Nuheara IQbuds 2 PRO Hearing Aid

Self-fitting Air-conduction Hearing Aid, Over The Counter

Nuheara Limited

The following data is part of a premarket notification filed by Nuheara Limited with the FDA for Nuheara Iqbuds 2 Pro Hearing Aid.

Pre-market Notification Details

Device IDK221064
510k NumberK221064
Device Name:Nuheara IQbuds 2 PRO Hearing Aid
ClassificationSelf-fitting Air-conduction Hearing Aid, Over The Counter
Applicant Nuheara Limited 13555 S.E. 36th St., Suite 100 Bellevue,  WA  98006
ContactJohn Luna
CorrespondentDeborah Arthur
DArthurConsulting 4830 Randolph Rd., Unit 3302 Charlotte,  NC  28211
Product CodeQUH  
CFR Regulation Number874.3325 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-04-11
Decision Date2022-10-30

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