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NCT Number: NCT07161154

Sentio Systematic Evaluation

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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Key information

Conditions

Hearing Loss, Bilateral or Unilateral Ear Diseases Hearing Aid Hearing Disorders Hearing Loss Hearing Loss, Conductive Hearing Loss, Mixed Conductive-Sensorineural Hearing-Impairment Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Single Sided Deafness

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcutaneous bone conduction hearing system

Device

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. Frequency of surgical events and complications

    Time frame: During surgery

  2. Assess surgical approaches and techniques

    Time frame: During surgery

  3. Frequency of post-operative complications

    Time frame: From surgery till end of follow-up (expected up to 10 years)

  4. 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.

  5. To assess improvement in hearing

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

    Free-field thresholds

Study contacts

Contact information is provided by the study sponsor or research team.

Kia N Iversen, PhD

CONTACT

[email protected]

+46760039141

Sponsors and collaborators

Lead sponsor

Oticon Medical

Industry

Registry information

Official study title

Sentio Systematic Evaluation - SENSE

Acronym: SENSE

Important dates

Study start
2025
Primary completion
2035
Study completion
2035
First posted
Sep 8, 2025
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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