Cleared Traditional

K223911 - Lumen 155-SF (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K223911 · Intricon Corporation · Ear, Nose, Throat device
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Oct 2023
Decision
292d
Days
Class 2
Risk

K223911 is an FDA 510(k) clearance for the Lumen 155-SF. Classified as Self-fitting Air-conduction Hearing Aid, Prescription (product code QDD), Class II - Special Controls.

Submitted by Intricon Corporation (Arden Hills, US). The FDA issued a Cleared decision on October 17, 2023 after a review of 292 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 Intricon Corporation devices

Submission Details

510(k) Number K223911 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2022
Decision Date October 17, 2023
Days to Decision 292 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
203d slower than avg
Panel avg: 89d · This submission: 292d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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. 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 - QDD Self-fitting Air-conduction Hearing Aid, Prescription

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