Trial Outcomes & Findings for Long Term Clinical Investigation to Evaluate Clinical Performance, Safety and Patient Reported Outcomes of an Active Osseointegrated Steady-State Implant System (NCT NCT04754477)
NCT ID: NCT04754477
Last Updated: 2024-06-10
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
6 months post-surgery to 24 months post-surgery
Results posted on
2024-06-10
Participant Flow
Participant milestones
| Measure |
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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|---|---|
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Overall Study
STARTED
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20
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Overall Study
COMPLETED
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19
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Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
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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|---|---|
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Overall Study
Withdrawal by Subject
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1
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Baseline Characteristics
Long Term Clinical Investigation to Evaluate Clinical Performance, Safety and Patient Reported Outcomes of an Active Osseointegrated Steady-State Implant System
Baseline characteristics by cohort
| Measure |
Active Osseointegrated Steady-State Implant System (OSI)
n=20 Participants
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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|---|---|
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Age, Continuous
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44.9 years
STANDARD_DEVIATION 20.8 • n=93 Participants
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Sex: Female, Male
Female
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11 Participants
n=93 Participants
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Sex: Female, Male
Male
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9 Participants
n=93 Participants
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|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=93 Participants
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Race (NIH/OMB)
Asian
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2 Participants
n=93 Participants
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|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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1 Participants
n=93 Participants
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|
Race (NIH/OMB)
Black or African American
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0 Participants
n=93 Participants
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Race (NIH/OMB)
White
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16 Participants
n=93 Participants
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|
Race (NIH/OMB)
More than one race
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0 Participants
n=93 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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1 Participants
n=93 Participants
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Region of Enrollment
Hong Kong
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2 participants
n=93 Participants
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Region of Enrollment
Australia
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18 participants
n=93 Participants
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PRIMARY outcome
Timeframe: 6 months post-surgery to 24 months post-surgeryThe adverse events are collected from the participant's last visit in study CBAS5751 (6 months post-surgery) and categorized by system organ class system
Outcome measures
| Measure |
Active Osseointegrated Steady-State Implant System (OSI)
n=20 Participants
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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|---|---|
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Number and Type of Reported Adverse Events
Total number of AEs
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44 Number of events
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Number and Type of Reported Adverse Events
Class congenital, familial and genetic disorders
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1 Number of events
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Number and Type of Reported Adverse Events
Class ear and labyrinth disorders
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16 Number of events
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Number and Type of Reported Adverse Events
Class gastrointestinal disorders
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2 Number of events
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Number and Type of Reported Adverse Events
Class general disorders and administration site conditions
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5 Number of events
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Number and Type of Reported Adverse Events
Class infections and infestations
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3 Number of events
|
|
Number and Type of Reported Adverse Events
Class injury, poisoning and procedural complications
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6 Number of events
|
|
Number and Type of Reported Adverse Events
Class musculoskeletal and connective tissue disorders
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3 Number of events
|
|
Number and Type of Reported Adverse Events
Class neoplasms benign, malignant and unspecified (incl cysts polyps)
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1 Number of events
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Number and Type of Reported Adverse Events
Class nervous system disorders
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1 Number of events
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Number and Type of Reported Adverse Events
Class psychiatric disorders
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3 Number of events
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Number and Type of Reported Adverse Events
Class skin and subcutaneous tissue disorders
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1 Number of events
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Number and Type of Reported Adverse Events
Class surgical and medical procedures
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2 Number of events
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PRIMARY outcome
Timeframe: 6 months post-surgery to 24 months post-surgeryThe device deficiencies are collected from the participant's last visit in study CBAS5751 (6 months post-surgery) and categorized by relationship
Outcome measures
| Measure |
Active Osseointegrated Steady-State Implant System (OSI)
n=20 Participants
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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Number and Type of Reported Device Deficiencies
Total number of device deficiencies
|
19 Number of events
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Number and Type of Reported Device Deficiencies
Number of deficiencies related to the sound processor
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19 Number of events
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PRIMARY outcome
Timeframe: 6 months post-surgery to 24 months post-surgeryConcomitant medication are collected from the participant's last visit in study CBAS5751 (6 months post-surgery)
Outcome measures
| Measure |
Active Osseointegrated Steady-State Implant System (OSI)
n=19 Participants
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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|---|---|
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Concomitant Medication Used
COVID-19 vaccine
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2 Participants
|
|
Concomitant Medication Used
Sofradex for prevention of moist ear
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1 Participants
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Concomitant Medication Used
Otodex for sore or itchy ear
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1 Participants
|
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Concomitant Medication Used
Soluble aspro clear for bumped head
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1 Participants
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PRIMARY outcome
Timeframe: 12 months post-surgeryPopulation: Data related to ear infection and hearing difficulties are reported.
