Sentio Systematic Evaluation

NCT07161154 | Not Yet Recruiting

• 1 other identifier: BC125
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

Active transcutaneous bone conduction hearing system

Outcome Measures

Primary Outcomes (1)

• 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).

  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

  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)

• To assess improvement in hearing

  At fitting and throughout follow-up period (expected up to 10 years)

Study Arms (1)

Sentio

Patients recieving the Sentio system

Device: Transcutaneous bone conduction hearing system

Interventions

Transcutaneous bone conduction hearing system DEVICE

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

Sentio

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients receiving the Sentio system in clinical practice

You may qualify if:

• 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.

You may not qualify if:

• Subjects enrolled in other clinical investigations leading to their Sentio implantation and subsequent follow-up deviating substantially from clinical practice

Sponsors & Collaborators

• Oticon Medical: lead

MeSH Terms

Conditions

Hearing Loss; Hearing Loss, Conductive; Hearing Loss, Mixed Conductive-Sensorineural

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Kia N Iversen, PhD

CONTACT

+46760039141; kinv@oticonmedical.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: September 8, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 1, 2035
• Study Completion (Estimated): December 1, 2035
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share