All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid— 510(k) K230538

Name: FDA 510(k) clearance K230538
Creator: U.S. Food and Drug Administration
Published: 2023-06-16

Substantially Equivalent

Sonova AG

FDA 510(k) clearance K230538 for All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid, Substantially Equivalent on 2023-06-16. Applicant: Sonova AG. Device class: 2.

Clearance details

Applicant: Sonova AG
Product code: Code QUH
Device class: Class 2
Regulation: 21 CFR 874.3325
Advisory panel: Ear, Nose, Throat
Date received: 2023-02-27
Decision date: 2023-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zurich, CH

Download summary PDF View on FDA.gov ↗

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K231550 — Sontro® OTC Hearing Aids (AI)2023-10-26
K221052 — Self-Fitting hearing aids2023-09-25

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Adverse events under product code QUH

product code QUH

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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