SWIR Otoscopy Study

The aim of this study is to provide preliminary data to support future studies to demonstrate that the short wave infrared (SWIR) otoscope is a better diagnostic tool than a white light otoscope for diagnosing middle ear infections (otitis media). Patients who are having a tympanostomy tube placement procedure will be participating in this study. Imaging will be performed with the white light otoscope and the SWIR otoscope to determine presence of absence of fluid. The SWIR otoscope will gather SWIR data and white light data simultaneously. As part of standard of care, patients who come in for this procedure have removal of middle ear fluid as part of their procedure, which will confirm presence or absence of fluid.

NCT Number	NCT06944795
Lead Sponsor	Stanford University Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)
Conditions	Otitis Media, Otitis Media Chronic, Otitis Media Effusion
Enrollment	100 participants
Start Date	2026-04-30
Primary Completion	2027-04-30 (estimated)
Study Completion	2027-07 (estimated)
Updated on ClinicalTrials.gov	2026-07-24