Cleared Traditional

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

K230538 · Sonova AG · Ear, Nose, Throat device
Jun 2023
Decision
109d
Days
Class 2
Risk

K230538 is an FDA 510(k) clearance for the All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid. This device is classified as a Self-fitting Air-conduction Hearing Aid, Over The Counter (Class II - Special Controls, product code QUH).

Submitted by Sonova AG (Zurich, CH). The FDA issued a Cleared decision on June 16, 2023, 109 days after receiving the submission on February 27, 2023.

This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3325. 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..

Submission Details

510(k) Number K230538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2023
Decision Date June 16, 2023
Days to Decision 109 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code QUH - Self-fitting Air-conduction Hearing Aid, Over The Counter
Device Class Class II - Special Controls
CFR Regulation 21 CFR 874.3325
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.