Product code LXB
- Device name
- Hearing Aid, Bone Conduction
- Medical specialty
- Ear, Nose, Throat
- Device class
- 2
- Regulation number
- 874.3302
- Review panel
- EN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250215 | Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand | Cochlear | 2025-05-29 |
| K243041 | contact forte Alpha | Bhm-Tech Produktionsgesellschaft Mbh | 2025-04-25 |
| K213733 | Ponto 5 SuperPower | Oticon Medical AB | 2021-12-16 |
| K212136 | Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App | Cochlear Americas | 2021-09-29 |
| K211640 | Ponto 5 Mini | Oticon Medical AB | 2021-08-10 |
| K202048 | Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App | Cochlear Americas | 2021-02-23 |
| K190540 | Ponto 4 | Oticon Medical AB | 2019-05-02 |
| K172460 | ADHEAR System | Med-El Elektromedizinische Geraete GmbH | 2018-04-27 |
| K171088 | Cochlear Baha SoundArc | Cochlear Americas | 2017-06-07 |
| K161671 | Ponto 3, Ponto 3 Power and Ponto 3 SuperPower | Oticon Medical AB | 2016-09-29 |
| K153391 | Sophono Bone Conduction Systems (S) Configuration and (M) Configuration | Sophono, Inc. | 2016-06-16 |
| K161123 | Baha 5 Power Sound Processor | Cochlear Americas | 2016-05-20 |
| K153245 | Baha 5 Super Power Sound Processor | Cochlear Americas | 2016-03-02 |
| K150751 | Cordelle II Sound Processor | Cochlear Americas | 2015-07-22 |
| K142907 | Baha 5 Sound Processor | Cochlear Americas | 2015-03-25 |
| K132775 | PONTO PLUS AND PONTO PLUS POWER | Oticon Medical AB | 2013-12-09 |
| K132189 | OTOMAG BONE CONDUCATION HEARING SYSTEM | Sophono, Inc. | 2013-11-22 |
| K131240 | COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACT | Cochlear Americas | 2013-11-07 |
| K132278 | COCHLEAR BAHA 4 SOUND PROCESSOR | Cochlear Americas | 2013-09-26 |
| K123962 | OTOMAG BONE CONDUCTION HEARING SYSTEM | Sophono, Inc. | 2013-04-08 |
| K121793 | AN EVO 1, CS EVO 1, CONTACT MINI, APOLLON | Audifon-USA, Inc. | 2012-11-01 |
| K110831 | SOUNDBITE HEARING SYSTEM BY SONITUS MEDICAL | Sonitus Medical, Inc. | 2011-06-21 |
| K103594 | PONTO PRO POWER | Oticon Medical AB | 2011-06-15 |
| K102199 | OTOMAG BONE CONDUCTION HEARING SYSTEM MODEL ALPHA 1 (S) AND ALPHA 1 (M) | Sophono, Inc. | 2011-05-23 |
| K110996 | BAHA 3 POWER SOUND PROCESSOR | Cochlear Americas | 2011-05-10 |
| K100649 | SOUNDBITE HEARING SYSTEM BY SONITUS | Sonitus Medical, Inc. | 2011-01-14 |
| K100360 | BIA300 SERIES IMPLANT AND ABUTMENT, BI300 IMPLANT, BA300 ABUTMENT | Cochlear Americas | 2010-07-13 |
| K100193 | OTOMAG BONE CONDUCTION HEARING SYSTEM | Sophono, Inc. | 2010-05-18 |
| K090996 | PONTO PRO | Oticon Medical AB | 2009-07-29 |
| K090720 | COCHLEAR BAHA BP100 | Cochlear Bone Anchored Systems AB | 2009-06-17 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 09120041056697 | contact forte Alpha | BHM-Tech Produktionsgesellschaft m.b.H. | 2026-04-17 |
| 09120041056673 | contact forte Alpha | BHM-Tech Produktionsgesellschaft m.b.H. | 2026-04-17 |
| 09120041056895 | Hearbow | BHM-Tech Produktionsgesellschaft m.b.H. | 2026-04-17 |
| 09120041056772 | contact forte | BHM-Tech Produktionsgesellschaft m.b.H. | 2026-04-17 |
| 09120041056765 | contact forte | BHM-Tech Produktionsgesellschaft m.b.H. | 2026-04-17 |
| 09120041056758 | contact forte | BHM-Tech Produktionsgesellschaft m.b.H. | 2026-04-17 |
| 09120041056741 | contact forte | BHM-Tech Produktionsgesellschaft m.b.H. | 2026-04-17 |
| 09120041056734 | contact forte | BHM-Tech Produktionsgesellschaft m.b.H. | 2026-04-17 |
| 09120041056727 | contact forte Alpha | BHM-Tech Produktionsgesellschaft m.b.H. | 2026-04-17 |
| 09120041056710 | contact forte Alpha | BHM-Tech Produktionsgesellschaft m.b.H. | 2026-04-17 |
| 09120041056703 | contact forte Alpha | BHM-Tech Produktionsgesellschaft m.b.H. | 2026-04-17 |
| 09321502026383 | Baha | Cochlear Bone Anchored Solutions AB | 2017-07-03 |
| 09321502021364 | Baha | Cochlear Bone Anchored Solutions AB | 2017-07-03 |
| 09321502021357 | Baha | Cochlear Bone Anchored Solutions AB | 2017-07-03 |
| 09321502021340 | Baha | Cochlear Bone Anchored Solutions AB | 2017-07-03 |
| 09321502021333 | Baha | Cochlear Bone Anchored Solutions AB | 2017-07-03 |
| 09321502021326 | Baha | Cochlear Bone Anchored Solutions AB | 2017-07-03 |
| 09321502021319 | Baha | Cochlear Bone Anchored Solutions AB | 2017-07-03 |
| 09321502019675 | Baha | Cochlear Bone Anchored Solutions AB | 2017-06-07 |
| 09321502020725 | Baha | Cochlear Bone Anchored Solutions AB | 2017-06-07 |
| 09321502016513 | Baha | Cochlear Bone Anchored Solutions AB | 2017-06-07 |
| 09321502015554 | Baha | Cochlear Bone Anchored Solutions AB | 2017-06-07 |
| 09321502013932 | Baha | Cochlear Bone Anchored Solutions AB | 2017-06-07 |
| 09321502025157 | Baha | Cochlear Bone Anchored Solutions AB | 2017-06-07 |
| 09321502025416 | Baha | Cochlear Bone Anchored Solutions AB | 2016-10-24 |
| 09321502012881 | Baha | Cochlear Bone Anchored Solutions AB | 2015-10-22 |
| 09321502012874 | Baha | Cochlear Bone Anchored Solutions AB | 2015-10-22 |
| 09321502012867 | Baha | Cochlear Bone Anchored Solutions AB | 2015-10-22 |
| 09321502019620 | Baha | Cochlear Bone Anchored Solutions AB | 2015-10-09 |
| 09321502019613 | Baha | Cochlear Bone Anchored Solutions AB | 2015-10-09 |