Abstract
Background/Objectives: Otoscopic examination is essential for the evaluation of ear diseases; however, conventional diagnostic devices have limitations related to portability, cost, and patient comfort. This study aimed to evaluate the feasibility and diagnostic performance of a newly developed pen-shaped otoscope compared with conventional otologic examination equipment. Methods: In this prospective study, 19 patients (28 ears) who underwent otologic examination at a tertiary referral center between April and June 2024 were included. Images of the external auditory canal and tympanic membrane were obtained using a pen-shaped otoscope, a video endoscope, and a microscope. Visualization of key tympanic membrane structures was assessed by physicians, and patients completed questionnaires evaluating pain, fear, image quality, and understanding of their disease. This prospective pilot feasibility study assessed the safety, usability, and preliminary diagnostic performance of the device. Results: Visualization rates of tympanic membrane structures using the pen-shaped otoscope, video endoscope, and microscope, respectively, were as follows: annulus tympanicus (57.1% vs. 89.3% vs. 9.1%), pars flaccida (89.3% vs. 96.4% vs. 45.5%), handle of the malleus (96.4% vs. 100% vs. 81.8%), and tympanic membrane vasculature (89.3% vs. 100% vs. 100%). No patients reported pain with the pen-shaped otoscope, whereas one patient reported pain with the video endoscope. Despite slightly lower image quality and disease understanding scores, several patients preferred the pen-shaped otoscope because of its ease of use and lack of discomfort. Conclusions: The pen-shaped otoscope provided clear visualization of key tympanic membrane structures, albeit with slightly lower image quality than the endoscope, while demonstrating high safety, portability, and ease of use. Its markedly lower cost supports its potential utility in smaller hospitals, outpatient clinics, and telemedicine applications. Further validation in larger cohorts and pediatric populations is warranted.