Clinical trial NCT03771287: Hearing Aid Noise Reduction in Pediatric Users (Oticon Study)
Official title: Learning to Listen in Noise: A Double-blind Randomized Control Trial of a New Hearing Aid Noise Reduction System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Impairment
Hearing Loss, Sensorineural
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: Oticon
First posted: 2018-12-11
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 will use a double-blind randomized control methodology of two participant matched (based on age and audiometric configuration) groups. The first group will include pediatric patients fit with bilateral Oticon OPN™ behind-the-ear hearing aids with the standard Omni-directional microphone setting enabled. Group two will include pediatric patients fit with the same hearing aid model 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 8 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 and 6-8 months post fitting.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline Word Recognition Abilities at 6 to 8 Months
timeFrame: 6-8 months
Secondary outcomes:
measure: Change from Baseline Speech, Spatial Qualities of Hearing Scale (SSQ) Scores at 6 to 8 Months
timeFrame: 6-8 months
measure: Hearing aid use time
timeFrame: 6-8 months
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: David R Moore, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stewart HJ, Cash EK, Pinkl J, Nakeva von Mentzer C, Lin L, Hunter LL, Moore DR; CCHMC Division of Audiology. Adaptive Hearing Aid Benefit in Children With Mild/Moderate Hearing Loss: A Registered, Double-Blind, Randomized Clinical Trial. Ear Hear. 2022 Sep-Oct 01;43(5):1402-1415. doi: 10.1097/AUD.0000000000001230. Epub 2022 Jun 27.