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510(k) Data Aggregation

    K Number
    K133352
    Device Name
    HYPERSOUND AUDIO SYSTEM (HSS)
    Manufacturer
    HYPERSOUND HEALTH, INC.
    Date Cleared
    2014-02-12

    (104 days)

    Product Code
    EPF
    Regulation Number
    874.3320
    Why did this record match?
    Product Code :

    EPF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HyperSound Group Auditory Trainer is indicated for use as a group auditory trainer or group hearing aid used to communicate simultaneously with one or more listeners with or without hearing loss and with or without the use of hearing aids in order to improve clarity and comprehension of sounds generated from sources such as a microphone, CD/DVD player, TV, Stereo System or other sound generation systems.
    Device Description
    The HyperSound Audio System (HSS) utilizes a specially designed emitter (speaker) that delivers beamlike sound that is clear to the listener. The beamed audio content begins to demodulate in the air within six inches of the emitter and results in a cone-like transmission of sound waves that can be directed towards the listener. This device is intended for sale as an over-the-counter product and can be used with any sound source and at any distance from 3 feet to 50 feet or more from the emitters (speakers). Ultrasonic technology has been used for many years in industry and is also utilized in medical devices, such as ultrasonic nebulizers. The ultrasonic sound waves this product is based upon have also used in commercial and localized communications, and they are below the ultrasonic sound safety limits established by OSHA as required by OSHA Noise Standard, 29 CFR 1910.95. The device consists of an amplifier, software, and an emitter (speaker). No ear plugs or head phones are required to use this device. The device is distant from and does not touch the intended patient/user.
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    K Number
    K982683
    Device Name
    TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSION
    Manufacturer
    TELEX COMMUNICATIONS, INC.
    Date Cleared
    1998-10-06

    (67 days)

    Product Code
    EPF
    Regulation Number
    874.3320
    Why did this record match?
    Product Code :

    EPF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    to amplify and transmit sound to the ear. The indication for use of the air conduction hearing aids for this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)): Severity: 1. Slight √, 2. Mild √, 3. Moderate √, 4. Severe √, 5. Profound √ Configuration: 1. High Frequency √, 2. Gradually Sloping √, 3. Reverse Slope √, 4. Flat √, 5. Other: Other: Low tolerance to Loudness The Telex Select 1-40 BTE FM System is best suited for students of middle school age and older who have a moderate to profound hearing loss. It may be appealing to older students that have rejected FM amplification because of the stigma associated with body-worn auditory trainers.
    Device Description
    assembled from standard components that are widely used by other hearing aid manufacturers. Technical characteristics: technical specifications comply with S3.2-1987 ANSI standards. Fit: frequency response per S3.2-1987 ANSI standard as shown on specification filed with 510(k). Controls: Volume control, Mode Switch, Audiological Controls (output and tone). Power: Standard hearing aid battery (675)
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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?
    Product Code :

    EPF

    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?
    Product Code :

    EPF

    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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    K Number
    K970665
    Device Name
    WILLIAMS SOUND, PERSONAL FM, HEARING HELPER
    Manufacturer
    WILLIAMS SOUND, LLC
    Date Cleared
    1997-05-02

    (70 days)

    Product Code
    EPF, LZI
    Regulation Number
    874.3320
    Why did this record match?
    Product Code :

    EPF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To improve the signal to noise ratio for a listener ir a var ety of ur vironments where background noise, poor acoustics, and distance from a desired sound source contribute to hearing difficulty. Any hearing and speech condition that can be improved by maximizing the signal to noise ratio for the listener. This includes: Low gain amplification for Attention Deficit Disorders, Learning Disabilition of Central Auditory Processing Disorders, amplification for mild to moderate conductive and senonineural hearing loss, and amplification moderate to severe conductive and sensorineural bearing loss when used in conjunction with a personal hearing aid.
    Device Description
    Not Found
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    K Number
    K970687
    Device Name
    WILLIAMS SOUND, PERSONAL FM, HEARING HELPER
    Manufacturer
    WILLIAMS SOUND, LLC
    Date Cleared
    1997-05-02

    (67 days)

    Product Code
    EPF, LZI
    Regulation Number
    874.3320
    Why did this record match?
    Product Code :

    EPF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To improve the signal to noise ratio for a listener in a variety of environments where background noise, the interest poor acoustics, and distance from a desired sound source contribute to hearing difficulty. Any hearing and speech condition that can be improved by maximizing the signal to noise ratio for the list the find of open condification for Atention Deficit Disorders, Leaming De the the for the the for the Central Autory Processing Disorders, amplification for midd to moderate sombetive and sensiblities, hearing loss, and amplification for mild to moderate conductive and senso hearing loss, and amplification for mild to moderate conductive and sensorineural conjunction with a personal heating and sensorineural hearing loss when used in conjunction with a personal hearing aid.
    Device Description
    WILLIAMS SOUND, HEARING HELPER PERSONAL FM SYSTEM, Model PFM 100 / PFM 200
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    K Number
    K960567
    Device Name
    HF MEGA EAR
    Manufacturer
    MAXI-AIDS, INC.
    Date Cleared
    1996-10-16

    (250 days)

    Product Code
    EPF
    Regulation Number
    874.3320
    Why did this record match?
    Product Code :

    EPF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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