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

Brief Title

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

Official Title

Short-Term Pediatric Acclimatization to Adaptive Hearing Aid Technology

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).
    

Study Type

Interventional

Primary Outcome

Word Recognition in Noise Abilities

Secondary Outcome

 Speech, Spatial Qualities of Hearing Scale (SSQ) Scores

Condition

Hearing Impairment

Intervention

Oticon OpenSound Navigator speech enhancement algorithm

Study Arms / Comparison Groups

 Exploratory

Description:  Participants were fit with Oticon OPN™ behind-the-ear hearing aids with the OpenSound Navigator algorithm enabled. Pre-intervention measures were obtained within one week of the hearing aid fit and post-intervention measures were obtained after two months of daily hearing aid use.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Device

Estimated Enrollment

15

Start Date

March 5, 2018

Completion Date

September 30, 2018

Primary Completion Date

September 30, 2018

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
      

Gender

All

Ages

6 Years - 12 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

David R Moore, Ph.D., , 

Location Countries

United States

Location Countries

United States

NCT ID

NCT04469946

Organization ID

2017-5953-2

Responsible Party

Sponsor

Study Sponsor

Children's Hospital Medical Center, Cincinnati

Study Sponsor

David R Moore, Ph.D., Principal Investigator, Children's Hospital Medical Center, Cincinnati

Verification Date

June 2020