Synopsis: The studies covered a total of 294 adults and children with various etiologies. Across all studies, 32 participants were affected by an adverse event. The most common complications were floating mass transducer extrusion, wound dehiscence, and dizziness. Device failure was observed in three patients; revision surgery was required in 20 patients. In a total of 144 patients, preoperative air conduction thresholds ranged from 64.9 to 82 dB hectoliters (HL), with a mean of 72 dB HL to 82 dB HL. Aided AC threshold values were 34.2 dB HL and 30 dB HL. Functional gain of the VSB at three months ranged from 12.5 dB to 43.4 dB HL. Speech recognition was shown to improve by 63% to 99% after at least three months of use, and by 52% to 81% after at least six months of use. The 50% speech recognition threshold was shown to improve by 33 dB to 41 dB after at least three months of use. There were no primary research studies comparing the efficacy of the VSB and bone conduction hearing implants (BCHI); however, MEIs were at least as safe as bone-anchored hearing aids (BAHAs), although in general BAHA patients reported more wound healing difficulties. Four studies compared VSB with ear reconstruction surgery plus hearing aids. Better AC thresholds were demonstrated with the VSB in the mid- to high frequencies; the functional gain with the VSB was also significantly better.
Bottom line: The VSB as an active device offers an effective alternative for patients with various middle ear pathologies, particularly with mixed hearing loss and failed previous tympanoplasties.
Citation: Ernst A, Todt I, Wagner J. Safety and effectiveness of the Vibrant Soundbridge in treating conductive and mixed hearing loss: A systematic review. Laryngoscope. 2016;126:1451-1457.