FDA Approves Hearing Implant

Description: 

The Food and Drug Administration (FDA) has approved a new surgical alternative to a hearing aid. The Vibrant Soundbridge is a surgically implanted hearing device intended to help adults with moderate to severe nerve hearing loss. The device is implanted behind the ear in the temporal (skull) bone. It converts sound to mechanical energy that is transferred to the middle ear, which vibrates the structures in the middle ear the way normal sound does. During the implant surgery, the surgeon implants a receiver behind the ear. A wire leads from the receiver to a small electromagnet attached to one of the middle ear bones.

In the US study, 81 patients who were followed up for at least 9 months were tested first with hearing aids in both ears and then with the implant in one ear. The results showed that the participants could hear about as well with the implant as with traditional hearing aids. One warning the FDA points out is that patients with the Vibrant Soundbridge may not have Magnetic Resonance Imaging (MRI) of any type because the Vibrant Soundbridge has an implanted magnet that is a potential safety problem, since the magnetic field of the MRI could dislodge the implant

The Food and Drug Administration (FDA) has approved a new surgical alternative to a hearing aid. The Vibrant Soundbridge is a surgically implanted hearing device intended to help adults with moderate to severe nerve hearing loss. The device is implanted behind the ear in the temporal (skull) bone. It converts sound to mechanical energy that is transferred to the middle ear, which vibrates the structures in the middle ear the way normal sound does. During the implant surgery, the surgeon implants a receiver behind the ear. A wire leads from the receiver to a small electromagnet attached to one of the middle ear bones.

In the US study, 81 patients who were followed up for at least 9 months were tested first with hearing aids in both ears and then with the implant in one ear. The results showed that the participants could hear about as well with the implant as with traditional hearing aids. One warning the FDA points out is that patients with the Vibrant Soundbridge may not have Magnetic Resonance Imaging (MRI) of any type because the Vibrant Soundbridge has an implanted magnet that is a potential safety problem, since the magnetic field of the MRI could dislodge the implant