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NCT05000931 · ClinicalTrials.gov registry record · NA
Osia 2 Pediatric Expansion Study
A NA study, sponsored by Cochlear.
- Completed
- Registry status
- NA
- Development phase
- 50
- Enrollment target
NCT05000931 is a NA study that has completed, run by Cochlear. The registered enrollment target is 50 participants.
The verdict
NCT05000931, a NA study, has completed, sponsored by Cochlear.
- COMPLETED
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
Study Summary
The CochlearTM Osia®2 System was cleared by the Food and Drug Administration November 15, 2019 (K191921) for individuals aged 12 years and older who present with conductive or mixed hearing loss (up to 55 dB HL) or single-sided-deafness (SSD).Published and unpublished data suggest significant pre to postoperative benefit and minimal risk in both children and adults who have received the Osia system. Thus the objective of this study is to examine the safety and effectiveness of the Cochlear Osia 2 system in a group of pediatric subjects aged 5 to 11 years who suffer from conductive or mixed hearing loss (up to 55 dB HL), or single-sided-deafness (SSD) with the intent of expanding the indications for use.
Interventions
- DEVICE Osia 2 System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2022-01-26 |
| Est. Completion | 2024-03-14 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05000931
The ClinicalTrials.gov registry entry for NCT05000931 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cochlear, which has 34 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Osia 2 System is the first listed.
NCT05000931 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05000931 about?
NCT05000931 is a clinical study titled "Osia 2 Pediatric Expansion Study". The CochlearTM Osia®2 System was cleared by the Food and Drug Administration November 15, 2019 (K191921) for individuals aged 12 years and older who present with conductive or mixed hearing loss (up to 55 dB HL) or single-sided-deafness (SSD).Published and unpublished data suggest significant pre to...
What is the current status of trial NCT05000931?
This trial is currently completed. It is a NA study. The enrollment target is 50 participants. The study started on 2022-01-26. Estimated completion is 2024-03-14.
What interventions are being tested in trial NCT05000931?
The interventions under investigation include: Osia 2 System (DEVICE).
Who is sponsoring clinical trial NCT05000931?
This trial is sponsored by Cochlear, which has 34 total clinical trials registered on ClinicalTrials.gov.
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