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    K Number
    K021867
    Device Name
    INSOUND XT SERIES HEARING AID
    Manufacturer
    INSOUND MEDICAL INC.
    Date Cleared
    2002-11-19

    (166 days)

    Product Code
    ESD
    Regulation Number
    874.3300
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    K964603,K921725
    Why did this record match?
    Device Name :

    INSOUND XT SERIES HEARING AID

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

    The InSound XT Hearing Aid is a disposable, extendedwear, air conduction hearing aid, designed to be used and worn by hearingimpaired persons. Hearing assistance is achieved through amplification of sound pressure waves, which are transmitted to the external ear canal via air conduction. The hearing aid is placed in the ear canal by an ENT physician and it can remain in the ear canal for up to 4 months or until the battery is depleted. Upon device removal, the hearing aid is discarded.

    Device Description

    The InSound XT Series Hearing Device amplifies and delivers sounds via air conduction to the external ear of persons with hearing loss. The microphone transforms sound waves into electrical signals and delivers it to the hearing aid circuit, which is powered by the battery. The hearing device is extendedwear (up to 4 months) and disposable. It is placed deep in the ear canal by an ENT physician. The amplification characteristics are contained in digitally programmable memory and adjustment of device parameters is achieved through the proprietary HandFit™ Fitting System and Software.

    AI/ML Overview

    1. Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Safety:
    Materials contacting skin meet USB Class 6 requirements and pass testing for antimicrobial, cytotoxicity, irritation, and sensitization.All materials contacting the skin meet USB Class 6 requirements and additionally passed testing for antimicrobial, cytotoxicity, irritation and sensitization.
    Device with battery assessed as per ANSI C18 Part 1-1999.The device with its battery has been assessed as per ANSI C18 Part 1-1999 and passed well within the specifications.
    Efficacy:
    Performance characteristics evaluated in accordance with ANSI S3.22-1996, "Specification of Hearing Aid Characteristics."The devices met all applicable specifications developed by the manufacturer in accordance with test methods outlined in the specifications.
    Clinical trials confirm comfort, safety, and efficacy for extended wear.Clinical trials for the InSound XT devices have confirmed that the hearing aids are comfortable, safe and efficacious for wear in human subjects.
    Clinical trials validate safe and effective use of accessories and fitting system.Additionally, the clinical trials validated the safe and effective use of the InSound XT accessories and the wireless hand-held fitting system.

    2. Sample Size Used for the Test Set and Data Provenance

    The document does not specify the exact sample size for the clinical trials or "test set." It only mentions "human subjects." The data provenance is described as "clinical trials" which are typically prospective studies. The country of origin of the data is not explicitly stated.

    3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

    The document does not specify the number of experts used or their qualifications for establishing ground truth in the clinical trials. It does mention that the device is "placed deep in the ear canal by an ENT physician," suggesting that ENT physicians would be involved in the clinical setting and potentially in evaluating the device's performance and comfort.

    4. Adjudication Method for the Test Set

    The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set or clinical trials.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned in the provided text, nor is there any discussion of an effect size for human readers improving with AI vs. without AI assistance. This is a hearing aid device, not an AI diagnostic tool.

    6. Standalone (Algorithm Only) Performance Study

    No standalone (algorithm only) performance study was done as this is a physical medical device (hearing aid), not an algorithm or AI system.

    7. Type of Ground Truth Used

    The ground truth for the clinical trials appears to be based on:

    • Clinical observations and subject feedback: Assessed comfort, safety, and efficacy during extended wear.
    • Hearing aid verification battery: Demonstrated user benefit during extended wear.
    • Compliance with ANSI standards: Performance characteristics were evaluated against established engineering specifications.

    8. Sample Size for the Training Set

    The document does not mention a separate "training set" or its sample size. The clinical trials described appear to serve as the evidence for efficacy and safety.

    9. How the Ground Truth for the Training Set was Established

    As no separate training set is explicitly mentioned, the establishment of ground truth would refer to how the clinical trial outcomes were determined, as described in point 7.

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