| Primary | 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 | | Posted | | Number | | Number of events | | 6 months post-surgery to 24 months post-surgery | | | | ID | Title | Description |
|---|
| OG000 | Active Osseointegrated Steady-State Implant System (OSI) | Active Osseointegrated Steady-State Implant System (OSI): 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 |
| | | Title | Denominators | Categories |
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| Total number of AEs | | | | Class congenital, familial and genetic disorders | | | | Class ear and labyrinth disorders | | |
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| Primary | 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 | | Posted | | Number | | Number of events | | 6 months post-surgery to 24 months post-surgery | | | | ID | Title | Description |
|---|
| OG000 | Active Osseointegrated Steady-State Implant System (OSI) | Active Osseointegrated Steady-State Implant System (OSI): 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 |
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| Primary | Concomitant Medication Used | Concomitant medication are collected from the participant's last visit in study CBAS5751 (6 months post-surgery) | | Posted | | Count of Participants | | Participants | | 6 months post-surgery to 24 months post-surgery | | | | ID | Title | Description |
|---|
| OG000 | Active Osseointegrated Steady-State Implant System (OSI) | Active Osseointegrated Steady-State Implant System (OSI): 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 |
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| Primary | 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 | Data related to ear infection and hearing difficulties are reported. | Posted | | Count of Participants | | Participants | | 12 months post-surgery | | | | ID | Title | Description |
|---|
| OG000 | Active Osseointegrated Steady-State Implant System (OSI) | Active Osseointegrated Steady-State Implant System (OSI): 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 |
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| Primary | 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 | Data related to ear infection and hearing difficulties are reported. | Posted | | Count of Participants | | Participants | | 24 months post-surgery | | | | ID | Title | Description |
|---|
| OG000 | Active Osseointegrated Steady-State Implant System (OSI) | Active Osseointegrated Steady-State Implant System (OSI): 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 |
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| Primary | 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 | As per protocol, if failed results regarding Pure Tone Average (PTA4), individual thresholds or Signal to Noise Ratio (SNR) were obtained, both unaided audiograms and BC Direct values could have been used to evaluate if the results depended on impaired unaided hearing or impaired performance of the Osia device. The results were collected, with no failed results for PTA4, individual thresholds or SNR recorded. Therefore the unaided audiograms and BC Direct values were not analysed further. | Posted | | | | | | Baseline before surgery, 12 months and 24 months post-surgery | | | | ID | Title | Description |
|---|
| OG000 | Active Osseointegrated Steady-State Implant System (OSI) | Active Osseointegrated Steady-State Implant System (OSI): 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 |
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| Secondary | 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) | Data received for 18 participants. | Posted | | Mean | Standard Deviation | dB (decibel) | | 3 or 6 months post-surgery, 12 and 24 months post-surgery | | | | ID | Title | Description |
|---|
| OG000 | Active Osseointegrated Steady-State Implant System (OSI) | Active Osseointegrated Steady-State Implant System (OSI): 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 |
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| Secondary | 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] | Data were received for 18 participants. | Posted | | Mean | Standard Deviation | dB (decibel) | | 3 or 6 months post-surgery, 12 and 24 months post-surgery | | | | ID | Title | Description |
|---|
| OG000 | Active Osseointegrated Steady-State Implant System (OSI) | Active Osseointegrated Steady-State Implant System (OSI): 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 |
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| Secondary | 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 | Data received for 18 participants. | Posted | | Mean | Standard Deviation | db SNR (decibel Speech to Noise Ratio) | | 3 or 6 months post-surgery, 12 and 24 months post-surgery | | | | ID | Title | Description |
|---|
| OG000 | Active Osseointegrated Steady-State Implant System (OSI) | Active Osseointegrated Steady-State Implant System (OSI): 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 |
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| Secondary | 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) | As per protocol, if failed results regarding PTA4, individual thresholds or SNR were obtained, both unaided audiograms and BC Direct values could have been used to evaluate if the results depended on impaired unaided hearing or impaired performance of the Osia device. The results were collected, with no failed results for PTA4, individual thresholds or SNR recorded. Therefore the unaided audiograms and BC Direct values were not analysed further. | Posted | | | | | | 3 or 6 months post-surgery, 12 and 24 months post-surgery | | | | ID | Title | Description |
|---|
| OG000 | Active Osseointegrated Steady-State Implant System (OSI) | Active Osseointegrated Steady-State Implant System (OSI): 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 |
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| Secondary | 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. | | Posted | | Mean | Standard Deviation | units on a scale | | 3 or 6 months post-surgery, 12 and 24 months post-surgery | | | | ID | Title | Description |
|---|
| OG000 | Active Osseointegrated Steady-State Implant System (OSI) | Active Osseointegrated Steady-State Implant System (OSI): 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 |
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| Secondary | 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. | | Posted | | Mean | Standard Deviation | score on a scale | | 3 or 6 months post-surgery, 12 and 24 months post-surgery | | | | ID | Title | Description |
|---|
| OG000 | Active Osseointegrated Steady-State Implant System (OSI) | Active Osseointegrated Steady-State Implant System (OSI): 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 |
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| Secondary | 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. | | Posted | | Mean | Standard Deviation | score on a scale | | 3 or 6 months post-surgery, 12 and 24 months post-surgery | | | | ID | Title | Description |
|---|
| OG000 | Active Osseointegrated Steady-State Implant System (OSI) | Active Osseointegrated Steady-State Implant System (OSI): 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 |
