DeviceClearance

Product code QUH— Ear, Nose, Throat

All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid

Classification name
Self-Fitting Air-Conduction Hearing Aid, Over The Counter
Device class
Class 2
Regulation
21 CFR 874.3325
Advisory panel
Ear, Nose, Throat
Total cleared
10
First cleared
Most recent

FDA classification definition

“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.”

— U.S. Food and Drug Administration, device classification record for product code QUH under 21 CFR 874.3325, via openFDA

Market context for product code QUH

FDA has cleared 10 devices under product code QUH between 2022 and 2026, filed by 10 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QUH

Adverse events under product code QUH

product code QUH
Other
1
Total
1

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code QUH

Data sourced from openFDA. This site is unofficial and independent of the FDA.