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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Self-Fitting Air-Conduction Hearing Aid, Prescription
510(k) Number K220303
Device Name MDHearingAid app, MDHearingAid Smart hearing aids
Applicant
Mdhearingaid
150 N Michigan Ave. Suite 400
Chicago,  IL  60601
Applicant Contact Doug Breaker
Correspondent
Mdhearingaid
150 N Michigan Ave. Suite 400
Chicago,  IL  60601
Correspondent Contact Doug Breaker
Regulation Number874.3325
Classification Product Code
QDD  
Date Received02/02/2022
Decision Date 08/04/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Clinical Trials NCT05165121
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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