Long Term Clinical Investigation to Evaluate Clinical Performance, Safety and Patient Reported Outcomes of an Active Osseointegrated Steady-State Implant System

Study Overview
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Brief Summary
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The aim of this clinical investigation is to collect long-term safety and performance data with the Active Osseointegrated Steady-State Implant System by following subjects from the previous Osia clinical investigation CBAS5751. In addition, questions regarding device satisfaction, sound satisfaction, usability and health care utilisation will be asked.

Official Title
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A Multicentre, Open, Long-term Clinical Investigation Evaluating Safety, Performance and Patient Reported Outcomes With an Active Osseointegrated Steady-State Implant System in Adult Subjects With Conductive Hearing Loss, Mixed Hearing Loss or Single-sided Sensorineural Deafness.

Conditions
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Hearing Loss

Intervention / Treatment
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* Device: Active Osseointegrated Steady-State Implant System (OSI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has performed Hearing assessment at 3 and/or 6 months in the clinical investigation CBAS5751 Willing and able to provide written informed consent Exclusion Criteria: Unable to follow investigational procedures, e.g. to complete quality of life scales, or unwilling to comply with the requirements of the clinical investigation as determined by the investigator Use of ototoxic drugs that could be harmful to the hearing, as judged by the investigator

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: Active Osseointegrated Steady-State Implant System (OSI)<br> | Device: Active Osseointegrated Steady-State Implant System (OSI)<br>* System includes the OSI200 implant surgically placed under the skin behind the ear, the BI300 implant osseointegrated in the bone and the external Osia 2 sound process<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and type of reported Adverse events | The adverse events are collected from the participant's last visit in study CBAS5751 (6 months post-surgery) and categorized by system organ class system | 6 months post-surgery to 24 months post-surgery | 
| Number and type of reported Device deficiencies | The device deficiencies are collected from the participant's last visit in study CBAS5751 (6 months post-surgery) and categorized by relationship | 6 months post-surgery to 24 months post-surgery | 
| Concomitant medication used | Concomitant medication are collected from the participant's last visit in study CBAS5751 (6 months post-surgery) | 6 months post-surgery to 24 months post-surgery | 
| Socio-economic health care data via the Client Service Receipt Inventory (CSRI) survey | Demographic data (marital status, cohabitation, usual place of residence, education level), employment status, Healthcare utilization and Hearing rehabilitation data are collected | 12 months post-surgery | 
| Socio-economic health care data via the Client Service Receipt Inventory (CSRI) survey | Demographic data (marital status, cohabitation, usual place of residence, education level), employment status, Healthcare utilization and Hearing rehabilitation data are collected | 24 months post-surgery | 
| Change in audiometric thresholds with the Active Osseointegrated Steady-State Implant System at 12 months post-surgery and 24 months post-surgery compared to preoperative thresholds via an audiogram | Bone- and air conduction thresholds, masked and unmasked | Baseline before surgery, 12 months and 24 months post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hearing performance with the Active Osseointegrated Steady-State Implant System at 12 months and 24 months post-surgery compared to last performed measurement (3 or 6 months) in the CBAS5751 study assessed via audiometric thresholds | Sound-field (Pure Tone Average 4, mean of 0.5, 1, 2 and 4 kHz) | 3 or 6 months post-surgery, 12 and 24 months post-surgery | 
| Change in hearing performance with the Active Osseointegrated Steady-State Implant System at 12 and 24 months post-surgery compared to last performed measurement (3 or 6 months) in the CBAS5751 study assessed via audiometric thresholds | Sound-field [0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz] | 3 or 6 months post-surgery, 12 and 24 months post-surgery | 
| Change in hearing performance with the Active Osseointegrated Steady-State Implant System at 12 and 24 months post-surgery compared to last performed measurement (3 or 6 months) in the CBAS5751 study assessed via adaptive speech recognition in noise | Speech-to-noise ratio, 50% speech understanding | 3 or 6 months post-surgery, 12 and 24 months post-surgery | 
| Change in hearing performance with the Active Osseointegrated Steady-State Implant System at 12 and 24 months post-surgery compared to last performed measurement (3 or 6 months) in the CBAS5751 study assessed via Bone Conduction (BC) direct | BC direct (0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0 and 6.0 kHz) | 3 or 6 months post-surgery, 12 and 24 months post-surgery | 
| Difference in self-reported hearing outcome with the Active Osseointegrated Steady-State Implant System at 12 and 24 months post-surgery compared to last performed measurement (3 or 6 months) in the CBAS5751 study | Assessed via Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire. APHAB produces a global score and scores for four subscales: Ease of Communication, Reverberation, Background Noise, and Aversiveness. Global score is the average of all subscales. All scales range from 0-100%, where 0% indicates no problem and 100% indicates always problem. A decrease in the APHAB values indicates an improvement. The difference in scores will be presented. A positive value indicates an improvement, a negative value an impairment. | 3 or 6 months post-surgery, 12 and 24 months post-surgery | 
| Change in self-reported hearing outcome with the Active Osseointegrated Steady-State Implant System at 12 and 24 months post-surgery compared to last performed measurement (3 or 6 months) in the CBAS5751 study | Assessed via the Speech, Spatial and Qualities of Hearing Scale (SSQ) questionnaire. Measuring change of speech, spatial and hearing experiences with the Active Osseointegrated Steady-State Implant System. The Total score summarizes the parameters speech, spatial and hearing. A scale from 0 to 10 is used, where 0 represents can not hear at all, and 10 hear perfectly. An increase of an SSQ value reflects an improvement. The change in scores will be presented. A positive value indicates improved hearing, a negative value indicates impaired hearing. | 3 or 6 months post-surgery, 12 and 24 months post-surgery | 
| Change in health-related quality of life with the Active Osseointegrated Steady-State Implant System at 12 and 24 months post-surgery compared to last performed measurement (3 or 6 months) in the CBAS5751 study | Assessed via the Health Utilities Index (HUI) questionnaire. Change of health status and health related quality of life using the generic quality of life scale Health Utilities Index when wearing the Active Osseointegrated Steady-State Implant System. A health utility value of 1.00 indicates perfect health while a score of 0.00 indicates death. The change in scores will be presented. A positive value indicates an improved quality of life, a negative value indicates impaired quality of life. | 3 or 6 months post-surgery, 12 and 24 months post-surgery | 
| Participant satisfaction with the investigational device (every-day situation and self-esteem) assessed on a Likert Scale | To express how much they agree or disagree with a particular statement. The scale goes from 1 to 7, where 1 represent Much worse and 7 represent Much better. | 12 months post-surgery | 
| Participant satisfaction with the investigational device (easiness to use) assessed on a Likert Scale | To express how much they agree or disagree with a particular statement. The scale goes from 1 to 5 where 1 represent Very difficult and 5 represent Very easy. | 12 months post-surgery | 
| Participant satisfaction with the investigational device (durability of the device and sound quality) assessed on a Likert Scale | To express how much they agree or disagree with a particular statement. The scale goes from 1 to 5, where 1 represent Very dissatisfied and 5 represent Very satisfied. | 12 months post-surgery | 
| Participant satisfaction with the investigational device (overall satisfaction) with question Yes/No. |  | 12 months post-surgery | 
| Participant satisfaction with the investigational device (every-day situation and self-esteem) assessed on a Likert Scale | To express how much they agree or disagree with a particular statement. The scale goes from 1 to 7, where 1 represent Much worse and 7 represent Much better. | 24 months post-surgery | 
| Participant satisfaction with the investigational device (easiness to use) assessed on a Likert Scale | To express how much they agree or disagree with a particular statement. The scale goes from 1 to 5 where 1 represent Very difficult and 5 represent Very easy. | 24 months post-surgery | 
| Participant satisfaction with the investigational device (durability of the device and sound quality) assessed on a Likert Scale | To express how much they agree or disagree with a particular statement. The scale goes from 1 to 5, where 1 represent Very dissatisfied and 5 represent Very satisfied. | 24 months post-surgery | 
| Participant satisfaction with the investigational device (overall satisfaction) with question Yes/No. |  | 24 months post-surgery | 
| Change in daily use of the Osia 2 sound processor at 12 and 24 months post-surgery compared to last performed measurement (3 or 6 months) in the CBAS5751 study | Average hours of daily use during the last week before each follow up visit | 3 or 6 months post-surgery, 12 and 24 months post-surgery | 
| Change in daily streaming time of the Osia 2 sound processor at 12 and 24 months post-surgery compared to last performed measurement (3 or 6 months) in the CBAS5751 study | Average hours of daily streaming during the last week before each follow up visit | 3 or 6 months post-surgery, 12 and 24 months post-surgery | 
| Change in battery lifetime of the Osia 2 sound processor at 12 and 24 months post-surgery compared to last performed measurement (3 or 6 months) in the CBAS5751 study | Average hours of battery lifetime for a single battery during the last week before each follow up visit | 3 or 6 months post-surgery, 12 and 24 months post-surgery | 
| Change in magnet choice of the Osia 2 sound processor at 12 and 24 months post-surgery compared to last performed measurement (3 or 6 months) in the CBAS5751 study | Magnet strength ranging from 1 to 4, strength 1 being the weakest and 4 the strongest. If the magnet strength has been changed the reason for change is captured in free text | 3 or 6 months post-surgery, 12 and 24 months post-surgery | 
| Change in use of SoftWear pad for the Osia 2 sound processor at 12 and 24 months post-surgery compared to last performed measurement (3 or 6 months) in the CBAS5751 study | SoftWear pad usage: Yes or No | 3 or 6 months post-surgery, 12 and 24 months post-surgery | 
| Change in retention of the Osia 2 sound processor at 12 and 24 months post-surgery compared to last performed measurement (3 or 6 months) in the CBAS5751 study | Assessed via a Visual Analog Scale (VAS) 100 mm where 0 mm represents insufficient retention and 100 mm excellent retention. | 3 or 6 months post-surgery, 12 and 24 months post-surgery | 
| Change in wearing comfort of the Osia 2 sound processor at 12 and 24 months post-surgery compared to last performed measurement (3 or 6 months) in the CBAS5751 study | Assessed via a Visual Analog Scale (VAS) 100 mm where 0 mm represents no comfort at all and 100 mm excellent comfort. | 3 or 6 months post-surgery, 12 and 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, Hearing Loss, Mixed, Deafness, sensorineural single-sided