The goal of newborn hearing screening is to identity infants with inner ear pathology (IEP), but most neonates who fail screening have conductive disorders (CD) rather than IEP, resulting in high false positive rates and costly follow-up diagnostic evaluation. The Rhode Island study (1993) has shown that the prevalence of conductive disorders (CD) over inner ear pathologies (IEP) to be 17 vs. 3-to-6 per 1000. While in N1CU the prevalence of CD over IEP rises to 36 vs. 23 per 1000. The ramifications of IEP and CD are different, so an accurate typing of the loss at the time of a newborn hearing screening is essential. The main objective of this proposal is to build a hearing-screening device that combines wideband reflectance measurement with DPOAE measurement into one system, where the former provides diagnostic evaluation for CD and the latter provides diagnostic evaluation for the IEP Thus in one test; both the conductive path and cochlear status are evaluated. Since both the reflectance measurement and the DPOAE measurement require an identical calibration step, the extra time needed to perform hearing screening, using the combined screening device, will be no more than few minutes. The benefit of the expected outcome is reduced false-positive rates, reduces follow up diagnostic costs, and reduced parental concern in the case of false positives. An important auxiliary benefit of the probe impedance, obtained by the reflectance measurement, is to allow for a direct estimate of the signal intensity level in the ear canal so as to mitigate the standing wave problem in the audiometric measurement. In conjunction with DPOAE measurement, the WR-DP screener will provide more accurate measurement above 3 kHz where standing wave problem occurs.
The specific aims of Phase II are (1) to complete the development of the wideband reflectance-distortion product otoacoustic emission (WR-DP) screening device, toward improving its efficiency, reliability and ease of use; (2) to perform clinical studies, to obtain baseline data for the WR-DP screener, and (3) to demonstrate the diagnostic capabilities and cost effectiveness of the WR-DP screener.

Agency
National Institute of Health (NIH)
Institute
National Institute on Deafness and Other Communication Disorders (NIDCD)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
2R44DC006554-02
Application #
6884335
Study Section
Special Emphasis Panel (ZRG1-IFCN-G (10))
Program Officer
Luethke, Lynn E
Project Start
2004-03-01
Project End
2006-12-31
Budget Start
2005-01-01
Budget End
2005-12-31
Support Year
2
Fiscal Year
2005
Total Cost
$709,890
Indirect Cost
Name
Mimosa Acoustics
Department
Type
DUNS #
837418615
City
Champaign
State
IL
Country
United States
Zip Code
61820
Hunter, Lisa L; Feeney, M Patrick; Lapsley Miller, Judi A et al. (2010) Wideband reflectance in newborns: normative regions and relationship to hearing-screening results. Ear Hear 31:599-610