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FDA 510(k)

Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application

K-Number: K223137 · 2023-03-14

ApplicantHearx SA (Pty) , Ltd.
Decision Date2023-03-14
Product CodeQUH
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application is a medical device manufactured by Hearx SA (Pty) , Ltd.. It received FDA 510(k) clearance on 2023-03-14 under approval number K223137. The device is classified under product code QUH. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application?

Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application is a medical device that received FDA 510(k) clearance on 2023-03-14. It is manufactured by Hearx SA (Pty) , Ltd.. The 510(k) number is K223137.

When was Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application approved by the FDA?

Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application received FDA 510(k) clearance on 2023-03-14, under approval number K223137.

What company makes Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application?

Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application is manufactured by Hearx SA (Pty) , Ltd..

What is the FDA product code for Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application?

The FDA product code for Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application is QUH.

Related Clinical Trials

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Other Devices by Hearx SA (Pty) , Ltd.

K231545hearOAE

Related Devices (Code: QUH)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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