Study: PhotoniCare’s OtoSight Produces More Accurate Diagnoses

Interim study results indicate PhotoniCare Inc.’s OtoSight Middle Ear Scope accurately diagnoses pediatric ear infections and cuts down on the number of antibiotic prescriptions necessary to treat the ailment.

Pediatric ear infections affect more than 80% of children by age three, account for millions of visits to the pediatrician each year, and are the leading cause of antibiotic use in kids. The multi-center, real-world effectiveness OTO-MATIC randomized controlled trial (RCT) showed a 50% reduction in the odds of antibiotic prescribing when PhotoniCare’s Optical Coherence Tomography (OCT) otoscope was used compared to the standard of care (SOC) with a traditional otoscope. An 83% target recruitment was included in the interim analysis, which was sufficiently powered.  

The study results, Otitis Treatment with OtoSight – Modification of Antibiotic Treatment Intervention in Children (OTO-MATIC), have been published via open access in the International Journal of Pediatric Otorhinolaryngology.

“Ear infections are not only the most common reason children receive antibiotics—they’re also a leading cause of surgery and hearing loss in pediatrics,” PhotoniCare Co-Founder/CEO Ryan Shelton, Ph.D., said. “The OtoSight Middle Ear Scope leverages OCT imaging to visualize through the eardrum and determine the presence or absence of fluid in the middle ear as well as characterize the type of fluid, even in the presence of earwax. These interim RCT results validate the power of the technology to improve diagnostic accuracy, support antibiotic stewardship, and ultimately help providers deliver better care for a condition that affects the vast majority of children.”

Children with ear-related complaints are misdiagnosed up to 50% of the time using the current gold standard, examination with an otoscope. Children can suffer from recurring ear infections for six to 12 months before they are referred to an ENT specialist, and are often prescribed increasingly potent antibiotics during this time. Often, the disease endpoint is insertion of tympanostomy tubes in the eardrum. More than 1 million tube surgeries are performed in the U.S. annually.

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“Our research reveals that the OtoSight device, through its advanced OCT imaging, can significantly curb unnecessary antibiotic use. It does this by providing clinicians with a clearer picture of middle ear conditions, leading to more accurate diagnoses and a 50% decrease in antibiotic prescriptions,” stated Dr. April Zambelli-Weiner, principal study investigator and president/CEO of TTi Health Research & Economics, the trial’s contract research organization. “It streamlines treatment approaches, encouraging single therapies over multimodal treatments. These findings, replicated across our entire study cohort, suggest a promising future for this technology in enhancing both diagnostic accuracy and antibiotic stewardship.”

The study data demonstrate a shift toward more singular treatment decisions, reducing reliance on combination therapies.

OtoSight is the first FDA cleared device for middle-ear visualization, offering unique CPT codes to capture the procedure. OtoSight has significant commercial traction, validating product-market fit in pediatrics, family practices and ENT, according to the company. In addition to the current large RCT, the company has previously published multiple peer-reviewed manuscripts demonstrating the device’s ability to help drive continued reimbursement and market adoption. 

Founded in 2013, PhotoniCare aims to improve clinical outcomes and serve unmet patient and provider needs by translating light-based technologies into objective medical practice, starting with the OtoSight Middle Ear Scope. The U.S. Food and Drug Administration (FDA)-cleared OtoSight Middle Ear Scope was developed for healthcare providers seeking a better solution for pediatric middle ear issues. With a more than 90% reader accuracy in determining the presence or absence of middle ear fluid, the OtoSight Middle Ear Scope eliminates subjectivity and speculation by providing patients with a non-invasive and comprehensive assessment of middle ear fluid, even in the presence of significant earwax. PhotoniCare has been recognized by numerous organizations, winning the 2025 NextMed Health MEDy Award, 2021 Northwest Arkansas Tech Summit Pitch Competition, the 2018 MedTech Innovator Execution Award, and the 2018 AdvaMed Accel Virginia Shimer Rybski Memorial Award. PhotoniCare has received more than $6 million in support from the National Institutes of Health, most recently a Phase SBIR II award for work in artificial intelligence. In 2015, PhotoniCare was the winner of a grant from the National Capital Consortium for Pediatric Device Innovation (NCC-PDI), an FDA-funded consortium led by Children’s National Hospital.