Sentio Systematic Evaluation

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorOticon Medical

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • Transcutaneous bone conduction hearing system

    Device

    The Sentio system is an active transcutaneous bone conduction hearing system (single armed study)

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Sentio1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
Completion of the surgical procedure is reported at the surgery. Device specific questionnaire is typically completed within the first year of follow-up, though timing may vary depending on local practice for follow-up.

Secondary outcomes

1

Frequency of surgical events and complications

Time frame
During surgery
2

Assess surgical approaches and techniques

Time frame
During surgery
3

Frequency of post-operative complications

Time frame
From surgery till end of follow-up (expected up to 10 years)
4

Timing of fitting

Days between surgery and fitting of sound processor.

Time frame
During fitting appointment (typically 2-15 weeks after surgery, depending on patient needs and local variations on practice)

Other outcomes

Locations

This trial has no 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: