FDA Product Code LXB: Hearing Aid, Bone Conduction
Leading manufacturers include Cochlear Americas, Bhm-Tech Produktionsgesellschaft Mbh and Cochlear.
FDA 510(k) Cleared Hearing Aid, Bone Conduction Devices (Product Code LXB)
About Product Code LXB - Regulatory Context
510(k) Submission Activity
49 total 510(k) submissions under product code LXB since 1986, with 49 receiving FDA clearance (average review time: 115 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under LXB have taken an average of 168 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 →