Clinical Investigation Study of Safety and Performance of the Sentio System.

Study Overview
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Brief Summary
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Prospective, open label, single-arm, multi-centre investigation, designed to follow clinical practice for Sentio bone conduction devices in 50 subjects, during 10 clinical visits, and 24 months follow-up.

Detailed Description
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The investigation is a 24-months multinational, multicentre, prospective, open label, single arm investigation on the Sentio system. The purpose of this investigation is to evaluate safety and performance three months after implantation of the new Sentio system. In addition, safety will be analysed six months after implantation, and long-term safety and performance will be evaluated over a 24-month follow-up period. The endpoints chosen, together with applicable measurements, are commonly used, both in the clinical setting as well as in bone anchored hearing research as shown in the scientific literature covering this area. That is, the primary objectives of this study is to demonstrate that the Sentio system improves hearing and speech recognition on the implanted ear. Secondary objectives includes investigation of hearing improvement, speech intelligibility, patient satisfaction, and quality of life. The study also aims to evaluate the safety profile of the Sentio system in terms of the occurrence of adverse events and serious adverse events related to the device.

Official Title
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A Prospective, Multi-center, Single-arm, Clinical Investigation of the Safety and Performance of the Sentio System in Users With Mixed/Conductive Hearing Losses and Single Sided Deafness

Conditions
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Hearing Loss, Unilateral, Hearing Loss, Conductive, Hearing Loss, Mixed

Intervention / Treatment
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* Device: Active transcutaneous bone conduction hearing system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed Informed Consent Form Adult subjects (18 years or older) Subjects with 3.1. conductive or mixed hearing losses with pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) of the indicated ear better than or equal to 45 dB HL. 3.2. OR subjects who have a profound sensorineural hearing loss in one ear and normal hearing in the opposite ear (i.e. SSD). The pure tone average (PTA) air conduction (AC) threshold of the hearing ear should then be better than or equal to 20 dB HL (measured at 0.5, 1, 2 and 3 kHz) 3.3. OR subjects who are indicated for an air-conduction contralateral routing of signals (ACCROS) hearing aid, but who for some reason cannot or will not use an AC CROS. Fluent in local language Subjects who have the ability and are willing to follow investigational procedures/requirements, e.g. to complete quality of life scales. Exclusion Criteria: Inability to undergo general or local anesthesia Prior implantation with percutaneous device or middle ear implant on the side to be implanted Known medical conditions that contraindicate undergoing surgery as judged by the investigator Untreated ongoing middle ear infection at the time of surgery Known insufficient bone quality/quantity/depth or skull size (scull abnormalities) for implantation of a Sentio Ti Implant Known or suspected contact allergy to silicone or other material used in the Sentio system. Known condition that could jeopardize wound healing and skin condition e.g. uncontrolled diabetes over time as judged by the investigator. Known skin or scalp conditions that may preclude attachment or interfere with the usage of the sound processor. Known retro cochlear pathology and auditory processing disorders that may have an impact on the outcome of the investigation Any other known condition that the investigator determines could interfere with compliance or investigation assessments. Use of ototoxic drugs that could be harmful to the hearing, as judged by the investigator. Subject that has received radiotherapy in the area of implantation or is planned for such radiotherapy or similar during the investigation period. For bilateral asymmetric candidates, subject already treated with a bone-anchored hearing solution on the side with the best bone conduction thresholds Known chronic or non-revisable vestibular or balance disorder Known abnormally progressive hearing loss For conductive and mixed losses: evidence that hearing loss is retro-cochlear or of central origin Participation in another clinical investigation with pharmaceuticals and/or devices which might cause interference with investigation participation. Use of active implantable or body worn device that for medical reasons cannot be removed or discontinued, such as implantable cardiac pacemakers, defibrillators, or neurostimulators. Known need for frequent MRI investigations for follow-up of other diseases. Any subject that according to the Declaration of Helsinki is deemed unsuitable for investigation enrolment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sentio system<br>Prospective, open label, single-arm multi-centre investigation following clinical practice for bone conduction devices. | Device: Active transcutaneous bone conduction hearing system<br>* The Sentio system consists of the Sentio 1 sound processor (SP) and Sentio Ti implant with fixation band and screws.<br>* Other names: Sentio system;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demonstrate that the Sentio system improves hearing on the implanted ear. | Functional gain with Sentio, i.e. the difference between preoperative unaided and aided sound field thresholds on the implanted ear. | 3 months post-surgery | 
| Demonstrate that the Sentio system provides patients with improved speech recognition on the implanted ear. | Difference in speech recognition score in percent between pre-operative unaided condition and aided with Sentio, measured in quiet on the implanted ear. | 3 months post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thorough assessment of performance (functional gain, effective gain, speech recognition), satisfaction, usability, comfort and health-related quality of life. | Sound field audiometry, speech testing in quiet and noise and patient reported outcomes on listed topics. | 3-24 months post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hearing Loss, Conductive, Mixed, Single-sided, Deafness