QUH · Class II · 21 CFR 874.3325

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..

10
Total
10
Cleared
202d
Avg days
2022
Since
Declining activity - 1 submissions in the last 2 years vs 9 in the prior period
Consistent review times: 188d avg (recent)

FDA 510(k) Cleared Self-fitting Air-conduction Hearing Aid, Over The Counter Devices (Product Code QUH)

10 devices
1–10 of 10
Cleared Mar 15, 2024
Concha Sol Hearing Aids (CL-1001)
K233747
Concha Labs
Ear, Nose, Throat · 114d
Cleared Feb 09, 2024
WSA Self-Fitting Hearing Aid Gen 2
K233464
Wsaud A/S
Ear, Nose, Throat · 109d
Cleared Oct 26, 2023
Sontro® OTC Hearing Aids (AI)
K231550
Soundwave Hearing, LLC
Ear, Nose, Throat · 149d
Cleared Sep 25, 2023
Self-Fitting hearing aids
K221052
Huizhou Jinghao Medical Technology Co., Ltd.
Ear, Nose, Throat · 532d
Cleared Sep 08, 2023
Intrisound™ Tuned Lumen® 155 Hearing Aids
K223848
Tuned , Ltd.
Ear, Nose, Throat · 260d
Cleared Jun 16, 2023
All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid
K230538
Sonova AG
Ear, Nose, Throat · 109d
Cleared Mar 14, 2023
Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application
K223137
Hearx SA (Pty) , Ltd.
Ear, Nose, Throat · 161d
Cleared Dec 21, 2022
Eargo 5 , Eargo 6
K221698
Eargo, Inc.
Ear, Nose, Throat · 191d
Cleared Oct 30, 2022
Nuheara IQbuds 2 PRO Hearing Aid
K221064
Nuheara Limited
Ear, Nose, Throat · 202d

About Product Code QUH - Regulatory Context

510(k) Submission Activity

10 total 510(k) submissions under product code QUH since 2022, with 10 receiving FDA clearance (average review time: 202 days).

Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 9 in the prior period.

FDA 510(k) Review Time - QUH Product Code

FDA review times for QUH submissions have been consistent, averaging 188 days recently vs 203 days historically.

QUH devices are reviewed by the Ear, Nose, Throat panel. Browse all Ear, Nose, Throat devices →