FDA Product Code ETA: Replacement, Ossicular Prosthesis, Total
Leading manufacturers include Med-El Elektromedizinische Ger?te GmbH.
FDA 510(k) Cleared Replacement, Ossicular Prosthesis, Total Devices (Product Code ETA)
About Product Code ETA - Regulatory Context
510(k) Submission Activity
39 total 510(k) submissions under product code ETA since 1976, with 39 receiving FDA clearance (average review time: 102 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 ETA have taken an average of 149 days to reach a decision - up from 100 days historically. Manufacturers should account for longer review timelines in current project planning.
ETA devices are reviewed by the Ear, Nose, Throat panel. Browse all Ear, Nose, Throat devices →