Unaided and aided Luetje et al 2002 pure tone audiometry, USA Tympanometry and acoustic reflex measurement, Speech III III-2 53 adults 18 weeks Safe and effective treatment reception in quiet and Prospective, single noise, Subjective arm trial outcomes using APHAB, HDSS and SHACQ Luetje et al. 2010 Unaided and aided USA pure tone audiometry, III III-3 31 adults 1-11 years Sustained gain Degree of device use Retrospective, using a questionnaire pre/post study Unaided and aided Mosnier et al 2008 France sound field audiometry, Speech intelligibility in quiet (65 III III-2 100 adults 5-8 years dB), Subjective Safe and effective treatment Prospective, single outcomes using arm trial Vibrant Questionnaire and GBI, Adverse events Unaided and aided In cases of SNHL with Pok et al. 2010 pure tone audiometry, unsatisfying benefit from Austria unaided and aided conventional HAs, the VSB IV III-3 54 adults not stated sound field system offers an attractive Retrospective, audiometry, Speech and effective hearing solution with/without intelligibility in quiet (65 dB, 80 dB)
Luetje et al 2002 USA III III-2 53 adults 18 weeks Unaided and aided pure tone audiometry, Tympanometry and acoustic reflex measurement, Speech reception in quiet and noise, Subjective outcomes using APHAB, HDSS and SHACQ Safe and effective treatment Prospective, single arm trial Luetje et al. 2010 USA III III-3 31 adults 1-11 years Unaided and aided pure tone audiometry, Degree of device use using a questionnaire Sustained gain Retrospective, pre/post study Mosnier et al 2008 France III III-2 100 adults 5-8 years Unaided and aided sound field audiometry, Speech intelligibility in quiet (65 dB), Subjective outcomes using Vibrant Questionnaire and GBI, Adverse events Safe and effective treatment Prospective, single arm trial Pok et al. 2010 Austria IV III-3 54 adults not stated Unaided and aided pure tone audiometry, unaided and aided sound field audiometry, Speech intelligibility in quiet (65 dB, 80 dB) In cases of SNHL with unsatisfying benefit from conventional HAs, the VSB system offers an attractive and effective hearing solution Retrospective, with/without
1365.1-SubmissionBasedAssessmentReport.docx