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510(k) Data Aggregation

    K Number
    K971298
    Device Name
    BETTER HEARING, INC. MODEL L-1 HEARING AID
    Manufacturer
    BETTER HEARING, INC.
    Date Cleared
    1997-07-23

    (107 days)

    Product Code
    ESD
    Regulation Number
    874.3300
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    To amplify and transmit sound to the ear. The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies): Severity: Severe, Profound. Configuration: High Frequency - Precipitously Sloping, Other. Other: Low tolerance To Loudness.

    Device Description

    BETTER HEARING, INC. model L-1 Hearing Aid. Type: Behind-The-Ear (BTE). Classification: Air Conduction Hearing Aid 77ESD Class 1 CFR 874.3300. Manufactured from materials commonly used in the industry. Hearing Aid has been tested per ANSI S3.22 1987. Fits: Mild to moderate hearing losses. Power: Size 675 Battery.

    AI/ML Overview

    Based on the provided text, the "Better Hearing, Inc. Model L-1 Hearing Aid" is a relatively simple device, and the submission document primarily focuses on its substantial equivalence to existing devices rather than a detailed study for novel performance claims. Therefore, much of the requested information (like expert ground truth, MRMC studies, training set details) is not applicable or not provided.

    Here's an analysis of the available information:

    Description of the Device and its Primary Claim:

    The device is a "Behind-The-Ear (BTE)" hearing aid whose "Intended Use: To amplify and transmit sound to the ear." Its classification is "Air Conduction Hearing Aid 77ESD Class 1 CFR 874.3300."

    A specific claim made by the manufacturer was its "compatibility with digital cellular telephones."

    Acceptance Criteria and Reported Device Performance

    The FDA did not accept the claim of compatibility with digital cellular telephones. Therefore, there are no reported device performance metrics for this specific claim that met acceptance criteria in this document.

    Acceptance CriteriaReported Device Performance
    General Functionality: Amplify and transmit sound to the ear."Hearing Aid has been tested per ANSI S3.22 1987." This standard likely covers basic acoustic performance (gain, frequency response, output). Specific numerical performance values are not provided in this document but are implied to have met the standard.
    Substantial Equivalence: To other medium power linear BTE hearing aids.Determined to be substantially equivalent by the FDA for its primary function as a hearing aid.
    Compatibility with digital cellular telephones.NOT ACCEPTED by FDA. "While your device has been deemed substantially equivalent to other legally marketed hearing aids, please be advised that the claim regarding electromagnetic compatibility with digital cellular telephones has not been adequately substantiated and cannot be permitted at this time. Based upon inadequate EMC test data submitted in this 510(k), use of such a claim may result in the device being misbranded."

    Study Details Related to the "Compatibility with digital cellular telephones" Claim:

    The FDA explicitly states that "inadequate EMC test data" was submitted for this claim. This implies some testing was done by the manufacturer, but it did not meet the FDA's criteria for substantiation.

    Since the claim was rejected, the following details pertain to the unaccepted study or data:

    1. Sample size used for the test set and the data provenance: Not specified. The document only mentions "inadequate EMC test data," suggesting internal testing by the manufacturer.
    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not specified. For an EMC claim, ground truth would typically be established by standardized measurement protocols rather than expert consensus on subjective interpretation.
    3. Adjudication method for the test set: Not applicable/not specified. EMC testing would involve objective measurements against a standard, not expert adjudication in the typical sense.
    4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This type of study is not relevant for an electromagnetic compatibility claim.
    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, implicitly. EMC testing is a standalone objective measurement of the device's interaction with electromagnetic fields.
    6. The type of ground truth used: Implied to be objective measurements against an electromagnetic compatibility standard (though the specific standard, beyond "inadequate EMC test data," is not detailed).
    7. The sample size for the training set: Not applicable. This is not an AI/machine learning device.
    8. How the ground truth for the training set was established: Not applicable. This is not an AI/machine learning device.

    Summary of FDA's Position:

    The FDA determined the Model L-1 Hearing Aid was substantially equivalent to predicate devices for its primary function as a hearing aid. However, its specific claim of "compatibility with digital cellular telephones" was not accepted due to insufficient data. The FDA offered to work with Better Hearing, Inc. to develop a testing protocol to substantiate an appropriate claim for EMC.

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