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 patien ts 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. Study Design: Single-subject repeated-measures evaluations were performed w ith each patient acting as his or her own control. Objective audiologic mea sures and subjective questionnaires also were used. Setting: Five tertiary referral and teaching hospitals. Subjects: Adult patients had bilateral sensorineural hearing loss (average hearing loss, 56 dB; range, 33-80 dB). Twenty-one patients had worn a conve ntional hearing aid before surgery (11 binaurally, 10 monaurally). Four pat ients had not used a conventional hearing aid before surgery. Intervention: Rehabilitative. Results: No significant change in residual hearing after surgery was observ ed. Functional gain was significantly superior with the VBS. No significant differences were observed for aided speech recognition in quiet. A signifi cant improvement in communication in various listening conditions was repor ted with the VBS as compared with conventional hearing aids. Conclusion: The VBS surgical implantation procedure does not affect the res idual hearing level in the implanted ear, nor does it present my unacceptab le risk. Measurable benefit from the VBS in comparison with conventional am plification was demonstrated with regard to the provision of superior usabl e amplification and greater ease in communication in daily listening enviro nments for the majority of patients.