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Cost-effective Hearing Aid Delivery Models

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03579563
Recruitment Status : Recruiting
First Posted : July 6, 2018
Last Update Posted : April 1, 2022
Vanderbilt University Medical Center
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Yu-Hsiang Wu, University of Iowa

Brief Summary:

One of the most commonly reported reasons for people not seeking hearing aids (HAs) intervention is the high cost of HAs and the associated audiological fitting services. Because HAs fitted using the audiologist-based service-delivery model (AUD model) are unaffordable, more and more Americans purchase amplification devices via over-the-counter service-delivery models (OTC 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, if there are outcome differences between AUD and OTC models, it is unknown if the clinical improvement in outcomes will be offset by the improved value (outcome relative to cost), or if it is possible to identify appropriate candidacy for each model to ensure optimal patient care for all. Finally, no prior research has investigated if "hybrid" service-delivery models, in which professionals provide streamlined services to fit OTC amplification devices, offer affordable and quality amplification interventions as has been recently advocated.

The overall goal of this project is to characterize the differential effect of service-delivery models on provision of amplification so that accessible and affordable hearing healthcare can be facilitated. This project proposes to conduct research that would provide new knowledge about the outcome, value, and candidacy of OTC, hybrid, and AUD models and the effect of professional evaluation/selection services, patient-centered services, and device-centered services on outcome and value. The proposed study will acquire this knowledge through a two-site, double-blinded, randomized controlled field trial. The results obtained will inform patients and hearing healthcare providers about what can be achieved with different service-delivery models, and will help us develop guidelines to facilitate the selection of the most appropriate and cost-effective intervention for a particular patient. The significance of the proposed project from the public health point of view is that it will facilitate not only accessible and affordable, but also quality, hearing healthcare.

Condition or disease Intervention/treatment Phase
Presbycusis Other: Audiologist-based fitting Other: Over-the-counter fitting Other: Hybrid fitting Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Cost-effective Hearing Aid Delivery Models: Outcomes, Value, and Candidacy
Actual Study Start Date : February 22, 2019
Estimated Primary Completion Date : January 30, 2023
Estimated Study Completion Date : May 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hearing Aids

Arm Intervention/treatment
Active Comparator: AUD (audiologist-based)
In this group, the audiologist-based fitting will be used to provide hearing aids.
Other: Audiologist-based fitting
Hearing aids will be fitted by audiologists using established procedures.

Experimental: OTC (over-the-counter)
In this group, the over-the-counter fitting will be used to provide hearing aids.
Other: Over-the-counter fitting
In this group, pre-configured Hearing aids will be provided to subjects. Subjects will take the full initiative and responsibility for learning and using hearing aids.

Experimental: OTC-Plus
In this group, the hybrid fitting will be used to provide hearing aids.
Other: Hybrid fitting
Audiology professionals provide streamlined services to fit pre-configured amplification devices.

Primary Outcome Measures :
  1. Hearing aid benefit as measured by the Glasgow Hearing Aid Benefit Profile (GHABP) [ Time Frame: 6-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 GHABP will be administered using a smartphone-based ecological momentary assessment methodology. The score ranges from 0 (no benefit) to 5 (lots of benefit).

Secondary Outcome Measures :
  1. Hearing aid performance/benefit as measured using the Profile of Hearing Aid Performance (PHAP) [ Time Frame: 6-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. Speech recognition performance as measured by the Connected Speech Test (CST) [ Time Frame: 6-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).

  3. Hearing handicap as measured by Hearing Handicap Inventory for the Elderly (HHIE) or Hearing Handicap Inventory for Adults (HHIA) [ Time Frame: 6-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 24 (more handicap).

  4. Hearing aid satisfaction as measured by the Hearing Aid Satisfaction Survey (HASS) [ Time Frame: 6-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).

  5. Willingness-to-pay [ Time Frame: 6-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.

  6. Quality of life as measured by the World Health Organization's Disability Assessment Schedule 2.0 (WHODAS 2.0) [ Time Frame: 6-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).

  7. Hearing aid satisfaction as measured by the Satisfaction with Amplification in Daily Life (SADL) [ Time Frame: 6-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).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • adult-onset, bilateral, mild-to-moderately severe sensorineural hearing loss
  • no previous hearing aid experience

Exclusion Criteria:

  • Non-native speaker of English

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03579563

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Contact: Yu-Hsiang Wu, PhD 319-335-8728
Contact: Elizabeth Stangl, AuD 31-335-9758

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United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Yu-Hsiang Wu, PhD         
United States, Tennessee
Vanderbilt University Medical Center Not yet recruiting
Nashville, Tennessee, United States, 37232
Contact: Todd Ricketts, PhD         
Sponsors and Collaborators
Yu-Hsiang Wu
Vanderbilt University Medical Center
National Institute on Deafness and Other Communication Disorders (NIDCD)
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Principal Investigator: Yu-Hsiang Wu, PhD University of Iowa
  Study Documents (Full-Text)

Documents provided by Yu-Hsiang Wu, University of Iowa:
Study Protocol and Informed Consent Form  [PDF] November 19, 2021


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Responsible Party: Yu-Hsiang Wu, Associate Professor, University of Iowa Identifier: NCT03579563    
Other Study ID Numbers: 201804771
1R01DC015997-01A1 ( U.S. NIH Grant/Contract )
First Posted: July 6, 2018    Key Record Dates
Last Update Posted: April 1, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The proposed research will include data from a total of 240 participants with hearing loss recruited State of Iowa, State of Tennessee and surrounding areas. The final dataset will include laboratory data (e.g., speech recognition score) and self-reported demographic and behavioral data (e.g., questionnaire). Contact the principle investigator for data access.
Time Frame: The date will be available starting 6 months after publication of the main findings of the trial.
Access Criteria: Even though the final dataset will be stripped of identifiers prior to release for sharing, there remains the possibility of deductive disclosure of subjects with the survey data being collected. Thus, we will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate technologies; and (3) a commitment to destroying or returning the data after analyses are completed.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yu-Hsiang Wu, University of Iowa:
Hearing aid
Additional relevant MeSH terms:
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Hearing Loss, Sensorineural
Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases