## 3 Results
\begin{table}
\begin{tabular}{c c c c} \hline
**Event Specifics** & **Number of Cases** & **Comment** & **Etiology** \\ \hline Magnet event & 2 & Magnet strength reduced due to pain & CSOM; Unknown \\ Pain & 2 & One resolved with antibiotics; one & Otitis externa; hereditary progressive \\  & 2 & mild ongoing & 2 \(\times\) CSOM; progressive; 2 \(\times\) unknown \\ Facial nerve insult & 5 & All spontaneously recovered & Noise-induced; trauma; cholesteatoma; \\ Wound infection & 4 & All resolved with antibiotics & \\  Tannitus & 1 & Unresolved mild & Unknown \\ \multicolumn{2}{c}{Dural tear} & 4 & All repaired intraoperatively & 2 \(\times\) CSOM; otsclerosis; unknown \\ \multicolumn{2}{c}{Chorda sacrifice} & 4 & Intraoperative event—no resolution & CSOM; Meatal stenosis; bilateral \\ \multicolumn{2}{c}{Ear canal damage} & 1 & Occurred during surgery & Otitis externa \\ \multicolumn{2}{c}{Adhesions/tissue growth} & 7 & One surgical removal; Six reimplanted & 5 \(\times\) CSOM; progressive; unknown \\ \multicolumn{2}{c}{FMT migration} & 2 & Rembolisation and repositioned & 2 \(\times\) CSOM \\ \multicolumn{2}{c}{Cholesteatoma} & 1 & Repositioned on OW & CSOM \\ \multicolumn{2}{c}{Device extrusion} & 1 & Reimplanted & CSOM \\ \multicolumn{2}{c}{Device failure} & 2 & Reimplanted & otosclerosis; unknown \\ \multicolumn{2}{c}{Wound infection} & 2 & One explanted; One & 2 \(\times\) CSOM \\ \multicolumn{2}{c}{} & intravenous antibiotics & \\ \multicolumn{2}{c}{Ossicular damage} & 4 & One explanted and three reimplanted & Inflammation and eczema; Alstrom’s syndrome; two unknown \\ \hline \end{tabular}
\end{table} 
Table 2: Device-related events for VSB cases. CSOM = Chronic suppurative otitis media; OW = Oxal window; FMT = Floating mass transducer. Figure 1: Number of events in three categories for the Bonebridge (BB) and the Soundbridge (VSB) devices. N indicates the total number of participants in that group. When comparing the timepoint at which different events occur, the BB (Figure 2) shows a bimodal distribution, with a peak during and immediately after surgery and another peak at 2-3 years post-device activation. For the VSB (Figure 3) the majority of events take place during and immediately after surgery with small numbers of events scattered across the years. Figure 3: Showing the timepoint post-implant when events occurred for Soundbridge (VSB) devices. Intraoperative issues are shown in the bar to the left of the ’0’ time point. Figure 2: Showing the timepoint post-implant when events occurred for Bonebridge (BB) devices. Intraoperative issues are shown in the bar to the left of the ’0’ time point. The etiology is listed in the tables above. A range of middle and inner ear pathologies and their consequences are evident throughout the data for both BB and VSB. There would appear to be some association between VSB cases with a history of chronic sup-purative otitis media (CSOM) and an inflammatory response to the implantation of the device. This is observed in cases of adhesions, tissue growth, device extrusion, and serious wound infections. Figures 2 and 3 show the distribution of events over time. Most adverse intraoperative events were resolved during surgery, except for irreversible cases of chorda typpani sacrifice that occurred for the VSB. The largest number of events for both devices occurred in the first month following device activation. Most events are resolved readily without recurrence. For the VSB, the number of serious events that required explantation steadily dropped until approximately 3-4 years, with the majority occurring within the first 12 months. A different pattern was observed for BB; again, there were more serious events occurring in the first year, and this did reduce, but there was another peak at around 4 years, suggesting a more prolonged risk for SAEs. One of the most frequently reported events for the BB was that the use of too strong a magnet results in pain or discomfort, particularly after the first few weeks when swelling of the skin flap has reduced.