Status:
COMPLETED
Hearing Aid Noise Reduction in Pediatric Users (Oticon Study)
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsors:
Oticon
Conditions:
Hearing Impairment
Hearing Loss, Sensorineural
Eligibility:
All Genders
6-13 years
Phase:
NA
Brief 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. Using ...
Detailed Description
OpenSound Navigator (OSN) is a speech enhancement hearing aid algorithm developed by Oticon that utilizes an adaptive directional microphone system with an automatic gain control noise reduction progr...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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
Exclusion
Key Trial Info
Start Date :
December 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03771287
Start Date
December 5 2018
End Date
August 30 2020
Last Update
December 22 2020
Active Locations (1)
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1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229