Auditory Training and Hearing Aid Satisfaction

Hearing Impairment, Sensorineural Clinical Trial

— ATandHAs  

Official title:

Auditory Brain Training to Enhance Satisfaction and Usage of New Hearing Aids by Older Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04230876
• Other study ID #: 201909043
• Status: Completed
• Phase: Phase 1
• Start date: September 1, 2020
• Est. completion date: February 28, 2021

Study information

• Verified date: August 2022
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Although hearing aids are the most common treatment for hearing loss, and have the potential to help seniors stay active and productive, almost 50% of them who receive hearing aids rarely if ever use them, a state of affairs sometimes referred to as "the hearing aid in the drawer" syndrome. clEAR's customized auditory brain training has been shown to be effective in improving adults' abilities to recognize speech, in reducing their perceptual effort associated with listening with a hearing loss, and in increasing their confidence to engage in everyday conversations. In the proposed research, we will determine whether older adults who receive hearing aids for the first time report higher satisfaction with their new hearing aids and have longer daily use time as a result of having completed clEAR's auditory brain training program for new hearing aid users.

Description:

Auditory training as the potential to dramatically affect older persons' adjustment to a new hearing aid and to maximize the benefits they receive from wearing one. In turn, by wearing hearing aids, they experience easier and more successful communication patterns. They enhance their ability to engage in everyday conversations and will be able to become more socially involved with their family and friends. In this study we will try to determine the extent to which web-based clEAR auditory brain training, with concomitant support from a clEAR in-house audiologist, affects satisfaction with new hearing aids and increases daily use time. The study will include thirty adults over the age of 60 years who have received hearing aids for the first time. After an adjustment period, half will complete clEAR's auditory brain training program right away and the other half will complete it after a delay period, and both will complete a control condition. To establish the level of feasibility and clinical utility. We will measure hearing aid satisfaction, benefit ratings, and hearing aid use time.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 28, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Must be a native English speaker

• Must have a mild to severe bilateral sensorineural hearing loss

• Must be a candidate for new hearing aid(s) (have never used hearing aids)

Exclusion Criteria:

• Cognitive impairment or any factors that would prohibit a participant from completing questionnaires

• Cognitive or speech production factors that would prohibit a participant from repeating words during a speech perception test.

Related Conditions & MeSH terms

• Deafness
• Hearing Impairment, Sensorineural
• Hearing Loss
• Hearing Loss, Sensorineural

Intervention

Behavioral:
• Auditory Brian Training Games/Activities
Game-based activities that encourage listening to words and sentences in noisy situations. Participants will receive subscriptions to the clEAR online auditory training activities and recommended protocol for those who recently received new hearing aids.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hearing Aid Satisfaction After Auditory Training	The Client Orientated Scale of Improvement (COSI), a subjective measure of improvement on self-defined goals. The scale is relative to a baseline assessed before wearing hearing aids. For each goal participants select from a scale of improvement including Worse (-1), No Difference (0), Slightly Better (+1), Better (+2), and Much Better (+3). Positive values between one and three indicate improvement, negative values indicate that the self-defined goals got worse, and zero is no improvement. COSI scores were assessed before and after participants used the Amptify DTx. The outcome measure reported is the difference between scores before and scores after using the Amptify DTx.	Three weeks after hearing aid fitting and after completing the four week training protocol.
Primary	Change in Hearing Aid Satisfaction After Auditory Training	The International Outcome Inventory for Hearing Aids (IOI-HA) is a hearing aid satisfaction questionnaire that averages a series of seven questions on a five-point scale (0-5 possible points of improvement). IOI-HA scores were assessed before and after participants used the Amptify DTx. The outcome measure reported is the difference between scores before and scores after using the Amptify DTx. Higher values between 1 and 5 indicate more relative satisfaction.	Three weeks after hearing aid fitting and after completing the four week training protocol.
Primary	Change in Hearing Aid Satisfaction After Auditory Training	Abbreviated Profile of Hearing Aid Benefit (APHAB) is common clinical questionnaire for determining hearing aid benefit using a series of 24 questions on a seven-point scale (A-G; the scale is then converted to "percent of time" from 1% (Never) to 99% (Always) and 50% means half of the time). Hearing aid benefit is calculated as the difference between the performance with a hearing and and performance without a hearing aid. More positive values indicate more benefit.	Three weeks after hearing aid fitting and after completing the four week training protocol.
Primary	Change in Hearing Aid Satisfaction After Auditory Training	The Speech, Spatial and Qualities of Hearing Scale (SSQ-12) is a subjective tool or assessing the quality of the sound from a hearing aid using a 12-item questionnaire. Questions focus on how well the participant could hear in various situations. The responses range on a scale from "Not At All" (0) to Perfectly (10). Higher values indicate better sound quality.	Three weeks after hearing aid fitting and after completing the four week training protocol.
Primary	Change in Hearing Aid Satisfaction After Auditory Training	Daily use (in hours/day) is logged by the participant. Improvement is indicated by an increase in the amount of time the participant uses the hearing aid each day.	Three weeks after hearing aid fitting and after completing the four week training protocol.
Secondary	Change in Percent Words Correct on Speech Perception Measures After Auditory Training	The NU-6 is a standard clinical assessment of word discrimination. Lists consist of 50 words in quiet and were presented through the Amptify DTx while wearing the hearing aid. NU-6 scores are in percent words correctly identified. Scores reported here are the difference between scores measured before and after completing the Amptify DTx.	At the time of hearing aid fitting (baseline), three weeks after hearing aid fitting, and after completing the four week training protocol.