The Lantos System is the First 3D Ear Scanning Technology to Attain Clearance as a 510(k) Medical Device
Cambridge, Mass., March 18, 2013. Lantos Technologies, Inc. today announced that it has received 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 in ear devices.
Lantos’ technology replaces the current laborious and often uncomfortable 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 3D Ear Scanning System also promises manufacturing efficiencies, simplifies logistics and improves the turnaround time for product delivery to the customer.
Developed and tested in collaboration with audiologists and hearing device manufacturers, the 3D Ear Scanning System is poised to drive innovation in the hearing aid, consumer audio, industrial noise protection, military and communication markets. “This is a technology that will greatly improve the audiologist’s ability to map the dimensions of a patient’s ear and ear canal,” said Brian Fligor, Sc.D., Director of Diagnostic Audiology at Boston Children’s Hospital. “The Lantos System makes it easier and safer to map deep into the ear canal, which is a necessity for devices that sit deeply in the ear canal, including popular, but challenging, invisible hearing devices.” The 3D Ear Scanning System will be commercially available later this year.
About the 3D Ear Scanning System
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. The image can rapidly be transferred electronically in a format applicable to any device manufacturer.
About Lantos Technologies, Inc.
Dedicated to providing breakthrough technology for the audiology industry, Lantos Technologies formed in 2009 as an M.I.T. spin out. The company is backed by leading venture capital groups and driven by a team of expert scientists, entrepreneurs and seasoned business executives. Committed to enabling innovation across a variety of markets – hearing device, consumer audio, industrial/military, hearing protection and communication, Lantos collaborates with industry leaders to provide the benefits of direct digital ear canal scanning to a global population.