3 results
Approved WMOPending
The major aim of this study is changes in tinnitus loudness (daily report mark) and annoyance (daily report mark) and the duration of this change (time).
Approved WMOCompleted
The purpose of this Clinical Investigation Plan is to collect data on the safety and performance of the WiCS-LV system. It is designed to satisfy requirements for clinical data and post market clinical follow-up for the Active Implantable Medical…
Approved WMOCompleted
5.1 Primary study objectives:5.1.1 SafetySafety of the device has been defined as 1. Device-related complications (24 hour perioperative and one month) 2. Procedure-related complications (24 hour perioperative and one month) 5.1.2…