Boulder, Colo. (PRWEB) January 31, 2013
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. The device underwent rigorous ASTM International tests for translation, torque, heating and signal loss artifacts produced in a magnetic resonance image by a passive implant.
As a result, individuals in Europe, and other countries outside the United States, who have the Sophono Alpha implant can undergo MRI tests – in both 1.5 and 3-tesla magnetic fields – with the device intact. “The absence of any contraindications for MRI with the Sophono Alpha device is a great step forward for Sophono, patients, and the physicians, audiologists and clinicians who serve those with hearing loss,” says Jim Kasic, president and CEO of Sophono. “Patients and providers now have full assurance that their implants will not need to be removed should the patient need to undergo MRI testing at any point in the future.”
Receipt of the European ASTM International designation is the first step toward worldwide clearance of the Alpha 2 device for MRI, explains Kasic. Sophono has completed testing for FDA clearance in the United States, and is awaiting notification.
Sophono, Inc. (http://www.sophono.com)
Sophono, Inc., is a medical device manufacturer specializing in implantable, bone conduction hearing devices. The company’s products are designed for individuals suffering from severe to profound hearing loss or impairment. The Sophono Alpha 2 System is the only abutment-free, implantable, bone-anchored hearing system available today. Treating those with conductive hearing loss, mixed hearing loss, and single-ear deafness, the FDA-cleared Alpha 2 device eliminates the problematic abutment of devices by using magnets to affix external sound processors.
Sophono corporate headquarters and manufacturing operations reside in Boulder, Colo. The company maintains an office in Germany, works with more than 20 distributors, and is actively selling in more than 30 countries.