Phase III clinical trial results with the Vibrant Soundbridge implantable middle ear hearing device: a prospective controlled multicenter study.
OBJECTIVE
The goal of the study was to evaluate the performance of a semi-implantable middle ear hearing device (Vibrant Soundbridge System [VSB]; Symphonix Devices, Inc).


METHODS
A prospective, single-subject, repeated-measures multicenter study was conducted to determine the safety and efficacy of the VSB using analog and digital external processors. Measures included residual hearing, functional gain, speech recognition, acoustic feedback, occlusion, and patient self-assessment to determine satisfaction, perceived performance, and device preference compared with an appropriately fit acoustic hearing aid. Fifty-three adult subjects with moderate to severe sensorineural hearing loss were evaluated at 4 or more intervals after implantation.


RESULTS
Improvements in satisfaction, performance, and preference were statistically significant with the VSB, as was functional gain across all test frequencies (P < 0.001). Occlusion and feedback were virtually eliminated. Aided speech recognition was comparable between VSB and the hearing aid. Residual hearing was unchanged.


CONCLUSIONS
The VSB is a safe and effective treatment option for adults with moderate to severe sensorineural hearing loss.
Luetje
Charles M
CM
Otologic Center, Inc, Kansas City, MO 64111, USA. Pam@nov8.net
Brackman
Derald
D
Balkany
Thomas J
TJ
Maw
Jennifer
J
Baker
R Stanley
RS
Kelsall
David
D
Backous
Douglas
D
Miyamoto
Richard
R
Parisier
Simon
S
Arts
Alexander
A
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001301:Audiometry, Pure-Tone; D003054:Cochlear Implants; D004867:Equipment Design; D005260:Female; D006319:Hearing Loss, Sensorineural / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D011446:Prospective Studies; D013067:Speech Perception; D016896:Treatment Outcome