ObjectiveTo evaluate the full degree and range of benefits provided by the Vibrant Soundbridge (VSB; Symphonix Devices, Inc., San Jose, CA, U.S.A.) and analyze pre-and postoperative results of audiologic tests.Study DesignSingle-subject study with each subject serving as his or her own control.SettingMulticenter clinical study conducted at 10 centers in Europe.Patients47 patients who met the selection criteria for participation in the study.InterventionsImplantation of the VSB direct-drive middle ear hearing device.Main Outcome MeasuresAverage change in unaided thresholds with the patient wearing headphones at each frequency pre-and postsurgery was measured. A mean threshold change less than 5 dB across all frequencies was considered clinically nonsignificant.Results47 patients had successful surgery for implantation and fitting with the VSB device.ConclusionThe VSB is a new middle ear implant device that can be used safely in the treatment of patients with moderate to severe sensorineural hearing loss.