Hearing Loss
Conditions
Keywords
Hearing Loss, Conductive, Hearing Loss, Mixed, Deafness, sensorineural single-sided
Brief summary
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.
Interventions
DEVICEActive 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
Sponsors
Statistiska Konsultgruppen
Cochlear
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number and Type of Reported Adverse Events | 6 months post-surgery to 24 months post-surgery | 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 |
| Number and Type of Reported Device Deficiencies | 6 months post-surgery to 24 months post-surgery | The device deficiencies are collected from the participant's last visit in study CBAS5751 (6 months post-surgery) and categorized by relationship |
| Concomitant Medication Used | 6 months post-surgery to 24 months post-surgery | Concomitant medication are collected from the participant's last visit in study CBAS5751 (6 months post-surgery) |
| Socio-economic Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey | 12 months post-surgery | Demographic data (marital status, cohabitation, usual place of residence, education level), employment status, Healthcare utilization and Hearing rehabilitation data are collected |
| 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 | Baseline before surgery, 12 months and 24 months post-surgery | Bone- and air conduction thresholds, masked and unmasked |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 3 or 6 months post-surgery, 12 and 24 months post-surgery | 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. |
| 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 | 3 or 6 months post-surgery, 12 and 24 months post-surgery | 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. |
| Participant Satisfaction With the Investigational Device (Every-day Situation and Self-esteem) Assessed on a Likert Scale | 12 months post-surgery | 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. |
| Participant Satisfaction With the Investigational Device (Easiness to Use) Assessed on a Likert Scale | 12 months post-surgery | 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. |
| Participant Satisfaction With the Investigational Device (Durability of the Device and Sound Quality) Assessed on a Likert Scale | 12 months post-surgery | 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. |
| Participant Satisfaction With the Investigational Device (Overall Satisfaction) With Question Yes/No. | 12 months post-surgery | — |
| 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 | 3 or 6 months post-surgery, 12 and 24 months post-surgery | Sound-field (Pure Tone Average 4, mean of 0.5, 1, 2 and 4 kHz) |
| 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 | 3 or 6 months post-surgery, 12 and 24 months post-surgery | Average hours of daily streaming during the last week before each follow up visit |
| 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 | 3 or 6 months post-surgery, 12 and 24 months post-surgery | Average hours of battery lifetime for a single battery during the last week before each follow up visit |
| 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 | 3 or 6 months post-surgery, 12 and 24 months post-surgery | 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 |
| 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 | 3 or 6 months post-surgery, 12 and 24 months post-surgery | SoftWear pad usage: Yes or No |
| 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 | 3 or 6 months post-surgery, 12 and 24 months post-surgery | Assessed via a Visual Analog Scale (VAS) 100 mm where 0 mm represents insufficient retention and 100 mm excellent retention. |
| 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 | 3 or 6 months post-surgery, 12 and 24 months post-surgery | Assessed via a Visual Analog Scale (VAS) 100 mm where 0 mm represents no comfort at all and 100 mm excellent comfort. |
| 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 | 3 or 6 months post-surgery, 12 and 24 months post-surgery | Average hours of daily use during the last week before each follow up visit |
| 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 | 3 or 6 months post-surgery, 12 and 24 months post-surgery | Sound-field \[0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz\] |
| 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 | 3 or 6 months post-surgery, 12 and 24 months post-surgery | Speech-to-noise ratio, 50% speech understanding |
| 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 | 3 or 6 months post-surgery, 12 and 24 months post-surgery | BC direct (0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0 and 6.0 kHz) |
| 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 | 3 or 6 months post-surgery, 12 and 24 months post-surgery | 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. |
Countries
Australia, Hong Kong
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Active Osseointegrated Steady-State Implant System (OSI) |
|---|---|
| Age, Continuous | 44.9 years STANDARD_DEVIATION 20.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 16 Participants |
| Region of Enrollment Australia | 18 participants |
| Region of Enrollment Hong Kong | 2 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 8 / 20 |
| serious Total, serious adverse events | 4 / 20 |
Outcome results
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
Time frame: Baseline before surgery, 12 months and 24 months post-surgery
Population: 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.
