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Clinical Trial
. 2001 Nov;22(6):962-72.
doi: 10.1097/00129492-200111000-00042.

Clinical experience with the Vibrant Soundbridge implant device

U Fisch  1 , C W Cremers, T Lenarz, B Weber, G Babighian, A S Uziel, D W Proops, A F O'Connor, R Charachon, J Helms, B Fraysse
Affiliations
Clinical Trial

Clinical experience with the Vibrant Soundbridge implant device

U Fisch et al. Otol Neurotol. 2001 Nov.

Abstract

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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