K-number	K223137
Device name	Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application
Applicant	Hearx SA (Pty) , Ltd.
Product code	QUH
Device class	Class II
Decision date	Mar 14, 2023
Decision	Substantially Equivalent
Regulation	874.3325

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Source

View the full FDA submission: accessdata.fda.gov

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Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application

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