Cleared Traditional

Vibe SF Self-Fitting Hearing Aid

K220403 · Wsaud A/S · Ear, Nose, Throat

Aug 2022

Decision

182d

Days

Class 2

Risk

About This 510(k) Submission

K220403 is an FDA 510(k) clearance for the Vibe SF Self-Fitting Hearing Aid, a Self-fitting Air-conduction Hearing Aid, Prescription (Class II — Special Controls, product code QDD), submitted by Wsaud A/S (Lynge, DK). The FDA issued a Cleared decision on August 12, 2022, 182 days after receiving the submission on February 11, 2022. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3325.

Submission Details

510(k) Number	K220403 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 11, 2022
Decision Date	August 12, 2022
Days to Decision	182 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF

Device Classification

Product Code	QDD — Self-fitting Air-conduction Hearing Aid, Prescription
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 A Prescription Hearing Aid.