FDA Product Code QDD: Self-fitting Air-conduction Hearing Aid, Prescription
A Self-fitting Air-conduction Hearing Aid Is A Wearable Sound Amplifying Device That Is Intended To Compensate For Impaired Hearing And Incorporates Technology, Including Software, That Allows Users To Program Their Hearing Aids. This Technology Integrates User Input With A Self-fitting Strategy And Enables Users To Independently Derive And Customize Their Hearing Aid Fitting And Settings. This Is A Prescription Hearing Aid.
Leading manufacturers include Bose Corporation, Kaz USA, Inc., A Helen of Troy Company and GN Hearing A/S.
FDA 510(k) Cleared Self-fitting Air-conduction Hearing Aid, Prescription Devices (Product Code QDD)
About Product Code QDD - Regulatory Context
510(k) Submission Activity
7 total 510(k) submissions under product code QDD since 2018, with 6 receiving FDA clearance (average review time: 152 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 3 in the prior period.
QDD devices are reviewed by the Ear, Nose, Throat panel. Browse all Ear, Nose, Throat devices →