Sentio Systematic Evaluation

Not yet recruiting

• Conditions: Hearing Loss, Bilateral or Unilateral; Hearing Loss, Conductive; Hearing Loss, Mixed Conductive-Sensorineural; Single Sided Deafness; Hearing Loss; Hearing-Impairment; Hearing Aid

• Registration Number: NCT07161154
• Lead Sponsor: Oticon Medical

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-07-29
• Status Verified: 2025-09
• Study Start: 2025-09-01
• Study First Submitted QC: 2025-09-03
• Last Update Submitted: 2025-09-03
• Study First Posted: 2025-09-08
• Last Update Posted: 2025-09-08
• Primary Completion: 2035-12
• Study Completion: 2035-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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