Cleared Special

K233464 - WSA Self-Fitting Hearing Aid Gen 2 (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K233464 · Wsaud A/S · Ear, Nose, Throat device
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Feb 2024
Decision
109d
Days
Class 2
Risk

K233464 is an FDA 510(k) clearance for the WSA Self-Fitting Hearing Aid Gen 2. Classified as Self-fitting Air-conduction Hearing Aid, Over The Counter (product code QUH), Class II - Special Controls.

Submitted by Wsaud A/S (Lynge, DK). The FDA issued a Cleared decision on February 9, 2024 after a review of 109 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3325 - the FDA ear, nose and throat device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Wsaud A/S devices

Submission Details

510(k) Number K233464 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 2023
Decision Date February 09, 2024
Days to Decision 109 days
Submission Type Special
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 89d · This submission: 109d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code QUH Self-fitting Air-conduction Hearing Aid, Over The Counter
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - QUH Self-fitting Air-conduction Hearing Aid, Over The Counter

All 8
Devices cleared under the same product code (QUH) and FDA review panel - the closest regulatory comparables to K233464.
Concha Sol Hearing Aids (CL-1001)
K233747 · Concha Labs · Mar 2024
Sontro® OTC Hearing Aids (AI)
K231550 · Soundwave Hearing, LLC · Oct 2023
Self-Fitting hearing aids
K221052 · Huizhou Jinghao Medical Technology Co., Ltd. · Sep 2023
Intrisound™ Tuned Lumen® 155 Hearing Aids
K223848 · Tuned , Ltd. · Sep 2023
All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid
K230538 · Sonova AG · Jun 2023
Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application
K223137 · Hearx SA (Pty) , Ltd. · Mar 2023