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510(k) Data Aggregation

    K Number
    K243041
    Device Name
    contact forte Alpha
    Manufacturer
    BHM-Tech Produktionsgesellschaft mbH
    Date Cleared
    2025-04-25

    (210 days)

    Product Code
    LXB
    Regulation Number
    874.3302
    Why did this record match?
    Applicant Name (Manufacturer) :

    BHM-Tech Produktionsgesellschaft mbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The contact forte Alpha is a Processor and is intended for use with the Sophono Headband or Softband (no age limitations), or with the Sophono Magnetic Implant (patients 5 years of age and up) for the following patients and indications: • Patients with conductive or mixed hearing losses, who can still benefit from amplification of sound. The pure tone average (PTA) bone conduction (BC) threshold for the indicated ear should be better than 45 dB HL (measured at 0.5, 1.2, and 3 kHz). • Bilateral fitting is applicable for most patients having a symmetrically conductive or mixed hearing loss. The difference between the left and right sides' BC thresholds should be less than 10 dB on average measured at 0.5, 1, 2, and 4 kHz, or less than 15 dB at individual frequencies. • Patients who have a profound sensorineural hearing loss in one ear and normal hearing in the opposite ear, who for some reason will not or cannot use an Air Conduction Contralateral Routing of Signal (AC CROS). The pure tone average (PTA) air conduction (AC) threshold of the hearing ear should be better than 20 dB HL (measured at 0.5, 1, 2 and 3 kHz).
    Device Description
    The contact forte Alpha Processor is a sound processor that converts sound into mechanical vibrations. The sound processor is magnetically connected to a Sophono Headband, Sophono Softband or Sophono Attract Magnetic Spacer by the integrated metal disk. Sound enters the audio processor through the microphones, which then goes through a DSP chip for signal processing. The output of the DSP chip drives an electromechanical transducer, which converts the signal into mechanical vibrations. These vibrations are transferred to the patient's skin through the Sophono Headband, Sophono Softband or the Sophono Attract magnetic spacer. The vibrations are carried through the patient's skin and skull to the cochlea where they are perceived as sound. The device is designed for use on either the right or left side application. The device has a "oval" housing with a symmetrical design ( for right or left side application). The material used: Plastic contact with intact skin;
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