Trials / Completed
CompletedNCT04041700
Clinical Performance, Safety and Patient Reported Outcomes of an Active Osseointegrated Steady-State Implant System
A Prospective, Multicentre, Open Clinical Investigation Evaluating Clinical Performance, Safety and Patient Reported Outcomes With an Active Osseointegrated Steady-State Implant System (OSI) in Adult Subjects With Conductive Hearing Loss, Mixed Hearing Loss or Single-sided Sensorineural Deafness
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 29 (actual)
- Sponsor
- Cochlear · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The aim of this clinical investigation is to collect data on objective and subjective hearing performance, quality of life and safety in adult subjects with conductive hearing loss, mixed hearing loss or single-sided sensorineural deafness.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Osia 2 system | 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 processor. |
Timeline
- Start date
- 2019-08-16
- Primary completion
- 2020-06-19
- Completion
- 2020-09-24
- First posted
- 2019-08-01
- Last updated
- 2021-08-18
- Results posted
- 2021-08-18
Locations
3 sites across 2 countries: Australia, Hong Kong
Source: ClinicalTrials.gov record NCT04041700. Inclusion in this directory is not an endorsement.