This proposal addresses the growing clinical need for non-invasive diagnostic tools that can efficiently evaluate middle ear diseases. Physical Sciences Inc. (PSI), in collaboration with the Massachusetts Eye and Ear Infirmary (MEEI), proposes to develop a clinically viable multimodal otoendoscopic imaging instrument that can analyze middle ear morphology, function, and biochemical changes in vivo in real-time. This will be possible by combining phase-sensitive optical coherence tomography (PsOCT) and Raman spectroscopy (RS) with a conventional video otoendoscopy (VO). Although this system can be applicable to various middle ear pathologies including otitis media, cholesteatoma, myringosclerosis and adenoma, in Phase I we will focus on otitis media (OM), a complex infection and inflammatory disease with the highest prevalence in the middle ear. During Phase I, PSI and MEEI will demonstrate the diagnostic capability of the multimodal imaging system. A prototype of the multimodal PsOCT/RS otoendoscopic system will be optimized on human cadaveric temporal bones, and then its capability for OM diagnosis will be evaluated on human patients. Based on the Phase I results and conclusions, a robust otoendoscopic system with improved performance and suitable size and design for clinical use in various middle ear pathologies will be proposed to be developed and validated on human patients in Phase II.

Public Health Relevance

The central focus of this project is to develop a clinical otoendoscopic imaging system that combines PsOCT/RS with conventional video otoendoscopy. This multimodal system will enable assessment of the morphological, biomechanical and biochemical characteristics of middle ear pathologies, and help clinicians to narrow the differential diagnosis of middle ear pathologies and formulate an adequate treatment plan for patients. Our novel multimodal otoendoscopic system will contribute to an improved outcome for patient care and reduce healthcare costs.

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 #
1R43DC017404-01
Application #
9620537
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Miller, Roger
Project Start
2018-08-07
Project End
2019-07-31
Budget Start
2018-08-07
Budget End
2019-07-31
Support Year
1
Fiscal Year
2018
Total Cost
Indirect Cost
Name
Physical Sciences, Inc
Department
Type
DUNS #
073800062
City
Andover
State
MA
Country
United States
Zip Code