# K253431: Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN, SHOKZHEAR BM410, SHOKZHEAR BM410MN, SHOKZHEAR BM420 and SHOKZHEAR BM420MN)

- Pathway: 510(k) (Traditional)
- Applicant: Shokz Health Global Limited
- Decided: Aug 19, 2026 after 322 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: 9 generations back to K861971 (1986). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161123: Baha 5 Power Sound Processor, Cochlear Americas (2016) Summary page 6.

## Indications for use
The device is intended to treat patients with hearing loss via bone conduction. The device is non-invasive bone conduction hearing device which is retained on the patient’s head. Indications: 1)Patients above 6 years old with conductive or mixed hearing loss. The pure tone average bone conduction hearing threshold (measured at 0.5, 1, 2, and 4kHz) should be better than or equal to 60 dB HL. 2)Patients 18 years and older with sensorineural hearing loss. The pure tone average bone conduction hearing threshold (measured at 0.5, 1, 2, and 4kHz) should be better than or equal to 60 dB HL.

Source page: https://510kreport.com/device/K253431
Methodology: https://510kreport.com/methodology