Clinical trial NCT04469946: Hearing Aid Noise Reduction in Pediatric Users Pilot Study (Oticon Pilot Study)
Official title: Short-Term Pediatric Acclimatization to Adaptive Hearing Aid Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Impairment
Sensorineural Hearing Loss, Bilateral
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2020-07-14
Enrollment: 15
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Pediatric hearing aid users (6 to 12 years old) participated in an intervention trial of a hearing aid with an integrated directionality and noise reduction program. Pre- to post-comparison measures were obtained after two months of intervention use.
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. 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).

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

Primary outcomes:
measure: Word Recognition in Noise Abilities
timeFrame: 2 months
measure: Word Recognition in Quiet Abilities
timeFrame: 2 months
measure: Memory
timeFrame: 2 months
measure: Executive Function
timeFrame: 2 months
measure: Mathematic Academic Performance
timeFrame: 2 months
measure: Academic Language Performance
timeFrame: 2 months
Secondary outcomes:
measure: Speech, Spatial Qualities of Hearing Scale (SSQ) Scores
timeFrame: 2 months
measure: Glasgow Hearing Aid Benefit Profile Scores
timeFrame: 2 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: