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510(k) Data Aggregation

    K Number
    K221698
    Device Name
    Eargo 5 , Eargo 6
    Manufacturer
    Eargo, Inc.
    Date Cleared
    2022-12-21

    (191 days)

    Product Code
    QUH
    Regulation Number
    874.3325
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    K211008
    Why did this record match?
    Applicant Name (Manufacturer) :

    Eargo, Inc.

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

    The Eargo Self-Fitting Hearing Aids are intended to amplify and transmit sound to the ear and thereby compensate for perceived mild to moderate hearing impairment in individuals 18 years of age or older. They are adjusted by the user to meet the user's hearing needs. No pre-programming or hearing test is necessary. The product is intended to be used without the assistance of a hearing care professional.

    Device Description

    The Eargo Self-Fitting Hearing Aid is a self-fitting air-conduction hearing aid system that incorporates wireless technology in its programming and use. The hearing aid system consists of a pair of earbud-style hearing aids (left and right), a charging case, and a companion mobile application (app) available for iOS (version 12 or later) and Android (version 7 or later) mobile devices. The hearing aids are designed to be virtually invisible, inserted completely and discreetly within the ear canal. Each hearing aid contains a microphone to allow for audio input, which is amplified by the hearing aid. The mobile app facilitates Eargo's proprietary self-fitting process using a combination of proprietary ultrasonic (for fitting) and Bluetooth Low Energy (BLE; for programming fitting settings) wireless communication. The mobile app also allows the user to control the hearing aids using proprietary ultrasonic wireless communication and enables firmware updates to the hearing aid system via BLE. App-based user controls include program and settings changes. In addition, each hearing aid contains an accelerometer sensor that allows for ondevice user control of the hearing aids. On-device user controls allow the user to make program changes without the mobile app. Each hearing aid contains a rechargeable Li-ion battery and is charged by the charging case that also functions as a carrying case. The charging case contains a single-cell Li-ion rechargeable battery, which charges the hearing aids via wireless (near-field inductive) charging when the hearing aids are correctly placed into the charging case.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study details for the Eargo Self-Fitting Hearing Aids, based on the provided text:

    Acceptance Criteria and Device Performance

    The document doesn't explicitly present a single "Table of Acceptance Criteria" with numerical targets and direct "Reported Device Performance" for each criterion in the same way one might find for a pass/fail mechanical test. Instead, the acceptance criteria are embedded within descriptions of various tests, and the "reported device performance" is the successful conclusion (e.g., "Pass," "Comparable to predicate," "Acceptable usability and satisfaction").

    However, I can extract the implicit acceptance criteria and the demonstrated performance where quantitative or qualitative measures are reported:

    Acceptance Criteria (Implicit)Reported Device Performance
    Safety and General Performance (Compliance with Standards)
    FCC Title 47 CFR, subpart 15 subpart C (Intentional Radiators)Pass
    IEC 60601-1:2014 (Basic Safety & Essential Performance)Pass
    IEC 60601-2-66:2019 (Basic Safety & Essential Performance for Hearing Instruments)Pass
    IEC 60601-1-2:2014 (Electromagnetic Compatibility - EMC)Pass
    IEC 60118-13:2019 (Hearing Aid EMC)Pass
    ANSI ASA S3.22:2014 (Hearing Aid Characteristics - Electroacoustics)Pass
    IEC 62304:2006 (Software Lifecycle Processes) & FDA Guidance (Software Content of Premarket Submissions)Pass (Software Verification and Validation)
    ISO 10993-1, -5, -10, -12 (Biocompatibility)Pass
    IEC 62366:2007 + A1:2014 & IEC 60601-1-6:2010 + A1:2013 & FDA Guidance (Summative Usability / Human Factors Validation)Pass
    FDA Guidance (Cybersecurity Compliance)Pass
    ASTM D4169-16 & D7386-16 (Package & Transit Testing)Pass
    Electroacoustic Performance (Table 3)
    MAX OSPL 90 (less than 117 dB SPL per OTC HA requirements)106 dB SPL (less than 117 dB SPL)
    HFA OSPL 90 (adequate for fitting mild-moderate HL as prescribed by NAL-NL2)104 dBSPL (Comparable to predicate, adequate for NAL-NL2)
    HFA FOG (adequate for fitting mild-moderate HL as prescribed by NAL-NL2)26 dB (Comparable to predicate, adequate for NAL-NL2)
    Reference Test Gain (RTG) (adequate for fitting mild-moderate HL as prescribed by NAL-NL2)26 dB (Comparable to predicate, adequate for NAL-NL2)
    Frequency Range (suitable for intended use per OTC HA requirements)
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