N/A
N=20
Long Term Clinical Investigation to Evaluate Clinical Performance, Safety and Patient Reported Outcomes of an Active Osseointegrated Steady-State Implant System
Hearing Loss
Bottom Line
View on ClinicalTrials.gov: NCT04754477 ↗Enrolled (actual)
20
Serious AEs
20.0%
Results posted
Jun 2024
Primary outcome: Primary: Number and Type of Reported Adverse Events — 44; 1; 16; 2 Number of events
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Active Osseointegrated Steady-State Implant System (OSI) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cochlear
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number and Type of Reported Adverse Events |
44; 1; 16; 2; 5; 3 | — |
| PRIMARY Number and Type of Reported Device Deficiencies |
19; 19 | — |
| PRIMARY Concomitant Medication Used |
2; 1; 1; 1 | — |
| PRIMARY Socio-economic Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey |
7; 4; 1; 3 | — |
| PRIMARY Socio-economic Health Care Data Via the Client Service Receipt Inventory (CSRI) Survey |
7; 4; 1; 3 | — |
| 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 |
— | — |
| 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 |
2.22; 3.68 | — |
| 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 |
3.33; 3.89; 2.78; 1.67; 3.89; 0.278 | — |
| 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 |
-0.106; -0.244 | — |
| 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 |
— | — |
| 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 |
-0.067; -0.626 | — |
| 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 |
0.227; -0.155 | — |
| 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 |
0.006; -0.014; 0.024; 0.008; -0.009; 0.000 | — |
| SECONDARY Participant Satisfaction With the Investigational Device (Every-day Situation and Self-esteem) Assessed on a Likert Scale |
0; 4; 3; 12; 2; 5 | — |
| SECONDARY Participant Satisfaction With the Investigational Device (Easiness to Use) Assessed on a Likert Scale |
15; 3; 1 | — |
| SECONDARY Participant Satisfaction With the Investigational Device (Durability of the Device and Sound Quality) Assessed on a Likert Scale |
6; 13; 8; 10; 1 | — |
| SECONDARY Participant Satisfaction With the Investigational Device (Overall Satisfaction) With Question Yes/No. |
18; 1 | — |
| SECONDARY Participant Satisfaction With the Investigational Device (Every-day Situation and Self-esteem) Assessed on a Likert Scale |
0; 4; 3; 12; 2; 5 | — |
| SECONDARY Participant Satisfaction With the Investigational Device (Easiness to Use) Assessed on a Likert Scale |
15; 3; 1 | — |
| SECONDARY Participant Satisfaction With the Investigational Device (Durability of the Device and Sound Quality) Assessed on a Likert Scale |
6; 13; 8; 10; 1 | — |
| SECONDARY Participant Satisfaction With the Investigational Device (Overall Satisfaction) With Question Yes/No. |
18; 1 | — |
| 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 |
8.25; 8.74; 8.47 | — |
| 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 |
0.400; 1.16; 0.789 | — |
| 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 |
24.7; 24.4; 23.3 | — |
| 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 |
9; 9; 2; 8; 10; 2 | — |
| 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 |
0; 20; 1; 18; 1; 18 | — |
| 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 |
75.7; 83.3; 82.8 | — |
| 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 |
86.7; 88.2; 87.8 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04754477). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.