The vibrant soundbridge for conductive and mixed hearing losses: European multicenter study results.
OBJECTIVE
The Vibrant Soundbridge (VSB) is an active middle ear implant, 'direct-drive' hearing system for the treatment of hearing loss. Recently, the VSB has been applied to conductive and mixed hearing losses. The aim of this study is to evaluate aided benefit, speech recognition in quiet and noise, subjective benefits, changes in residual hearing, and medical and surgical complications in adults with conductive or mixed hearing losses implanted with the VSB using Round Window (RW) Vibroplasty.


METHODS
Twelve German-speaking adults participated in a single-subject, repeated measures study design comparing their performance using the VSB with their own unaided preoperative performance. Hearing performance and changes in residual hearing were assessed using routine audiometric measures, sound field thresholds, and word and sentence recognition in quiet and in noise. Subjective benefits, including subjective hearing performance, device satisfaction, and quality of life were evaluated using the Abbreviated Profile of Hearing Aid Benefit, the Hearing Device Satisfaction Scale, and the Glasgow Benefit Inventory, respectively.


RESULTS
Aided hearing thresholds, word recognition at conversational levels, and sentence recognition in quiet and noise were significantly improved without significant changes in residual cochlear hearing and without major medical and surgical complications. One subject required repositioning surgery to improve transducer coupling with the RW membrane. Subjective benefit and device satisfaction were good, as were overall and general quality of life.


CONCLUSIONS
The VSB, implanted using RW vibroplasty, is a safe and effective treatment for adults with conductive and mixed hearing losses who may have few, if any, other options.
Baumgartner
W-D
WD
Böheim
K
K
Hagen
R
R
Müller
J
J
Lenarz
T
T
Reiss
S
S
Schlögel
M
M
Mlynski
R
R
Mojallal
H
H
Colletti
V
V
Opie
J
J
D000328:Adult; D000368:Aged; D001299:Audiometry; D001309:Auditory Threshold; D005060:Europe; D005260:Female; D005500:Follow-Up Studies; D006314:Hearing Loss, Conductive / Q000601:surgery / Q000628:therapy*; D046089:Hearing Loss, Mixed Conductive-Sensorineural / Q000601:surgery / Q000628:therapy*; D006320:Hearing Tests; D006801:Humans; D008297:Male; D008875:Middle Aged; D009998:Ossicular Prosthesis / Q000009:adverse effects; D017060:Patient Satisfaction; D011446:Prospective Studies; D011788:Quality of Life; D013067:Speech Perception; D016896:Treatment Outcome