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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name air-conduction hearing aid software
De Novo Number DEN230081
Device Name Hearing Aid Feature (HAF)
Requester
apple, inc.
one apple park way
cupertino,  CA  95014
Contact kevin go
Regulation Number874.3335
Classification Product Code
SCR  
Date Received12/04/2023
Decision Date 09/12/2024
Decision granted (DENG)
Classification Advisory Committee Ear Nose & Throat
Review Advisory Committee Ear Nose & Throat
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 Yes
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