NCT04469946

Hearing Aid Noise Reduction in Pediatric Users Pilot Study (Oticon Pilot Study)

Short-Term Pediatric Acclimatization to Adaptive Hearing Aid Technology

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Accepted

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).

Conditions

• Hearing Impairment
• Sensorineural Hearing Loss, Bilateral

Interventions

Type	Name	Description
DEVICE	Oticon OpenSound Navigator speech enhancement algorithm	OpenSound Navigator (OSN) is a speech enhancement algorithm developed by Oticon. The feature is built in Oticon's current OPN™ hearing aid platform and can be adjusted and disabled in the programming. It is designed to automatically enhance speech while reducing unwanted background noise to improve communication for the user.

Timeline

• Start date: 2018-03-05
• Primary completion: 2018-09-30
• Completion: 2018-09-30
• First posted: 2020-07-14
• Last updated: 2020-07-14

Locations

1 site across 1 country: United States