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| Secondary | 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. | | Posted | | Count of Participants | | Participants | | 12 months post-surgery | | | | ID | Title | Description |
|---|
| OG000 | Active Osseointegrated Steady-State Implant System (OSI) | Active Osseointegrated Steady-State Implant System (OSI): 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 |
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| Secondary | 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. | | Posted | | Count of Participants | | Participants | | 12 months post-surgery | | | | ID | Title | Description |
|---|
| OG000 | Active Osseointegrated Steady-State Implant System (OSI) | Active Osseointegrated Steady-State Implant System (OSI): 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 |
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| Secondary | 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. | | Posted | | Count of Participants | | Participants | | 12 months post-surgery | | | | ID | Title | Description |
|---|
| OG000 | Active Osseointegrated Steady-State Implant System (OSI) | Active Osseointegrated Steady-State Implant System (OSI): 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 |
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| Secondary | Participant Satisfaction With the Investigational Device (Overall Satisfaction) With Question Yes/No. | | | Posted | | Count of Participants | | Participants | | 12 months post-surgery | | | | ID | Title | Description |
|---|
| OG000 | Active Osseointegrated Steady-State Implant System (OSI) | Active Osseointegrated Steady-State Implant System (OSI): 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 |
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| Secondary | 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. | | Posted | | Count of Participants | | Participants | | 24 months post-surgery | | | | ID | Title | Description |
|---|
| OG000 | Active Osseointegrated Steady-State Implant System (OSI) | Active Osseointegrated Steady-State Implant System (OSI): 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 |
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| Secondary | 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. | | Posted | | Count of Participants | | Participants | | 24 months post-surgery | | | | ID | Title | Description |
|---|
| OG000 | Active Osseointegrated Steady-State Implant System (OSI) | Active Osseointegrated Steady-State Implant System (OSI): 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 |
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| Secondary | 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. | | Posted | | Count of Participants | | Participants | | 24 months post-surgery | | | | ID | Title | Description |
|---|
| OG000 | Active Osseointegrated Steady-State Implant System (OSI) | Active Osseointegrated Steady-State Implant System (OSI): 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 |
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| Secondary | Participant Satisfaction With the Investigational Device (Overall Satisfaction) With Question Yes/No. | | | Posted | | Count of Participants | | Participants | | 24 months post-surgery | | | | ID | Title | Description |
|---|
| OG000 | Active Osseointegrated Steady-State Implant System (OSI) | Active Osseointegrated Steady-State Implant System (OSI): 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 |
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| Secondary | 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 | Data not collected for all 20 participants at all time points. | Posted | | Mean | Standard Deviation | hours/day | | 3 or 6 months post-surgery, 12 and 24 months post-surgery | | | | ID | Title | Description |
|---|
| OG000 | Active Osseointegrated Steady-State Implant System (OSI) | Active Osseointegrated Steady-State Implant System (OSI): 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 |
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| Secondary | 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 | Data were not received for all 20 participants at all time points. | Posted | | Mean | Standard Deviation | hours/day | | 3 or 6 months post-surgery, 12 and 24 months post-surgery | | | | ID | Title | Description |
|---|
| OG000 | Active Osseointegrated Steady-State Implant System (OSI) | Active Osseointegrated Steady-State Implant System (OSI): 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 |
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| Secondary | 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 | Data not received for all 20 participants at 12 and 24 months. | Posted | | Mean | Standard Deviation | Hours | | 3 or 6 months post-surgery, 12 and 24 months post-surgery | | | | ID | Title | Description |
|---|
| OG000 | Active Osseointegrated Steady-State Implant System (OSI) | Active Osseointegrated Steady-State Implant System (OSI): 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 |
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| Secondary | 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 | Data were not received at 24 months for all 20 participants. | Posted | | Count of Participants | | Participants | | 3 or 6 months post-surgery, 12 and 24 months post-surgery | | | | ID | Title | Description |
|---|
| OG000 | Active Osseointegrated Steady-State Implant System (OSI) | Active Osseointegrated Steady-State Implant System (OSI): 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 |
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| Secondary | 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 | Data not received for all 20 participants. | Posted | | Count of Participants | | Participants | | 3 or 6 months post-surgery, 12 and 24 months post-surgery | | | | ID | Title | Description |
|---|
| OG000 | Active Osseointegrated Steady-State Implant System (OSI) | Active Osseointegrated Steady-State Implant System (OSI): 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 |
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| Secondary | 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. | Data were not received for all 20 participants at all time points. | Posted | | Mean | Standard Deviation | units on a scale | | 3 or 6 months post-surgery, 12 and 24 months post-surgery | | | | ID | Title | Description |
|---|
| OG000 | Active Osseointegrated Steady-State Implant System (OSI) | Active Osseointegrated Steady-State Implant System (OSI): 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 |
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| Secondary | 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. | Data were not received for all 20 participants. | Posted | | Mean | Standard Deviation | units on a scale | | 3 or 6 months post-surgery, 12 and 24 months post-surgery | | | | ID | Title | Description |
|---|
| OG000 | Active Osseointegrated Steady-State Implant System (OSI) | Active Osseointegrated Steady-State Implant System (OSI): 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 |
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