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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Air-Conduction Hearing Aid Software
510(k) Number K254044
Device Name Hearing assist
Applicant
Meta Platform Technologies, LLC
333 Airport Blvd.
Burlingame,  CA  94010
Applicant Contact Lucas Fernandez
Correspondent
Meta Platform Technologies, LLC
333 Airport Blvd.
Burlingame,  CA  94010
Correspondent Contact Lucas Fernandez
Classification Product Code
SCR  
Date Received12/17/2025
Decision Date 07/13/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Clinical Trials NCT07115979
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 Yes
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