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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name self-fitting air-conduction hearing aid, over the counter
510(k) Number K221064
Device Name Nuheara IQbuds 2 PRO Hearing Aid
Nuheara Limited
13555 S.E. 36th St., Suite 100
Bellevue,  WA  98006
Applicant Contact John Luna
4830 Randolph Rd., Unit 3302
Charlotte,  NC  28211
Correspondent Contact Deborah Arthur
Regulation Number874.3325
Classification Product Code
Date Received04/11/2022
Decision Date 10/30/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No