(1045) Middle Ear Effusion Analysis Using a Novel Otoscope With Ultrasound Waveform Analysis Algorithm

Introduction: Otitis media (OM) is a common pediatric condition that often leads to indiscriminate antibiotic prescriptions due to difficulty distinguishing between bacterial and non-bacterial middle ear effusions creating difficulty with medical treatment. To improve diagnostic accuracy, an advanced ultrasound otoscope was designed to differentiate middle ear effusions. It uses unique through-air ultrasound technology and a machine learning-developed predictive algorithm to detect the presence and type of middle ear effusions.

Methods: Patients aged 6 months to 12 years undergoing pressure equalization (PE) tube surgery for the first time were included in the study from 2022-2023. Cultures and Polymerase Chain Reaction (PCR) testing was performed for fluid obtained from the middle ear and correlated with ultrasound measurements. Data was obtained on quality of the image, ease of device use, effusion volume, color, and tympanic membrane characteristics. Machine learning was used to train on approximately 100 ultrasound waveform features. The primary objective was to evaluate the diagnostic utility of the ultrasound otoscope in detecting bacterial versus non-bacterial fluid in the middle ear.

Results: This study evaluated 310 ultrasound measurements from 132 ears. Culture and PCR testing showed that 55 ears (123 measurements) had bacterial effusion and 77 ears (187 measures) had non-bacterial effusion in the middle ear. The algorithm predicted the detection of bacterial fluid at a sensitivity of 92% and a specificity of 91%.

Conclusions: The study validates the use of machine learning to analyze features of the ultrasound waveform characteristics which can then be used to differentiate between bacterial and non-bacterial middle ear effusions in pediatric patients. This device has the potential helping clinician with judicious decisions regarding antibiotic treatment for otitis media, thereby addressing a critical need identified by the American Academy of Pediatrics and potentially contributing to the reduction of antibiotic resistance.