OtoRead Screener Intended Use Page 1
About this Manual
This manual is valid for the OtoRead™. These products are
manufactured by:
Interacoustics A/S
Audiometer Allé 1
5500 Middelfart
Denmark
Tel.: +45 6371 3555
Fax: +45 6371 3522
E-mail: info@interacoustics.com
Web: www.interacoustics.com
Intended Use
The OtoRead OAE Test Instrument is designed to be a screening
device for hearing loss. Sensitivity and specificity of this type of
device are based on the test characteristics defined by the user, and
may vary depending on environmental and operating conditions. The
presence of otoacoustic emissions suggests normal outer hair cell
function, which in turn correlates to normal hearing. However, a
passing result using this instrument is not an indication that the full
auditory system is normal. Thus, a PASS result should not be
allowed to override other indications that hearing is not normal. A full
audiologic evaluation should be administered if concerns about
hearing sensitivity persist. A REFER test result should not be
assumed to be an indicator of a lack of auditory function; however, it
should be followed with full audiologic diagnostic testing.
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