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510(k) Data Aggregation

    K Number
    K234095
    Device Name
    OtoNova/OtoNova Pro
    Manufacturer
    Otodynamics
    Date Cleared
    2024-06-21

    (178 days)

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

    Otodynamics

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This Otonova Pro device is indicated for use when there is a requirement to screen for hearing disorders by objective and non-invasive means. ABR, TEOAE and DPOAE screening test results are automatically interpreted and a clear "Pass' or 'Refer' result is presented to the user. Use of the device is indicated when the patient is unable to give reliable voluntary responses to sound, especially with infants. Use of the device facilitates the early detection of hearing loss and its characterization. Where the individual to be screened is healthy with no medical conditions related to the ear, as in the case of well-baby hearing screening, the user can be a trained screener. In all other cases the user should be an audiologist or medical professional. The TEOAE and DPOAE analytical functions of the device are indicated when objective non-invasive clinical investigations require the characterization and monitoring of the peripheral auditory function. For this purpose, the device is intended to be used by audiologists or other professionals skilled in audiology. These TEOAE and DPOAE tests are applicable to populations of any age to obtain objective evidence of peripheral auditory function.
    Device Description
    OtoNova is a compact, portable battery-powered electronic device which records physiological responses to sound for the purpose of hearing testing. It Is controlled wirelessly from a local controlling device. OtoNova has two hardware variants: OtoNova and OtoNova Pro. Both the OtoNova and OtoNova Pro devices have been directly engineered from Otodynamics' currently marketed Otoport OAE+ABR device, retaining all the testing algorithms of the Otoport OAE+ABR device. The primary aim of the development was to physically separate the control console from the testing device while maintaining the same performance and effectiveness. Like the predicate Otoport OAE+ABR device, both OtoNova devices can record two different physiological indicators of a functioning auditory system's peripheral response to sound namely a) Otoacoustic emission (OAEs), which are small sounds made by the inner ear in response to acoustic stimulation, and b) Auditory brainstem responses (ABRs) are tiny electrical signals emanating from the auditory brainstem in response to sound. Automatic recognition of an ABR response is referred to as AABR. During ABR or OAE testing, low-level sounds are delivered to the ear. The responses to multiple presentations of these sounds (either acoustic or electrical responses) are recorded digitally and added together to enhance repeated responses with respect to the random/ noise signals that are always present. The averaged signal is automatically analysed by the device to identify and quantify true physiological response component and to assess the degree of noise contamination. This allows the quality/ accuracy of the recording to be determined for evidence of response validity. The processed data is reported to and displayed on the controlling device.
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    K Number
    K240430
    Device Name
    Otoport Pro
    Manufacturer
    Otodynamics Ltd
    Date Cleared
    2024-03-15

    (30 days)

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

    Otodynamics Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Otoport Pro device is indicated for use when there is a requirement to screen for hearing disorders by objective and non-invasive means. ABR, TEOAE and DPOAE screening test results are automatically interpreted and a clear "Pass' or 'Refer' result is presented to the device is indicated when the patient is unable to give reliable voluntary responses to sound, especially with infants. Use of the device facilitates the early detection of hearing loss and its characterization. Where the individual to be screened is healthy with no medical conditions related to the ear, as in the case of well-baby hearing screening, the user can be a trained screener. In all other cases the user should be an audiologist or medical professional. The TEOAE and DPOAE analytical functions of the device are indicated when objective non-invasive clinical investigations require the characterization and monitoring of the peripheral auditory function. For this purpose, the device is intended to be used by audiologists or other professionals skilled in audiology. These TEOAE and DPOAE tests are applicable to populations of any age to obtain objective evidence of peripheral auditory function.
    Device Description
    The Otodynamics Ltd ("Otodynamics") Otoport Pro device is a compact handheld device capable of high quality OAE measurements for clinical purposes and also automated ABR and OAE testing for fast infant screening. Responses to sound are recorded via an applied earphone and or adhesive surface electrode pad. Specifically, the device can record Otoacoustic Emissions (type DPOAEs or TEOAEs) and auditory brainstem responses (ABRs) to sound. These responses are especially useful in the hearing of infants for deafness. The more detailed analysis of DPOAE and TEOAE responses is additionally useful as a component of the audiological diagnostic test battery. The Otoport Pro is simple to use with customizable automation to make testing easy and the results clear. It has user access controls, graphical display panel, and extensive test database features. The Otoport Pro when configured for clinical use has advanced test features including extensive raw data capture for offline review and analysis if required. Otoport Pro device is a hardware/ software revision of the currently marketed Otoport OAE+ABR, having the same performance and intended uses as the Otoport OAE+ABR device.
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    K Number
    K143395
    Device Name
    Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck OAE+ABR, Otocheck OAE+ABR LE, Otocheck ABR Screener-Otodynamics ABR Upgrade Kit
    Manufacturer
    OTODYNAMICS, LTD.
    Date Cleared
    2015-02-23

    (89 days)

