LXB
- 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)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253431 | 2026-08-19 | Shokz Health Global Limited | Bone conduction Hearing Aid (BM100, BM300, BM310, SH | |
| K254296 | 2026-07-22 | Sounduct | Ossiclear (Ossiclear System) | |
| K260452 | 2026-06-15 | Zdeer Technology (Henan) Co., Ltd. | Bone Conduction Hearing Aid (G41157, G41158, G41159, | |
| K261256 | 2026-06-11 | Shenzhen Magnet Technology Co., Ltd. | Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D | |
| K250215 | 2025-05-29 | Cochlear | Baha 7 Sound Processor; Baha Fitting Software 7 (P21 | |
| K243041 | 2025-04-25 | Bhm-Tech Produktionsgesellschaft Mbh | contact forte Alpha |
Official FDA classification page: LXB
Classification and pathway per current FDA publications. Data from openFDA (CC0).