Trials / Completed
CompletedNCT03086135
Clinical Performance of a New Implant System for Bone Conduction Hearing
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 51 (actual)
- Sponsor
- Cochlear · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
To study the initial experience with implanting and fitting the new Bone conduction system in patients with conductive, mixed or Single sided Sensorineural deafness.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Osia System | An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea. |
Timeline
- Start date
- 2017-03-09
- Primary completion
- 2018-10-30
- Completion
- 2019-06-20
- First posted
- 2017-03-22
- Last updated
- 2021-10-14
- Results posted
- 2020-02-05
Locations
5 sites across 5 countries: United States, Australia, Germany, Netherlands, Poland
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03086135. Inclusion in this directory is not an endorsement.