LXB · Class II · 21 CFR 874.3302

FDA Product Code LXB: Hearing Aid, Bone Conduction

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

52
Total
52
Cleared
116d
Avg days
1986
Since
Growing category - 5 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 144d recently vs 113d historically

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

52 devices
1–24 of 52
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 Aug 09, 1996
NOBELPHARMA BONE ANCHORED HEARING AID
K955713
Nobelpharma USA, Inc.
Ear, Nose, Throat · 235d
Cleared May 10, 1994
VIENNATONE AN, VIENNATONE AS FIDELITY F228, FIDELITY F229
K935701
Starkey Laboratories, Inc.
Ear, Nose, Throat · 161d
Cleared Nov 30, 1988
MODIFIED IMPLANT FOR XOMED AUDIANT BONE CONDUCTOR
K884056
Xomed, Inc.
Ear, Nose, Throat · 65d
Cleared Jun 21, 1988
XOMED AUDIANT BONE CONDUCTOR
K881382
Xomed, Inc.
Ear, Nose, Throat · 81d
Cleared Mar 14, 1988
ADDITIONAL INDICATIONS FOR XOMED AUDIANT BONE CON.
K875277
Xomed, Inc.
Ear, Nose, Throat · 81d
Cleared Jun 30, 1987
XOMED AUDIANT BONE CONDUCTOR AT THE EAR SOUND PRO.
K872168
Xomed, Inc.
Ear, Nose, Throat · 22d
Cleared May 30, 1986
XOMED AUDIANT BONE CONDUCTOR W/IMPROVED AA COIL
K861971
Xomed, Inc.
Ear, Nose, Throat · 9d
Cleared Apr 03, 1986
AUDIANT BONE CONDUCTOR OR A.B.C.
K855059
Xomed, Inc.
Ear, Nose, Throat · 106d

About Product Code LXB - Regulatory Context

510(k) Submission Activity

52 total 510(k) submissions under product code LXB since 1986, with 52 receiving FDA clearance (average review time: 116 days).

Submission volume has increased in recent years - 5 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 144 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 →