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510(k) Data Aggregation

    K Number
    K971399
    Date Cleared
    1997-06-13

    (59 days)

    Product Code
    Regulation Number
    874.3300
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    AURIS AE, AURIS TL, AURIS HS, AURIS AC, AURIS MM, AURIS COE, AURIS CIC

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

    Mild to severe conductive, mixed or sensoryneural hearing loss
    Mild to severe conductive, mixed or sensoryneural hearing loss when cosmetics are of some concern
    Mild to moderate conductive, mixed or sensoryneural hearing loss when cosmetics are of major concern, but the ear can not accommodate a complete in the canal style
    Mild to moderate conductive, mixed or sensoryneural hearing loss when cosmetics are of major concern.
    Mild to severe conductive, mixed or sensoryneural hearing loss when a more cosmetic AE is desired.
    Mild to severe conductive, mixed or sensoryneural hearing loss when cosmetics are a major concern but the ear prevents use of a CIC or MM.
    Normal low and middle frequency hearing with a sloping mild to moderate high frequency sensory neural or mixed loss.

    Device Description

    To amplify and transmit sound to the ear.
    DSD K-amp or Intrigue programmable circuitry
    Assembled from standard components that are widely used by other hearing aid manufacturers.
    "Technical specifications comply with S3.2-1987 ANSI Standards"
    Frequency response dictated by individual audiogram
    Volume control similar to other devices.
    Standard size 13 battery
    Standard size 312 battery
    Standard size 10A battery
    Standard size 10a or 5a battery

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth establishment for the Auris hearing aids. The documents describe different models of Auris hearing aids, their intended use, features, technical characteristics, and the FDA's 510(k) clearance approval, but they do not include any specific clinical study data or performance metrics against defined acceptance criteria.

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