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NCT04469946
Hearing Aid Noise Reduction in Pediatric Users Pilot Study (Oticon Pilot Study)
NA trial testing Oticon OpenSound Navigator speech enhancement algorithm in Hearing Impairment in 15 participants. Completed in 30 September 2018.
30 September 2018
Quick facts
| Lead sponsor | Children's Hospital Medical Center, Cincinnati |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 15 |
| Start date | 5 March 2018 |
| Primary completion | 30 September 2018 |
| Estimated completion | 30 September 2018 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Oticon OpenSound Navigator speech enhancement algorithm
Conditions studied
- Hearing Impairment — all drugs for Hearing Impairment →
- Sensorineural Hearing Loss, Bilateral — all drugs for Sensorineural Hearing Loss, Bilateral →
Sponsor
Children's Hospital Medical Center, Cincinnati
Who can join
Adults 6 to 12, any sex, with Hearing Impairment or Sensorineural Hearing Loss, Bilateral. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04469946
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Oticon OpenSound Navigator speech enhancement algorithm
Trials testing the same drug.
- NCT03771287 — Hearing Aid Noise Reduction in Pediatric Users (Oticon Study) · NA · completed
Other recruiting trials for Hearing Impairment
Currently open trials in the same condition.
- NCT06663917 — Clinical Evaluation of Frequency Allocation for Bimodal CI Users · NA · recruiting
- NCT06680934 — CABP2 Patient Registry and Natural History Study · recruiting
- NCT05847426 — Improving Early Intervention in Hearing Impaired Children Using Functional Near-Infrared Spectroscopy (fNIRS) · NA · recruiting
- NCT05805384 — Evaluating a Noise Reduction Algorithm With Cochlear Implant Users · NA · recruiting
- NCT05946057 — Otoferlin Patient Registry and Natural History Study · recruiting
Other Children's Hospital Medical Center, Cincinnati trials
Trials by the same sponsor.
- NCT07430332 — GLP-1 RA for Stage 1 Type 1 Diabetes · Phase 2 · not yet recruiting
- NCT07077213 — 18F-Fibroblast Activation Protein Inhibitor (18F-FAPI-74) in Tuberculosis Patients · recruiting
- NCT07265141 — An Automated Virtual Reality Intervention to Enhance Firearm Safety Counseling in Pediatrics · NA · not yet recruiting
- NCT07217444 — Improving Outcomes in Adolescent Inpatient Depression With Deep Transcranial Magnetic Stimulation · NA · recruiting
- NCT07195123 — Evaluation of the SMART IBD App in Pediatric IBD · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04469946 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati
- Last refreshed: 14 July 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04469946.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing