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Clinical Trials/NCT04030299
NCT04030299
Completed
N/A

Longitudinal Outcomes of Over-the-Counter Hearing Aids

Yu-Hsiang Wu1 site in 1 country34 target enrollmentSeptember 1, 2019
ConditionsPresbycusis

Overview

Phase
N/A
Intervention
Not specified
Conditions
Presbycusis
Sponsor
Yu-Hsiang Wu
Enrollment
34
Locations
1
Primary Endpoint
Hearing Aid Benefit as Measured by the Glasgow Hearing Aid Benefit Profile (GHABP)
Status
Completed
Last Updated
last year

Overview

Brief Summary

Age-related hearing loss is a substantial national problem due to its high prevalence and significant psychosocial consequences. Although hearing aids (HAs) are the primary intervention for the management of age-related hearing loss, only 15-30% of those who could benefit from HAs actually seek them out. HA adoption rates are even worse for people with lower income and for racial and ethnic minorities. One of the most commonly reported reasons for people not seeking HA intervention is the high cost of HAs and the associated audiological fitting services. Because HAs fitted using the audiologist-based service-delivery model are unaffordable, more and more Americans (1.5 million in 2010) purchase amplification devices via over-the-counter (OTC) service-delivery models to compensate for their impaired hearing.

Although OTC amplification devices are gaining popularity and are regarded as an important option for promoting accessible and affordable hearing healthcare, it is unclear if they are viable solutions for age-related hearing loss as OTC models exclude professional services. Further, although there is some evidence supporting the effectiveness of OTC HAs, all previous studies measured short-term outcomes (e.g., 6 weeks). It is unknown what the long-term outcomes of OTC HAs would look like. The outcomes could improve across time because users may eventually figure out how to use HAs. On the other hand, the outcomes of OTC HAs could become poorer across time because, unlike traditional HA fitting, users do not have professionals to support them. Therefore, the overall goal of this project is to examine the longitudinal changes in OTC HA outcomes over 3 months.

Detailed Description

Although hearing aids (HAs) are the first treatment of choice for age-related hearing loss, only 15-30% of those older Americans who could benefit, actually seek HAs out and use them. HA adoption rates are even lower for people with lower income and for racial and ethnic minorities. Although the answer to why so few older adults seek or use amplification is multidimensional, one common thread is that many people believe that HAs fitted using the audiologist-based model cost too much. Therefore, it is not surprising that there has been increased advocacy for a variety of over-the-counter (OTC) service-delivery models, which have increasingly been identified as important options for managing mild-to-moderate age-related hearing loss. Is the amplification intervention delivered using the OTC model an appropriate solution for age-related hearing loss? Although there is some evidence supporting the effectiveness of OTC HAs, all previous studies measured short-term outcomes (e.g., 6 weeks). It is unknown what the long-term outcomes of OTC HAs would look like. The purpose of this project is to examine the longitudinal changes in OTC HA outcomes over 3 months. Older adults with age-related hearing loss will be recruited. Pre-configured hearing aids (that simulate OTC hearing aids) will be provided to subjects. Subjects will take the full initiative and responsibility for learning and using hearing aids. HA outcomes will be measured at 6-week and 12-week post intervention.

Registry
clinicaltrials.gov
Start Date
September 1, 2019
End Date
September 1, 2022
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Yu-Hsiang Wu
Responsible Party
Sponsor Investigator
Principal Investigator

Yu-Hsiang Wu

Associate Professor

University of Iowa

Eligibility Criteria

Inclusion Criteria

  • adult-onset, bilateral, mild-to-moderately severe sensorineural hearing loss

Exclusion Criteria

  • Non-native speaker of English

Outcomes

Primary Outcomes

Hearing Aid Benefit as Measured by the Glasgow Hearing Aid Benefit Profile (GHABP)

Time Frame: 1-week, 6-week, and 12-week post-intervention

The Glasgow Hearing Aid Benefit Profile (GHABP) is a questionnaire that measures hearing aid users' listening experience in four situations (TV listening, small conversation in quiet, conversation in noise, and group conversation). The score ranges from 0 (no benefit) to 5 (lots of benefit). The score at 1-week, 6-week and 12-week post intervention is the primary outcome.

Secondary Outcomes

  • Willingness-to-pay(6-week and 12-week post intervention)
  • Quality of Life as Measured by the World Health Organization's Disability Assessment Schedule 2.0 (WHODAS 2.0)(1-week, 6-week, and 12-week post-intervention)
  • Hearing Aid Performance/Benefit as Measured Using the Profile of Hearing Aid Performance (PHAP)(1-week, 6-week, and 12-week post-intervention)
  • Hearing Handicap as Measured by Hearing Handicap Inventory for the Elderly (HHIE) or Hearing Handicap Inventory for Adults (HHIA)(1-week, 6-week, and 12-week post-intervention)
  • Hearing Aid Satisfaction as Measured by the Hearing Aid Satisfaction Survey (HASS)(1-week, 6-week, and 12-week post-intervention)
  • Speech Recognition Performance as Measured by the Connected Speech Test (CST)(1-week, 6-week, and 12-week post-intervention)
  • Hearing Aid Satisfaction as Measured by the Satisfaction With Amplification in Daily Life (SADL)(1-week, 6-week, and 12-week post-intervention)

Study Sites (1)

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