Lantos Technologies said the FDA granted 510(k) clearance for its 3D ear canal imaging device, designed to enhance the design of customized hearing aids.
Initially developed at the Mass. Institute of Technology, the Lantos device uses ultrasound to create a 3D image of the ear canal and is designed to obviate the need for siliconm molding of the canal.
"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," chairman & CEO Jeffrey Leathe said in prepared remarks.
Lantos said it’s aiming to get the device on the market "later this year, according to a press release.
Originally founded by MIT mechanical engineer Douglas Hart in 2009 with $50,000 in seed funding provided by an MIT tech transfer office, Lantos landed $1.6 million in Series A funding for product development back in September 2010.