Bose Hearing Aid

Self-fitting Air-conduction Hearing Aid

Bose Corporation

The following data is part of a De Novo classification by Bose Corporation with the FDA for Bose Hearing Aid.

Pre-market Notification Details

DeNovo IDDEN180026
Device Name:Bose Hearing Aid
ClassificationSelf-fitting Air-conduction Hearing Aid
Applicant Bose Corporation the Mountain Framingham,  MA  01701
ContactJames Yeagle
Product CodeQDD  
CFR Regulation Number874.3325 [🔎]
DecisionGranted (DENG)
501(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardEar Nose & Throat
Classification AdvisoryEar Nose & Throat
Date Received2018-05-11
Decision Date2018-10-05
FDA ReviewDecision Summary
Reclassification Order:Reclassification Order

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