FDA OKs Sophono

Sophono, Inc. today announces that it has obtained marketing clearance from the US Food and Drug Administration for its implantable Otomag Alpha 1(M) Bone Conduction Hearing System. The Alpha 1 (M) is an implantable hearing device and an alternative to traditional bone anchored hearing devices which 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," says Dr. David Friedland, MD, PhD, the Division Chief of Otology and Research at the Medical College of Wisconsin.

The Alpha 1 (M) 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," continues Friedland.

According to the National Institute on Deafness and Other Communication Disorders, the US has approximately 36 million adults who report some degree of hearing loss and of those only 1 out of every 5 people who could benefit from a hearing device actually wear one. "Sophono is committed to providing hearing impaired individuals with innovative new technologies to improve their quality of life," says Jim Kasic, President and CEO of Sophono, Inc.

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 start-up funding from the Colorado Institute for Drug, Device and Diagnostic Development.

Source: Sophono