus Relief Device (2002), 1 descendant of its own
- K070648: The Inhibitor, Model 001 (2007), 0 descendants of its own

Source page: https://510kreport.com/device/K951678
Methodology: https://510kreport.com/methodology