Sophono Inc, Boulder, Colo, reports that people who have the Sophono Alpha 2™ bone-anchored hearing system and live in Europe and other countries outside the United States may receive magnetic resonance imaging (MRI) with the magnetic device intact.
The company says that its Alpha 2 hearing device 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.
Receipt of the European ASTM International designation is the first step toward worldwide clearance of the Alpha 2 device for MRI, explains Jim Kasic, president and CEO of Sophono. Sophono has completed testing for FDA clearance in the United States, and is awaiting notification.
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 Kasic. “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.”
The Sophono Alpha 2 is said to be 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 problems associated with other bone conduction hearing systems. These include drilling a hole in the patient’s skull and installing a noticeable screw that pokes out through the skin on the side of the head, according to the company.
SOURCE: Sophono Inc