Demographic data (marital status, cohabitation, usual place of residence, education level), employment status, Healthcare utilization and Hearing rehabilitation data are collected
Outcome measures
| Measure |
Active Osseointegrated Steady-State Implant System (OSI)
n=19 Participants
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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Socio-economic Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
One or more clinical ENT consultation
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8 Participants
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Socio-economic Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
Visit to audiologist due to ear infections or hearing difficulties
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8 Participants
|
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Socio-economic Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
One or more diagnostic tests because of ear infections or hearing difficulties
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2 Participants
|
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Socio-economic Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
Stopped, reduced or missed work as a consequence of ear infection and/or hearing difficulties
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0 Participants
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PRIMARY outcome
Timeframe: 24 months post-surgeryPopulation: Data related to ear infection and hearing difficulties are reported.
Demographic data (marital status, cohabitation, usual place of residence, education level), employment status, Healthcare utilization and Hearing rehabilitation data are collected
Outcome measures
| Measure |
Active Osseointegrated Steady-State Implant System (OSI)
n=19 Participants
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
|
|---|---|
|
Socio-economic Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
One or more clinical ENT consultation
|
7 Participants
|
|
Socio-economic Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
Visit to audiologist due to ear infections or hearing difficulties
|
4 Participants
|
|
Socio-economic Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
One or more diagnostic tests because of ear infections or hearing difficulties
|
1 Participants
|
|
Socio-economic Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey
Stopped, reduced or missed work as a consequence of ear infection and/or hearing difficulties
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3 Participants
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PRIMARY outcome
Timeframe: Baseline before surgery, 12 months and 24 months post-surgeryPopulation: 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.
Bone- and air conduction thresholds, masked and unmasked
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 or 6 months post-surgery, 12 and 24 months post-surgeryPopulation: Data received for 18 participants.
Sound-field (Pure Tone Average 4, mean of 0.5, 1, 2 and 4 kHz)
Outcome measures
| Measure |
Active Osseointegrated Steady-State Implant System (OSI)
n=18 Participants
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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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
From 6 months to 12 months
|
2.22 dB (decibel)
Standard Deviation 5.10
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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
From 6 months to 24 months
|
3.68 dB (decibel)
Standard Deviation 5.15
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SECONDARY outcome
Timeframe: 3 or 6 months post-surgery, 12 and 24 months post-surgeryPopulation: Data were received for 18 participants.
