About this trial
The study is designed as an international, multi-center, single-armed, non-interventional/observational study including subjects who has received or are planned to receive the Sentio system as part of normal clinical practice.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subject who is scheduled for or have undergone Sentio implantation in clinical practice.
Subject who has consented to participation or are covered by consent waiver.
Disqualifiers
Subjects enrolled in other clinical investigations leading to their Sentio implantation and subsequent follow-up deviating substantially from clinical practice
Trial population
Patients receiving the Sentio system in clinical practice
Trial design
Cohort
Other
Treatments tested in this trial
Transcutaneous bone conduction hearing system
DeviceThe Sentio system is an active transcutaneous bone conduction hearing system (single armed study)
Treatment groups
Trial outcomes
Primary outcomes
Rate of succesful use of the device
Successful use is defined as a composite outcome consisting of completion of the surgical procedure and patient reported satisfaction after fitting and use of the device (assessed through a device specific questionnaire).
Secondary outcomes
Frequency of surgical events and complications
Assess surgical approaches and techniques
Frequency of post-operative complications
Timing of fitting
Days between surgery and fitting of sound processor.
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: