Hearing Aid Noise Reduction in Pediatric Users Pilot Study (Oticon Pilot Study)
Condition: Hearing Impairment; Sensorineural Hearing Loss, Bilateral
MeSH terms: Hearing Loss; Deafness; Hearing Loss, Sensorineural; Hearing Loss, Bilateral
Study type: Interventional

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).
    

Intervention name(s): Oticon OpenSound Navigator speech enhancement algorithm
Intervention type(s): Device
Intervention description(s): 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.
Other intervention name(s): OSN
Allocation: Non-Randomized
Intervention model: Single Group Assignment
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.
Masking: None (Open Label)
Primary purpose: Treatment