Table 34 The estimated rate of recurring pathologies – Event Time Observed Instantaneous Source Pathology n count interval probability rate Agius Otitis externa 48 13 2 w 0,27083 1 1992 House 2 (1-15) EAC exostosis 91 8 0,08791 0,023 2008 yrs Ahmed Excessive up to 2 500 16 0,03200 0,0081 2009 cerumen yrs Adverse events In the scope of the economic evaluation an adverse event refers to minor events that are not related to a device failure and can resolve on their own or with surgical treatment. Of the eight studies identified in Section B.6.2 that reported on safety outcomes with AMEI, four provided sufficient information over a long enough study timeframe for the Vibrant Soundbridge and Maxum/Soundtec. These studies were re-evaluated to obtain values for all possible outcomes of having an adverse event. The study characteristics and derived estimates are given in Table 35. For the VSB the weighted mean (based on sample size) of the instantaneous rates were used to derive the 6-month probability of the respective variables. Considering that individuals are at constant risk at developing an adverse event, estimated probabilities were kept constant in the model.
Table 34 – The estimated rate of recurring pathologies Source Pathology n Event count Time interval Observed probability Instantaneous rate Agius 1992 Otitis externa 48 13 2 w 0,27083 1 House 2008 EAC exostosis 91 8 2 (1-15) yrs 0,08791 0,023 Ahmed 2009 Excessive cerumen 500 16 up to 2 yrs 0,03200 0,0081 Adverse events In the scope of the economic evaluation an adverse event refers to minor events that are not related to a device failure and can resolve on their own or with surgical treatment. Of the eight studies identified in Section B.6.2 that reported on safety outcomes with AMEI, four provided sufficient information over a long enough study timeframe for the Vibrant Soundbridge and Maxum/Soundtec. These studies were re-evaluated to obtain values for all possible outcomes of having an adverse event. The study characteristics and derived estimates are given in Table 35. For the VSB the weighted mean (based on sample size) of the instantaneous rates were used to derive the 6-month probability of the respective variables. Considering that individuals are at constant risk at developing an adverse event, estimated probabilities were kept constant in the model.
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