FDA Product Code ESD: Hearing Aid, Air-conduction, Prescription
An Air-conduction Hearing Aid Is A Wearable Sound Amplifying Device Intended To Compensate For Impaired Hearing That Conducts Sound To The Ear Through The Air. This Is A Prescription Hearing Aid.
Leading manufacturers include Sonova AG.
1367
Total
1367
Cleared
56d
Avg days
1976
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Hearing Aid, Air-conduction, Prescription Devices (Product Code ESD)
1367 devices
About Product Code ESD - Regulatory Context
510(k) Submission Activity
1367 total 510(k) submissions under product code ESD since 1976, with 1367 receiving FDA clearance (average review time: 56 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
ESD devices are reviewed by the Ear, Nose, Throat panel. Browse all Ear, Nose, Throat devices →