A 1993 NIH Consensus Conference recommended that all newborns be screened for auditory function. Initial attempts to develop an effective screening approach relied on diagnostic devices not optimized for neonatal screening and have had to supplement the measures with a separate screening device for evoked potential measurements. The issue of transient middle-ear conditions that can render the otoacoustic emissions (OAE) measurements invalid has not been addressed. Kedly, Inc. and Washington University propose to develop a handheld neonatal auditory screening device optimized for the nursery environment that will include three measurement subsystems; a tympanometer, an OAE device and an evoked potential device. The tympanometer can be used to identify middle-ear abnormalities that require medical intervention, to interpret the OAE properly, and to improve the OAE measurements by counterbalancing common abnormal middle-ear air pressures. This will be the first neonatal device that incorporates all three screening methods in a single, battery operated, handheld unit and will allow comprehensive and innovative screening at a low cost per test. Estimated device cost will be about 2500 dollars in mass production. Device can be operated with minimal training given its automatic test sequencing and pass/refer indication in addition to the comprehensive reporting.
Development of a single handheld device capable of screening for auditory impairments in newborns can be marketed to both regular and intensive care nurseries. This device will enable the accurate assessment of middle-ear and inner-ear conditions.
