LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K971535
    Device Name
    WIDEX SENSO DIGITAL (MINI CANAL)
    Manufacturer
    WIDEX HEARING AID CO., INC.
    Date Cleared
    1997-06-06

    (39 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

    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
    ✓2. Mild
    ✓3. Moderate
    ✓4. Severe

    Configuration:
    ✓1. High Frequency - Precipitously Sloping
    ✓2. Gradually Sloping
    ✓3. Reverse Slope
    ✓4. Flat

    Other
    ✓1. Low tolerance To Loudness

    B. Specific Indications (Only if appropriate.):

    (Most psychoacoustic indications such as improved speech
    intellicibility in background noise, must be supported by clinical
    data.)

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a hearing aid device (Widex Senso Digital Mini Canal). It does not contain information about acceptance criteria, study details, or performance data for the device.

    The document primarily focuses on establishing "substantial equivalence" of the Widex Senso Digital Mini Canal to a predicate device already on the market, thereby allowing its marketing. It outlines the regulatory classification, general controls, and some potential future considerations (like electromagnetic interference).

    Therefore, I cannot fulfill your request for the tables and study details based on the provided text, as this information is not present.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1