Clinical Experience with the Vibrant Soundbridge Implant Device

Objective To 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 Design Single-subject study with each subject serving as his or her own control. Setting Multicenter clinical study conducted at 10 centers in Europe. Patients 47 patients who met the selection criteria for participation in the study. Interventions Implantation of the VSB direct-drive middle ear hearing device. Main Outcome Measures Average 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. Results 47 patients had successful surgery for implantation and fitting with the VSB device. Conclusion The 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.

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