Lantos Technologies of Cambridge, Massachusetts, has developed a revolutionary 3D Ear Scanning System for investigation, navigation and measurement of the ear canal. Their state-of-the-art technology captures ear canal shape and dynamics and has changed the custom ear products market.
The traditional way to make hearing aids and ear molds are made from a "cast" of the ear or an ear impression. An audiologist places a special cotton or foam dam in the ear canal to protect the eardrum, and then a waxy material is placed in the ear canal. After the material as hardened (about 5 to 10 minutes later) the wax cast, along with the dam are removed from the ear canal.
The 3D dynamic digital representation of the ear canal was developed by Dr. Douglas Hart at the Massachusetts Institute of Technology. Lantos Technologies makes custom hearing devices while eliminating the traditional ear impression process. The hand held Lantos scanner is inserted into the ear canal. Then the membrane conforms and expands to the shape of the ear. The fiberscope navigates and inspects the ear canal and makes a 3D image of the ear canal which takes less than 60 seconds. Then the scanning data is sent electronically anywhere in the world.
Currently, Lantos Technologies is within the Federal Drug Administration process. Approximately 40 medical devices approved each year by the FDA and an additional 3,000 510 (k) clearances are provided. The development of a medical device from concept to product launch can take between 4-10 years before approval and can cost between $5 to $300 million dollars depending on the complexity of the device and required regulatory process. In addition, FDA requires user fees when a technology is submitted for regulatory review. The user fees support the operation of the FDA and can range from $200K for a pre-market approval submission down to $3,500 for a new 510 (k) submission.
Lantos Technologies states the 3D Ear Scanning device will be available in the second quarter of 2013.