Primary
Concomitant Medication Used
Concomitant medication are collected from the participant's last visit in study CBAS5751 (6 months post-surgery)
Time frame: 6 months post-surgery to 24 months post-surgery
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Active Osseointegrated Steady-State Implant System (OSI) | Concomitant Medication Used | COVID-19 vaccine | 2 Participants |
| Active Osseointegrated Steady-State Implant System (OSI) | Concomitant Medication Used | Sofradex for prevention of moist ear | 1 Participants |
| Active Osseointegrated Steady-State Implant System (OSI) | Concomitant Medication Used | Otodex for sore or itchy ear | 1 Participants |
| Active Osseointegrated Steady-State Implant System (OSI) | Concomitant Medication Used | Soluble aspro clear for bumped head | 1 Participants |
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
Time frame: 6 months post-surgery to 24 months post-surgery
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Active Osseointegrated Steady-State Implant System (OSI) | Number and Type of Reported Adverse Events | Total number of AEs | 44 Number of events |
| Active Osseointegrated Steady-State Implant System (OSI) | Number and Type of Reported Adverse Events | Class congenital, familial and genetic disorders | 1 Number of events |
| Active Osseointegrated Steady-State Implant System (OSI) | Number and Type of Reported Adverse Events | Class ear and labyrinth disorders | 16 Number of events |
| Active Osseointegrated Steady-State Implant System (OSI) | Number and Type of Reported Adverse Events | Class gastrointestinal disorders | 2 Number of events |
| Active Osseointegrated Steady-State Implant System (OSI) | Number and Type of Reported Adverse Events | Class general disorders and administration site conditions | 5 Number of events |
| Active Osseointegrated Steady-State Implant System (OSI) | Number and Type of Reported Adverse Events | Class infections and infestations | 3 Number of events |
| Active Osseointegrated Steady-State Implant System (OSI) | Number and Type of Reported Adverse Events | Class injury, poisoning and procedural complications | 6 Number of events |
| Active Osseointegrated Steady-State Implant System (OSI) | Number and Type of Reported Adverse Events | Class musculoskeletal and connective tissue disorders | 3 Number of events |
| Active Osseointegrated Steady-State Implant System (OSI) | Number and Type of Reported Adverse Events | Class neoplasms benign, malignant and unspecified (incl cysts polyps) | 1 Number of events |
| Active Osseointegrated Steady-State Implant System (OSI) | Number and Type of Reported Adverse Events | Class nervous system disorders | 1 Number of events |
| Active Osseointegrated Steady-State Implant System (OSI) | Number and Type of Reported Adverse Events | Class psychiatric disorders | 3 Number of events |
| Active Osseointegrated Steady-State Implant System (OSI) | Number and Type of Reported Adverse Events | Class skin and subcutaneous tissue disorders | 1 Number of events |
| Active Osseointegrated Steady-State Implant System (OSI) | Number and Type of Reported Adverse Events | Class surgical and medical procedures | 2 Number of events |
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
Time frame: 6 months post-surgery to 24 months post-surgery
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Active Osseointegrated Steady-State Implant System (OSI) | Number and Type of Reported Device Deficiencies | Total number of device deficiencies | 19 Number of events |
| Active Osseointegrated Steady-State Implant System (OSI) | Number and Type of Reported Device Deficiencies | Number of deficiencies related to the sound processor | 19 Number of events |
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
Time frame: 12 months post-surgery
Population: Data related to ear infection and hearing difficulties are reported.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Active Osseointegrated Steady-State Implant System (OSI) | Socio-economic Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey | One or more clinical ENT consultation | 8 Participants |
| Active Osseointegrated Steady-State Implant System (OSI) | Socio-economic Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey | Visit to audiologist due to ear infections or hearing difficulties | 8 Participants |
| Active Osseointegrated Steady-State Implant System (OSI) | 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 | 2 Participants |
| Active Osseointegrated Steady-State Implant System (OSI) | 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 | 0 Participants |
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
Time frame: 24 months post-surgery
Population: Data related to ear infection and hearing difficulties are reported.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Active Osseointegrated Steady-State Implant System (OSI) | Socio-economic Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey | One or more clinical ENT consultation | 7 Participants |
| Active Osseointegrated Steady-State Implant System (OSI) | 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 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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 | 3 Participants |
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
Time frame: 3 or 6 months post-surgery, 12 and 24 months post-surgery
Population: Data not received for all 20 participants at 12 and 24 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Osseointegrated Steady-State Implant System (OSI) | 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 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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
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.
