BOULDER, CO–A new bone-conduction implantable hearing device received market clearance from the U.S. Food and Drug Administration (FDA) on June 1. Known as the Otomag Alpha 1, the system was developed by Boulder-based Sophono, Inc. (sophono.com), to treat conductive and mixed hearing loss, as well as single-sided deafness.
Existing bone-conduction systems, such as those made by Oticon Medical and Cochlear, use a titanium abutment embedded in the patient’s skull to transmit sound to the inner ear. However, the Otomag Alpha 1 uses magnetic coupling rather than an abutment to securely affix the external sound processor to a titanium implant to keep the device in place. The company says that this makes the system an attractive alternative to existing products, in part because it reduces the likelihood of complications. The system is designed for adults and for children 5 and over.
Sophono has received startup funding from the Colorado Institute for Drug, Device and Diagnostic Development. The president and CEO is Jim Kasic, who was founder of Boulder BioMed. He was formerly with Otologics, a manufacturer of middle ear implantable hearing aids.