Sophono Alpha 2 Hearing System Receives FDA Clearance for Use With MRI
Clearance assures absence of contraindications for abutment-free, implantable hearing device
BOULDER, Colo., April 11, 2013 /PRNewswire/ — Sophono, Inc.- manufacturer of abutment-free, implantable, bone conduction hearing devices – has received clearance from the U.S. Food and Drug Administration for magnetic resonance imaging (MRI).
With the clearance, individuals in the United States who have the Sophono Alpha 2(TM) System can undergo MRI – in both 1.5 and 3-tesla magnetic fields – without removing the magnetic implant. In January, the Sophono Alpha earned clearance for use in an MRI field for device wearers in Europe and other countries around the world by passing tests from ASTM International, the globally recognized leader in the development and delivery of international voluntary consensus standards.
“Worldwide clearance of the Alpha 2 device for MRI gives patients and providers full assurance that the Sophono Alpha implant will not need to be removed should the patient need to undergo MRI testing at any point in the future,” says Jim Kasic, president and CEO of Sophono. “The absence of contraindications for MRI with the Sophono Alpha System is a great step forward for patients, as well as the physicians, audiologists and clinicians who serve those with hearing loss.”
Sophono, Inc., is a Colorado-based medical device manufacturer. The Sophono Alpha 2 System is the only abutment-free, implantable, bone-anchored hearing system 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.
Sophono, Inc. (www.sophono.com)
Sophono, Inc., is a medical device manufacturer specializing in abutment-free, implantable, bone conduction hearing systems. The company’s products are designed for individuals suffering from severe to profound hearing loss or impairment. The Sophono Alpha 2(TM) 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 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.
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SOURCE Sophono, Inc.