Sound-field \[0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz\]
Outcome measures
| Measure |
Active Osseointegrated Steady-State Implant System (OSI)
n=18 Participants
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
|
|---|---|
|
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
Change from 6 months to 12 months-250 Hz
|
3.33 dB (decibel)
Standard Deviation 8.22
|
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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
Change from 6 months to 12 months-500 Hz
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3.89 dB (decibel)
Standard Deviation 7.78
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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
Change from 6 months to 12 months-750 Hz
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2.78 dB (decibel)
Standard Deviation 6.69
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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
Change from 6 months to 12 months-1000 Hz
|
1.67 dB (decibel)
Standard Deviation 7.28
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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
Change from 6 months to 12 months-1500 Hz
|
3.89 dB (decibel)
Standard Deviation 6.54
|
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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
Change from 6 months to 12 months-2000 Hz
|
0.278 dB (decibel)
Standard Deviation 5.278
|
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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
Change from 6 months to 12 months-3000 Hz
|
1.94 dB (decibel)
Standard Deviation 6.67
|
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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
Change from 6 months to 12 months-4000 Hz
|
3.06 dB (decibel)
Standard Deviation 5.98
|
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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
Change from 6 months to 12 months-6000 Hz
|
3.61 dB (decibel)
Standard Deviation 6.82
|
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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
Change from 6 months to 12 months-8000 Hz
|
3.61 dB (decibel)
Standard Deviation 14.33
|
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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
Change from 6 months to 24 months-250 Hz
|
4.17 dB (decibel)
Standard Deviation 11.79
|
|
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
Change from 6 months to 24 months-500 Hz
|
3.89 dB (decibel)
Standard Deviation 6.54
|
|
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
Change from 6 months to 24 months-750 Hz
|
3.61 dB (decibel)
Standard Deviation 4.47
|
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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
Change from 6 months to 24 months-1000 Hz
|
3.89 dB (decibel)
Standard Deviation 7.96
|
|
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
Change from 6 months to 24 months-1500 Hz
|
5.28 dB (decibel)
Standard Deviation 7.37
|
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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
Change from 6 months to 24 months-2000 Hz
|
2.50 dB (decibel)
Standard Deviation 5.49
|
|
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
Change from 6 months to 24 months-3000 Hz
|
2.78 dB (decibel)
Standard Deviation 7.32
|
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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
Change from 6 months to 24 months-4000 Hz
|
4.44 dB (decibel)
Standard Deviation 7.05
|
|
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
Change from 6 months to 24 months-6000 Hz
|
1.67 dB (decibel)
Standard Deviation 7.07
|
|
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
Change from 6 months to 24 months-8000 Hz
|
5.00 dB (decibel)
Standard Deviation 11.88
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SECONDARY outcome
Timeframe: 3 or 6 months post-surgery, 12 and 24 months post-surgeryPopulation: Data received for 18 participants.
Speech-to-noise ratio, 50% speech understanding
Outcome measures
| Measure |
Active Osseointegrated Steady-State Implant System (OSI)
n=18 Participants
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
|
|---|---|
|
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
Change from 6 months to 12 months
|
-0.106 db SNR (decibel Speech to Noise Ratio)
Standard Deviation 2.726
|
|
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
Change from 6 months to 24 months
|
-0.244 db SNR (decibel Speech to Noise Ratio)
Standard Deviation 0.913
|
SECONDARY outcome
Timeframe: 3 or 6 months post-surgery, 12 and 24 months post-surgeryPopulation: 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.
BC direct (0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0 and 6.0 kHz)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 or 6 months post-surgery, 12 and 24 months post-surgeryAssessed 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.
Outcome measures
| Measure |
Active Osseointegrated Steady-State Implant System (OSI)
n=19 Participants
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
|
|---|---|
|
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
From 6 months to 12 months
|
-0.067 units on a scale
Standard Deviation 7.376
|
|
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
From 6 months to 24 months
|
-0.626 units on a scale
Standard Deviation 9.533
|
SECONDARY outcome
Timeframe: 3 or 6 months post-surgery, 12 and 24 months post-surgeryAssessed 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.
Outcome measures
| Measure |
Active Osseointegrated Steady-State Implant System (OSI)
n=19 Participants
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
|
|---|---|
|
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
Change from 6 months to 12 months
|
0.227 score on a scale
Standard Deviation 0.834
|
|
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
Change from 6 months to 24 months
|
-0.155 score on a scale
Standard Deviation 1.389
|
SECONDARY outcome
Timeframe: 3 or 6 months post-surgery, 12 and 24 months post-surgeryAssessed 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.
