Cleared Traditional

Intrisound? Tuned Lumen? 155 Hearing Aids

K223848 · Tuned , Ltd. · Ear, Nose, Throat

Sep 2023

Decision

260d

Days

Class 2

Risk

About This 510(k) Submission

K223848 is an FDA 510(k) clearance for the Intrisound? Tuned Lumen? 155 Hearing Aids, a Self-fitting Air-conduction Hearing Aid, Over The Counter (Class II — Special Controls, product code QUH), submitted by Tuned , Ltd. (Gan Yoshiya, IL). The FDA issued a Cleared decision on September 8, 2023, 260 days after receiving the submission on December 22, 2022. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3325.

Submission Details

510(k) Number	K223848 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 22, 2022
Decision Date	September 08, 2023
Days to Decision	260 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF

Device Classification

Product Code	QUH — Self-fitting Air-conduction Hearing Aid, Over The Counter
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 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.