Hearing Aid Noise Reduction in Pediatric Users (Oticon Study)
Completed · Not applicable
Conditions studied: Hearing Impairment, Hearing Loss, Sensorineural
In brief
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. Using a double-blind experimental design, the investigators aim to compare two treatment groups of pediatric (ages 6-12) patients with symmetrical sensorineural hearing losses ranging from the mild to moderately-severe degree. One group will be fit with bilateral Oticon OPN™ behind-the-ear hearing aids set with an omni-directional microphone setting. The other group will be fit with the same hearing aid model with the OSN algorithm enabled. Participants from the groups will be age and audiogram-matched. The investigators will evaluate hearing aid benefit through word recognition in noise (behavioral testing) and everyday hearing/listening abilities (parental/legal guardian reported) at hearing aid fitting and 6-8 months post fitting.
Key facts
- Study ID
- NCT03771287
- Run by
- Children's Hospital Medical Center, Cincinnati
- People needed
- 40
- Starts
- 2018-12-05
- Expected to finish
- 2020-08-30
- Last updated by the study team
- 2020-12-22
Who can join
Age: 6 and older, up to 13. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- children ages 6 to 13 years
- English as the primary home language
- positive for bilateral symmetrical mild to moderately-severe sensorineural hearing loss
- currently using hearing aids that were dispensed at least 18 months prior to enrollment of the study
- negative for major cognitive handicap or developmental delay that would prevent or restrict participation, as determined by the PI or designee
- negative for learning disability, for example attention-deficit/hyperactivity disorder, as determined by the PI or designee
- negative for serious neurological or psychiatric disease that would prevent or restrict participation, as determined by the PI or designee
- informed consent of parent/guardian
- assent of participating child if aged 11 years and over
- standard MRI inclusion criteria as set by the Cincinnati Children's Hospital Medical Center department of Radiology
- not currently pregnant or breast feeding
- willingness and ability of the participant and/or the participant's caregiver to comply with study requirements
- no history of medical neglect of caregiver
Where it is running
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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