LXB

Hearing Aid, Bone Conduction

Product code
LXB
Device name
Hearing Aid, Bone Conduction
Device class
Class 2
21 CFR
21 CFR 874.3302
Medical specialty
Ear, Nose, Throat
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
6
Summaries archived here
6 (direct download)
510(k) clearances (all years, FDA)
53 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (6)

Last three years. Most recent: 2026-08-19.

NumberDecision dateApplicantDevice nameSummary
K2534312026-08-19Shokz Health Global LimitedBone conduction Hearing Aid (BM100, BM300, BM310, SHPDF
K2542962026-07-22SounductOssiclear (Ossiclear System)PDF
K2604522026-06-15Zdeer Technology (Henan) Co., Ltd.Bone Conduction Hearing Aid (G41157, G41158, G41159,PDF
K2612562026-06-11Shenzhen Magnet Technology Co., Ltd.Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-DPDF
K2502152025-05-29CochlearBaha 7 Sound Processor; Baha Fitting Software 7 (P21PDF
K2430412025-04-25Bhm-Tech Produktionsgesellschaft Mbhcontact forte AlphaPDF

6 summaries are archived here for direct download.

Official FDA classification page: LXB
Classification and pathway per current FDA publications. Data from openFDA (CC0).