# K953872: Second Ear Bone Conduction Hearing Aid

- Pathway: 510(k) (Traditional)
- Applicant: Wordcomp International Communication Group (Wicg)
- Decided: Apr 12, 1996 after 239 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
Longest line of descent: 1 generation back to K884288 (1989). 2 ancestors in all.
3 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)
- K884288: Hearing Aid, Unitron Bte Model UM60-AGC0, Unitron Industries, Inc. (1989) Summary page 4.
- K923784: Starkey SM Series Bte Hearing Aids, Starkey Laboratories, Inc. (1992) Summary page 4.
- (no number) Radioear B70 Series Audio Transducers: named in the summary without a submission number

## Most influential descendants
- K050653: Transear Bone Conduction Hearing Aid (2005), 2 descendants of its own
- K100649: Soundbite Hearing System by Sonitus (2011), 1 descendant of its own
- K110831: Soundbite Hearing System by Sonitus Medical (2011), 0 descendants of its own

## Indications for use
Moderate to severe conductive hearing losses. Particularly useful for conductive losses compounded by congenital or secondary obstruction of auditory air conduction mechanisms

Source page: https://510kreport.com/device/K953872
Methodology: https://510kreport.com/methodology