Outcome measures
| Measure |
Active Osseointegrated Steady-State Implant System (OSI)
n=19 Participants
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
|
|---|---|
|
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
Change in comprehensive health status form 6 months to 24 months
|
-0.045 score on a scale
Standard Deviation 0.151
|
|
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
Change in comprehensive health status from 6 months to 12 months
|
0.006 score on a scale
Standard Deviation 0.115
|
|
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
Change in vision attribute from 6 months to 12 months
|
-0.014 score on a scale
Standard Deviation 0.085
|
|
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
Change in hearing attribute from 6 months to 12 months
|
0.024 score on a scale
Standard Deviation 0.130
|
|
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
Change in speech attribute form 6 months to 12 months
|
0.008 score on a scale
Standard Deviation 0.069
|
|
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
Change in ambulation attribute from 6 months to 12 months
|
-0.009 score on a scale
Standard Deviation 0.039
|
|
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
Change in dexterity attribute from 6 months to 12 months
|
0.000 score on a scale
Standard Deviation 0.000
|
|
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
Change in emotion attribute form 6 months to 12 months
|
-0.009 score on a scale
Standard Deviation 0.666
|
|
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
Change in cognition attribute from 6 months to 12 months
|
-0.003 score on a scale
Standard Deviation 0.060
|
|
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
Change in pain attribute from 6 months to 12 months
|
0.015 score on a scale
Standard Deviation 0.146
|
|
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
Change in vision attribute from 6 months to 24 months
|
-0.016 score on a scale
Standard Deviation 0.086
|
|
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
Change in hearing attribute from 6 months to 24 months
|
0.003 score on a scale
Standard Deviation 0.139
|
|
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
Change in speech attribute from 6 months to 24 months
|
0.017 score on a scale
Standard Deviation 0.080
|
|
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
Change in ambulation attribute from 6 months to 24 months
|
-0.060 score on a scale
Standard Deviation 0.163
|
|
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
Change in dexterity attribute from 6 months to 24 months
|
-0.014 score on a scale
Standard Deviation 0.062
|
|
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
Change in emotion attribute from 6 months to 24 months
|
-0.005 score on a scale
Standard Deviation 0.056
|
|
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
Change in cognition attribute from 6 months to 24 months
|
-0.012 score on a scale
Standard Deviation 0.036
|
|
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
Change in pain attribute from 6 months to 24 months
|
-0.001 score on a scale
Standard Deviation 0.161
|
SECONDARY outcome
Timeframe: 12 months post-surgeryTo 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.
Outcome measures
| Measure |
Active Osseointegrated Steady-State Implant System (OSI)
n=19 Participants
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
|
|---|---|
|
Participant Satisfaction With the Investigational Device (Every-day Situation and Self-esteem) Assessed on a Likert Scale
Everyday situation-no change
|
1 Participants
|
|
Participant Satisfaction With the Investigational Device (Every-day Situation and Self-esteem) Assessed on a Likert Scale
Everyday situation-a little better
|
2 Participants
|
|
Participant Satisfaction With the Investigational Device (Every-day Situation and Self-esteem) Assessed on a Likert Scale
Everyday situation-somewhat better
|
3 Participants
|
|
Participant Satisfaction With the Investigational Device (Every-day Situation and Self-esteem) Assessed on a Likert Scale
Everyday situation-much better
|
13 Participants
|
|
Participant Satisfaction With the Investigational Device (Every-day Situation and Self-esteem) Assessed on a Likert Scale
Self-esteem-no change
|
3 Participants
|
|
Participant Satisfaction With the Investigational Device (Every-day Situation and Self-esteem) Assessed on a Likert Scale
Self-esteem-a little better
|
3 Participants
|
|
Participant Satisfaction With the Investigational Device (Every-day Situation and Self-esteem) Assessed on a Likert Scale
Self-esteem-somewhat better
|
7 Participants
|
|
Participant Satisfaction With the Investigational Device (Every-day Situation and Self-esteem) Assessed on a Likert Scale
Self-esteem-much better
|
6 Participants
|
SECONDARY outcome
Timeframe: 12 months post-surgeryTo 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.