Time frame: 3 or 6 months post-surgery, 12 and 24 months post-surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Osseointegrated Steady-State Implant System (OSI) | 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 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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 0.06 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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 0.08 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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 0.13 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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
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
Time frame: 3 or 6 months post-surgery, 12 and 24 months post-surgery
Population: Data received for 18 participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Osseointegrated Steady-State Implant System (OSI) | 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 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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
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 \[0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz\]
Time frame: 3 or 6 months post-surgery, 12 and 24 months post-surgery
Population: Data were received for 18 participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Osseointegrated Steady-State Implant System (OSI) | 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 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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 | 3.89 dB (decibel) | Standard Deviation 7.78 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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 | 2.78 dB (decibel) | Standard Deviation 6.69 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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 |
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)
Time frame: 3 or 6 months post-surgery, 12 and 24 months post-surgery
Population: 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.
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)
Time frame: 3 or 6 months post-surgery, 12 and 24 months post-surgery
Population: Data received for 18 participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Osseointegrated Steady-State Implant System (OSI) | 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 5.1 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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 |
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.
Time frame: 3 or 6 months post-surgery, 12 and 24 months post-surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Osseointegrated Steady-State Implant System (OSI) | 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 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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
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
Time frame: 3 or 6 months post-surgery, 12 and 24 months post-surgery
Population: Data were not received for all 20 participants at all time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Osseointegrated Steady-State Implant System (OSI) | 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 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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
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
Time frame: 3 or 6 months post-surgery, 12 and 24 months post-surgery
Population: Data not collected for all 20 participants at all time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Osseointegrated Steady-State Implant System (OSI) | 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 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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 3.9 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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
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.
Time frame: 3 or 6 months post-surgery, 12 and 24 months post-surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Osseointegrated Steady-State Implant System (OSI) | 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 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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
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
Time frame: 3 or 6 months post-surgery, 12 and 24 months post-surgery
Population: Data were not received at 24 months for all 20 participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Active Osseointegrated Steady-State Implant System (OSI) | 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 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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
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.
Time frame: 12 months post-surgery
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Active Osseointegrated Steady-State Implant System (OSI) | Participant Satisfaction With the Investigational Device (Durability of the Device and Sound Quality) Assessed on a Likert Scale | Durability-satisfied | 9 Participants |
| Active Osseointegrated Steady-State Implant System (OSI) | Participant Satisfaction With the Investigational Device (Durability of the Device and Sound Quality) Assessed on a Likert Scale | Durability-very satisfied | 9 Participants |
| Active Osseointegrated Steady-State Implant System (OSI) | Participant Satisfaction With the Investigational Device (Durability of the Device and Sound Quality) Assessed on a Likert Scale | Sound quality-neutral | 1 Participants |
| Active Osseointegrated Steady-State Implant System (OSI) | Participant Satisfaction With the Investigational Device (Durability of the Device and Sound Quality) Assessed on a Likert Scale | Sound quality-satisfied | 7 Participants |
| Active Osseointegrated Steady-State Implant System (OSI) | Participant Satisfaction With the Investigational Device (Durability of the Device and Sound Quality) Assessed on a Likert Scale | Sound quality-very satisfied | 11 Participants |
| Active Osseointegrated Steady-State Implant System (OSI) | Participant Satisfaction With the Investigational Device (Durability of the Device and Sound Quality) Assessed on a Likert Scale | Durability-neutral | 1 Participants |
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.
