Table 28 - Summary of the evidence base supporting the therapeutic claims Comparison Therapeutic claim The level and quality of the Statistical precision and size Consistency of the evidence of the effect results over the trials presented Partially Significant improvement in sound-field Level III to Level IV evidence Based on clinical significance Demonstrated in 15/16 implantable MEI hearing thresholds from non-randomised pre-post defined as a shift in threshold studies covering 377 for patients with or with/without studies. > 10 dB HL patients SNHL+medical Reference standard in Significantly better speech Meta-analysis: mean Improvement in speech condition vs. no audiology is dedicated clinical recognition/comprehension in quiet improvement of 35.69% (95% comprehension scores in treatment follow-up. CI levels, 29.23 - 42.15), Z = all seven included studies 10.83 (P< 0.00001) (see Table 18) Significantly better speech Based on clinical significance Consistent improvement recognition/comprehension in noisy defined as a mean change of seen in three studies situations 10% (see Table 21) Few difficulties in understanding No unaided comparison Comparable values speech in relatively easy listening available, statistical analysis across included studies conditions, as compared to noisy not applicable (see Table 21) conditions; and improves health in general Is a safe procedure with minor Statistical analysis not Not applicable adverse events resolving on their own applicable (see Table 26 ) or with local treatment Small but non-significant shift in bone Based on clinical significance Demonstrated in 5 conduction thresholds over time defined as a shift in threshold studies at a long-term < 10 dB HL follow-up Constant functional gain over time Long-term mean FG:26 dB Single study by Mosnier (2008) Short-term mean FG: 27 dB Slight decrease in recognition/ Mean WRS at long-term: 81 Single study by Mosnier comprehension over time, yet still +/-5.3%; at short-term: 89 +/- (2008) significantly better outcomes than 4.0% (N=27, paired t-test, p baseline 0.05)
Table 28 - Summary of the evidence base supporting the therapeutic claims Comparison Therapeutic claim The level and quality of the evidence Statistical precision and size of the effect Consistency of the results over the trials presented Partially implantable MEI for patients with SNHL+medical condition vs. no treatment Significant improvement in sound-field hearing thresholds Level III to Level IV evidence from non-randomised pre-post or with/without studies. Reference standard in audiology is dedicated clinical follow-up. Based on clinical significance defined as a shift in threshold > 10 dB HL Demonstrated in 15/16 studies covering 377 patients Significantly better speech recognition/comprehension in quiet Meta-analysis: mean improvement of 35.69% (95% CI levels, 29.23 - 42.15), Z = 10.83 (P< 0.00001) (see Table 18) Improvement in speech comprehension scores in all seven included studies Significantly better speech recognition/comprehension in noisy situations Based on clinical significance defined as a mean change of 10% (see Table 21) Consistent improvement seen in three studies Few difficulties in understanding speech in relatively easy listening conditions, as compared to noisy conditions; and improves health in general No unaided comparison available, statistical analysis not applicable (see Table 21) Comparable values across included studies Is a safe procedure with minor adverse events resolving on their own or with local treatment Statistical analysis not applicable (see Table 26 ) Not applicable Small but non-significant shift in bone conduction thresholds over time Based on clinical significance defined as a shift in threshold < 10 dB HL Demonstrated in 5 studies at a long-term follow-up Constant functional gain over time Long-term mean FG:26 dB Short-term mean FG: 27 dB Single study by Mosnier (2008) Slight decrease in recognition/ comprehension over time, yet still significantly better outcomes than baseline Mean WRS at long-term: 81 +/-5.3%; at short-term: 89 +/- 4.0% (N=27, paired t-test, p 0.05) Single study by Mosnier (2008)
1365.1-SubmissionBasedAssessmentReport.docx