Outcome measures
| Measure |
Active Osseointegrated Steady-State Implant System (OSI)
n=19 Participants
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
|
|---|---|
|
Participant Satisfaction With the Investigational Device (Easiness to Use) Assessed on a Likert Scale
Very easy
|
16 Participants
|
|
Participant Satisfaction With the Investigational Device (Easiness to Use) Assessed on a Likert Scale
Somewhat easy
|
3 Participants
|
SECONDARY outcome
Timeframe: 12 months post-surgeryTo 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.
Outcome measures
| Measure |
Active Osseointegrated Steady-State Implant System (OSI)
n=19 Participants
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
|
|---|---|
|
Participant Satisfaction With the Investigational Device (Durability of the Device and Sound Quality) Assessed on a Likert Scale
Durability-neutral
|
1 Participants
|
|
Participant Satisfaction With the Investigational Device (Durability of the Device and Sound Quality) Assessed on a Likert Scale
Durability-satisfied
|
9 Participants
|
|
Participant Satisfaction With the Investigational Device (Durability of the Device and Sound Quality) Assessed on a Likert Scale
Durability-very satisfied
|
9 Participants
|
|
Participant Satisfaction With the Investigational Device (Durability of the Device and Sound Quality) Assessed on a Likert Scale
Sound quality-neutral
|
1 Participants
|
|
Participant Satisfaction With the Investigational Device (Durability of the Device and Sound Quality) Assessed on a Likert Scale
Sound quality-satisfied
|
7 Participants
|
|
Participant Satisfaction With the Investigational Device (Durability of the Device and Sound Quality) Assessed on a Likert Scale
Sound quality-very satisfied
|
11 Participants
|
SECONDARY outcome
Timeframe: 12 months post-surgeryOutcome measures
| Measure |
Active Osseointegrated Steady-State Implant System (OSI)
n=19 Participants
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
|
|---|---|
|
Participant Satisfaction With the Investigational Device (Overall Satisfaction) With Question Yes/No.
Yes
|
19 Participants
|
|
Participant Satisfaction With the Investigational Device (Overall Satisfaction) With Question Yes/No.
No
|
0 Participants
|
SECONDARY outcome
Timeframe: 24 months post-surgeryTo 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.
Outcome measures
| Measure |
Active Osseointegrated Steady-State Implant System (OSI)
n=19 Participants
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
|
|---|---|
|
Participant Satisfaction With the Investigational Device (Every-day Situation and Self-esteem) Assessed on a Likert Scale
Every day situation-no change
|
0 Participants
|
|
Participant Satisfaction With the Investigational Device (Every-day Situation and Self-esteem) Assessed on a Likert Scale
Every day situation-a little better
|
4 Participants
|
|
Participant Satisfaction With the Investigational Device (Every-day Situation and Self-esteem) Assessed on a Likert Scale
Every day situation-somewhat better
|
3 Participants
|
|
Participant Satisfaction With the Investigational Device (Every-day Situation and Self-esteem) Assessed on a Likert Scale
Every day situation-much better
|
12 Participants
|
|
Participant Satisfaction With the Investigational Device (Every-day Situation and Self-esteem) Assessed on a Likert Scale
Self-esteem-no change
|
2 Participants
|
|
Participant Satisfaction With the Investigational Device (Every-day Situation and Self-esteem) Assessed on a Likert Scale
self-esteem-a little better
|
5 Participants
|
|
Participant Satisfaction With the Investigational Device (Every-day Situation and Self-esteem) Assessed on a Likert Scale
self-esteem-somewhat better
|
5 Participants
|
|
Participant Satisfaction With the Investigational Device (Every-day Situation and Self-esteem) Assessed on a Likert Scale
self-esteem-much better
|
7 Participants
|
SECONDARY outcome
Timeframe: 24 months post-surgeryTo 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.
Outcome measures
| Measure |
Active Osseointegrated Steady-State Implant System (OSI)
n=19 Participants
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
|
|---|---|
|
Participant Satisfaction With the Investigational Device (Easiness to Use) Assessed on a Likert Scale
Very easy
|
15 Participants
|
|
Participant Satisfaction With the Investigational Device (Easiness to Use) Assessed on a Likert Scale
Somewhat easy
|
3 Participants
|
|
Participant Satisfaction With the Investigational Device (Easiness to Use) Assessed on a Likert Scale
Neither difficult or easy
|
1 Participants
|
SECONDARY outcome
Timeframe: 24 months post-surgeryTo 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.
