Cleared Traditional

BHA100 Series Braun Clear Hearing Aid

K212609 · Kaz USA, Inc., A Helen of Troy Company · Ear, Nose, Throat
Jan 2022
Decision
141d
Days
Class 2
Risk

About This 510(k) Submission

K212609 is an FDA 510(k) clearance for the BHA100 Series Braun Clear Hearing Aid, a Self-fitting Air-conduction Hearing Aid, Prescription (Class II — Special Controls, product code QDD), submitted by Kaz USA, Inc., A Helen of Troy Company (Marlborough, US). The FDA issued a Cleared decision on January 5, 2022, 141 days after receiving the submission on August 17, 2021. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3325.

Submission Details

510(k) Number K212609 FDA.gov
FDA Decision Cleared SESE
Date Received August 17, 2021
Decision Date January 05, 2022
Days to Decision 141 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.