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510(k) Data Aggregation

    K Number
    K150491
    Device Name
    ER36 Series OAE Test System
    Manufacturer
    ETYMOTIC RESEARCH, INC.
    Date Cleared
    2015-03-26

    (29 days)

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

    ETYMOTIC RESEARCH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ER36 Series OAE Test System is indicated for testing of cochlear function in infants, children, and adults by measuring otoacoustic emissions (OAEs). The OAEs are generated by a series of clicks or tones that are directed into the ear canal. Otoacoustic emissions are low level audio frequency sounds that are produced by the cochlea as part of the normal hearing process. Available evidence suggests that otoacoustic emissions are generated by the cochlea's outer hair cells and that the presence of OAE's is an indication that the outer hair cells are viable. Clinical evidence indicates that these emissions normally occur with normal hearing, or at most, mild hearing loss (usually 30-40dB HL). The majority of hearingimpaired individuals will be identified by a simple OAE test.
    Device Description
    The ER36 Series OAE Test System is a battery powered, hand-held microprocessor-controlled instrument designed to measure otoacoustic emissions. The ER36 is connected by a 1 meter, thin flexible cable to the ER36 MicroProbe OAE Test Probe (Ear Probe). The Ear Probe incorporates a field replaceable Probe Tip (9-lumen tube) that is inserted and acoustically sealed to the test ear canal with a compliant ear tip. The ER36 provides otoacoustic emissions measurements by two methods: distortion product otoacoustic emissions (DPOAE), and transient-evoked otoacoustic emissions (TEOAE). The OAEs are generated by a series of clicks or tones that are directed into the ear canal. Otoacoustic emissions are low level audio-frequency sounds that are produced by the cochlea as part of the normal hearing process.
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    K Number
    K112733
    Device Name
    ER35 ERO-SCAN PRO HEARING TEST SYSTEM
    Manufacturer
    ETYMOTIC RESEARCH, INC.
    Date Cleared
    2011-12-16

    (87 days)

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

    ETYMOTIC RESEARCH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ER35 ERO•SCAN Pro Hearing Test System is indicated for testing of cochlear and middle ear function in infants, children, and adults by measuring otoacoustic emissions (OAEs), tympanometry, and acoustic reflex.
    Device Description
    The ER35 is a microprocessor-controlled instrument designed to screen otoacoustic emissions, tympanic membrane performance, and acoustic reflex. Test information is stored in memory, displayed on a graphic LCD, and can be printed by a printer or stored on a computer. The product is manufactured and delivered completely assembled to the retailer using materials and techniques widely used by manufacturers of hearing devices.
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    K Number
    K070880
    Device Name
    ER35 ERO-SCAN PRO HEARING TEST SYSTEM
    Manufacturer
    ETYMOTIC RESEARCH, INC.
    Date Cleared
    2007-06-07

    (69 days)

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

    ETYMOTIC RESEARCH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ER35 is intended to be a test instrument that measures otoacoustic emissions and tympanic membrane performance (tympanometry). The ER35 ERO-SCAN Pro Hearing Test System (ER35) is indicated for testing of cochlear and middle ear function in infants, children, and adults by measuring otoacoustic emissions (OAEs) and tympanometry.
    Device Description
    The ER35 is a microprocessor-controlled instrument designed to screen otoacoustic emissions and tympanic membrane performance (tympanometry). Test information is stored in memory, displayed on a graphic LCD, and can be printed by a dot matrix printer or stored on a computer. The product is manufactured and delivered completely assembled to the retailer using materials and techniques widely used by manufacturers of hearing devices
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