PHASE 1 EVALUATION OF A NOVEL OTOSCOPE TIP AIMED AT IMPROVING PEDIATRIC OTOSCOPY VISUALIZATION AND CERUMEN MANAGEMENT: THE OTOSHOW

Lith NASIF, Abhinav MEHTA, Navya BELLAMKONDA, Ron MITCHELL

The Journal of Pediatric Research - 2026;13(2):163-169

University of Texas Southwestern Medical Center, Department of Otolaryngology, Division of Pediatric Otolaryngology, Dallas, United States of America

 

Aim: Cerumen is a common barrier to accurate otoscopic examinations in children, yet pediatricians lack effective removal tools. The Otoshow is a novel otoscope speculum with a retractable curette attachment designed to address this gap. This study aimed to characterize cerumen impaction as a barrier to tympanic membrane (TM) visualization and to evaluate the safety, effectiveness, and clinician satisfaction of the Otoshow. Materials and Methods: A prospective, non-randomized, survey-based, phase 1 study was conducted in two pediatric otolaryngology clinics from March to May 2025. Five Advanced Practice Providers (APPs) used the Otoshow tip during clinic encounters, replacing or supplementing standard specula and cerumen removal tools at their discretion. The data consisted of clinician surveys including pre-study, per-encounter, and post-study surveys. Results: A total of 101 encounters were surveyed. The children ranged in age from 6 months to 17 years, with 80% aged 1-10 years. The pre-survey showed all clinicians encountered cerumen at least occasionally, and none were very satisfied with current removal methods. Per-encounter surveys showed cerumen obstructed the TM in 29% of the children and 33% with ear-related complaints. The Otoshow curette was used in 72% of obstruction cases, improving TM visualization in 43%. The APPs were satisfied with its use in 34% of encounters. In the post-study survey, the Otoshow was rated as equally safe or safer, more time-efficient, and more comfortable than the standard methods. No device-related adverse events occurred. Conclusion: Cerumen is a significant barrier to TM visualization in children. The Otoshow otoscope tip demonstrated safety, feasibility, and the potential to improve visualization and child comfort without prolonging procedure times. While satisfaction with the device was modest, iterative design enhancements may increase clinical adoption. Future studies are warranted to assess the device's impact in primary care and emergency settings where cerumen impaction poses an equal or greater diagnostic challenge.