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NCT04469946 · ClinicalTrials.gov registry record · NA
Hearing Aid Noise Reduction in Pediatric Users Pilot Study (Oticon Pilot Study)
A NA study, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- NA
- Development phase
- 15
- Enrollment target
NCT04469946: Completed NA study, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT04469946 is a NA study that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 15 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04469946, a NA study, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy of OpenSound Navigator (OSN), a hearing aid speech-enhancement algorithm developed by Oticon, as treatment for pediatric hearing aid users. The study used a within-subjects design with pre- and post-comparisons involving fifteen pediatric (ages 6-12) patients with symmetrical sensorineural hearing losses ranging from the mild to moderately-severe degree. All participants were fit with bilateral Oticon OPN™ behind-the-ear hearing aids set with the OSN algorithm enabled. The investigators evaluated hearing aid benefit through word recognition in noise (behavioral testing) and everyday hearing/listening abilities (parental/legal guardian reported) within one week of the hearing aid fitting (pre-intervention) and two months post fitting (post-intervention).
Primary Outcome
Aided speech perception in noise was evaluated using a novel word recognition in noise test. Recorded target word intensity was fixed at 65 decibels (dB) sound pressure level (SPL) with an adaptive noise level set at an initial level of 55 dB SPL. Participants were instructed to keep their head still, listen closely to the target word and repeat the word back. If the repeated word was correct, the noise level increased by 4 dB, if incorrect, the noise reduced by 4 dB. After the second reversal,
Interventions
- DEVICE Oticon OpenSound Navigator speech enhancement algorithm
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2018-03-05 |
| Est. Completion | 2018-09-30 |
| Phase | NA |
What the finished NCT04469946 record still lists
NCT04469946 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Oticon OpenSound Navigator speech enhancement algorithm is the first listed.
NCT04469946 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04469946 about?
NCT04469946 is a clinical study titled "Hearing Aid Noise Reduction in Pediatric Users Pilot Study (Oticon Pilot Study)". The purpose of this study is to evaluate the efficacy of OpenSound Navigator (OSN), a hearing aid speech-enhancement algorithm developed by Oticon, as treatment for pediatric hearing aid users. The study used a within-subjects design with pre- and post-comparisons involving fifteen pediatric (ages 6...
What is the current status of trial NCT04469946?
This trial is currently completed. It is a NA study. The enrollment target is 15 participants. The study started on 2018-03-05. Estimated completion is 2018-09-30.
What interventions are being tested in trial NCT04469946?
The interventions under investigation include: Oticon OpenSound Navigator speech enhancement algorithm (DEVICE).
Who is sponsoring clinical trial NCT04469946?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04469946's enrollment target sits among peer trials
15 1881st of 2000 higher than 92 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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