This program will develop innovative noninvasive methodology employing ultrasound to measure middle ear fluid viscosity to better identify children at risk for bacterial (purulent) acute otitis media (AOM) as well as children at high risk for """"""""glue ear"""""""" (mucoid) likely to require surgical intervention. The technology will go beyond near-routine detection of middle ear fluid to a determination of the quality of the fluid. This will have significant impact on the approach to middle ear disease in children as it will support differentiation of bacterial from non-bacterial or mucoid otitis and provide an additional tool to differentiate children likely to benefit from antimicrobial therapy. Also, identification of children with thick viscous fluid in the middle ear will permit early identification of those at highest risk for persistent effusion and conductive hearing loss. All acoustic excitation and measurements will be made through the tympanic membrane to minimize the invasiveness of the procedure making it suitable for a number of clinical settings. In Phase I, an experimental facility capturing the acoustic and fluid dynamic characteristics of the middle ear will be built and the feasibility of measuring viscosities demonstrated. A concept for a clinical device will be developed incorporating the findings.

Proposed Commercial Applications

This project will create a new class of measurement instruments to improve management of Otitis Media by providing information on the nature of middle ear fluids that cannot now be obtained. As acute Otitis Media is the most common diagnosis made by healthcare professionals caring for children and the most frequent reason for the administration of prescription drugs for children under 2 years old, there should be a substantial clinical market for these instruments. In addition, devices for home use may also be practical. This would create a larger market. Instruments of the type to be developed may also find other medical and nonmedical applications where noninvasive characterization of fluids is required.

Agency
National Institute of Health (NIH)
Institute
National Institute on Deafness and Other Communication Disorders (NIDCD)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
1R43DC004973-01
Application #
6349641
Study Section
Special Emphasis Panel (ZRG1-IFCN-6 (02))
Program Officer
Luethke, Lynn E
Project Start
2000-09-15
Project End
2001-09-14
Budget Start
2000-09-15
Budget End
2001-09-14
Support Year
1
Fiscal Year
2000
Total Cost
$80,259
Indirect Cost
Name
Prodyne Corporation
Department
Type
DUNS #
622331283
City
Waban
State
MA
Country
United States
Zip Code
02468