Atlas FDA

LXB

52 FDA 510(k) clearances · Product code

105 daysmedian time to decision
214 days90th percentile
52clearances measured

FDA profile

Official device name
Hearing Aid, Bone Conduction
Device class
Class II (moderate risk)
Regulation
21 CFR 874.3302
Medical specialty
Ear, Nose, Throat
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 490 · 2022: 387 · 2023: 348 · 2024: 232 · 2025: 261 · 2026: 184
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Ossiclear (Ossiclear System) (K254296)Sounduct2026-07-22
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) (K260452)Zdeer Technology (Henan) Co., Ltd.2026-06-15
Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3) (K261256)Shenzhen Magnet Technology Co., Ltd.2026-06-11
Baha 7 Sound Processor; Baha Fitting Software 7 (P2121898); Baha Smart App (iOS) (P1646054); Baha Smart App (Android) (P1646035); Baha SoundBand (K250215)Cochlear2025-05-29
contact forte Alpha (K243041)Bhm-Tech Produktionsgesellschaft Mbh2025-04-25
Ponto 5 SuperPower (K213733)Oticon Medical AB2021-12-16
Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App (K212136)Cochlear Americas2021-09-29
Ponto 5 Mini (K211640)Oticon Medical AB2021-08-10
Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App (K202048)Cochlear Americas2021-02-23
Ponto 4 (K190540)Oticon Medical AB2019-05-02
ADHEAR System (K172460)Med-El Elektromedizinische Geraete GmbH2018-04-27
Cochlear Baha SoundArc (K171088)Cochlear Americas2017-06-07
Ponto 3, Ponto 3 Power and Ponto 3 SuperPower (K161671)Oticon Medical AB2016-09-29
Sophono Bone Conduction Systems (S) Configuration and (M) Configuration (K153391)Sophono, Inc.2016-06-16
Baha 5 Power Sound Processor (K161123)Cochlear Americas2016-05-20
Baha 5 Super Power Sound Processor (K153245)Cochlear Americas2016-03-02
Cordelle II Sound Processor (K150751)Cochlear Americas2015-07-22
Baha 5 Sound Processor (K142907)Cochlear Americas2015-03-25
PONTO PLUS AND PONTO PLUS POWER (K132775)Oticon Medical AB2013-12-09
OTOMAG BONE CONDUCATION HEARING SYSTEM (K132189)Sophono, Inc.2013-11-22
COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACT (K131240)Cochlear Americas2013-11-07
COCHLEAR BAHA 4 SOUND PROCESSOR (K132278)Cochlear Americas2013-09-26
OTOMAG BONE CONDUCTION HEARING SYSTEM (K123962)Sophono, Inc.2013-04-08
AN EVO 1, CS EVO 1, CONTACT MINI, APOLLON (K121793)Audifon-USA, Inc.2012-11-01
SOUNDBITE HEARING SYSTEM BY SONITUS MEDICAL (K110831)Sonitus Medical, Inc.2011-06-21
PONTO PRO POWER (K103594)Oticon Medical AB2011-06-15
OTOMAG BONE CONDUCTION HEARING SYSTEM MODEL ALPHA 1 (S) AND ALPHA 1 (M) (K102199)Sophono, Inc.2011-05-23
BAHA 3 POWER SOUND PROCESSOR (K110996)Cochlear Americas2011-05-10
SOUNDBITE HEARING SYSTEM BY SONITUS (K100649)Sonitus Medical, Inc.2011-01-14
BIA300 SERIES IMPLANT AND ABUTMENT, BI300 IMPLANT, BA300 ABUTMENT (K100360)Cochlear Americas2010-07-13
OTOMAG BONE CONDUCTION HEARING SYSTEM (K100193)Sophono, Inc.2010-05-18
PONTO PRO (K090996)Oticon Medical AB2009-07-29
COCHLEAR BAHA BP100 (K090720)Cochlear Bone Anchored Systems AB2009-06-17
OBC BONE ANCHORED HEARING AID SYSTEM (K082108)Oticon Medical AB2008-11-14
BAHA INTENSO (K081606)Cochlear Americas2008-08-28
TRANSEAR BONE CONDUCTION HEARING AID (K062404)Ear Technology Corp.2006-09-08
TRANSEAR BONE CONDUCTION HEARING AID (K050653)United Hearing Systems, Inc.2005-07-01
BAHA DIVINO (K042017)Entific Medical Systems, Inc.2004-08-26
BRANENMARK BONE-ANCHORED-HEARING AID (BAHA) (K021837)Entific Medical Systems, Inc.2002-08-30
BILATERAL FITTING OF THE BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM. (K011438)Entific Medical Systems, Inc.2001-07-23
HEADBAND FOR BAHA (K002913)Entific Medical Systems, Inc.2000-10-17
BRANEMARK BONE-ANCHORED HEARING AID (BAHA) CORDELLE II (K992872)Entific Medical Systems, Inc.1999-11-24
NOBELPHARMA BONE ANCHORED HEARING AID (K955713)Nobelpharma USA, Inc.1996-08-09
SECOND EAR BONE CONDUCTION HEARING AID (K953872)Wordcomp International Communication Group (Wicg)1996-04-12
HI SONIC 2000 DIGITAL HEARING INSTRUMENT (K951678)Hearing Innovations, Inc.1995-06-07
VIENNATONE AN, VIENNATONE AS FIDELITY F228, FIDELITY F229 (K935701)Starkey Laboratories, Inc.1994-05-10
MODIFIED IMPLANT FOR XOMED AUDIANT BONE CONDUCTOR (K884056)Xomed, Inc.1988-11-30
XOMED AUDIANT BONE CONDUCTOR (K881382)Xomed, Inc.1988-06-21
ADDITIONAL INDICATIONS FOR XOMED AUDIANT BONE CON. (K875277)Xomed, Inc.1988-03-14
XOMED AUDIANT BONE CONDUCTOR AT THE EAR SOUND PRO. (K872168)Xomed, Inc.1987-06-30
XOMED AUDIANT BONE CONDUCTOR W/IMPROVED AA COIL (K861971)Xomed, Inc.1986-05-30
AUDIANT BONE CONDUCTOR OR A.B.C. (K855059)Xomed, Inc.1986-04-03

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Every clearance here is in the API, with alerts when new ones post.