# K062404: Transear Bone Conduction Hearing Aid

- Pathway: 510(k) (Special)
- Applicant: Ear Technology Corp.
- Decided: Sep 8, 2006 after 22 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’s file for it is a 510(k) statement, which names no predicate.

## 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
TransEar® is intended for individuals with single sided deafness or unaidable unilateral hearing loss, with single sided deafness being defined as an ear having one or more of the following characteristics: 1) Profound sensorineural hearing loss of such magnitude that there is no perceived benefit from an air conduction hearing aid coupled to the same ear. 2) A hearing loss greater than 50 dB HTL at frequencies of 500 Hz - 4000 Hz with speech recognition ability less than 50% when presented in quiet, at a 40 dB sensation level relative to the user's speech reception threshold. 3) A hearing loss greater than 50 dB HTL at frequencies of 500 Hz - 4000 Hz with a small dynamic range, for loudness less than 20 dB for amplified speech, which makes the use of an air conduction hearing aid intolerable to the user. The "better" cochlea should have pure tone air conduction thresholds 30 dB HTL or better for the test frequencies of 500, 1000, 2000 Hz and 60 dB HTL or better at 3000 Hz. For individuals with a "better" ear that exhibits a mixed or conductive hearing loss, bone conduction thresholds should be 30 dB HTL or better for the test frequencies of 500, 1000, 2000 Hz and 60 db HTL or better at 3000 Hz.

Source page: https://510kreport.com/device/K062404
Methodology: https://510kreport.com/methodology