A multicenter study of the Vibrant Soundbridge middle ear implant: early clinical results and experience.
OBJECTIVE
The Vibrant Soundbridge (VBS; Symphonix Devices, Inc., San Jose, CA, U.S.A.) is an active, semi-implantable, middle ear hearing device that directly drives the ossicular chain and is used in the treatment of patients with mild to severe sensorineural hearing loss. The benefits of the VBS and the effects of surgery were examined and compared with the preoperative aided condition in 25 patients with implants.


METHODS
Single-subject repeated-measures evaluations were performed with each patient acting as his or her own control. Objective audiologic measures and subjective questionnaires also were used.


METHODS
Five tertiary referral and teaching hospitals.


METHODS
Adult patients had bilateral sensorineural hearing loss (average hearing loss, 56 dB; range, 33-80 dB). Twenty-one patients had worn a conventional hearing aid before surgery (11 binaurally, 10 monaurally). Four patients had not used a conventional hearing aid before surgery.


METHODS
Rehabilitative.


RESULTS
No significant change in residual hearing after surgery was observed. Functional gain was significantly superior with the VBS. No significant differences were observed for aided speech recognition in quiet. A significant improvement in communication in various listening conditions was reported with the VBS as compared with conventional hearing aids.


CONCLUSIONS
The VBS surgical implantation procedure does not affect the residual hearing level in the implanted ear, nor does it present any unacceptable risk. Measurable benefit from the VBS in comparison with conventional amplification was demonstrated with regard to the provision of superior usable amplification and greater ease in communication in daily listening environments for the majority of patients.
Fraysse
B
B
Centre Hospitalier Universitaire Purpan, Service ORL, Pavilion Dieulafoy, Place du Dr Baylac, F-31059 Toulouse Cedex, France.
Lavieille
J P
JP
Schmerber
S
S
Enée
V
V
Truy
E
E
Vincent
C
C
Vaneecloo
F M
FM
Sterkers
O
O
D000161:Acoustic Stimulation / Q000295:instrumentation; D000328:Adult; D000368:Aged; D001301:Audiometry, Pure-Tone; D001309:Auditory Threshold / Q000502:physiology; 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; D011182:Postoperative Care; D011300:Preoperative Care; D019736:Prostheses and Implants; D012720:Severity of Illness Index