LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K973885
    Device Name
    OTICON DIGISOUND ITE
    Manufacturer
    OTICON, INC.
    Date Cleared
    1997-11-04

    (21 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 :

    OTICON DIGISOUND ITE

    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 5. Profound Configuration: 1. High Frequency - Precipitously Sloping ✓ 2. Gradually Sloping ✓ 3. Reverse Slope 4. Flat ✓ 5. Other Other 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.) 1. To amplify and deliver sound to the ear via air conduction 2. 3.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but I cannot answer your request as the provided text does not contain any information about acceptance criteria or a study proving that a device meets such criteria. The document is an FDA letter regarding the substantial equivalence of a hearing aid (Oticon DigiSound ITE Hearing Aid) to previously marketed devices. It primarily discusses regulatory classifications, general controls, and potential issues like electromagnetic interference, and provides indications for use for the device.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1