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.


METHODS
Single-subject study with each subject serving as his or her own control.


METHODS
Multicenter clinical study conducted at 10 centers in Europe.


METHODS
47 patients who met the selection criteria for participation in the study.


METHODS
Implantation of the VSB direct-drive middle ear hearing device.


METHODS
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.


CONCLUSIONS
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.
Fisch
U
U
ORL-Zentrum, Klinik Hirslanden, Universitätsspital Zürich, Witellikerstrasse 40, CH-8029 Zürich, Switzerland.
Cremers
C W
CW
Lenarz
T
T
Weber
B
B
Babighian
G
G
Uziel
A S
AS
Proops
D W
DW
O'Connor
A F
AF
Charachon
R
R
Helms
J
J
Fraysse
B
B
D000161:Acoustic Stimulation / Q000295:instrumentation; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004432:Ear, Middle / Q000601:surgery*; D004867:Equipment Design; D005260:Female; D006310:Hearing Aids; D006319:Hearing Loss, Sensorineural / Q000175:diagnosis / Q000534:rehabilitation / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D019736:Prostheses and Implants; D017755:Prosthesis Fitting; D012720:Severity of Illness Index