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510(k) Data Aggregation

    K Number
    K974069
    Device Name
    OPUS 2 - CANAL SERIES (ITC)
    Manufacturer
    BERNAFON-MAICO, INC.
    Date Cleared
    1997-12-15

    (48 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 :

    OPUS 2 - CANAL SERIES (ITC)

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

    A. General Indications: The intended use of this model hearing aid is to amplify sound pressure waves and transmit the signal to the external ear, through the medium of air, to compensate for impaired hearing. This device is indicated for individuals with losses in the following categories: Severity: 1. Slight X 2. Mild X 3. Moderate X 4. Severe 5. Profound Configuration: 1. High Frequency - Precipitously Sloping X 2. Gradually Sloping 3. Reverse Slope X 4. Flat 5. Other Other: X 1. Low Tolerance To Loudness 2. 3.

    Device Description

    OPUS 2 - CANAL SERIES ( ITC )

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the Opus 2 - Canal Series (ITC) hearing aid and does not contain the specific information required to answer the prompt.

    The letter acknowledges the device's substantial equivalence to previously marketed devices and outlines regulatory requirements. However, it does not include studies or data on acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies. These types of details would typically be found in the 510(k) submission itself, which is not provided here.

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