Boulder, Colo — The United States Food and Drug Administration (FDA) has cleared the new implantableAlpha 1 (M) Bone Conduction Hearing System from Boulder-based Sophono Inc.

The Alpha 1 (M) is a fully implantable hearing device, thus it differs from traditional bone anchored hearing devices (BAHAs) in that the patient does not have a visible skin abutment, such as a titanium screw, after surgery. In addition, no permanent hair removal or daily hygiene routines are needed. Instead, the device utilizes bone conduction via an implanted magnetic coupling (right).

The Alpha 1 (M) delivers a fully digital solution for those with bone conduction hearing thresholds of 45 dB or less. Another advantage to the Alpha 1 (M) is that it eliminates the necessity of daily site cleansing of the abutment.

It was first implanted in 2006 and approved for release in Europe in 2010. The company reports that hundreds of Alpha 1 (M) implants and sound processors have been placed in patients in Germany and Western Europe. Thus far, the company says that there have been no reported loss of implants or issues with postsurgical infections.

David Friedland, MD, PhD, division chief of Otology and Research at the Medical College of Wisconsin, commented in the press release, “Many patients suffer with their hearing loss rather than choose a penetrating abutment.” He added that the absence of an abutment should greatly reduce the significant level of complications seen with current bone anchored hearing aids.

A video of the implant procedure is below:

 SOURCE: Sophono