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NCT03086135 · ClinicalTrials.gov registry record · NA
Clinical Performance of a New Implant System for Bone Conduction Hearing
A NA study, sponsored by Cochlear.
- Completed
- Registry status
- NA
- Development phase
- 51
- Enrollment target
NCT03086135: Completed NA study, sponsored by Cochlear.
NCT03086135 is a NA study that has completed, run by Cochlear. The registered enrollment target is 51 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03086135, a NA study, has completed, sponsored by Cochlear.
- COMPLETED
- Registry status
- NA
- Development phase
- 51 participants
- Enrollment target
Study 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.
Primary Outcome
The change of hearing performance from the unaided hearing situation before surgery to the aided hearing situation with the OSIA system at 3 month, measured as free-field hearing test; Threshold audiometry PTA4 (mean of 500, 1000, 2000 and 4000 Hz) is presented. A Pure Tone Average (PTA) refers to the average of hearing threshold levels at a set of specified frequencies: typically 500, 1000, 2000 and 4000 Hz. This value gives a snapshot of an individual's hearing level. If PTA is \<25 dB, the ov
Interventions
- DEVICE Osia System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2017-03-09 |
| Est. Completion | 2019-06-20 |
| Phase | NA |
What the finished NCT03086135 record still lists
NCT03086135 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Osia System is the first listed.
NCT03086135 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03086135 about?
NCT03086135 is a clinical study titled "Clinical Performance of a New Implant System for Bone Conduction Hearing". To study the initial experience with implanting and fitting the new Bone conduction system in patients with conductive, mixed or Single sided Sensorineural deafness.
What is the current status of trial NCT03086135?
This trial is currently completed. It is a NA study. The enrollment target is 51 participants. The study started on 2017-03-09. Estimated completion is 2019-06-20.
What interventions are being tested in trial NCT03086135?
The interventions under investigation include: Osia System (DEVICE).
Who is sponsoring clinical trial NCT03086135?
This trial is sponsored by Cochlear, which has 34 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03086135's enrollment target sits among peer trials
51 1279th of 2000 higher than 722 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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