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510(k) Data Aggregation

    K Number
    K973320
    Device Name
    ARTICULATE FITTING SYSTEM
    Manufacturer
    DECIBEL INSTRUMENTS, INC.
    Date Cleared
    1997-11-25

    (83 days)

    Product Code
    EWO
    Regulation Number
    874.1050
    Why did this record match?
    Applicant Name (Manufacturer) :

    DECIBEL INSTRUMENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended Use: The Articulate Fitting System™ is used with the ProDigit 2000™ Personal Digital Audiometer to fit and program Articulate Hearing Devices. The ProDigit 2000™ Audiometer produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.
    Device Description
    The Articulate Fitting System™ is used with the Decibel Instruments ProDigit 2000™ Personal Digital Audiometer for audiometric testing, real ear measurements, and fitting and programming the commercially available Decibel Instruments Articulate Hearing Devices. The System has four main components: - The legally marketed Decibel Instruments ProDigit 2000™ Personal Digital Audiometer, a computer-based audiometry system; - The Decibel Instruments IntraCanal Probe™ (ICP), a transducer placed in the ear canal for audiometric testing; - The Decibel Instruments IntraCanal Probe™ Interface, which provides the communication link between the ICP and the ProDigit 2000™ Audiometer and allows real ear measurements; and - The commercially available HI-PRO hearing aid programmer with the Articulate Fitting software utilizes automated fitting algorithms and visual tools to program the Articulate Hearing Devices following audiometric evaluation.
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    K Number
    K964603
    Device Name
    ARTICULAR HEARING AIDS
    Manufacturer
    DECIBEL INSTRUMENTS, INC.
    Date Cleared
    1996-12-06

    (18 days)

    Product Code
    ESD
    Regulation Number
    874.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    DECIBEL INSTRUMENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Articulate G1 Series Hearing Aids are wearable, sound-amplifying devices that are intended to compensate for impaired hearing. The intended use of the Articulate series hearing aids is identical to that of the legally marketed predicate devices.
    Device Description
    The Articulate G1 Series Hearing Aids amplify and deliver sounds via air conduction to the external ear of persons with hearing losses. The microphone transforms sound waves into electrical signals and delivers it to the hearing aid circuit, which is powered by the battery. In the non-programmable Articulate models, the potentiometers of the circuit are used by the hearing aid dispenser to manually modify the amplification characteristics of the incoming signal. In the programmable Articulate models, the amplification characteristics are contained in digitally programmable memory; the programming port allows direct programming of the circuit and adjustment of device parameters through the interface to a personal computer and proprietary Articulate Programming Software.
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