Time frame: 24 months post-surgery
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Active Osseointegrated Steady-State Implant System (OSI) | Participant Satisfaction With the Investigational Device (Durability of the Device and Sound Quality) Assessed on a Likert Scale | Durability-satisfied | 6 Participants |
| Active Osseointegrated Steady-State Implant System (OSI) | Participant Satisfaction With the Investigational Device (Durability of the Device and Sound Quality) Assessed on a Likert Scale | Durability-very satisfied | 13 Participants |
| Active Osseointegrated Steady-State Implant System (OSI) | Participant Satisfaction With the Investigational Device (Durability of the Device and Sound Quality) Assessed on a Likert Scale | Sound quality-satisfied | 8 Participants |
| Active Osseointegrated Steady-State Implant System (OSI) | Participant Satisfaction With the Investigational Device (Durability of the Device and Sound Quality) Assessed on a Likert Scale | Sound quality-very satisfied | 10 Participants |
| Active Osseointegrated Steady-State Implant System (OSI) | 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
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.
Time frame: 12 months post-surgery
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Active Osseointegrated Steady-State Implant System (OSI) | Participant Satisfaction With the Investigational Device (Easiness to Use) Assessed on a Likert Scale | Very easy | 16 Participants |
| Active Osseointegrated Steady-State Implant System (OSI) | Participant Satisfaction With the Investigational Device (Easiness to Use) Assessed on a Likert Scale | Somewhat easy | 3 Participants |
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.
Time frame: 24 months post-surgery
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Active Osseointegrated Steady-State Implant System (OSI) | Participant Satisfaction With the Investigational Device (Easiness to Use) Assessed on a Likert Scale | Very easy | 15 Participants |
| Active Osseointegrated Steady-State Implant System (OSI) | Participant Satisfaction With the Investigational Device (Easiness to Use) Assessed on a Likert Scale | Somewhat easy | 3 Participants |
| Active Osseointegrated Steady-State Implant System (OSI) | Participant Satisfaction With the Investigational Device (Easiness to Use) Assessed on a Likert Scale | Neither difficult or easy | 1 Participants |
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.
Time frame: 12 months post-surgery
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Active Osseointegrated Steady-State Implant System (OSI) | Participant Satisfaction With the Investigational Device (Every-day Situation and Self-esteem) Assessed on a Likert Scale | Everyday situation-no change | 1 Participants |
| Active Osseointegrated Steady-State Implant System (OSI) | Participant Satisfaction With the Investigational Device (Every-day Situation and Self-esteem) Assessed on a Likert Scale | Everyday situation-a little better | 2 Participants |
| Active Osseointegrated Steady-State Implant System (OSI) | Participant Satisfaction With the Investigational Device (Every-day Situation and Self-esteem) Assessed on a Likert Scale | Everyday situation-somewhat better | 3 Participants |
| Active Osseointegrated Steady-State Implant System (OSI) | Participant Satisfaction With the Investigational Device (Every-day Situation and Self-esteem) Assessed on a Likert Scale | Everyday situation-much better | 13 Participants |
| Active Osseointegrated Steady-State Implant System (OSI) | Participant Satisfaction With the Investigational Device (Every-day Situation and Self-esteem) Assessed on a Likert Scale | Self-esteem-no change | 3 Participants |
| Active Osseointegrated Steady-State Implant System (OSI) | Participant Satisfaction With the Investigational Device (Every-day Situation and Self-esteem) Assessed on a Likert Scale | Self-esteem-a little better | 3 Participants |
| Active Osseointegrated Steady-State Implant System (OSI) | Participant Satisfaction With the Investigational Device (Every-day Situation and Self-esteem) Assessed on a Likert Scale | Self-esteem-somewhat better | 7 Participants |
| Active Osseointegrated Steady-State Implant System (OSI) | Participant Satisfaction With the Investigational Device (Every-day Situation and Self-esteem) Assessed on a Likert Scale | Self-esteem-much better | 6 Participants |
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.
