Sensorineural hearing loss (SNHL) is a source of significant morbidity and in isolated cases is irreversible. Most cases of SNHL are associated with damage or loss of cochlear hair cells. The diagnosis of SNHL is based primarily on audiometric testing as the inner ear cannot be ?biopsied? without causing profound hearing loss. Contemporary imaging techniques (computed tomography (CT) and magnetic resonance imaging (MRI)) provide a macroscopic glimpse of peripheral and central auditory pathways but cannot resolve detailed anatomy of the inner ear, at the cellular level. The rapidly growing field of hair cell regeneration is poised to transform our ability to improve SNHL using small molecule or gene therapy approaches but is hampered by the inability to directly image hair cell pathology. Physical Sciences Inc. (PSI), in collaboration with the Eaton Peabody Laboratories at the Massachusetts Eye and Ear Infirmary (MEEI) proposes to develop a multimodal endoscopic imaging system that combines optical coherence tomography (OCT) and auto-fluorescence imaging (AFI) to simultaneously acquire anatomical and biochemical changes of the cochlea, which can be used to diagnose SNHL. During a Phase I program, PSI has developed a bench-top OCT/AFI instrument and has demonstrated the feasibility of this approach to reliably visualize intracochlear anatomy and biochemical functionality in a mouse animal model of SNHL. In a Phase II program we propose to develop an endoscopic OCT/AFI instrument with improved performance, suitable for in vivo use in a large animal model of SNHL. If successful, this technology will be a major step forward in our ability to diagnose SNHL and guide future targeted therapies for inner ear regeneration. Furthermore, this technology will be invaluable in surgical planning during hearing preservation approaches for cochlear implantation.

Public Health Relevance

The central focus of this project is to develop a clinically viable multimodal endoscopic imaging system to enable detailed imaging of cellular pathology of the cochlea. This novel device will help clinicians to narrow the differential diagnoses of inner ear pathologies associated with SNHL and to guide appropriate therapies. Therefore, this technology may lead to significantly improved outcomes of the inner ear surgery and drug delivery therapy.

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 #
2R44DC015414-02A1
Application #
9777820
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Miller, Roger
Project Start
2016-04-01
Project End
2021-04-30
Budget Start
2019-05-06
Budget End
2020-04-30
Support Year
2
Fiscal Year
2019
Total Cost
Indirect Cost
Name
Physical Sciences, Inc
Department
Type
DUNS #
073800062
City
Andover
State
MA
Country
United States
Zip Code
01810