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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hearing Aid, Air-Conduction, Prescription
510(k) Number K232999
Device Name Lyric4 Hearing Aid
Applicant
Sonova AG
28 Laubisruetistrasse
Staefa,  CH 8712
Applicant Contact Kateryna Konovalenko
Correspondent
Sonova AG
28 Laubisruetistrasse
Staefa,  CH 8712
Correspondent Contact Kateryna Konovalenko
Regulation Number874.3300
Classification Product Code
ESD  
Date Received09/22/2023
Decision Date 04/11/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Clinical Trials NCT05349981
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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