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    K Number
    K223137
    Device Name
    Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application
    Manufacturer
    hearX SA (Pty) Ltd.
    Date Cleared
    2023-03-14

    (161 days)

    Product Code
    QUH
    Regulation Number
    874.3325
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    K212609
    Why did this record match?
    Device Name :

    Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Lexie Lumen Self-Fitting OTC Hearing Aid(s) with Lexie Application is a self-fitting air-conduction hearing aid, intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. The device is adjusted by the user to meet the user's hearing needs. The device is intended for use without the assistance of a hearing care professional.

    Device Description

    The Lexie Lumen Self-Fitting OTC Hearing Aid(s) with Lexie Application is a self-fitting, air conduction hearing aid consisting of the IntriCon hardware, Lexie Software, Lexie Application and accessories supplied in the carton. The Lexie App is available on Android and iOS. The Lumen self-fitting OTC hearing aid is the only model applicable to this 510(k). The Lexie Lumen Self-Fitting OTC Hearing Aid(s) with Lexie Application is a behind the ear device that includes self-adjustable coupling by means of a slim tube and ear tip/dome. The hearing aids can be fine-tuned remotely by trained hearing experts, at the request of the user, in the Lexie contact center. The Lexie app receives custom remote settings as performed through the Lexie adjustment wizard and fitting portal (internet service).

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study details for the Lexie Lumen Self-Fitting OTC Hearing Aid(s) with Lexie Application, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    CategoryAcceptance Criteria (from study)Reported Device Performance (Lexie SF Group vs. AF Group)Conclusion
    Clinical Performance (Effectiveness)
    Primary Endpoint: APHAB Global Benefit(Implicit: Outcomes equivalent to AF group)2-weeks: SF group had less difficulty in background noise (p .05). All subscales within 1-point margin. Total score within 5-point margin.Met
    Secondary Endpoint: Speech-in-Noise (DIN)1.8 dB SNR acceptance criteria2-weeks: DIN aided scores poorer for AF group than SF (p .05) or calculated benefit scores.Met
    SafetyNo Serious Adverse Events (SAEs)One participant withdrew due to a middle ear infection (unrelated to device). No SAEs occurred.Met
    Human Factors TestingSuccess rate > 79% on all use-related critical tasks> 79% success rate on all use-related critical tasks. High user satisfaction (65.5% found it "easy to use" and "user-friendly"). One minor issue with slim tube size/domes not impacting safety.Met
    Non-clinical Performance Testing(Each standard has its specific pass/fail criteria)All tested standards (IEC 60601-1, IEC 60601-1-11, IEC 60601-2-66, IEC 60601-1-2, IEC 60118-13, ANSI/ASA S3.22, ANSI CTA 2051, ANSI ASA S3.6, IEC 62304, ISO 10993 series, IEC 60601-1-6, FDA Cybersecurity Guidance, IEEE / ANSI C63.27, ANSI C63.19)Pass
    ANSI ASA S3.22 (Acoustic Performance)Max OSPL90:
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