Implantable Hearing Device Cleared by FDA

An implantable middle ear hearing device for treating moderate to severe hearing loss has been cleared by the U.S. Food and Drug Administration (FDA). The device is designed to work with the natural structures of the middle ear to enhance hearing.

Called the Vibrant Soundbridge, the device utilizes direct-drive technology to stimulate the tiny bones in the middle ear. Its design addresses problems associated with acoustic hearing aids such as poor sound quality, feedback, background noise, and discomfort. Implantation of the device is performed as an outpatient surgical procedure that lasts one-and-a-half to two hours. Patients usually return to normal activities within a few days.

The vibrant Soundbridge was developed by Symphonix Devices, Inc. (San Jose, CA, USA). Patients who participated in the clinical trial of the device reported improved sound clarity and quality, better overall fit and comfort, and perceived benefit in many listening situations as compared to their own hearing aids.

Current options for the hearing-impaired are less than adequate, said Kirk Davis, president and CEO of Symphonix. The approval of this revolutionary device represents the first new treatment in more than a century for the millions of adults with moderate to severe sensorineural hearing loss.