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The TOMi Scope is intended for use as an imaging tool for real-time visualization of the human tympanic membrane and fluid or air within the middle ear space. In the presence of middle ear fluid, the TOM Scope is used to visualize the fluid density. The TOMi Scope is also used to provide surface images of the ear canal and tympanic membrane. It is indicated for use in children and adults.

Model 34R TOMi Scope is a multiple use, non-sterile device which provides a surface view of the eardrum, equivalent to the functionality of a video otoscope. Additionally, the TOMi Scope provides a view through the surface to visualize the contents of the middle ear using Low-Coherence Interferometry (LC). LCI is an implementation of OCT which, rather than generating 2-D or 3-D images, is limited to the generation of a onedimensional in-depth density profile displayed over time, which reveals the optical reflective property of the tympanic membrane (TM), as well as the content(s) which are present behind the TM. The TOMi Scope has a form factor which allows for ease of imaging the middle ear by the clinician, who will utilize disposable specula tips and position the TOMi Scope in the external ear canal in the same way routinely utilized for the current gold standard otoscopy. A push-button on the handheld is used to put the device into active recording mode, capturing both surface and LCI images simultaneously.