The technologies listed below have been evaluated by an independent investigator and the Texas Department of State Health Services (DSHS) and have been found to meet requirements for conducting newborn hearing screening. This means that each device:
(1) has been approved by the Food and Drug Administration (FDA);
(2) is capable of identifying hearing loss as defined in § 37.502(5) of the state regulations; and
(3) can electronically link to the DSHS information system (OZ Systems, eSP).
The list will be updated as additional technologies are brought forward for evaluation. The appropriate device (or devices) for a given birthing facility depends on the specific needs of that organization. Therefore, DSHS and the independent investigator do not endorse a particular technology.
Bio-logic Systems
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ABaer
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ABR and OAE
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TR and DP
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Bio-logic Systems
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AuDX
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OAE
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DP
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Bio-logic Systems
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Scout Sport
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OAE
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TR and DP
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GSI-Viasys
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Audioscreener
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ABR and OAE
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DP
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Intelligent Hearing Systems
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SmartScreener
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ABR
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Intelligent Hearing Systems
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SmartEP-ASSR
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ABR
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Intelligent Hearing Systems
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SmartDPOAE
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OAE
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DP
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Intelligent Hearing Systems
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SmartTrOAE
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OAE
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TR
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Intelligent Hearing Systems
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SmartScreener-Plus 2
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ABR and OAE
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TR and DP
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Maico Diagnostics
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ERO-SCAN
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OAE
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DP
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Maico Diagnostics
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MB-11
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ABR
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Natus Medical
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Echo-Screen
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OAE and ABR
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TR and DP
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Natus Medical
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ALGO 5
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ABR
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Natus Medical
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ALGO 3i
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ABR
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Natus Medical
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ALGO 3
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ABR
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Natus Medical
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ALGO 2e color
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ABR
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Natus Medical
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ALGO 2e
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ABR
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Natus Medical
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ALGO 2
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ABR
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Otodynamics
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ILO288 Echoport
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OAE
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TR and DP
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Otodynamics
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ILO292 DP Echoport
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OAE
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TR and DP
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Otodynamics
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Otoport/Otocheck
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OAE
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TR
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Otodynamics
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EchoCheck
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OAE
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TR
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Otodynamics
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Otocheck
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OAE
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TR
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Starkey Laboratories
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DP2000
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OAE
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DP
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Vivosonic, Inc.
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Aurix
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ABR
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Abbreviation: OAE = Otoacoustic emission: ABR = Auditory brainstem response: TR =Transient: DP = Distortion product.
For further information about a particular technology, contact the company's sales representative.
Contact Dr. Craig A. Champlin (512)-471-6345; champlin@mail.utexas.edu for further information about the evaluation process or to schedule an appointment to have a device assessed.
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