Kraus et al.2011 AC and BC pure tone thresholds, USA 57 12 Functional gain, Speech recognition hearing results are statistically superior to baseline, best-fit III III-2 adults months in quiet and noise, Quality of life, HAs for SRT and WRS and the Esteem system is safe. Prospective, Adverse events multicenter study Fully implantable device: CARINA Bruschini et al. 2010 is a viable treatment for moderate to severe SNHL and for mixed hearing loss and that in selected cases it could Italy AC and BC pure tone thresholds, represent an alternative to conventional hearing aids. 7 12-21 IV III-3 Functional gain, Speech recognition Implantation without affecting residual cochlear hearing adults months Prospective, in quiet, Quality of life levels and auditory performance could be shown to be pre/post study similar or better than that reported with Ha's. Device proved to be well tolerated. Jenkins et al. 2008 feasibility and lack of deleterious effects on native hearing was shown. Significant challenges in its clinical application USA AC and BC pure tone thresholds, have been encountered, and the company is addressing 20 12 Functional gain, Speech recognition III III-1 these issues in design revisions. Patient subjective adults months in quiet and noise, Quality of life, Prospective questionnaires demonstrated improved naturalness of Adverse events multicenter study sound and functional hearing that are similar to their baseline hearing aids. Tringali et al. 2010 MET seems to be a suitable and successful treatment France option resulting in significant improvement in speech AC and BC pure tone thresholds, 7 24 comprehension, especially after 6 months, in patients with III III-2 Functional gain, Speech recognition Prospective, adults montths severe sensorineural hearing loss. During the 24-month in quiet, Quality of life follow-up of this study, the MET has been a safe and longitudional study effective treatment for severe hearing loss Partially implantable device: SOUNDTEC AC and BC pure tone thresholds, Hough et al. 2002 Functional gain, USA 103 4-5 III III-2 Speech recognition in quiet and significant improvement in outcomes adults months Prospective, noise, Quality of life, multicenter trial Adverse events
Kraus et al.2011 USA III III-2 57 adults 12 months AC and BC pure tone thresholds, Functional gain, Speech recognition in quiet and noise, Quality of life, Adverse events hearing results are statistically superior to baseline, best-fit HAs for SRT and WRS and the Esteem system is safe. Prospective, multicenter study Fully implantable device: CARINA Bruschini et al. 2010 Italy IV III-3 7 adults 12-21 months AC and BC pure tone thresholds, Functional gain, Speech recognition in quiet, Quality of life is a viable treatment for moderate to severe SNHL and for mixed hearing loss and that in selected cases it could represent an alternative to conventional hearing aids. Implantation without affecting residual cochlear hearing levels and auditory performance could be shown to be similar or better than that reported with Ha's. Device proved to be well tolerated. Prospective, pre/post study Jenkins et al. 2008 USA III III-1 20 adults 12 months AC and BC pure tone thresholds, Functional gain, Speech recognition in quiet and noise, Quality of life, Adverse events feasibility and lack of deleterious effects on native hearing was shown. Significant challenges in its clinical application have been encountered, and the company is addressing these issues in design revisions. Patient subjective questionnaires demonstrated improved naturalness of sound and functional hearing that are similar to their baseline hearing aids. Prospective multicenter study Tringali et al. 2010 France III III-2 7 adults 24 montths AC and BC pure tone thresholds, Functional gain, Speech recognition in quiet, Quality of life MET seems to be a suitable and successful treatment option resulting in significant improvement in speech comprehension, especially after 6 months, in patients with severe sensorineural hearing loss. During the 24-month follow-up of this study, the MET has been a safe and effective treatment for severe hearing loss Prospective, longitudional study Partially implantable device: SOUNDTEC Hough et al. 2002 USA III III-2 103 adults 4-5 months AC and BC pure tone thresholds, Functional gain, Speech recognition in quiet and noise, Quality of life, Adverse events significant improvement in outcomes Prospective, multicenter trial
1365.1-SubmissionBasedAssessmentReport.docx