BHA100 Series Braun Clear Hearing Aid

Self-fitting Air-conduction Hearing Aid

Kaz USA, Inc., A Helen Of Troy Company

The following data is part of a premarket notification filed by Kaz Usa, Inc., A Helen Of Troy Company with the FDA for Bha100 Series Braun Clear Hearing Aid.

Pre-market Notification Details

Device IDK212609
510k NumberK212609
Device Name:BHA100 Series Braun Clear Hearing Aid
ClassificationSelf-fitting Air-conduction Hearing Aid
Applicant Kaz USA, Inc., A Helen Of Troy Company 400 Donald Lynch Boulevard, Suite 300 Marlborough,  MA  01752
ContactMatt J. Baun
CorrespondentMatt J. Baun
Kaz USA, Inc., A Helen Of Troy Company 400 Donald Lynch Boulevard, Suite 300 Marlborough,  MA  01752
Product CodeQDD  
CFR Regulation Number874.3325 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-17
Decision Date2022-01-05

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