Boulder, CO (PRWEB) October 24, 2013
Sophono, Inc. – manufacturer of abutment-free, implantable, bone conduction hearing devices – has received clearance from the Canadian Therapeutic Products Directorate, Medical Devices Bureau of Health Canada for magnetic resonance imaging (MRI) with the Alpha System™.
With the clearance, patients throughout any Canadian Province who have the Alpha System from Sophono can undergo an MRI scan, without removing the magnetic implant. The clearance approves the Alpha Magnetic Implant use for the patient within the average MRI scan of 1.5 to 3 Teslas.
In April of this year, the Alpha System received MRI clearance from the Food and Drug Administration in the United States for implanted patients. Last January, the Alpha System 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.
“We are pleased that our implanted patients who have the Alpha bone conduction hearing system throughout Canada can easily have an MRI without any contraindication or need to have the Alpha magnetic implant removed,” explains Dr. Peter Ruppersberg, CEO of Sophono. “Enabling our patients to have an MRI allows for their audiologist, physician or clinician to schedule this procedure as needed and further their patient’s medical care for their hearing loss.”
Sophono is a Colorado-based medical device manufacturer of the Alpha System, 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 Alpha System 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. (http://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 original Sophono Alpha 1 System™ and next generation 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 System 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.