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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 the device name listed in this FDA 510(k) record. The listed applicant is Hearx SA (Pty) , Ltd.. It received FDA 510(k) clearance on 2023-03-14 under 510(k) 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. The listed applicant is Hearx SA (Pty) , Ltd.. The 510(k) number is K223137.

When did Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application receive FDA 510(k) clearance?

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

Who is the listed applicant for Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application?

The FDA 510(k) record lists Hearx SA (Pty) , Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06560918Self-efficacy-based Auditory Rehabilitation With Over-the-Counter Hearing AidsCOMPLETEDNCT07690670WhatsApp AI Support vs Paper Support for First-Time Hearing Aid UsersRECRUITINGNCT06309264Comparing Hearing Aid Fitting Methods in Blast-exposed VeteransRECRUITINGNCT06112860OTC Hearing Aid and MCIRECRUITINGNCT07255586Self-monitoring of Hearing Aids Using Artificial IntelligenceNOT_YET_RECRUITINGNCT07288463Hearing Loss and Brain Health StudyNOT_YET_RECRUITING

Other records listing Hearx SA (Pty) , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231545hearOAE

Related Devices (Code: QUH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254108Jabra Enhance Select Self-fit (Jabra Enhance Select 550)GN Hearing A/SK233747Concha Sol Hearing Aids (CL-1001)Concha LabsK233464WSA Self-Fitting Hearing Aid Gen 2Wsaud A/SK231550Sontro® OTC Hearing Aids (AI)Soundwave Hearing, LLCK221052Self-Fitting hearing aidsHuizhou Jinghao Medical Technology Co., Ltd.K223848Intrisound™ Tuned Lumen® 155 Hearing AidsTuned , Ltd.

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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