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

NCT04469946 | Completed

• 1 other identifier: 2017-5953-2
• Study Type: interventional
• Target: 15
• 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. 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).

Conditions

Hearing Impairment; Sensorineural Hearing Loss, Bilateral

Outcome Measures

Primary Outcomes (6)

• Word Recognition in Noise Abilities

  Aided speech perception in noise was evaluated using a novel word recognition in noise test. Recorded target word intensity was fixed at 65 decibels (dB) sound pressure level (SPL) with an adaptive noise level set at an initial level of 55 dB SPL. Participants were instructed to keep their head still, listen closely to the target word and repeat the word back. If the repeated word was correct, the noise level increased by 4 dB, if incorrect, the noise reduced by 4 dB. After the second reversal, the adaptive noise level changed to 2 dB increments. This continued for six more noise level reversals for an overall signal-to-noise ratio (SNR) threshold calculation. The final threshold score indicates the estimated SNR level in which the participant correctly recognizes monosyllabic words 50% of the time (SNR-50). This test was performed within a week of hearing aid fitting and again after two months.

  2 months

• Word Recognition in Quiet Abilities

  Aided speech perception in quiet was evaluated within a week of hearing aid fitting and again after two months. Recorded sentences were presented at 50 dB SPL, and scoring was based on accuracy of each recited word.

  2 months

• Memory

  Long-term vocabulary memory and episodic memory were evaluated using subtests from the standardized NIH Tool Box test. Subtests included the Picture Vocabulary test and the Picture Sequence Memory Test. Tests produced a standardized age-adjusted numeric score. Testing was completed within a week of hearing aid fitting and again after two months.

  2 months

• Executive Function

  Executive function was evaluated using subtests from the standardized NIH Tool Box test. Subtests included the Flanker Inhibitory Control and Attention test and and the Dimensional Change Card Sort test. Tests produced a standardized age-adjusted numeric score. Testing was completed within a week of hearing aid fitting and again after two months.

  2 months

• Mathematic Academic Performance

  Mathematic skills were evaluated using a standardized battery called the Woodcock-Johnson IV Test of Achievement (WJ-IV). Subtests included Applied Problems and Calculation. Tests produced a standardized age-adjusted numeric score. Testing was completed within a week of hearing aid fitting and again after two months.

  2 months

• Academic Language Performance

  Language skills were evaluated using WJ-IV. Subtests included Letter-Word Identification and Passage Comprehension. Tests produced a standardized age-adjusted numeric score. Testing was completed within a week of hearing aid fitting and again after two months.

  2 months

Secondary Outcomes (2)

• Speech, Spatial Qualities of Hearing Scale (SSQ) Scores

  2 months

• Glasgow Hearing Aid Benefit Profile Scores

  2 months

Study Arms (1)

Exploratory

EXPERIMENTAL

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.

Device: Oticon OpenSound Navigator speech enhancement 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

Exploratory

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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
• 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

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

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: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pediatric hearing aid users (6 to 12 years old) participated in an intervention trial of a hearing aid with an integrated directionality and noise reduction program. Pre- to post-comparison measures were obtained after two months of intervention use.

Study Record Dates

• First Submitted: June 21, 2020
• First Posted: July 14, 2020
• Study Start: March 5, 2018
• Primary Completion: September 30, 2018
• Study Completion: September 30, 2018
• Last Updated: July 14, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)