Improving otitis media with effusion diagnosis in the primary care setting with the laser otoscope

Abstract
MSTATT (also known as Lighthanded) is developing a safe, low-power digital laser otoscope for the improved
identification and diagnosis of otitis media with effusion (OME) in young children. OME is a type of middle ear
effusion and is the most common cause of childhood hearing loss in the United States, with roughly 2.2 million
cases per year. Pediatricians have poor rates of accurate diagnosis of OME in children due to a lack of adequate
training and available equipment. Current methods of diagnosis include audiology screenings, otoscopy,
pneumatic otoscopy, acoustic reflectometry, or tympanometry. However, in practice, primary care physicians,
residents, and pediatricians often do not have enough experience or training to utilize these methods with high
accuracy. Further, time in a well-child exam is limited, making OME assessments with these methods even less
feasible. Studies have shown that non-otolaryngologists are correct in diagnosing OME from healthy ears only
53-60% of the time. This misdiagnosis holds significant importance, given that primary care physicians and
pediatricians often serve as gatekeepers in referring patients to specialized audiology care, meaning a missed
OME diagnosis means the child is unlikely to receive any further audiology care. Clinicians are aware of this
diagnostic gap, and discussions with pediatric ENTs and pediatricians reveal their eagerness for a cost-effective
solution. The project's overarching clinical goal is to facilitate efficient screening for OME during routine, primary-
care exams of children without specific ear complaints but at a high risk of persistent OME due to their age.
Detecting "silent" OME enables doctors to recommend follow-up, monitoring occurrences, and suggesting
treatment for frequent or prolonged cases. MSTATT is developing a safe, low-power digital laser otoscope to
address the diagnostic gap in the primary care setting. The laser otoscope is integrated into a traditional otoscope
and with press of an additional button provides an effusion-detecting mode, which shines a weak, cross-
polarized laser onto the tympanic membrane (TM) of the ear. This light spot essentially allows for the familiar
technique of trans-illumination to determine the contents of the middle ear. If any fluid is present, the laser light
will be scattered, and the TM will appear to glow in the presence of effusion. If only air is present, only the laser
spot will be highly visible. The presence of light scattering due to effusion fluid is much more obvious with this
laser illumination method than in a standard white-light illumination. The laser otoscope will help clinicians of any
skill level to diagnose OME based upon the presence or absence of visible scattering. To further the research
and development of the laser otoscope, MSTATT is proposing the following aims for this Phase I proposal: 1)
Prototype a Digital Laser Otoscope for Enhanced Image Analysis and Telehealth Applications and 2)
Comparative Assessment of a Laser Otoscope versus Standard Otoscopy in Detecting OME. A clinical study
will be conducted to quantify the improvement in OME detection sensitivity of the laser otoscope as compared
to standard otoscopy. The study will be conducted prior to ear tube placements at Cleveland Clinic.

Grant Number: 1R43DC022815-01A1
NIH Institute/Center: NIH
Principal Investigator: Steven Burns