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

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
Device: Transcutaneous bone conduction hearing 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

Oticon Medical

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

Keywords

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.

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