The US Food and Drug Administration (FDA) has cleared Sophono's Alpha 2 magnetic implant system for use with magnetic resonance imaging (MRI).
The clearance allows US patients implanted with Sophono Alpha 2 abutment-free, bone conduction hearing device to undergo MRI in both 1.5 and 3-tesla magnetic fields.
The implant has also been cleared for use in an MRI field for device wearers in Europe and other countries by passing tests from ASTM International.
Sophono president and CEO Jim Kasic said worldwide clearance of the Alpha 2 device for MRI gives patients and providers full assurance that the implant need not to be removed during undergo MRI testing at any point in the future.
"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," Kasic added.
