LXB · Class II · 21 CFR 874.3302

FDA Product Code LXB: Hearing Aid, Bone Conduction

Leading manufacturers include Cochlear Americas, Oticon Medical AB and Xomed, Inc..

53
Total
53
Cleared
120d
Avg days
1986
Since
Growing category - 6 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 173d recently vs 113d historically

FDA 510(k) Cleared Hearing Aid, Bone Conduction Devices (Product Code LXB)

53 devices
1–24 of 53
Cleared Aug 19, 2026
Bone conduction Hearing Aid (BM100, BM300, BM310, SHOKZHEAR BM400, SHOKZ BM400MN, SHOKZHEAR BM410, SHOKZHEAR BM410MN, SHOKZHEAR BM420 and SHOKZHEAR BM420MN)
K253431
Shokz Health Global Limited
Ear, Nose, Throat · 322d
Cleared Jul 22, 2026
Ossiclear (Ossiclear System)
K254296
Sounduct
Ear, Nose, Throat · 203d
Cleared Jun 15, 2026
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.
Ear, Nose, Throat · 124d
Cleared Jun 11, 2026
Bone Conduction Hearing Aid (XTS-AISW-D1, XTS-AISW-D2, XTS-AISW-D3)
K261256
Shenzhen Magnet Technology Co., Ltd.
Ear, Nose, Throat · 56d
Cleared May 29, 2025
Baha 7 Sound Processor
K250215
Cochlear
Ear, Nose, Throat · 125d
Cleared Apr 25, 2025
contact forte Alpha
K243041
Bhm-Tech Produktionsgesellschaft Mbh
Ear, Nose, Throat · 210d
Cleared Dec 16, 2021
Ponto 5 SuperPower
K213733
Oticon Medical AB
Ear, Nose, Throat · 20d
Cleared Sep 29, 2021
Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App
K212136
Cochlear Americas
Ear, Nose, Throat · 83d
Cleared Aug 10, 2021
Ponto 5 Mini
K211640
Oticon Medical AB
Ear, Nose, Throat · 75d
Cleared Feb 23, 2021
Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App
K202048
Cochlear Americas
Ear, Nose, Throat · 214d
Cleared May 02, 2019
Ponto 4
K190540
Oticon Medical AB
Ear, Nose, Throat · 59d
Cleared Apr 27, 2018
ADHEAR System
K172460
Med-El Elektromedizinische Geraete GmbH
Ear, Nose, Throat · 256d
Cleared Jun 07, 2017
Cochlear Baha SoundArc
K171088
Cochlear Americas
Ear, Nose, Throat · 56d
Cleared Sep 29, 2016
Ponto 3, Ponto 3 Power and Ponto 3 SuperPower
K161671
Oticon Medical AB
Ear, Nose, Throat · 105d
Cleared Jun 16, 2016
Sophono Bone Conduction Systems (S) Configuration and (M) Configuration
K153391
Sophono, Inc.
Ear, Nose, Throat · 205d
Cleared May 20, 2016
Baha 5 Power Sound Processor
K161123
Cochlear Americas
Ear, Nose, Throat · 29d
Cleared Mar 02, 2016
Baha 5 Super Power Sound Processor
K153245
Cochlear Americas
Ear, Nose, Throat · 114d
Cleared Jul 22, 2015
Cordelle II Sound Processor
K150751
Cochlear Americas
Ear, Nose, Throat · 121d
Cleared Mar 25, 2015
Baha 5 Sound Processor
K142907
Cochlear Americas
Ear, Nose, Throat · 170d
Cleared Dec 09, 2013
PONTO PLUS AND PONTO PLUS POWER
K132775
Oticon Medical AB
Ear, Nose, Throat · 95d
Cleared Nov 22, 2013
OTOMAG BONE CONDUCATION HEARING SYSTEM
K132189
Sophono, Inc.
Ear, Nose, Throat · 130d
Cleared Nov 07, 2013
COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACT
K131240
Cochlear Americas
Ear, Nose, Throat · 190d
Cleared Sep 26, 2013
COCHLEAR BAHA 4 SOUND PROCESSOR
K132278
Cochlear Americas
Ear, Nose, Throat · 65d
Cleared Apr 08, 2013
OTOMAG BONE CONDUCTION HEARING SYSTEM
K123962
Sophono, Inc.
Ear, Nose, Throat · 103d

About Product Code LXB - Regulatory Context

510(k) Submission Activity

53 total 510(k) submissions under product code LXB since 1986, with 53 receiving FDA clearance (average review time: 120 days).

Submission volume has increased in recent years - 6 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - LXB Product Code

Recent submissions under LXB have taken an average of 173 days to reach a decision - up from 113 days historically. Manufacturers should account for longer review timelines in current project planning.

LXB devices are reviewed by the Ear, Nose, Throat panel. Browse all Ear, Nose, Throat devices →