LXBClass II
Hearing Aid, Bone Conduction
21 CFR 874.3302 / Ear, Nose, Throat
LXB is the FDA product code for Hearing Aid, Bone Conduction, a class II device type, regulated under 21 CFR 874.3302. As of , FDA records hold 53 510(k) clearances under this code, the most recent dated , and 7 recalls.
Classification record
- Product code
- LXB
- Device name
- Hearing Aid, Bone Conduction
- Regulation
- 21 CFR 874.3302
- Device class
- Class II
- Review panel
- Ear, Nose, Throat
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 53
- Ingested recalls
- 7
Clearances, product code LXB
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1986 | 2 |
| 1987 | 1 |
| 1988 | 3 |
| 1994 | 1 |
| 1995 | 1 |
| 1996 | 2 |
| 1999 | 1 |
| 2000 | 1 |
| 2001 | 1 |
| 2002 | 1 |
| 2004 | 1 |
| 2005 | 1 |
| 2006 | 1 |
| 2008 | 2 |
| 2009 | 2 |
| 2010 | 2 |
| 2011 | 5 |
| 2012 | 1 |
| 2013 | 5 |
| 2015 | 2 |
| 2016 | 4 |
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2021 | 4 |
| 2025 | 2 |
| 2026 | 4 |
Applicants with the most clearances
Product code LXB| Applicant | Clearances |
|---|---|
| Cochlear Americas | 12 |
| Oticon Medical AB | 8 |
| Xomed, Inc. | 6 |
| Entific Medical Systems, Inc. | 5 |
| Sophono, Inc. | 5 |
| Sonitus Medical, Inc. | 2 |
| Audifon-USA, Inc. | 1 |
| BHM-Tech Produktionsgesellschaft mbH | 1 |
| Cochlear Ltd | 1 |
| Cochlear Bone Anchored Systems AB | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.