Cleared Traditional

K233747 - Concha Sol Hearing Aids (CL-1001) (FDA 510(k) Clearance)

K233747 · Concha Labs · Ear, Nose, Throat device
Mar 2024
Decision
114d
Days
Class 2
Risk

K233747 is an FDA 510(k) clearance for the Concha Sol Hearing Aids (CL-1001). This device is classified as a Self-fitting Air-conduction Hearing Aid, Over The Counter (Class II - Special Controls, product code QUH).

Submitted by Concha Labs (San Mateo, US). The FDA issued a Cleared decision on March 15, 2024, 114 days after receiving the submission on November 22, 2023.

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 K233747 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2023
Decision Date March 15, 2024
Days to Decision 114 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.