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510(k) Data Aggregation

    K Number
    K043090
    Device Name
    EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMS
    Manufacturer
    PHONIC EAR, INC.
    Date Cleared
    2004-12-23

    (45 days)

    Product Code
    LZI
    Regulation Number
    874.3320
    Why did this record match?
    Applicant Name (Manufacturer) :

    PHONIC EAR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sound Field wireless amplification systems are intended for use as group auditory trainers used to communicate simultaneously with one or more listeners with normal hearing or hearing impairments. The device is used with an associated transmitter microphone and speaker systems and does not provide coupling to the ear through either earphones or earmolds. These systems use FM and/or infrared wireless technology which include receivers, transmitters, and strategic placement of high quality speaker systems and can be used with or without BTF hearing aids and/or personal FM devices. The talker's voice with or which bI E throughout the room to assist listeners, regardless of seating location, to consistently hear what the talker is saying.
    Device Description
    Sound Field group amplification systems consist of FM or IR transmitters and microphone used by a speaker/instructor to send auditory signals to FM or IR receiver/amplifier which noreesses the voice signals and broadcast the signals through one or more loudspeakers. These systems are generally installed under the guidance of an audiologist or a sound contractor. Sound Field systems consist of an on/off switch and volume controls. Specifications and user guider in cre provided for Sound Field installation and use. Sound Field systems are assembled from standard electronic components widely used by Group Hearing Aid and Group Auditory Trainer manufacturers. Sound Field wireless ampification systems amplify and broadcast the speaker/instructor's voice through strategically-mnounted.will and/or ceiling loud speakers placed throughout the listening area to distribute the final moder want signal (sound) of the speaker/instructor and are not directly connected or coupled to the piroener. Sound Field wireless amplification systems are intended for use as group auditory trainers used to communicate simultaneously with one or more listeners with normal hearing on he aring impairments. The device is used with an associated transmitter microphone and speakers systems and does not provide coupling to the ear through either earphones or earmolds. These systems use FM and/or infrared wireless technology which include receivers, transmitters, and strategic placement of high quality speaker systems and can be used with or without BTE hearing aids and/or personal FM devices. The talker's voice is mildly amplified and dispersed throughout the room to assist listeners, regardless of seating location, to consistently bear what the talker is saying.
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    K Number
    K974658
    Device Name
    INFRARED GROUP AMPLIFICATION SYSTEM, INFRARED EMITTER, INFRARED BODY WORN RECEIVER, INFRARED HEADSET RECEIVER-STEREO, IT
    Manufacturer
    PHONIC EAR, INC.
    Date Cleared
    1998-02-25

    (72 days)

    Product Code
    EPF
    Regulation Number
    874.3320
    Why did this record match?
    Applicant Name (Manufacturer) :

    PHONIC EAR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Model PE 600 Series devices form the Impaired Group Amplification System which is used by adults and children in public halls, theaters, churches, courtrooms and other public gatherings and provide auditory assistance to hearing impaired persons.
    Device Description
    The Model PE 600 Series consists of: 1. The Model PE 600E is a power amplifier which is combined with an infrared LED array. Audio signals from a sound system are processed and broadcast into the listening area by means of infrared light. 2. The Model PE 600R is a body worn infrared receiver. It receives the infrared light signals from the PE 600E and converts these signals to high level audio signals required by the hearing impaired listener. The audio signals can be adjusted to meet the user. 3. The PE 601R is an Infrared Headset Receiver. It receives the infrared light signals from the PE 600E and converts these signals to audio signals required by the hearing impaired listener. This devise is capable of stereo reception so that different audio signals can be received simultaneously and fed to each ear separately. 4. The PE 602R is an Infrared Headset Receiver. It receives the infrared light signals from the PE 600E and converts these signals to audio signals required by the hearing impaired listener. The device is capable of receiving infrared light signals transmitted on two separate frequencies. A switch on the headset allows the user to select the program frequency desired. The selected program is heard in each ear.
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    K Number
    K974287
    Device Name
    FM RECEIVER - AUDITORY TRAINER
    Manufacturer
    PHONIC EAR, INC.
    Date Cleared
    1998-02-10

    (88 days)

    Product Code
    EPF
    Regulation Number
    874.3320
    Why did this record match?
    Applicant Name (Manufacturer) :

    PHONIC EAR, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is a receiver for an FM group auditory trainer. It is intended to be used with the Phonic Ear PE 571t group auditory trainer transmitter. Auditory trainers are used primarily in institutions (schools, churches, theaters, etc.) to allow teachers, ministers, etc. to communicate with individuals with hearing deficits. This device can also be used with its built-in microphones or plug-in microphones as a stand alone assistive listening device.
    Device Description
    This device is a receiver for an FM group auditory trainer. It is intended to be used with the Phonic Ear PE 571t group auditory trainer transmitter. The device is powered by low voltage batteries which are contained within a battery compartment that is fitted with a locking cover to prevent inadvertent opening. The battery circuit is fused to prevent over heating should a short circuit occur. The devices' plastic housing is made of Cycolac plastic. The device includes controls for maximum power output, sound pressure level of built-in receiver microphones and FM signal, CHG/LOW BATT LED, NO FM LED, enlarging lens for FM frequency channel number, a 3 position switch for operating modes, a 7 position FM level switch for each ear, a 7 position SSPL switch for each ear, a 7 position GAIN switch for each ear, a 7 position TONE switch for each ear, and a 2 position microphone switch. It uses solid state surface mount components and integrated circuits. The receiver's FM receiving frequency is controlled by 2 rotary switches accessible under a latching cover.
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