Hearing Aid Noise Reduction in Pediatric Users (Oticon Study)

NCT03771287 | Completed

• 1 other identifier: 2017-5953
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Hearing Impairment; Hearing Loss, Sensorineural

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Word Recognition Abilities at 6 to 8 Months

  Aided speech perception in noise within a week of hearing aid fitting and again 6-8 months later.

  6-8 months

Secondary Outcomes (2)

• Change from Baseline Speech, Spatial Qualities of Hearing Scale (SSQ) Scores at 6 to 8 Months

  6-8 months

• Hearing aid use time

  6-8 months

Study Arms (2)

OpenSound Navigator (OSN) Hearing Aid

EXPERIMENTAL

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

omni-directional Hearing Aid

ACTIVE COMPARATOR

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

Interventions

Oticon OpenSound Navigator speech enhancement algorithm 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.

Also known as: OSN

OpenSound Navigator (OSN) Hearing Aid

Oticon omni-directional microphone algorithm DEVICE

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

Also known as: omni-directional mic

omni-directional Hearing Aid

Eligibility Criteria

• Age: 6 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• Oticon: collaborator

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (1)

• 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.

  PMID: 35758427 DERIVED

MeSH Terms

Conditions

Hearing Loss; Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David R Moore, Ph.D.

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2018
• First Posted: December 11, 2018
• Study Start: December 5, 2018
• Primary Completion: July 30, 2020
• Study Completion: August 30, 2020
• Last Updated: December 22, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)