FDA Product Code ETB: Prosthesis, Partial Ossicular Replacement
Leading manufacturers include Med-El Elektromedizinische Ger?te GmbH.
FDA 510(k) Cleared Prosthesis, Partial Ossicular Replacement Devices (Product Code ETB)
About Product Code ETB - Regulatory Context
510(k) Submission Activity
74 total 510(k) submissions under product code ETB since 1976, with 74 receiving FDA clearance (average review time: 77 days).
Submission volume has increased in recent years - 4 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 ETB have taken an average of 148 days to reach a decision - up from 73 days historically. Manufacturers should account for longer review timelines in current project planning.
ETB devices are reviewed by the Ear, Nose, Throat panel. Browse all Ear, Nose, Throat devices →