FDA Product Code QUH: Self-fitting Air-conduction Hearing Aid, Over The Counter
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 An Over The Counter Hearing Aid. For Information On The Final Rule establishing Over-the-counter Hearing Aids, Please See 87 Fr 50698, Available At Https://www.govinfo.gov/content/pkg/fr-2022-08-17/pdf/2022-17230.pdf.
Leading manufacturers include Huizhou Jinghao Medical Technology Co., Ltd., Nuheara Limited and Eargo, Inc..
FDA 510(k) Cleared Self-fitting Air-conduction Hearing Aid, Over The Counter Devices (Product Code QUH)
About Product Code QUH - Regulatory Context
510(k) Submission Activity
9 total 510(k) submissions under product code QUH since 2022, with 9 receiving FDA clearance (average review time: 203 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 9 in the prior period.
QUH devices are reviewed by the Ear, Nose, Throat panel. Browse all Ear, Nose, Throat devices →