LXB — Hearing Aid, Bone Conduction Class II
FDA product code LXB covers "Hearing Aid, Bone Conduction", a Class II medical device regulated under 21 CFR 874.3302. Submissions are reviewed by the Ear, Nose, Throat panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LXB
- Device Class
- Class II
- Regulation Number
- 874.3302
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260452 | zdeer technology (henan) co | Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151, G42152, G42 | June 15, 2026 |
| K261256 | shenzhen magnet technology co | Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3) | June 11, 2026 |
| K250215 | cochlear | Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) | May 29, 2025 |
| K243041 | bhm-tech produktionsgesellschaft mbh | contact forte Alpha | April 25, 2025 |
| K213733 | oticon medical | Ponto 5 SuperPower | December 16, 2021 |
| K212136 | cochlear americas | Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Sma | September 29, 2021 |
| K211640 | oticon medical | Ponto 5 Mini | August 10, 2021 |
| K202048 | cochlear americas | Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear | February 23, 2021 |
| K190540 | oticon medical | Ponto 4 | May 2, 2019 |
| K172460 | med-el elektromedizinische geraete | ADHEAR System | April 27, 2018 |
| K171088 | cochlear americas | Cochlear Baha SoundArc | June 7, 2017 |
| K161671 | oticon medical | Ponto 3, Ponto 3 Power and Ponto 3 SuperPower | September 29, 2016 |
| K153391 | sophono | Sophono Bone Conduction Systems (S) Configuration and (M) Configuration | June 16, 2016 |
| K161123 | cochlear americas | Baha 5 Power Sound Processor | May 20, 2016 |
| K153245 | cochlear americas | Baha 5 Super Power Sound Processor | March 2, 2016 |
| K150751 | cochlear americas | Cordelle II Sound Processor | July 22, 2015 |
| K142907 | cochlear americas | Baha 5 Sound Processor | March 25, 2015 |
| K132775 | oticon medical | PONTO PLUS AND PONTO PLUS POWER | December 9, 2013 |
| K132189 | sophono | OTOMAG BONE CONDUCATION HEARING SYSTEM | November 22, 2013 |
| K131240 | cochlear americas | COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACT | November 7, 2013 |