Cleared Traditional

K220303 - MDHearingAid app, MDHearingAid Smart hearing aids
(FDA 510(k) Clearance)

K220303 · Mdhearingaid · Ear, Nose, Throat
Aug 2022
Decision
183d
Days
Class 2
Risk

K220303 is an FDA 510(k) clearance for the MDHearingAid app, MDHearingAid Smart hearing aids, a Self-fitting Air-conduction Hearing Aid, Prescription (Class II — Special Controls, product code QDD), submitted by Mdhearingaid (Chicago, US). The FDA issued a Cleared decision on August 4, 2022, 183 days after receiving the submission on February 2, 2022. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3325.

Submission Details

510(k) Number K220303 FDA.gov
FDA Decision Cleared SESE
Date Received February 02, 2022
Decision Date August 04, 2022
Days to Decision 183 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.