Brief Title
Hearing Aid Noise Reduction in Pediatric Users Pilot Study (Oticon Pilot Study)
Official Title
Short-Term Pediatric Acclimatization to Adaptive Hearing Aid Technology
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. 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).
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 program. This hearing aid feature is intended for adult hearing aid users and its potential benefits of speech, vocabulary and listening development in pediatric users has not been investigated. Here the investigators aim to evaluate the efficacy of OSN programming in pediatric hearing aid users (6-12 years of age) diagnosed with a symmetrical sensorineural hearing loss in the mild to moderately-severe range. The investigators used a within-subjects study design with pre- and post-comparisons. All participants were fit with bilateral Oticon OPN™ behind-the-ear hearing aids with the OSN feature enabled. Participants will undergo standard audiometric diagnostic testing and will be fit with the hearing aids by a licensed clinical audiologist. Participants are required to wear the hearing aids full time (at least 6 hours per day average) during the duration of the study. The evaluation measures will include speech recognition testing in controlled background noise and the Speech, Spatial and Qualities of Hearing Scale questionnaire (completed by parents/legal guardian). Testing will be performed within a week of the hearing aid fitting (pre-intervention) and two months post fitting (post-intervention).
Study Type
Interventional
Primary Outcome
Word Recognition in Noise Abilities
Secondary Outcome
Speech, Spatial Qualities of Hearing Scale (SSQ) Scores
Condition
Hearing Impairment
Intervention
Oticon OpenSound Navigator speech enhancement algorithm
Study Arms / Comparison Groups
Exploratory
Description: Participants were fit with Oticon OPN™ behind-the-ear hearing aids with the OpenSound Navigator algorithm enabled. Pre-intervention measures were obtained within one week of the hearing aid fit and post-intervention measures were obtained after two months of daily hearing aid use.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
15
Start Date
March 5, 2018
Completion Date
September 30, 2018
Primary Completion Date
September 30, 2018
Eligibility Criteria
Inclusion Criteria: - children ages 6 to 12 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
Gender
All
Ages
6 Years - 12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
David R Moore, Ph.D., ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04469946
Organization ID
2017-5953-2
Responsible Party
Sponsor
Study Sponsor
Children's Hospital Medical Center, Cincinnati
Study Sponsor
David R Moore, Ph.D., Principal Investigator, Children's Hospital Medical Center, Cincinnati
Verification Date
June 2020