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NCT Number: NCT04030299

Longitudinal Outcomes of Hearing Aids

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.

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Key information

Conditions

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

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Iowa

Iowa City, Iowa, 52242, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Non-native speaker of English

Treatment and study plan

Over-the-counter fitting

Device

In this group, pre-configured hearing aids, which simulate over-the-counter hearing aids, will be provided to subjects. Subjects will take the full initiative and responsibility for learning and using hearing aids.

Primary outcomes

  1. 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

  1. Hearing Aid Performance/Benefit as Measured Using the Profile of Hearing Aid Performance (PHAP)

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

    The PHAP is a questionnaire designed to measures the performance of hearing aids in speech communication. The score ranges from 1 (good performance) to 99 (poor performance).

  2. Hearing Handicap as Measured by Hearing Handicap Inventory for the Elderly (HHIE) or Hearing Handicap Inventory for Adults (HHIA)

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

    The HHIE and HHIA are questionnaires designed to measure subject's perceived hearing handicap. For subjects order and younger 65 years old, the HHIE and HHIA will be used, respectively. The score ranges from 0 (no handicap) to 100 (more handicap).

  3. Hearing Aid Satisfaction as Measured by the Hearing Aid Satisfaction Survey (HASS)

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

    The HASS is a questionnaire developed to measures subject's perceived hearing aid satisfaction. The score ranges from 0 (low satisfaction) to 10 (high satisfaction).

  4. Willingness-to-pay

    Time frame: 6-week and 12-week post intervention

    Willingness-to-pay (WTP) estimates the extent to which (in dollars) a subjects, at a maximum, is willing to pay out-of pocket for the amplification devices and the associated services used in the study..

  5. Quality of Life as Measured by the World Health Organization's Disability Assessment Schedule 2.0 (WHODAS 2.0)

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

    The WHODAS is a questionnaire designed to measure quality of life. The summary score ranges from 0 (No disability) to 100 (Full disability).

  6. Hearing Aid Satisfaction as Measured by the Satisfaction With Amplification in Daily Life (SADL)

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

    The SADL is a questionnaire designed to measures subject's perceived hearing aid satisfaction. The score ranges from 1 (low satisfaction) to 7 (high satisfaction).

  7. Speech Recognition Performance as Measured by the Connected Speech Test (CST)

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

    The CST is a speech recognition test designed to simulate daily speech communication. The score ranges from 0 (understand no speech) to 100 (understand all speech).

Sponsors and collaborators

Lead sponsor

Yu-Hsiang Wu

Other

Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

Registry information

Official study title

Longitudinal Outcomes of Over-the-Counter Hearing Aids

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jul 23, 2019
Registry last updated
Aug 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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