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510(k) Data Aggregation

    K Number
    K970880
    Device Name
    POWER D, TRU 5, PERSONA, PERSONA CHOICE, MERIDIAN
    Manufacturer
    MICRO-EAR TECHNOLOGY, INC.
    Date Cleared
    1997-06-06

    (88 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

    The indication for use of the air conduction hearing aids in this submission is to amplify weak sound and attenuate strong sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following category (ies). (Check appropriate space (s)): Severity: 1. Slight, 2. Mild, 3. Moderate, 4. Severe. Frequency: 1. High Frequency, 2. Gradually Sloping, 3. Reverse Slope, 4. Flat.

    Device Description

    The following hearing aids are available in full concha, I.T.E., low profile, and half shells.

    AI/ML Overview

    I am sorry, but the provided text does not contain the necessary information to answer your request. The document is an FDA 510(k) clearance letter for a line of hearing aids. It specifies regulatory details, indications for use, and severity categories for hearing loss that the devices address. However, it does not include any acceptance criteria, details of a study that proves the device meets acceptance criteria, sample sizes, ground truth establishment, expert qualifications, or information about AI involvement, which are all part of your request.

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