FDA Product Code
FDA Product Code LXB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ear, Nose, Throat
- 21 CFR Citation
- 874.3302
510(k) Clearances — 53 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253431 | Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN, SHOKZHEAR BM410, SHOKZHEAR BM410MN, SHOKZHEAR BM420 and SHOKZHEAR BM420MN) | Shokz Health Global Limited | 2026-08-19 | Traditional | PDF ↗ |
| K254296 | Ossiclear (Ossiclear System) | Sounduct | 2026-07-22 | Traditional | PDF ↗ |
| 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, G45157, G45158, G45159, G45160, G46151, G46152, G46153, G46154, G46155, G46156, G46157, G46158) | Zdeer Technology (Henan) Co., Ltd. | 2026-06-15 | Traditional | PDF ↗ |
| K261256 | Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3) | Shenzhen Magnet Technology Co., Ltd. | 2026-06-11 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K243041 | contact forte Alpha | Bhm-Tech Produktionsgesellschaft Mbh | 2025-04-25 | Traditional | PDF ↗ |
| K213733 | Ponto 5 SuperPower | Oticon Medical AB | 2021-12-16 | Special | PDF ↗ |
| K212136 | Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App | Cochlear Americas | 2021-09-29 | Traditional | PDF ↗ |
| K211640 | Ponto 5 Mini | Oticon Medical AB | 2021-08-10 | Special | PDF ↗ |
| K202048 | Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App | Cochlear Americas | 2021-02-23 | Traditional | PDF ↗ |
| K190540 | Ponto 4 | Oticon Medical AB | 2019-05-02 | Traditional | PDF ↗ |
| K172460 | ADHEAR System | Med-El Elektromedizinische Geraete GmbH | 2018-04-27 | Traditional | PDF ↗ |
| K171088 | Cochlear Baha SoundArc | Cochlear Americas | 2017-06-07 | Special | PDF ↗ |
| K161671 | Ponto 3, Ponto 3 Power and Ponto 3 SuperPower | Oticon Medical AB | 2016-09-29 | Traditional | PDF ↗ |
| K153391 | Sophono Bone Conduction Systems (S) Configuration and (M) Configuration | Sophono, Inc. | 2016-06-16 | Traditional | PDF ↗ |
| K161123 | Baha 5 Power Sound Processor | Cochlear Americas | 2016-05-20 | Special | PDF ↗ |
| K153245 | Baha 5 Super Power Sound Processor | Cochlear Americas | 2016-03-02 | Traditional | PDF ↗ |
| K150751 | Cordelle II Sound Processor | Cochlear Americas | 2015-07-22 | Traditional | PDF ↗ |
| K142907 | Baha 5 Sound Processor | Cochlear Americas | 2015-03-25 | Traditional | PDF ↗ |
| K132775 | PONTO PLUS AND PONTO PLUS POWER | Oticon Medical AB | 2013-12-09 | Traditional | PDF ↗ |
| K132189 | OTOMAG BONE CONDUCATION HEARING SYSTEM | Sophono, Inc. | 2013-11-22 | Traditional | PDF ↗ |
| K131240 | COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACT | Cochlear Americas | 2013-11-07 | Traditional | PDF ↗ |
| K132278 | COCHLEAR BAHA 4 SOUND PROCESSOR | Cochlear Americas | 2013-09-26 | Special | PDF ↗ |
| K123962 | OTOMAG BONE CONDUCTION HEARING SYSTEM | Sophono, Inc. | 2013-04-08 | Traditional | PDF ↗ |
| K121793 | AN EVO 1, CS EVO 1, CONTACT MINI, APOLLON | Audifon-USA, Inc. | 2012-11-01 | Abbreviated | PDF ↗ |
| K110831 | SOUNDBITE HEARING SYSTEM BY SONITUS MEDICAL | Sonitus Medical, Inc. | 2011-06-21 | Traditional | PDF ↗ |
