Sentio Systematic Evaluation (SENSE)
September 3, 2025 updated by: Oticon Medical
Sentio Systematic Evaluation - SENSE
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kia N Iversen, PhD
- Phone Number: +46760039141
- Email: kinv@oticonmedical.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients receiving the Sentio system in clinical practice
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Subjects enrolled in other clinical investigations leading to their Sentio implantation and subsequent follow-up deviating substantially from clinical practice
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Sentio
Patients recieving the Sentio system
|
The Sentio system is an active transcutaneous bone conduction hearing system (single armed study)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of succesful use of the device
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.
|
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).
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Frequency of surgical events and complications
Time Frame: During surgery
|
During surgery
|
|
|
Assess surgical approaches and techniques
Time Frame: During surgery
|
During surgery
|
|
|
Frequency of post-operative complications
Time Frame: From surgery till end of follow-up (expected up to 10 years)
|
From surgery till end of follow-up (expected up to 10 years)
|
|
|
Timing of fitting
Time Frame: During fitting appointment (typically 2-15 weeks after surgery, depending on patient needs and local variations on practice)
|
Days between surgery and fitting of sound processor.
|
During fitting appointment (typically 2-15 weeks after surgery, depending on patient needs and local variations on practice)
|
|
To assess improvement in hearing
Time Frame: At fitting and throughout follow-up period (expected up to 10 years)
|
Free-field thresholds
|
At fitting and throughout follow-up period (expected up to 10 years)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 1, 2025
Primary Completion (Estimated)
December 1, 2035
Study Completion (Estimated)
December 1, 2035
Study Registration Dates
First Submitted
July 29, 2025
First Submitted That Met QC Criteria
September 3, 2025
First Posted (Estimated)
September 8, 2025
Study Record Updates
Last Update Posted (Estimated)
September 8, 2025
Last Update Submitted That Met QC Criteria
September 3, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BC125
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
To protect integrity of patients.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.