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

    OTODYNAMICS, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Otodynamics Otoport/Otocheck OAE+ABR device is indicated for use when there is a requirement to screen for hearing disorders by objective and non-invasive means. ABR, TEOAE and DPOAE screening test results are automatically interpreted and a clear 'Pass' or 'Refer' result is presented to the user who will be a trained screener, audiologist or medical professional. Use of the device is indicated when the patient is unable to give reliable voluntary responses to sound, especially with infants. Use of the device facilitates the early detection of hearing loss and its characterization. The TEOAE and DPOAE analytical functions of the device are indicated when objective non-invasive clinical investigations require the characterization and monitoring of the functional status of the peripheral auditory function. For this purpose the device is intended to be used by audiologically skilled professionals. These TEOAE and DPOAE tests are applicable to populations of any age to obtain objective evidence of peripheral auditory function.
    Device Description
    The Otodynamics Otoport/Otocheck OAE+ABR device is a compact, handheld, batterypowered electronic device which records physiological responses to sound for the purpose of hearing testing. The device records two responses of the auditory system to sound, namely the otoacoustic emission (OAE) response from the inner ear and the auditory brainstem response (ABR) from the brain. The OAE response is acoustically stimulated and recorded via an insert earphone device called a 'probe'. The ABR response is also acoustically stimulated via the OAE probe but is recorded electrically via self-adhesive conducting pads called 'electrodes', which are placed on the scalp. The device provides- - A hearing screening function based on the detection of either OAE or ABR responses - An analysis of OAE responses for use in the clinical investigation of hearing disorders. For hearing screening purposes the responses are automatically analyzed and interpreted to give an unambiguous Pass / Refer result. A 'Pass' result means that normally expected responses to the primary speech frequency sounds have been positively identified and no further audiological investigation is indicated. A 'Refer' result means that normally expected responses have not been identified indicating further audiological investigation unless a poor test environment is indicated in which case a retest under better conditions is recommended. The Otoport/Otocheck OAE+ABR provides identical OAE analyses to the predicate Otoport OAE device, which is incorporated in the new device. The ABR screening function of the new device uses the same conventional ABR technologies used by the predicate devices. Tests have demonstrated the device to perform well in the clinical environment and to deliver high sensitivity and specificity as a screener.
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    K Number
    K072033
    Device Name
    OTODYNAMICS OTOPORT
    Manufacturer
    OTODYNAMICS, LTD.
    Date Cleared
    2007-11-13

    (112 days)

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

    OTODYNAMICS, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Otoport can perform Transient Evoked (TE) and Distortion Product (DP) Oto-Acoustic Emission (OAE) measurements on ears via an ear piece or "probe" fitted into the ear canal.
    Device Description
    The Otoport is a compact, sclf-contained, handheld Otoacoustic emission analyzer which has integral. rechargeable batteries for use. The Otoport can screen for cochlear function using either Transicnt Evoked or Distortion Product Otacoustic Emissions (TE or DPOAEs). It uses state-of-the-art technology and high performance signal analysis to provide robust indications of cochlear function and high immunity to extraneous noise. The Otoport has a high degree of connectivity, being capable of immediate connection to any IBM compatible PC via either USB port or Bluctooth wireless technology. The instrument will acccpt probes that are already in use with other products in the Otodynamics range of otoacoustic emission analyzer instruments. There is 100% compatibility between data recorded on the Otoport and data recorded on other Otodynamics OAE products.
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    K Number
    K983350
    Device Name
    ILO292 DP ECHOPORT PLUS OAE SYSTEM
    Manufacturer
    OTODYNAMICS, LTD.
    Date Cleared
    1998-12-11

    (79 days)

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

    OTODYNAMICS, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Otodynamics ILO288 ECHOPORTplus OAE System is designed to perform an auditory screening function by objectively testing for normal function of the cochlea. The system is designed to operate standalone, or optionally interface to an IBM compatible PC, using the parallel port.
    Device Description
    Not Found
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    K Number
    K983351
    Device Name
    ILO292 DP ECHOPORT PLUS OAE SYSTEM
    Manufacturer
    OTODYNAMICS, LTD.
    Date Cleared
    1998-12-11

    (79 days)

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

    OTODYNAMICS, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Otodynamics ILO292 DP ECHOPORTplus system performs an auditory screening function by objectively testing for normal function of the cochlea. It is a new concept in OAE screening and analysis since it operates in standalone mode, without a PC. It is based on the DP ECHOPORT Instrument but with added built-in processor and graphic display. Otodynamics ILO292 DP ECHOPORTplus system provides DPOAE facilities in addition to all the screening and TEOAE functions of the ECHOPORT plus. Both TEOAE's and DPOAE's are useful as screening tests for cochlear function in infants, children and adults. They are particularly useful when the patient is unable to respond DPOAE's are useful with older patients, as the method can tolerate sub-clinical depression of cochlear activity. DPOAE's are also of use to test the higher frequency region of the cochlea.
    Device Description
    The Otodynamics ILO292 DP ECHOPORTplus system performs an auditory screening function by objectively testing for normal function of the cochlea. It is a new concept in OAE screening and analysis since it operates in standalone mode, without a PC. It is based on the DP ECHOPORT Instrument but with added built-in processor and graphic display. Otodynamics ILO292 DP ECHOPORTplus system provides DPOAE facilities in addition to all the screening and TEOAE functions of the ECHOPORT plus.
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    K Number
    K983352
    Device Name
    ILO2088 ENCHOCHECK OR ILO2088 OTOCHECK
    Manufacturer
    OTODYNAMICS, LTD.
    Date Cleared
    1998-12-11

    (79 days)

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

    OTODYNAMICS, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K962995
    Device Name
    ILO88. OTODYNAMIC ANALYSER, KIT SYSTEM FOR PC
    Manufacturer
    OTODYNAMICS, LTD.
    Date Cleared
    1997-01-10

    (162 days)

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

    OTODYNAMICS, LTD

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

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