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510(k) Data Aggregation

    K Number
    K071462
    Device Name
    UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2)
    Manufacturer
    SIEMENS HEARING INSTRUMENTS, INC.
    Date Cleared
    2007-06-05

    (11 days)

    Product Code
    ETW
    Regulation Number
    874.3310
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2)

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

    The Unity 2 HIA and Probe are intended to be used as a system to: (1) perform Real Ear Measurement; (2) get an objective indication of the characteristics of a hearing aid; and (3) assist in the adjustment of hearing aids while in use by the patient. It is used by ENTprofessionals and in clinics for hearing aid fitting.

    Device Description

    Siemens Unity 2 HIA and Probe (for use with Siemens Unity 2 System)

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study proving the device meets them. The document is an FDA 510(k) clearance letter for the Siemens Unity 2 HIA and Probe, indicating it has been found substantially equivalent to a legally marketed predicate device.

    Therefore, I cannot provide the requested table or details about a study.

    The document only states the "Indications For Use" for the device, which are:

    1. Perform Real Ear Measurement.
    2. Get an objective indication of the characteristics of a hearing aid.
    3. Assist in the adjustment of hearing aids while in use by the patient.

    It also mentions that the device is used by ENT professionals and in clinics for hearing aid fitting.

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