# K050653: Transear Bone Conduction Hearing Aid

- Pathway: 510(k) (Traditional)
- Applicant: United Hearing Systems, Inc.
- Decided: Jul 1, 2005 after 112 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: 4 generations back to K861971 (1986). 11 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923784: Starkey SM Series Bte Hearing Aids, Starkey Laboratories, Inc. (1992) Summary page 2.
- K884288: Hearing Aid, Unitron Bte Model UM60-AGC0, Unitron Industries, Inc. (1989) Summary page 2.
- K953872: Second Ear Bone Conduction Hearing Aid, Wordcomp International Communication Group (Wicg) (1996) Summary page 2.
- K021837: Branenmark Bone-Anchored-Hearing Aid (Baha), Entific Medical Systems, Inc. (2002) Summary page 2.
- K042017: Baha Divino, Entific Medical Systems, Inc. (2004) Summary page 2.
- (no number) Various behind-the-ear air conduction hearing aids consisting of a digital sound processor and standard ear mold: named in the summary without a submission number

## Most influential descendants
- 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
The TransEARTM Bone Conduction Hearing Aid is indicated for persons with single sided deafness to provide the perception of sound from the deaf ear. The amplified signal is received into the deaf ear and transferred through the bones of the skull to the better cochlea.

Source page: https://510kreport.com/device/K050653
Methodology: https://510kreport.com/methodology