Cleared Traditional

Concha Sol Hearing Aids (CL-1001)

K233747 · Concha Labs · Ear, Nose, Throat

Mar 2024

Decision

114d

Days

Class 2

Risk

About This 510(k) Submission

K233747 is an FDA 510(k) clearance for the Concha Sol Hearing Aids (CL-1001), 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 review panel. Regulated under 21 CFR 874.3325.

Submission Details

510(k) Number	K233747 FDA.gov
FDA Decision	Cleared 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.