Cleared Traditional

K220403 - Vibe SF Self-Fitting Hearing Aid (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence.

K220403 · Wsaud A/S · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2022
Decision
182d
Days
Class 2
Risk

K220403 is an FDA 510(k) clearance for the Vibe SF Self-Fitting Hearing Aid. Classified as Self-fitting Air-conduction Hearing Aid, Prescription (product code QDD), Class II - Special Controls.

Submitted by Wsaud A/S (Lynge, DK). The FDA issued a Cleared decision on August 12, 2022 after a review of 182 days - an extended review cycle.

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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Wsaud A/S devices

Submission Details

510(k) Number K220403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d slower than avg
Panel avg: 89d · This submission: 182d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code QDD Self-fitting Air-conduction Hearing Aid, Prescription
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 A Prescription Hearing Aid.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Consultant

Hogan Lovells US LLP
John Smith

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT04972162 Completed Interventional Industry-sponsored

Fitting Strategy Study

Web App Fitting Strategy Validation NSR Device Study

28
Patients (actual)
1
Site
Treatment
Purpose
Double blind
Masking
Condition studied Hearing Loss, Sensorineural
Study design Crossover
Eligibility All sexes · 18 Years+
Principal investigator Lindsey Jorgensen
Sponsor WSAUD A/S (industry)
Started 2021-07-26 → Primary completion 2021-11-12
Primary outcome
Abbreviated Profile of Hearing Aid Benefit (APHAB)
View full study on ClinicalTrials.gov

Regulatory Peers - QDD Self-fitting Air-conduction Hearing Aid, Prescription

Devices cleared under the same product code (QDD) and FDA review panel - the closest regulatory comparables to K220403.
Lumen 155-SF
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K211008 · Bose Corporation · May 2021