Sentio Systematic Evaluation

NCT07161154 — Not yet recruiting, 100 participants, Oticon Medical

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Sentio Systematic Evaluation - SENSE

Registry	NCT07161154, acronym SENSE
Status	Not yet recruiting
Study type	Observational
Enrollment	100 (Estimated)
Sponsor	Oticon Medical (Industry)
Conditions	Hearing Loss, Bilateral or Unilateral, Hearing Loss, Conductive, Hearing Loss, Mixed Conductive-Sensorineural, Single Sided Deafness, Hearing Loss, Hearing-Impairment, Hearing Aid
Interventions	Transcutaneous bone conduction hearing system (Device)
Dates	start 2025-09-01 (estimated), primary completion 2035-12-01 (estimated), completion 2035-12-01 (estimated), first posted 2025-09-08, last updated 2025-09-08

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Sentio		Device: Transcutaneous bone conduction hearing system	Patients recieving the Sentio system

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

+Outcome measures

Primary outcomes

Rate of succesful use of the device [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).

Secondary outcomes

Frequency of surgical events and complications [During surgery]
Assess surgical approaches and techniques [During surgery]
Frequency of post-operative complications [From surgery till end of follow-up (expected up to 10 years)]
Timing of fitting [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.
To assess improvement in hearing [At fitting and throughout follow-up period (expected up to 10 years)]: Free-field thresholds

+Eligibility

Sex: All

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