Cleared Traditional

Lumen 155-SF

K223911 · Intricon Corporation · Ear, Nose, Throat

Oct 2023

Decision

292d

Days

Class 2

Risk

About This 510(k) Submission

K223911 is an FDA 510(k) clearance for the Lumen 155-SF, a Self-fitting Air-conduction Hearing Aid, Prescription (Class II — Special Controls, product code QDD), submitted by Intricon Corporation (Arden Hills, US). The FDA issued a Cleared decision on October 17, 2023, 292 days after receiving the submission on December 29, 2022. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3325.

Submission Details

510(k) Number	K223911 FDA.gov
FDA Decision	Cleared 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

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.