Sophono Inc, manufacturer of abutment-free, implantable, bone conduction hearing devices, has received clearance from the US Food and Drug Administration for magnetic resonance imaging (MRI).
With the clearance, individuals in the United States who have the Sophono Alpha 2™ 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.