FDA Clears TOMi Scope for Noninvasive Imaging of Middle Ear

The Food and Drug Administration has granted 510(k) clearance to TOMi Scope (PhotoniCare) as an imaging tool for visualization of the human tympanic membrane and middle ear space.

The TOMi Scope uses video otoscopy and optical coherence tomography to directly visualize the contents of the middle ear providing a high-resolution depth image on-screen. The device provides cross-sectional images of the middle ear as well as a high resolution video of the eardrum surface. Clinicians are able to directly visualize fluid in the middle ear and measure the fluid’s density, even in the presence of wax. These images may also be saved for later analysis.

The Company expects to immediately launch the TOMi Scope in a limited release in select US geographies, with a full national launch later in 2020.

“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, MD, PhD of the Children’s National Hospital in Washington, DC, a lead investigator for clinical studies of the device. “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.”

For more information visit photoni.care.