Panels › Ear, Nose, Throat › Product code LXB · Class 2
Hearing Aid, Bone Conduction
Regulation 874.3302
4510(k)s in 12 months (53 all time)
0recalls in 12 months (7 all time)
7recalls that name a 510(k)
Top companies in LXB
| Company | 510(k)s | Recalls |
|---|---|---|
| Cochlear Americas | 12 | 2 |
| Oticon Medical AB | 8 | 0 |
| Sonitus Medical, Inc. | 2 | 5 |
| Xomed, Inc. | 6 | 0 |
| Entific Medical Systems, Inc. | 5 | 0 |
| Sophono, Inc. | 5 | 0 |
| Audifon-USA, Inc. | 1 | 0 |
| Bhm-Tech Produktionsgesellschaft Mbh | 1 | 0 |
| Cochlear | 1 | 0 |
| Cochlear Bone Anchored Systems AB | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 19, 2026 | K253431 | Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN, SHOKZHEAR BM410, SHOKZHEAR BM410MN, SH Shokz Health Global Limited, HK | LXB |
| Jul 22, 2026 | K254296 | Ossiclear (Ossiclear System) Sounduct, FR | LXB |
| Jun 15, 2026 | K260452 | Bone Conduction Hearing Aid (G41157, G41158, G41159, G41160, G42151, G42152, G42153, G42154, G42155, G42156, G42157, G42 Zdeer Technology (Henan) Co., Ltd., CN | LXB |
| Jun 11, 2026 | K261256 | Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3) Shenzhen Magnet Technology Co., Ltd., CN | LXB |
| May 29, 2025 | K250215 | Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P Cochlear | LXB |
| Apr 25, 2025 | K243041 | contact forte Alpha Bhm-Tech Produktionsgesellschaft Mbh, AT | LXB |
| Dec 16, 2021 | K213733 | Ponto 5 SuperPower Oticon Medical AB, SE | LXB |
| Sep 29, 2021 | K212136 | Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App Cochlear Americas | LXB |
| Aug 10, 2021 | K211640 | Ponto 5 Mini Oticon Medical AB, SE | LXB |
| Feb 23, 2021 | K202048 | Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App Cochlear Americas | LXB |
| May 2, 2019 | K190540 | Ponto 4 Oticon Medical AB, SE | LXB |
| Apr 27, 2018 | K172460 | ADHEAR System Med-El Elektromedizinische Geraete GmbH, AT | LXB |
| Jun 7, 2017 | K171088 | Cochlear Baha SoundArc Cochlear Americas | LXB |
| Sep 29, 2016 | K161671 | Ponto 3, Ponto 3 Power and Ponto 3 SuperPower Oticon Medical AB, SE | LXB |
| Jun 16, 2016 | K153391 | Sophono Bone Conduction Systems (S) Configuration and (M) Configuration Sophono, Inc. | LXB |
| May 20, 2016 | K161123 | Baha 5 Power Sound Processor Cochlear Americas | LXB |
| Mar 2, 2016 | K153245 | Baha 5 Super Power Sound Processor Cochlear Americas | LXB |
| Jul 22, 2015 | K150751 | Cordelle II Sound Processor Cochlear Americas | LXB |
| Mar 25, 2015 | K142907 | Baha 5 Sound Processor Cochlear Americas | LXB |
| Dec 9, 2013 | K132775 | PONTO PLUS AND PONTO PLUS POWER Oticon Medical AB, SE | LXB |
| Nov 22, 2013 | K132189 | OTOMAG BONE CONDUCATION HEARING SYSTEM Sophono, Inc. | LXB |
| Nov 7, 2013 | K131240 | COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACT Cochlear Americas | LXB |
