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 |
|---|---|---|---|
| K260452 | Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151, G42152, G42153, G42154, G42155, G42156, G42157, G42158, G42159, G42160, G43151, G43152, G43153, G43154, G43155, G43156, G45151, G45152, G45153, G45154, G45155, G45156, ... | Zdeer Technology (Henan) Co., Ltd. | 2026-06-15 |
| K261256 | Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3) | Shenzhen Magnet Technology Co., Ltd. | 2026-06-11 |
| 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 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00643169719583 | ATTRACT™ | MEDTRONIC XOMED, INC. | 2017-10-02 |
| 00643169719576 | ATTRACT™ | MEDTRONIC XOMED, INC. | 2017-10-02 |
| 00643169719569 | ATTRACT™ | MEDTRONIC XOMED, INC. | 2017-10-02 |
| 00643169719552 | ATTRACT™ | MEDTRONIC XOMED, INC. | 2017-10-02 |
| 00643169719545 | ATTRACT™ | MEDTRONIC XOMED, INC. | 2017-10-02 |
| 00643169644816 | Otomag™ Attract™ Magnetic Spacer | MEDTRONIC XOMED, INC. | 2016-04-15 |
| 00643169649064 | NA | MEDTRONIC XOMED, INC. | 2016-04-15 |
| 00643169644892 | NA | MEDTRONIC XOMED, INC. | 2016-04-15 |
| 00643169644885 | Otomag™ Attract™ Magnetic Spacer | MEDTRONIC XOMED, INC. | 2016-04-15 |
| 00643169644878 | Otomag™ Attract™ Magnetic Spacer | MEDTRONIC XOMED, INC. | 2016-04-15 |
| 00643169644861 | Otomag™ Attract™ Magnetic Spacer | MEDTRONIC XOMED, INC. | 2016-04-15 |
| 00643169644854 | Otomag™ Attract™ Magnetic Spacer | MEDTRONIC XOMED, INC. | 2016-04-15 |
| 00643169644847 | Otomag™ Attract™ Magnetic Spacer | MEDTRONIC XOMED, INC. | 2016-04-15 |
| 00643169644830 | Otomag™ Attract™ Magnetic Spacer | MEDTRONIC XOMED, INC. | 2016-04-15 |
| 00643169644823 | Otomag™ Attract™ Magnetic Spacer | MEDTRONIC XOMED, INC. | 2016-04-15 |
| 00643169644656 | Otomag™ Attract™ Magnetic Spacer | MEDTRONIC XOMED, INC. | 2016-04-15 |
| 00643169644809 | Otomag™ Attract™ Magnetic Spacer | MEDTRONIC XOMED, INC. | 2016-04-15 |
| 00643169644793 | Otomag™ Attract™ Magnetic Spacer | MEDTRONIC XOMED, INC. | 2016-04-15 |
| 00643169644786 | Otomag™ Attract™ Magnetic Spacer | MEDTRONIC XOMED, INC. | 2016-04-15 |
| 00643169644779 | Otomag™ Attract™ Magnetic Spacer | MEDTRONIC XOMED, INC. | 2016-04-15 |
| 00643169644762 | Otomag™ Attract™ Magnetic Spacer | MEDTRONIC XOMED, INC. | 2016-04-15 |
| 00643169644755 | Otomag™ Attract™ Magnetic Spacer | MEDTRONIC XOMED, INC. | 2016-04-15 |
| 00643169644748 | Otomag™ Attract™ Magnetic Spacer | MEDTRONIC XOMED, INC. | 2016-04-15 |
| 00643169644731 | Otomag™ Attract™ Magnetic Spacer | MEDTRONIC XOMED, INC. | 2016-04-15 |
| 00643169644717 | Otomag™ Attract™ Magnetic Spacer | MEDTRONIC XOMED, INC. | 2016-04-15 |
| 00643169644700 | Otomag™ Attract™ Magnetic Spacer | MEDTRONIC XOMED, INC. | 2016-04-15 |
| 00643169644694 | Otomag™ Attract™ Magnetic Spacer | MEDTRONIC XOMED, INC. | 2016-04-15 |
| 00643169644687 | Otomag™ Attract™ Magnetic Spacer | MEDTRONIC XOMED, INC. | 2016-04-15 |
| 00643169644670 | Otomag™ Attract™ Magnetic Spacer | MEDTRONIC XOMED, INC. | 2016-04-15 |
| 00643169644663 | Otomag™ Attract™ Magnetic Spacer | MEDTRONIC XOMED, INC. | 2016-04-15 |