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

December 18, 2020 updated by: Children's Hospital Medical Center, Cincinnati

Learning to Listen in Noise: A Double-blind Randomized Control Trial of a New Hearing Aid Noise Reduction System

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 13 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • children ages 6 to 13 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: OpenSound Navigator (OSN) Hearing Aid
Participants will be fit with Oticon OPN™ behind-the-ear hearing aids with the OpenSound Navigator algorithm enabled. Participants are to use the hearing aids at least an average of 8 hours per day over the course of 6-8 months.
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.
Other Names:
  • OSN
ACTIVE_COMPARATOR: omni-directional Hearing Aid
Participants will be fit with Oticon OPN™ behind-the-ear hearing aids with the Omni-directional microphone system enabled. Participants are to use the hearing aids at least an average of 8 hours per day over the course of 6-8 months.
Device: Oticon omni-directional microphone algorithm
Omni-directional microphone setups come standard for all Oticon hearing aid models. The hearing microphones have equal sensitivity across all directions.
Other Names:
  • omni-directional mic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Word Recognition Abilities at 6 to 8 Months
Time Frame: 6-8 months
Aided speech perception in noise within a week of hearing aid fitting and again 6-8 months later.
6-8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Speech, Spatial Qualities of Hearing Scale (SSQ) Scores at 6 to 8 Months
Time Frame: 6-8 months
Speech, Spatial and Qualities of Hearing Scale (SSQ), a survey utilizing an ordinal scale specifically measuring hearing aid benefit with regard to speech understanding, spatial awareness, perceptual quality of sound, and conversation, will be completed by parents/legal guardian within a week of the hearing aid fitting and after wearing the study hearing aids for 6-8 months. There are 4 survey sections. Section A: Speech has 8 questions, Section B: Spatial Hearing has 5 questions, Section C: Qualities of Hearing has 8 questions and Section D: Conversational Uses of Hearing has 5 questions. Each question uses a scale ranging from 0 (poorest possible outcome) to 100 (best possible outcome). Each section calculates an average score across the corresponding questions for a total of 4 individual scores.
6-8 months
Hearing aid use time
Time Frame: 6-8 months
Average daily use of hearing aids.
6-8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Medical Center, Cincinnati

Collaborators

Oticon

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 5, 2018

Primary Completion (ACTUAL)

July 30, 2020

Study Completion (ACTUAL)

August 30, 2020

Study Registration Dates

First Submitted

November 27, 2018

First Submitted That Met QC Criteria

December 7, 2018

First Posted (ACTUAL)

December 11, 2018

Study Record Updates

Last Update Posted (ACTUAL)

December 22, 2020

Last Update Submitted That Met QC Criteria

December 18, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-5953

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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