# K261256: Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Magnet Technology Co., Ltd.
- Decided: Jun 11, 2026 after 56 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: 2 generations back to K935701 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121793: AN Evo 1, CS Evo 1, Contact Mini, Apollon, Audifon-USA, Inc. (2012) Summary page 5.

## Indications for use
Bone Conduction Hearing Aid (models: XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3) is wearable sound-amplifying device intended to compensate impairments in personal hearing. The fundamental operating principle is to receive, amplify, and transfer sound via the skin and the bone of the skull to the inner ear of a hearing impaired person. The amplification suits the needs of a mild to a moderate hearing loss. They require individual fitting in performance executed by a hearing aid professional. The device is intended for adults and children (=12 years).

Source page: https://510kreport.com/device/K261256
Methodology: https://510kreport.com/methodology