Massachusetts-based Lantos Technologies has announced clearance from the United States Food & Drug Administration (FDA) to market the Lantos 3D Ear Scanning System. Initially developed in the laboratories of Massachusetts Institute of Technology, the system streamlines the process of obtaining ear topology measurements for custom-fit earpiece devices. The Lantos System is the first 3D ear scanning technology to attain clearance as a 510(k) Medical Device.
Lantos’ technology is designed to replace the current process of taking a silicone impression for the production of custom-fit ear devices. According to Jeffrey Leathe, CEO and Chairman of the Board at Lantos, “The straightforward process of obtaining a 3D representation of the ear canal by our system provides opportunities to improve efficiencies across the hearing device value chain. We are excited to receive FDA 510(k) clearance – it demonstrates our commitment to offer innovative and disruptive technology that is both safe and efficacious”.
The Lantos 3D Ear Scanning System is composed of a portable handheld scanner with a video otoscope for visualization and navigation of the ear canal. A membrane-based consumable expands to conform to the ear canal anatomy. The scope captures images and generates a 3D scan of the ear using state-of-the-art optics and stitching algorithms in less than one minute. This approach enables the ability to measure changes in ear canal shape that accompany body movements such as opening the mouth, producing a dynamic 3D image of the canal that can be transferred electronically in a format applicable to any device manufacturer.
Possible applications include the hearing aid, consumer audio, industrial noise protection, military and communication markets. The 3D Ear Scanning System will be commercially available later this year.