FDA Product Code LXB: Hearing Aid, Bone Conduction
Leading manufacturers include Cochlear Americas.
2
Total
2
Cleared
149d
Avg days
2021
Since
List of Hearing Aid, Bone Conduction devices cleared through 510(k)
2 devices
Cleared
Sep 29, 2021
Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App
Cochlear Americas
Ear, Nose, Throat
83d
Cleared
Feb 23, 2021
Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App
Cochlear Americas
Ear, Nose, Throat
214d
How to use this database
This page lists all FDA 510(k) submissions for Hearing Aid, Bone Conduction devices (product code LXB). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Ear, Nose, Throat FDA review panel. Browse all Ear, Nose, Throat devices →