Hearing Loss, Bilateral or UnilateralSENSENCT07161154
Sentio Systematic Evaluation
An observational study of Hearing Loss, Bilateral or Unilateral and Hearing Loss, Conductive, run by Oticon Medical.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hearing Loss, Bilateral or Unilateral, Hearing Loss, Conductive, Hearing Loss, Mixed Conductive-Sensorineural
- What is being tested?
- Transcutaneous bone conduction hearing system
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to Dec 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients receiving the Sentio system in clinical practice
Who may be able to join
- 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.
Who cannot join
- Subjects enrolled in other clinical investigations leading to their Sentio implantation and subsequent follow-up deviating substantially from clinical practice
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Hearing Loss, Bilateral or Unilateral, Hearing Loss, Conductive, Hearing Loss, Mixed Conductive-Sensorineural, Single Sided Deafness, Hearing Loss, Hearing-Impairment
- Being tested
- Transcutaneous bone conduction hearing system
- Keywords
- Active transcutaneous bone conduction hearing system
- Medical subject headings
- Hearing Loss, Hearing Loss, Conductive, Hearing Loss, Mixed Conductive-Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous bone conduction hearing systemDevice
The Sentio system is an active transcutaneous bone conduction hearing system (single armed study)
| Study group | Role | What they receive |
|---|---|---|
| Sentio | Patients recieving the Sentio system Receives: Device: Transcutaneous bone conduction hearing system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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 (5)
Frequency of surgical events and complications
Measured: During surgery
Assess surgical approaches and techniques
Measured: During surgery
Frequency of post-operative complications
Measured: From surgery till end of follow-up (expected up to 10 years)
Timing of fitting
Days between surgery and fitting of sound processor.
Measured: During fitting appointment (typically 2-15 weeks after surgery, depending on patient needs and local variations on practice)
To assess improvement in hearing
Free-field thresholds
Measured: At fitting and throughout follow-up period (expected up to 10 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study startSep 2025 (estimated)
- Primary completionDec 2035 (estimated)
- Study completionDec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, Bilateral or UnilateralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oticon Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07161154
- Sponsor's protocol ID
- BC125
- Acronym
- SENSE
- Status last verified
- Sep 2025
- First submitted
- 29 Jul 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To protect integrity of patients.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sentio Systematic Evaluation - SENSE
- ClinicalTrials.gov ID
- NCT07161154
- Acronym / sponsor ID
- SENSE / BC125
- Conditions
- Hearing Loss, Bilateral or Unilateral, Hearing Loss, Conductive, Hearing Loss, Mixed Conductive-Sensorineural, Single Sided Deafness, Hearing Loss, Hearing-Impairment
- Keywords
- Active transcutaneous bone conduction hearing system
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Oticon MedicalIndustry (pharma, biotech, devices)
- Study start
- Sep 2025 (estimated)
- Primary completion
- Dec 2035 (estimated)
- Study completion
- Dec 2035 (estimated)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sentio | – | Device: Transcutaneous bone conduction hearing systemPatients recieving the Sentio system |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients receiving the Sentio system in clinical practice
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Subjects enrolled in other clinical investigations leading to their Sentio implantation and subsequent follow-up deviating substantially from clinical practice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous bone conduction hearing systemThe Sentio system is an active transcutaneous bone conduction hearing system (single armed study) | Device | Sentio |
Primary outcome
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).
5 secondary outcomes
Frequency of surgical events and complications
Time frame: During surgery
Assess surgical approaches and techniques
Time frame: During surgery
Frequency of post-operative complications
Time frame: 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)
To assess improvement in hearing
Time frame: At fitting and throughout follow-up period (expected up to 10 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: No. To protect integrity of patients.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss, Bilateral or Unilateral and Hearing Loss, Conductive, run by Oticon Medical.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kia N Iversen, PhD (+46760039141, kinv@oticonmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.