Sentio Systematic Evaluation

NCT ID: NCT07161154

Last Updated: 2025-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-30

Study Completion Date

2035-12-31

Brief Summary

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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

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Sentio

Patients recieving the Sentio system

Transcutaneous bone conduction hearing system

Intervention Type DEVICE

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

Interventions

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Transcutaneous bone conduction hearing system

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

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oticon Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Kia N Iversen, PhD

Role: CONTACT

+46760039141

Other Identifiers

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BC125

Identifier Type: -

Identifier Source: org_study_id

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