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510(k) Data Aggregation

    K Number
    K972431
    Device Name
    MERIDIAN DSP
    Manufacturer
    MICRO-EAR TECHNOLOGY, INC.
    Date Cleared
    1997-07-23

    (29 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 sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)); Severity: Slight, Mild, Moderate, Severe. Configuration: High Frequency - Precipitously Sloping, Gradually Sloping, Reverse Slope, Flat. Other: Low tolerance To Loudness.

    Device Description

    Meridian DSP (Hearing Aid)

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets those criteria. The document is an FDA 510(k) clearance letter for a hearing aid (Meridian DSP) in 1997. It primarily focuses on:

    • Substantial Equivalence: Confirming the device is substantially equivalent to legally marketed predicate devices.
    • Regulatory Classification: Stating the device's regulatory class (Class I) and applicable regulations.
    • General Controls: Mentioning requirements like annual registration, listing, good manufacturing practice, labeling, and prohibitions against misbranding/adulteration.
    • Electromagnetic Interference (EMI): Advising the manufacturer about potential EMI from digital cellular telephones and suggesting labeling modifications.
    • Indications for Use: Detailing the types and severities of hearing loss the device is intended for.

    The document does not include any performance metrics, study design, sample sizes, ground truth establishment, or expert involvement related to the device's efficacy or performance characteristics. It's a regulatory clearance document, not a scientific study report.

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