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Hearing Aid Noise Reduction in Pediatric Users (Oticon Study)

NCT ID: NCT03771287

Last Updated: 2020-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-05

Study Completion Date

2020-08-30

Brief Summary

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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

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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.

Conditions

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Hearing Impairment Hearing Loss, Sensorineural

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Double-blinded randomized control trial of OpenSound Navigator (OSN) enabled/disabled hearing aids. Only the fitting audiologist will know if the OSN algorithm is enabled or disabled in the research hearing aids. Will be un-blinded after data collection is complete in order to carry out group comparison analysis.

Study Groups

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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.

Group Type EXPERIMENTAL

Oticon OpenSound Navigator speech enhancement algorithm

Intervention Type DEVICE

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 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.

Group Type ACTIVE_COMPARATOR

Oticon omni-directional microphone algorithm

Intervention Type DEVICE

Omni-directional microphone setups come standard for all Oticon hearing aid models. The hearing microphones have equal sensitivity across all directions.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

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OSN omni-directional mic

Eligibility Criteria

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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
* 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
Minimum Eligible Age

6 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Oticon

UNKNOWN

Sponsor Role collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David R Moore, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

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Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status

Countries

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United States

References

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Stewart HJ, Cash EK, Pinkl J, Nakeva von Mentzer C, Lin L, Hunter LL, Moore DR; CCHMC Division of Audiology. Adaptive Hearing Aid Benefit in Children With Mild/Moderate Hearing Loss: A Registered, Double-Blind, Randomized Clinical Trial. Ear Hear. 2022 Sep-Oct 01;43(5):1402-1415. doi: 10.1097/AUD.0000000000001230. Epub 2022 Jun 27.

Reference Type DERIVED
PMID: 35758427 (View on PubMed)

Other Identifiers

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2017-5953

Identifier Type: -

Identifier Source: org_study_id