| K103594 | PONTO PRO POWER | Oticon Medical AB | 2011-06-15 | Traditional | PDF ↗ |
| K102199 | OTOMAG BONE CONDUCTION HEARING SYSTEM MODEL ALPHA 1 (S) AND ALPHA 1 (M) | Sophono, Inc. | 2011-05-23 | Traditional | PDF ↗ |
| K110996 | BAHA 3 POWER SOUND PROCESSOR | Cochlear Americas | 2011-05-10 | Special | PDF ↗ |
| K100649 | SOUNDBITE HEARING SYSTEM BY SONITUS | Sonitus Medical, Inc. | 2011-01-14 | Traditional | PDF ↗ |
| K100360 | BIA300 SERIES IMPLANT AND ABUTMENT, BI300 IMPLANT, BA300 ABUTMENT | Cochlear Americas | 2010-07-13 | Traditional | PDF ↗ |
| K100193 | OTOMAG BONE CONDUCTION HEARING SYSTEM | Sophono, Inc. | 2010-05-18 | Traditional | PDF ↗ |
| K090996 | PONTO PRO | Oticon Medical AB | 2009-07-29 | Traditional | PDF ↗ |
| K090720 | COCHLEAR BAHA BP100 | Cochlear Bone Anchored Systems AB | 2009-06-17 | Traditional | PDF ↗ |
| K082108 | OBC BONE ANCHORED HEARING AID SYSTEM | Oticon Medical AB | 2008-11-14 | Traditional | PDF ↗ |
| K081606 | BAHA INTENSO | Cochlear Americas | 2008-08-28 | Traditional | PDF ↗ |
| K062404 | TRANSEAR BONE CONDUCTION HEARING AID | Ear Technology Corp. | 2006-09-08 | Special | PDF ↗ |
| K050653 | TRANSEAR BONE CONDUCTION HEARING AID | United Hearing Systems, Inc. | 2005-07-01 | Traditional | PDF ↗ |
| K042017 | BAHA DIVINO | Entific Medical Systems, Inc. | 2004-08-26 | Traditional | PDF ↗ |
| K021837 | BRANENMARK BONE-ANCHORED-HEARING AID (BAHA) | Entific Medical Systems, Inc. | 2002-08-30 | Traditional | PDF ↗ |
| K011438 | BILATERAL FITTING OF THE BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM. | Entific Medical Systems, Inc. | 2001-07-23 | Traditional | PDF ↗ |
| K002913 | HEADBAND FOR BAHA | Entific Medical Systems, Inc. | 2000-10-17 | Traditional | PDF ↗ |
| K992872 | BRANEMARK BONE-ANCHORED HEARING AID (BAHA) CORDELLE II | Entific Medical Systems, Inc. | 1999-11-24 | Traditional | PDF ↗ |
| K955713 | NOBELPHARMA BONE ANCHORED HEARING AID | Nobelpharma USA, Inc. | 1996-08-09 | Traditional | PDF ↗ |
| K953872 | SECOND EAR BONE CONDUCTION HEARING AID | Wordcomp International Communication Group (Wicg) | 1996-04-12 | Traditional | PDF ↗ |
| K951678 | HI SONIC 2000 DIGITAL HEARING INSTRUMENT | Hearing Innovations, Inc. | 1995-06-07 | Traditional | PDF ↗ |
| K935701 | VIENNATONE AN, VIENNATONE AS FIDELITY F228, FIDELITY F229 | Starkey Laboratories, Inc. | 1994-05-10 | Traditional | PDF ↗ |
| K884056 | MODIFIED IMPLANT FOR XOMED AUDIANT BONE CONDUCTOR | Xomed, Inc. | 1988-11-30 | Traditional | PDF ↗ |
| K881382 | XOMED AUDIANT BONE CONDUCTOR | Xomed, Inc. | 1988-06-21 | Traditional | PDF ↗ |
| K875277 | ADDITIONAL INDICATIONS FOR XOMED AUDIANT BONE CON. | Xomed, Inc. | 1988-03-14 | Traditional | PDF ↗ |
| K872168 | XOMED AUDIANT BONE CONDUCTOR AT THE EAR SOUND PRO. | Xomed, Inc. | 1987-06-30 | Traditional | PDF ↗ |
| K861971 | XOMED AUDIANT BONE CONDUCTOR W/IMPROVED AA COIL | Xomed, Inc. | 1986-05-30 | Traditional | PDF ↗ |
| K855059 | AUDIANT BONE CONDUCTOR OR A.B.C. | Xomed, Inc. | 1986-04-03 | Traditional | PDF ↗ |
Product code LXB · Class II · Ear, Nose, Throat. Data: openFDA.