Roland et al. 2001 23 6 AC pure tone threshold, increased high-frequency gain without feedback. Patient USA III III-3 adults months Functional gain,Quality of life satisfaction Prospective, pre/post study Silverstein et al. AC and BC pure tone thresholds, well tolerated in the majority of patients, with a significant 2005 USA 64 3 Functional gain, increase in functional gain over conventional hearing aids III III-3 adults months Speech recognition in quiet. and reduces occlusion effect and feedback. Magnet Retrospective, Quality of life instability and noise were the most frequent complaints. pre/post study Table 13 - Summary of Vibrant Soundbridge study characteristics included in the evaluation level of evidence Follow-up/Testing Study n Outcomes Conclusions interval EbM Oxford NHMRC Partially implantable device: VIBRANT SOUNDBRIDGE Boeheim et al. 2010 Unaided and aided Austria sound field thresholds, IV III-3 10 adults 5-56 months Significant improvement Speech recognition in Prospective, quiet and noise with/without Böheim et al. 2007 Unaided and aided Austria PTA4 , Speech IV III-3 9 adults 6 months Significant Improvement recognition in quiet Retrospective and noise pre/post study
Roland et al. 2001 USA III III-3 23 adults 6 months AC pure tone threshold, Functional gain,Quality of life increased high-frequency gain without feedback. Patient satisfaction Prospective, pre/post study Silverstein et al. 2005 USA III III-3 64 adults 3 months AC and BC pure tone thresholds, Functional gain, Speech recognition in quiet. Quality of life well tolerated in the majority of patients, with a significant increase in functional gain over conventional hearing aids and reduces occlusion effect and feedback. Magnet instability and noise were the most frequent complaints. Retrospective, pre/post study Table 13 - Summary of Vibrant Soundbridge study characteristics included in the evaluation Study level of evidence n Follow-up/Testing interval Outcomes Conclusions Oxford EbM NHMRC Partially implantable device: VIBRANT SOUNDBRIDGE Boeheim et al. 2010 Austria IV III-3 10 adults 5-56 months Unaided and aided sound field thresholds, Speech recognition in quiet and noise Significant improvement Prospective, with/without Böheim et al. 2007 Austria IV III-3 9 adults 6 months Unaided and aided PTA4 , Speech recognition in quiet and noise Significant Improvement Retrospective pre/post study