Outcome measures
| Measure |
Active Osseointegrated Steady-State Implant System (OSI)
n=19 Participants
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
|
|---|---|
|
Participant Satisfaction With the Investigational Device (Durability of the Device and Sound Quality) Assessed on a Likert Scale
Durability-satisfied
|
6 Participants
|
|
Participant Satisfaction With the Investigational Device (Durability of the Device and Sound Quality) Assessed on a Likert Scale
Durability-very satisfied
|
13 Participants
|
|
Participant Satisfaction With the Investigational Device (Durability of the Device and Sound Quality) Assessed on a Likert Scale
Sound quality-satisfied
|
8 Participants
|
|
Participant Satisfaction With the Investigational Device (Durability of the Device and Sound Quality) Assessed on a Likert Scale
Sound quality-very satisfied
|
10 Participants
|
|
Participant Satisfaction With the Investigational Device (Durability of the Device and Sound Quality) Assessed on a Likert Scale
Sound quality-very dissatisfied
|
1 Participants
|
SECONDARY outcome
Timeframe: 24 months post-surgeryOutcome measures
| Measure |
Active Osseointegrated Steady-State Implant System (OSI)
n=19 Participants
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
|
|---|---|
|
Participant Satisfaction With the Investigational Device (Overall Satisfaction) With Question Yes/No.
No
|
1 Participants
|
|
Participant Satisfaction With the Investigational Device (Overall Satisfaction) With Question Yes/No.
Yes
|
18 Participants
|
SECONDARY outcome
Timeframe: 3 or 6 months post-surgery, 12 and 24 months post-surgeryPopulation: Data not collected for all 20 participants at all time points.
Average hours of daily use during the last week before each follow up visit
Outcome measures
| Measure |
Active Osseointegrated Steady-State Implant System (OSI)
n=20 Participants
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
|
|---|---|
|
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
At 6 months
|
8.25 hours/day
Standard Deviation 4.63
|
|
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
At 12 months
|
8.74 hours/day
Standard Deviation 3.90
|
|
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
At 24 months
|
8.47 hours/day
Standard Deviation 5.15
|
SECONDARY outcome
Timeframe: 3 or 6 months post-surgery, 12 and 24 months post-surgeryPopulation: Data were not received for all 20 participants at all time points.
Average hours of daily streaming during the last week before each follow up visit
Outcome measures
| Measure |
Active Osseointegrated Steady-State Implant System (OSI)
n=20 Participants
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
|
|---|---|
|
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
At 6 months
|
0.400 hours/day
Standard Deviation 0.681
|
|
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
At 12 months
|
1.16 hours/day
Standard Deviation 2.36
|
|
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
At 24 months
|
0.789 hours/day
Standard Deviation 1.437
|
SECONDARY outcome
Timeframe: 3 or 6 months post-surgery, 12 and 24 months post-surgeryPopulation: Data not received for all 20 participants at 12 and 24 months.
Average hours of battery lifetime for a single battery during the last week before each follow up visit
Outcome measures
| Measure |
Active Osseointegrated Steady-State Implant System (OSI)
n=20 Participants
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
|
|---|---|
|
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
At 6 months
|
24.7 Hours
Standard Deviation 12.9
|
|
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
At 12 months
|
24.4 Hours
Standard Deviation 10.3
|
|
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
At 24 months
|
23.3 Hours
Standard Deviation 9.2
|
SECONDARY outcome
Timeframe: 3 or 6 months post-surgery, 12 and 24 months post-surgeryPopulation: Data were not received at 24 months for all 20 participants.
