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

Intervention name(s): Oticon OpenSound Navigator speech enhancement algorithm; Oticon omni-directional microphone algorithm
Intervention type(s): Device; 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.; Omni-directional microphone setups come standard for all Oticon hearing aid models. The hearing microphones have equal sensitivity across all directions.
Other intervention name(s): OSN; omni-directional mic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment