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510(k) Data Aggregation

    K Number
    K953872
    Device Name
    SECOND EAR BONE CONDUCTION HEARING AID
    Date Cleared
    1996-04-12

    (239 days)

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

    WORDCOMP INTERNATIONAL COMMUNICATION GROUP (WICG)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Moderate to severe conductive hearing losses. Particularly useful for conductive losses compounded by congenital or secondary obstruction of auditory air conduction mechanisms
    Device Description
    The EC-1000 Second Ear ' is a bone conduction-type hearing aid. Unlike conventional products which depend upon acoustic coupling through air, the EC-1000 Second Earl is based on bone conduction technology. Sound is transmitted directly through the bones of the skull to the cochlea, bypassing the outer and middle ear. The EC-1000 Second Ear offers an innovative tone control system, providing flexible audio control adjustments. Also, features such as a voice filter which when selected, reduces additional exterior sound. As an added feature an auxiliary input jack allows the user to connect Search Eas ® directly to TV, CD players, portable radios, tape players or even telephones. State of the art nickel-metal-hydride rechargeable battery technology is used for maximum battery life while minimizing size and weight. Transducer The EC-1000 Second Ear consists of a transducer unit, a shirt pocket sized audio processor/driver module and a wire cable for connecting the transducer with the audio processor/driver. The transducer is a convenient sized unit that is held against the head and is driven electrically to transmit audio vibrations to the underlying bones of the skull. It is a lowimpedance device, similar to a loudspeaker. Audio Processor/Driver The audio processor/driver module connects the transducer through the wire cable and usually would be carried in the users pocket. The wire cable connecting the audio processor/driver and the transducer can be placed comfortably at sensitive location such as behindear. The audio processor/driver module is completely self-contained and is battery powered. It also has a built-in microphone for picking up sound. A rechargeable battery pack is the power source. Battery Pack The battery pack can be charged in place in the unit or snapped out for easy exchanging. By purchasing a spare battery pack, the user can be using one battery while charging the other, guaranteeing uninterrupted use of the EC-1000. The user should be able to obtain 24 to 48 hours of operation in normal use from fully charged batteries. Volume setting and environmental conditions affect battery life.
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