FDA Product Code EWO: Audiometer
Leading manufacturers include Otodynamics, Otodynamics, Ltd. and Hearx SA (Pty) , Ltd..
FDA 510(k) Cleared Audiometer Devices (Product Code EWO)
About Product Code EWO - Regulatory Context
510(k) Submission Activity
235 total 510(k) submissions under product code EWO since 1976, with 235 receiving FDA clearance (average review time: 103 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 3 in the prior period.
FDA Review Time
Recent submissions under EWO have taken an average of 178 days to reach a decision - up from 103 days historically. Manufacturers should account for longer review timelines in current project planning.
EWO devices are reviewed by the Ear, Nose, Throat panel. Browse all Ear, Nose, Throat devices →