Figure 1.
Timeline of key events relative to device fitting (week 0). *Presurgical baseline FLORA measured with no device. ✝Post-device fitting baseline FLORA at week 17. ‡Subject 4 ceased FLORA measurements at week 20 for reasons unrelated to the device. §Only subject 3 had FLORA and IVI-VLV performed at weeks 80 and 92 because of the impacts of the COVID-19 pandemic in 2020. ||Endpoint is defined as the last time point in the study where FLORA and IVI-VLV were performed for subjects 1, 2, and 3, which were at 110, 109, and 136 weeks (approximately two years) post-device fitting, respectively. The timing of the endpoint for subject 3 was extended because of the COVID-19 pandemic in 2020. #The gray zone marks the time range where subjects began using the device unsupervised at home (subject 1 = week 21.0, subject 2 = week 20.3, subject 3 = week 23.3, subject 4 = week 27.6).