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    K Number
    K212609
    Device Name
    BHA100 Series Braun Clear Hearing Aid
    Manufacturer
    Kaz USA, Inc., a Helen of Troy Company
    Date Cleared
    2022-01-05

    (141 days)

    Product Code
    QDD
    Regulation Number
    874.3325
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    K151025,K211008
    Why did this record match?
    Device Name :

    BHA100 Series Braun Clear Hearing Aid

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

    The BHA100 Series Braun® Clear™ Hearing Aid 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. It is adjusted by the user to meet the user's hearing needs. The device is intended for direct-to-consumer sale and use without the assistance of a hearing health care professional.

    Device Description

    The BHA100 Series Braun® Clear™ Hearing Aid is a self-fitting, air conduction hearing aid. It features digital signal processing (16 channel-wide dynamic input compression, 3 channel fast-acting output compression, 16 channel noise reduction, feedback cancellation,) bi-directional microphone with windscreen, volume and program control (environment selection - Quiet, Noisy, Concert, TV), 3 channel equalizer, self-adjustable wire and ear tips, and customization through the Braun® Clear™ Mobile Application. The Braun® ClearCheck™ Hearing Test aims to detect accurate auditory thresholds, partnering with a smart phone application to deliver user-customized sound through the Braun® Clear™ Hearing Aid. These thresholds are used to program the device using a proprietary fitting algorithm.

    AI/ML Overview

    This document describes a medical device, the BHA100 Series Braun® Clear™ Hearing Aid, and its supporting clinical study. The device is a self-fitting, air conduction hearing aid intended for individuals 18 years or older with perceived mild to moderate hearing impairment, for direct-to-consumer use without professional assistance.

    Here's an analysis of the acceptance criteria and the study that proves the device meets them:

    1. A table of acceptance criteria and the reported device performance

    The document doesn't explicitly present a single table labeled "acceptance criteria" with a clear pass/fail status for each, but the study results are presented against implicit or stated criteria. I've synthesized these from the descriptions of the primary and secondary endpoints.

    Acceptance Criteria (Stated or Implied)Reported Device Performance and Confidence Interval (95% CI)Pass/Fail (Interpreted)
    Phase 1 Primary Endpoint: Mean Absolute Difference (MAD) between self-fitting and audiologist-executed Pure Tone Average (PTA) thresholds (dB)
    • Within the 10 dB margin of the acceptance criteria. | MAD: 2.8 dB
    • 95% CI: 2.4 dB to 3.2 dB
    • p
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