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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 self-fitting air-conduction hearing aid, prescription
De Novo Number DEN180026
Device Name Bose Hearing Aid
Requester
bose corporation
the mountain
framingham,  MA  01701
Contact james yeagle
Regulation Number874.3325
Classification Product Code
QDD  
Date Received05/11/2018
Decision Date 10/05/2018
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		 No
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