Trials / Completed
CompletedNCT04754477
Long Term Clinical Investigation to Evaluate Clinical Performance, Safety and Patient Reported Outcomes of an Active Osseointegrated Steady-State Implant System
A Multicentre, Open, Long-term Clinical Investigation Evaluating Safety, Performance and Patient Reported Outcomes With an Active Osseointegrated Steady-State Implant System in Adult Subjects With Conductive Hearing Loss, Mixed Hearing Loss or Single-sided Sensorineural Deafness.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Cochlear · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 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 |
Timeline
- Start date
- 2021-05-06
- Primary completion
- 2022-03-21
- Completion
- 2022-03-21
- First posted
- 2021-02-15
- Last updated
- 2024-06-10
- Results posted
- 2024-06-10
Locations
3 sites across 2 countries: Australia, Hong Kong
Source: ClinicalTrials.gov record NCT04754477. Inclusion in this directory is not an endorsement.