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
Outcome measures
| Measure |
Active Osseointegrated Steady-State Implant System (OSI)
n=20 Participants
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
|
|---|---|
|
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
At 6 months- strength 4
|
9 Participants
|
|
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
At 6 months- strength 3
|
9 Participants
|
|
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
At 6 months- strength 2
|
2 Participants
|
|
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
At 12 months- strength 4
|
8 Participants
|
|
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
At 12 months- strength 3
|
10 Participants
|
|
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
At 12 months- strength 2
|
2 Participants
|
|
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
At 24 months- strength 4
|
8 Participants
|
|
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
At 24 months- strength 3
|
8 Participants
|
|
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
At 24 months- strength 2
|
3 Participants
|
SECONDARY outcome
Timeframe: 3 or 6 months post-surgery, 12 and 24 months post-surgeryPopulation: Data not received for all 20 participants.
SoftWear pad usage: Yes or No
Outcome measures
| Measure |
Active Osseointegrated Steady-State Implant System (OSI)
n=20 Participants
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
|
|---|---|
|
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
At 6 months-Yes
|
0 Participants
|
|
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
At 6 months-No
|
20 Participants
|
|
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
At 12 months-Yes
|
1 Participants
|
|
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
At 12 months-No
|
18 Participants
|
|
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
At 24 months-Yes
|
1 Participants
|
|
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
At 24 months-No
|
18 Participants
|
SECONDARY outcome
Timeframe: 3 or 6 months post-surgery, 12 and 24 months post-surgeryPopulation: Data were not received for all 20 participants at all time points.
Assessed via a Visual Analog Scale (VAS) 100 mm where 0 mm represents insufficient retention and 100 mm excellent retention.
Outcome measures
| Measure |
Active Osseointegrated Steady-State Implant System (OSI)
n=20 Participants
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
|
|---|---|
|
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
At 6 months
|
75.7 units on a scale
Standard Deviation 21.9
|
|
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
At 12 months
|
83.3 units on a scale
Standard Deviation 14.2
|
|
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
At 24 months
|
82.8 units on a scale
Standard Deviation 15.0
|
SECONDARY outcome
Timeframe: 3 or 6 months post-surgery, 12 and 24 months post-surgeryPopulation: Data were not received for all 20 participants.
Assessed via a Visual Analog Scale (VAS) 100 mm where 0 mm represents no comfort at all and 100 mm excellent comfort.
Outcome measures
| Measure |
Active Osseointegrated Steady-State Implant System (OSI)
n=20 Participants
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
|
|---|---|
|
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
At 6 months
|
86.7 units on a scale
Standard Deviation 12.4
|
|
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
At 12 months
|
88.2 units on a scale
Standard Deviation 11.0
|
|
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
At 24 months
|
87.8 units on a scale
Standard Deviation 10.3
|
Adverse Events
Active Osseointegrated Steady-State Implant System (OSI)
Serious events: 4 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Active Osseointegrated Steady-State Implant System (OSI)
n=20 participants at risk
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
|
|---|---|
|
Infections and infestations
Hospitalisation due to unexplained fever
|
5.0%
1/20 • Number of events 1 • 12 months
|
|
Infections and infestations
Hospitalisation for marsupialisation of Bartholin's abscess
|
5.0%
1/20 • Number of events 1 • 12 months
|
|
Congenital, familial and genetic disorders
Hospitalisation for bowel surgery for treatment of Hirschsprung's disease
|
5.0%
1/20 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Hospitalisation for ankle surgery
|
5.0%
1/20 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Hospitalisation for hip replacement
|
5.0%
1/20 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Hospitalisation for surgery to close ileostomy
|
5.0%
1/20 • Number of events 1 • 12 months
|
Other adverse events
| Measure |
Active Osseointegrated Steady-State Implant System (OSI)
n=20 participants at risk
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
|
|---|---|
|
Ear and labyrinth disorders
Ear infection
|
20.0%
4/20 • Number of events 8 • 12 months
|
|
Ear and labyrinth disorders
Ear pain
|
10.0%
2/20 • Number of events 4 • 12 months
|
|
Injury, poisoning and procedural complications
Bumped head
|
10.0%
2/20 • Number of events 2 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place