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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
Bose Corporation
the mountain
framingham,  MA  01701
Contact james yeagle
Regulation Number874.3325
Classification Product Code
Date Received05/11/2018
Decision Date 10/05/2018
Decision granted (DENG)
Classification Advisory Committee Ear Nose & Throat
Review Advisory Committee Ear Nose & Throat
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct