Cleared Traditional

K223848 - Intrisound™ Tuned Lumen® 155 Hearing Aids (FDA 510(k) Clearance)

K223848 · Tuned , Ltd. · Ear, Nose, Throat device
Sep 2023
Decision
260d
Days
Class 2
Risk

K223848 is an FDA 510(k) clearance for the Intrisound™ Tuned Lumen® 155 Hearing Aids. This device is classified as 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 FDA review panel. Regulated under 21 CFR 874.3325. 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..

Submission Details

510(k) Number K223848 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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.