| Sep 26, 2013 | K132278 | COCHLEAR BAHA 4 SOUND PROCESSOR Cochlear Americas | LXB |
| Apr 8, 2013 | K123962 | OTOMAG BONE CONDUCTION HEARING SYSTEM Sophono, Inc. | LXB |
| Nov 1, 2012 | K121793 | AN EVO 1, CS EVO 1, CONTACT MINI, APOLLON Audifon-USA, Inc. | LXB |
| Jun 21, 2011 | K110831 | SOUNDBITE HEARING SYSTEM BY SONITUS MEDICAL Sonitus Medical, Inc. | LXB |
| Jun 15, 2011 | K103594 | PONTO PRO POWER Oticon Medical AB, SE | LXB |
| May 23, 2011 | K102199 | OTOMAG BONE CONDUCTION HEARING SYSTEM MODEL ALPHA 1 (S) AND ALPHA 1 (M) Sophono, Inc. | LXB |
| May 10, 2011 | K110996 | BAHA 3 POWER SOUND PROCESSOR Cochlear Americas | LXB |
| Jan 14, 2011 | K100649 | SOUNDBITE HEARING SYSTEM BY SONITUS Sonitus Medical, Inc. | LXB |
| Jul 13, 2010 | K100360 | BIA300 SERIES IMPLANT AND ABUTMENT, BI300 IMPLANT, BA300 ABUTMENT Cochlear Americas | LXB |
| May 18, 2010 | K100193 | OTOMAG BONE CONDUCTION HEARING SYSTEM Sophono, Inc. | LXB |
| Jul 29, 2009 | K090996 | PONTO PRO Oticon Medical AB, SE | LXB |
| Jun 17, 2009 | K090720 | COCHLEAR BAHA BP100 Cochlear Bone Anchored Systems AB | LXB |
| Nov 14, 2008 | K082108 | OBC BONE ANCHORED HEARING AID SYSTEM Oticon Medical AB, SE | LXB |
| Aug 28, 2008 | K081606 | BAHA INTENSO Cochlear Americas | LXB |
| Sep 8, 2006 | K062404 | TRANSEAR BONE CONDUCTION HEARING AID Ear Technology Corp. | LXB |
| Jul 1, 2005 | K050653 | TRANSEAR BONE CONDUCTION HEARING AID United Hearing Systems, Inc. | LXB |
| Aug 26, 2004 | K042017 | BAHA DIVINO Entific Medical Systems, Inc. | LXB |
| Aug 30, 2002 | K021837 | BRANENMARK BONE-ANCHORED-HEARING AID (BAHA) Entific Medical Systems, Inc. | LXB |
| Jul 23, 2001 | K011438 | BILATERAL FITTING OF THE BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM. Entific Medical Systems, Inc. | LXB |
| Oct 17, 2000 | K002913 | HEADBAND FOR BAHA Entific Medical Systems, Inc. | LXB |
| Nov 24, 1999 | K992872 | BRANEMARK BONE-ANCHORED HEARING AID (BAHA) CORDELLE II Entific Medical Systems, Inc. | LXB |
| Aug 9, 1996 | K955713 | NOBELPHARMA BONE ANCHORED HEARING AID Nobelpharma USA, Inc. | LXB |
| Apr 12, 1996 | K953872 | SECOND EAR BONE CONDUCTION HEARING AID Wordcomp International Communication Group (Wicg) | LXB |
| Jun 7, 1995 | K951678 | HI SONIC 2000 DIGITAL HEARING INSTRUMENT Hearing Innovations, Inc. | LXB |
| May 10, 1994 | K935701 | VIENNATONE AN, VIENNATONE AS FIDELITY F228, FIDELITY F229 Starkey Laboratories, Inc. | LXB |
| Nov 30, 1988 | K884056 | MODIFIED IMPLANT FOR XOMED AUDIANT BONE CONDUCTOR Xomed, Inc. | LXB |
| Jun 21, 1988 | K881382 | XOMED AUDIANT BONE CONDUCTOR Xomed, Inc. | LXB |
| Mar 14, 1988 | K875277 | ADDITIONAL INDICATIONS FOR XOMED AUDIANT BONE CON. Xomed, Inc. | LXB |
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