Fisch et al. 2001 Unaided pure tone Europe audiometry, Subjective Safety of the surgical III III-2 47 adults 3 months impressions of sound procedure was demonstrated Prospective, single quality - not reported arm trial Unaided and aided Measurable benefit from the Fraysse et al. 2001 sound field thresholds VBS in comparison with HA France (PTA4), Speech (superior amplification,greater IV III-2 25 adults 22 months recognition, Subjective ease in communication in Prospective, pre/post outcomes using the noise) study APHAB Garin et al. 2005 Belgium Speech intelligibility in III III-2 11 adults 9-24 months Improvement in Outcomes noise (55 dB) Retrospective, with/without Labassi et al 2005 France Adverse events IV IV 1100 adults 7 years Reliable middle ear implant during/after surgery Retrospective study Lenarz et 2001 Unaided and aided sound field Germany audiometry, Speech IV III-3 34 adults 6 months intelligibility in quiet Significant improvement and noise, Subjective Retrospective, outcomes using the pre/post study PHAB questionnaire
Fisch et al. 2001 Europe III III-2 47 adults 3 months Unaided pure tone audiometry, Subjective impressions of sound quality - not reported Safety of the surgical procedure was demonstrated Prospective, single arm trial Fraysse et al. 2001 France IV III-2 25 adults 22 months Unaided and aided sound field thresholds (PTA4), Speech recognition, Subjective outcomes using the APHAB Measurable benefit from the VBS in comparison with HA (superior amplification,greater ease in communication in noise) Prospective, pre/post study Garin et al. 2005 Belgium III III-2 11 adults 9-24 months Speech intelligibility in noise (55 dB) Improvement in Outcomes Retrospective, with/without Labassi et al 2005 France IV IV 1100 adults 7 years Adverse events during/after surgery Reliable middle ear implant Retrospective study Lenarz et 2001 Germany IV III-3 34 adults 6 months Unaided and aided sound field audiometry, Speech intelligibility in quiet and noise, Subjective outcomes using the PHAB questionnaire Significant improvement Retrospective, pre/post study
1365.1-SubmissionBasedAssessmentReport.docx