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Published on: January 9, 2019
Clinical experience with the Vibrant Soundbridge implant device
U Fisch1, C W Cremers, T Lenarz
1ORL-Zentrum, Klinik Hirslanden, Universitätsspital Zürich, Witellikerstrasse 40, CH-8029 Zürich, Switzerland.
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.