Time frame: 24 months post-surgery
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Active Osseointegrated Steady-State Implant System (OSI) | Participant Satisfaction With the Investigational Device (Every-day Situation and Self-esteem) Assessed on a Likert Scale | Every day situation-somewhat better | 3 Participants |
| Active Osseointegrated Steady-State Implant System (OSI) | Participant Satisfaction With the Investigational Device (Every-day Situation and Self-esteem) Assessed on a Likert Scale | Every day situation-much better | 12 Participants |
| Active Osseointegrated Steady-State Implant System (OSI) | Participant Satisfaction With the Investigational Device (Every-day Situation and Self-esteem) Assessed on a Likert Scale | Self-esteem-no change | 2 Participants |
| Active Osseointegrated Steady-State Implant System (OSI) | Participant Satisfaction With the Investigational Device (Every-day Situation and Self-esteem) Assessed on a Likert Scale | self-esteem-a little better | 5 Participants |
| Active Osseointegrated Steady-State Implant System (OSI) | Participant Satisfaction With the Investigational Device (Every-day Situation and Self-esteem) Assessed on a Likert Scale | self-esteem-somewhat better | 5 Participants |
| Active Osseointegrated Steady-State Implant System (OSI) | Participant Satisfaction With the Investigational Device (Every-day Situation and Self-esteem) Assessed on a Likert Scale | self-esteem-much better | 7 Participants |
| Active Osseointegrated Steady-State Implant System (OSI) | Participant Satisfaction With the Investigational Device (Every-day Situation and Self-esteem) Assessed on a Likert Scale | Every day situation-no change | 0 Participants |
| Active Osseointegrated Steady-State Implant System (OSI) | 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 |
Secondary
Participant Satisfaction With the Investigational Device (Overall Satisfaction) With Question Yes/No.
Time frame: 12 months post-surgery
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Active Osseointegrated Steady-State Implant System (OSI) | Participant Satisfaction With the Investigational Device (Overall Satisfaction) With Question Yes/No. | Yes | 19 Participants |
| Active Osseointegrated Steady-State Implant System (OSI) | Participant Satisfaction With the Investigational Device (Overall Satisfaction) With Question Yes/No. | No | 0 Participants |
Secondary
Participant Satisfaction With the Investigational Device (Overall Satisfaction) With Question Yes/No.
Time frame: 24 months post-surgery
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Active Osseointegrated Steady-State Implant System (OSI) | Participant Satisfaction With the Investigational Device (Overall Satisfaction) With Question Yes/No. | Yes | 18 Participants |
| Active Osseointegrated Steady-State Implant System (OSI) | Participant Satisfaction With the Investigational Device (Overall Satisfaction) With Question Yes/No. | No | 1 Participants |
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.
Time frame: 3 or 6 months post-surgery, 12 and 24 months post-surgery
Population: Data were not received for all 20 participants at all time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Osseointegrated Steady-State Implant System (OSI) | 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 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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 |
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
Time frame: 3 or 6 months post-surgery, 12 and 24 months post-surgery
Population: Data not received for all 20 participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Active Osseointegrated Steady-State Implant System (OSI) | 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 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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
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.
Time frame: 3 or 6 months post-surgery, 12 and 24 months post-surgery
Population: Data were not received for all 20 participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Osseointegrated Steady-State Implant System (OSI) | 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 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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 |
| Active Osseointegrated Steady-State Implant System (OSI) | 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 |