Auditory Training and Hearing Aid Satisfaction

NCT04230876 | Completed Phase 1 Results

• 1 other identifier: 201909043
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hearing Impairment, Sensorineural

Keywords

Auditory Training

Outcome Measures

Primary Outcomes (5)

• 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.

• 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.

• 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.

• 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.

• 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 Outcomes (1)

• Change in Percent Words Correct on Speech Perception Measures After Auditory Training

  At the time of hearing aid fitting (baseline), three weeks after hearing aid fitting, and after completing the four week training protocol.

Interventions

Auditory Brian Training Games/Activities BEHAVIORAL

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.

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 62220, United States

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Chris Cardinal
• Organization: Amptify

Chris@amptify.com

3143999940

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are unaware if they are in the late or early intervention group.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants experience the same interventions and assessments. Subjects are divided into either early or late intervention groups.

Study Record Dates

• First Submitted: January 10, 2020
• First Posted: January 18, 2020
• Study Start: September 1, 2020
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: September 19, 2022
• Results First Posted: September 19, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)