FDA clears PhotoniCare's handheld OCT scanner for checking ear infections

PhotoniCare received FDA 510(k) clearance for its hand-held, noninvasive imaging scope that allows physicians to check for fluids deep behind the eardrum—one of the main signs of childhood ear infections.

The TOMi Scope diagnostic device uses optical coherence tomography, or OCT, to scan the middle ear with near-infrared light and provide a cross-section image similar to an ultrasound. It can then determine whether fluid is present and characterize its type and density, even in cases with heavy wax buildup.

“Current tools can only provide a view of the surface of the eardrum, forcing physicians to make an assessment with very limited information, or to employ invasive surgical procedures to accurately identify middle ear pathologies,” said Diego Preciado of Children's National Hospital in Washington, D.C., who served as a lead investigator for the device’s clinical studies. 

According to PhotoniCare, middle ear infections affect more than 80% of children, though they can be misdiagnosed up to half of the time following examination with a traditional otoscope. These potentially recurrent infections are also a leading cause of hearing loss, tube surgeries and antibiotic use, the company said.

RELATED: FDA approves new tube system for childhood ear infections designed for a doctor's visit

“TOMi Scope’s advanced light-based technology could dramatically alter the way children with ear problems are evaluated, enhancing our ability to inform optimal treatments,” said Preciado.

Designed for use by nurse practitioners, physician assistants or other technicians, PhotoniCare said it plans to begin its launch of the TOMi Scope at select locations in the U.S. in the near future with a larger, national rollout planned for later in 2020.