Sophono, Inc.– manufacturer of abutment-free, implantable, bone conduction hearing devices – has met key industry standards, making it possible for people who have the Sophono Alpha 2™ system, and live in Europe and other countries around the world, to receive magnetic resonance imaging (MRI) with the magnetic device intact.
Sophono, Inc., is a Colorado-based medical device manufacturer. The Sophono Alpha 2 is the only abutment-free, implantable, bone-anchored hearing device on the market, treating those with conductive hearing loss, mixed hearing loss and single-sided deafness. Fitted to the patient’s head with the use of small, implantable magnets, the Sophono Alpha 2 eliminates the problems associated with other bone conduction hearing systems. These include drilling a hole in the patient’s skull and installing a very noticeable screw that pokes out through the skin on the side of the head.
The Alpha 2 hearing device from Sophono has earned clearance for use in an MRI field after passing rigorous tests from ASTM International, the globally recognized leader in the development and delivery of international voluntary consensus standards.