FDA 510(k) Applications for Medical Device Product Code "LXB"
(Hearing Aid, Bone Conduction)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K121793 | AUDIFON-USA INC. | AN EVO 1, CS EVO 1, CONTACT MINI, APOLLON | 11/01/2012 |
| K243041 | BHM-Tech Produktionsgesellschaft mbH | contact forte Alpha | 04/25/2025 |
| K250215 | Cochlear | Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand | 05/29/2025 |
| K110996 | COCHLEAR AMERICAS | BAHA 3 POWER SOUND PROCESSOR | 05/10/2011 |
| K161123 | Cochlear Americas | Baha 5 Power Sound Processor | 05/20/2016 |
| K142907 | COCHLEAR AMERICAS | Baha 5 Sound Processor | 03/25/2015 |
| K153245 | COCHLEAR AMERICAS | Baha 5 Super Power Sound Processor | 03/02/2016 |
| K081606 | COCHLEAR AMERICAS | BAHA INTENSO | 08/28/2008 |
| K100360 | COCHLEAR AMERICAS | BIA300 SERIES IMPLANT AND ABUTMENT, BI300 IMPLANT, BA300 ABUTMENT | 07/13/2010 |
| K132278 | COCHLEAR AMERICAS | COCHLEAR BAHA 4 SOUND PROCESSOR | 09/26/2013 |
| K202048 | Cochlear Americas | Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App | 02/23/2021 |
| K212136 | Cochlear Americas | Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App | 09/29/2021 |
| K131240 | COCHLEAR AMERICAS | COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACT | 11/07/2013 |
| K171088 | Cochlear Americas | Cochlear Baha SoundArc | 06/07/2017 |
| K150751 | COCHLEAR AMERICAS | Cordelle II Sound Processor | 07/22/2015 |
| K090720 | COCHLEAR BONE ANCHORED SYSTEMS AB | COCHLEAR BAHA BP100 | 06/17/2009 |
| K062404 | EAR TECHNOLOGY CORP. | TRANSEAR BONE CONDUCTION HEARING AID | 09/08/2006 |
| K042017 | ENTIFIC MEDICAL SYSTEMS, INC. | BAHA DIVINO | 08/26/2004 |
| K011438 | ENTIFIC MEDICAL SYSTEMS, INC. | BILATERAL FITTING OF THE BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM. | 07/23/2001 |
| K992872 | ENTIFIC MEDICAL SYSTEMS, INC. | BRANEMARK BONE-ANCHORED HEARING AID (BAHA) CORDELLE II | 11/24/1999 |
| K021837 | ENTIFIC MEDICAL SYSTEMS, INC. | BRANENMARK BONE-ANCHORED-HEARING AID (BAHA) | 08/30/2002 |
| K002913 | ENTIFIC MEDICAL SYSTEMS, INC. | HEADBAND FOR BAHA | 10/17/2000 |
| K172460 | MED-EL Elektromedizinische Geraete GmbH | ADHEAR System | 04/27/2018 |
| K955713 | NOBELPHARMA USA, INC. | NOBELPHARMA BONE ANCHORED HEARING AID | 08/09/1996 |
| K082108 | OTICON MEDICAL AB | OBC BONE ANCHORED HEARING AID SYSTEM | 11/14/2008 |
| K161671 | OTICON MEDICAL AB | Ponto 3, Ponto 3 Power and Ponto 3 SuperPower | 09/29/2016 |
| K190540 | Oticon Medical AB | Ponto 4 | 05/02/2019 |
| K211640 | Oticon Medical AB | Ponto 5 Mini | 08/10/2021 |
| K213733 | Oticon Medical AB | Ponto 5 SuperPower | 12/16/2021 |
| K132775 | OTICON MEDICAL AB | PONTO PLUS AND PONTO PLUS POWER | 12/09/2013 |
| K090996 | OTICON MEDICAL AB | PONTO PRO | 07/29/2009 |
| K103594 | OTICON MEDICAL AB | PONTO PRO POWER | 06/15/2011 |
| K100649 | SONITUS MEDICAL INC | SOUNDBITE HEARING SYSTEM BY SONITUS | 01/14/2011 |
| K110831 | SONITUS MEDICAL INC | SOUNDBITE HEARING SYSTEM BY SONITUS MEDICAL | 06/21/2011 |
| K153391 | SOPHONO INC. | Sophono Bone Conduction Systems (S) Configuration and (M) Configuration | 06/16/2016 |
| K132189 | SOPHONO, INC | OTOMAG BONE CONDUCATION HEARING SYSTEM | 11/22/2013 |
| K100193 | SOPHONO, INC | OTOMAG BONE CONDUCTION HEARING SYSTEM | 05/18/2010 |
| K123962 | SOPHONO, INC | OTOMAG BONE CONDUCTION HEARING SYSTEM | 04/08/2013 |
| K102199 | SOPHONO, INC | OTOMAG BONE CONDUCTION HEARING SYSTEM MODEL ALPHA 1 (S) AND ALPHA 1 (M) | 05/23/2011 |
| K050653 | UNITED HEARING SYSTEMS, INC. | TRANSEAR BONE CONDUCTION HEARING AID | 07/01/2005 |
| K953872 | WORDCOMP INTERNATIONAL COMMUNICATION GROUP (WICG) | SECOND EAR BONE CONDUCTION HEARING AID | 04/12/1996 |
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