Table 12 - Summary of comparator study characteristics included in the evaluation level of evidence Study n Outcomes Conclusion ebM Oxford NHMRC Fully implantable device: ESTEEM Barbara et al. 2011 AC and BC pure tone thresholds, Italy 18 1.5-2 beneficial results in subjects suffering from high frequency, III III-3 Speech recognition in quiet, adults months severe bilateral sensorineural hearing loss (SNHL) Prospective, Quality of life pre/post study Barbaraet al. 2014 Italy 34 3 delayed facial nerve (FN) impairment and taste IV IV Adverse events adults months disturbances were found in a limited number of subjects. Prospective, study Chen et al. 2004 AC and BC pure tone thresholds, USA 7 4 Functional gain, Speech recognition feasibility of a totally implantable middle-ear device for III III-2 adults months in quiet and noise, Quality of life, sensorineural hearing loss was proven Prospective, Adverse events multicenter study Gerard et al. 2012 AC and BC pure tone thresholds, offers good functional and satisfaction results; however, Belgium 13 not Functional gain, Speech recognition careful selection of patients is required. The implant is safe III III-3 adults stated in quiet and noise, Quality of Life, and only associated with classic auditory implant Retrospective, Adverse events complications pre/post study Monini et al. 2013 Germany possible beneficial role for rehabilitation of SNHL in 15 3 Functional gain, Speech recognition III III-3 selected candidates and improvement of quality of life was adults months in quiet, Quality of life Retrospective, concluded cohort study surgery seems to be realtively safe. Correct selection of Memari et al. 2011 Iran patients is very important and infuences postoperative 10 19-40 AC and BC pure tone thresholds, III III-2 results. Hearing gain in current devices is similar to adults months Functional gain, Adverse events Prospective, conventional hearing aids, but with better subjective pre/post study hearing quality.
Table 12 - Summary of comparator study characteristics included in the evaluation Study level of evidence n Outcomes Conclusion Oxford ebM NHMRC Fully implantable device: ESTEEM Barbara et al. 2011 Italy III III-3 18 adults 1.5-2 months AC and BC pure tone thresholds, Speech recognition in quiet, Quality of life beneficial results in subjects suffering from high frequency, severe bilateral sensorineural hearing loss (SNHL) Prospective, pre/post study Barbaraet al. 2014 Italy IV IV 34 adults 3 months Adverse events delayed facial nerve (FN) impairment and taste disturbances were found in a limited number of subjects. Prospective, study Chen et al. 2004 USA III III-2 7 adults 4 months AC and BC pure tone thresholds, Functional gain, Speech recognition in quiet and noise, Quality of life, Adverse events feasibility of a totally implantable middle-ear device for sensorineural hearing loss was proven Prospective, multicenter study Gerard et al. 2012 Belgium III III-3 13 adults not stated AC and BC pure tone thresholds, Functional gain, Speech recognition in quiet and noise, Quality of Life, Adverse events offers good functional and satisfaction results; however, careful selection of patients is required. The implant is safe and only associated with classic auditory implant complications Retrospective, pre/post study Monini et al. 2013 Germany III III-3 15 adults 3 months Functional gain, Speech recognition in quiet, Quality of life possible beneficial role for rehabilitation of SNHL in selected candidates and improvement of quality of life was concluded Retrospective, cohort study Memari et al. 2011 Iran III III-2 10 adults 19-40 months AC and BC pure tone thresholds, Functional gain, Adverse events surgery seems to be realtively safe. Correct selection of patients is very important and infuences postoperative results. Hearing gain in current devices is similar to conventional hearing aids, but with better subjective hearing quality. Prospective, pre/post study
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