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

Mstatt Llc, Lakewood OH

Investigators

Abstract

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.