Device Offers Effective Alternative to Middle Ear Surgery, Hearing Aids

What advantages, if any, does the Vibrant Soundbridge (VSB) offer in the hearing performance of people with mixed and conductive hearing impairment?

Background: The previous treatment strategy for patients with mixed and conductive hearing impairment consisted of middle ear surgery with replacement of defective ossicles and, if possible, the fitting of a hearing aid. Since then, different coupling techniques (vibroplasty) have been developed to adapt middle ear implants (MEIs) to nearly every pathophysiological situation and to restore hearing by residual hearing amplification.

Study design: Retrospective selection and data extraction from 34 studies published between January 2006 and April 2014.

Setting: PubMed, OvidSP (MEDLINE), Embase (DIMDI), the National Institute for Health Research (NIHR) Centre for Reviews and Dissemination (including the National Health Service Economic Evaluation Database, Database of Abstracts of Reviews of Effects, and Health Technology Assessment), and the Cochrane Library.

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.