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510(k) Data Aggregation

    K Number
    K971699
    Device Name
    ARGOSY DYNAMEQ
    Manufacturer
    ARGOSY ELECTRONICS
    Date Cleared
    1997-07-03

    (56 days)

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

    ARGOSY DYNAMEQ

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

    A. General Indications:

    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:

    1. Slight
      X 2. Mild
      X 3. Moderate
      X 4. Severe
    2. Profound

    Configuration:
    X 1. High Frequency - Precipitously Sloping
    X 2. Gradually Sloping
    3. Reverse Slope
    X 4. Flat
    X 5. Other Steeply sloping

    Other
    X 1. Low tolerance To Loudness
    2.
    3.

    B. Specific Indications (Only if appropriate.): (Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.)

    Device Description

    Argosy Dynameq Series Models: HS, CCA,Cameo, Passport, Passport Deluxe, Shado, Eclipse, CCAS, CCAS Deluxe, and CCA-Mini Canal

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a series of hearing aids. It does not contain information about acceptance criteria or a study proving the device meets those criteria.

    The letter primarily focuses on the device's substantial equivalence to previously marketed devices and general regulatory compliance. It does not include:

    • A table of acceptance criteria and reported device performance.
    • Details about sample sizes for test sets or data provenance.
    • Information on experts used for ground truth or adjudication methods.
    • Any mention of multi-reader multi-case (MRMC) comparative effectiveness studies.
    • Results from standalone algorithm performance studies.
    • Details regarding the type of ground truth used.
    • Information on the training set size or how its ground truth was established.

    The document only states the general indications for use of the hearing aids, primarily for amplifying sound for individuals with impaired hearing across various severity and configuration categories of hearing loss. It also mentions a general caution about potential electromagnetic interference but does not present any study data related to this or any other performance aspect of the device.

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