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NCT05034731 · ClinicalTrials.gov registry record
Evaluation of Remote Fitting in Adult and Pediatric Users of the HiResolution Bionic Ear System
A clinical trial, sponsored by Advanced Bionics.
- Completed
- Registry status
- 19
- Enrollment target
NCT05034731: Completed study, sponsored by Advanced Bionics.
NCT05034731 is a clinical trial that has completed, run by Advanced Bionics. The registered enrollment target is 19 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05034731 has completed, sponsored by Advanced Bionics.
- COMPLETED
- Registry status
- 19 participants
- Enrollment target
Study Summary
This is a prospective within-subjects repeated-measures study that will enroll 17 users 13 years or older implanted with a HiResolution Bionic Ear System.
Primary Outcome
The primary efficacy endpoint is the chronic AzBio sentence recognition scores in quiet captured two-to-three weeks post investigational remote fitting (visit 3) as compared to the chronic AzBio sentence recognition scores in quiet captured two-to-three weeks post control in-office fitting (visit 2). Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome.
Interventions
- DEVICE Remote Fitting
- DEVICE In-Office Fitting
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2021-08-18 |
| Est. Completion | 2022-05-23 |
What the finished NCT05034731 record still lists
NCT05034731 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which Remote Fitting is the first listed.
NCT05034731 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05034731 about?
NCT05034731 is a clinical study titled "Evaluation of Remote Fitting in Adult and Pediatric Users of the HiResolution Bionic Ear System". This is a prospective within-subjects repeated-measures study that will enroll 17 users 13 years or older implanted with a HiResolution Bionic Ear System.
What is the current status of trial NCT05034731?
This trial is currently completed. The enrollment target is 19 participants. The study started on 2021-08-18. Estimated completion is 2022-05-23.
What interventions are being tested in trial NCT05034731?
The interventions under investigation include: Remote Fitting (DEVICE), In-Office Fitting (DEVICE).
Who is sponsoring clinical trial NCT05034731?
This trial is sponsored by Advanced Bionics, which has 8 total clinical trials registered on ClinicalTrials.gov.
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