Sophono Inc. in Boulder on Wednesday obtained marketing clearance from the U.S. Food and Drug Administration for an implantable hearing device.
The Otomag Alpha 1 Bone Conduction Hearing System is an alternative to traditional bone anchored hearing devices that require a through the skin abutment, typically called baha’s.
“Many patients suffer with their hearing loss rather than choose a penetrating abutment. The Alpha 1 system will make a very attractive option for these patients,” said Dr. David Friedland, the division chief of otology and research at the Medical College of Wisconsin.
The Alpha 1 is a treatment for hearing disorders such as conductive and mixed hearing loss, as well as single sided deafness. It differs from currently available, implanted bone conduction hearing devices by using magnetic coupling.
The Alpha system does not require an abutment (a titanium screw sticking out of the side of the head) or permanent hair removal and the daily hygiene routines required by an abutment.
“The absence of an abutment should greatly reduce the significant level of complications seen with current bone anchored hearing aids,” Friedland said.
The Sophono device can be used by adults and children as young as 5 years old.
Sophono Inc. is the first company to emerge from the Boulder BioMed commercialization accelerator and has received startup funding from the Colorado Institute for Drug, Device and Diagnostic Development.
