Cost-effective Hearing Aid Delivery Models

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ClinicalTrials.gov Identifier: NCT03579563

Recruitment Status : Recruiting

First Posted : July 6, 2018

Last Update Posted : April 27, 2021

See Contacts and Locations

Sponsor:

Collaborators:

Vanderbilt University Medical Center

National Institute on Deafness and Other Communication Disorders (NIDCD)

Information provided by (Responsible Party):

Yu-Hsiang Wu, University of Iowa

Study Description

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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Detailed Description:

Age-related hearing loss is a substantial national problem due to its high prevalence and significant psychosocial consequences. However, the adoption rate of the primary intervention of age-related hearing loss, i.e., hearing aids (HAs), is quite low (15-30%). One of the most commonly reported reasons that people do not seek HA intervention is the high cost of devices plus the costly professional (e.g., audiologist) fitting services. This type of intervention-HAs fitted using the audiologist-based service-delivery model (AUD model)-is considered to be the best practice for management of adults with hearing loss. Because the AUD model is unaffordable for many Americans who need HAs (64%), there has been increased advocacy for a variety of over-the-counter service-delivery models (OTC models). In 2010, 1.5 million Americans purchased amplification devices via OTC models to compensate for their impaired hearing.

Although the OTC models are gaining popularity and are regarded as an important option for promoting accessible and affordable hearing healthcare, major questions remain unanswered. Specifically, the OTC models proposed to date rely on assumptions that patients can appropriately self-diagnose, self-select, self-fit and (in some cases) self-adjust amplification. However, there is little data to support any of the underlying assumptions. A recent study suggests that the AUD model yields better outcomes than the OTC models, but it is unclear if a rigorous randomized controlled trial can replicate this result. Furthermore, 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. The central hypothesis is that an OTC model or a hybrid model is a viable solution for many, but not all, patients with mild-to-moderately-severe age-related hearing loss. Since the optimal OTC model and the definition of OTC amplification device is still in question, the investigators propose to focus on the role of professional services in the provision of cost-effective amplification. To answer the research questions, the investigators have designed procedures to implement an OTC model, in which research participants will take the full initiative and responsibility for learning and using amplification. The investigators then systematically add professional patient-centered services (e.g., device orientation and counselling) to the OTC model to create a hybrid model. Finally, the investigators add device-centered services (e.g., device adjustment under the guidance of real-ear measures) to the hybrid model to create an AUD model that serves as the control. The investigators will electronically configure HAs to simulate OTC devices (e.g., fixed frequency response) and will use the same devices as HAs in the AUD model. The investigators will conduct a two-site, randomized controlled study to document the intervention outcomes of these four models using a test battery that consists of behavioral and self-report measures. Several patient-centered variables, including degree and configuration of hearing loss, cognitive functions, and personality will be measured and used as candidacy predictors.

Aim 1. To determine the outcome, value, and candidacy of the OTC model relative to the AUD model. The OTC model excludes professional services and represents the simplest form of the OTC model (referred to as the OTC model). The AUD model, in which professionals will use a core set of best practices to fit entry-level HAs, likely represents the most cost-effective AUD model (referred to as the AUD model). Based on the preliminary data, it is hypothesized that the OTC model will yield poorer outcomes than the AUD model. The value, which will be compared using cost-effectiveness analysis, is less predictable because the model hypothesized to yield better outcomes is more expensive. The investigators further hypothesize that at least some patient-centered variables will be predictive of outcome difference between the models and thus can be used to help decide which model a patient should choose.

Aim 2. To determine the outcome, value, and candidacy of the hybrid model. The hybrid model is the OTC-Plus model, in which professionals provide streamlined services to fit OTC devices. It is hypothesized that the outcomes of the hybrid model will be poorer than the AUD model but better than the OTC model. Because the investigators are proposing a total of three levels of service (including no service), achieving this aim will also allow us to document the effect of professional service on outcome and value. It is hypothesized that professional services will contribute to outcomes, and that each increase in the level of professional service will lead to an incremental improvement in outcomes. The value of each level of service in the hybrid model is less predictable. It is also hypothesized that at least some patient-centered variables will predict equal outcomes for some individuals across hybrid and AUD models.

Study Design

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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 Genetics related topics: Age-related hearing loss

MedlinePlus related topics: Hearing Aids

U.S. FDA Resources

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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 :

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).
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).
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).
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).
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.
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).
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).

Eligibility Criteria

Information from the National Library of Medicine

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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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Non-native speaker of English

Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT03579563

Contacts

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Contact: Yu-Hsiang Wu, PhD	319-335-8728	yu-hsiang-wu@uiowa.edu
Contact: Elizabeth Stangl, AuD	31-335-9758	elizabeth-stangl@uiowa.edu

Locations

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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)

Investigators

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Principal Investigator:	Yu-Hsiang Wu, PhD	University of Iowa

More Information

Publications:

Abrams HB, Chisolm TH, McManus M, McArdle R. Initial-fit approach versus verified prescription: comparing self-perceived hearing aid benefit. J Am Acad Audiol. 2012 Nov-Dec;23(10):768-78. doi: 10.3766/jaaa.23.10.3.

Abrams HB, Hnath-Chisolm T, Guerreiro SM, Ritterman SI. The effects of intervention strategy on self-perception of hearing handicap. Ear Hear. 1992 Oct;13(5):371-7.

Bainbridge KE, Ramachandran V. Hearing aid use among older U.S. adults; the national health and nutrition examination survey, 2005-2006 and 2009-2010. Ear Hear. 2014 May-Jun;35(3):289-94. doi: 10.1097/01.aud.0000441036.40169.29.

Callaway SL, Punch JL. An electroacoustic analysis of over-the-counter hearing aids. Am J Audiol. 2008 Jun;17(1):14-24. doi: 10.1044/1059-0889(2008/003).

Donahue A, Dubno JR, Beck L. Guest editorial: accessible and affordable hearing health care for adults with mild to moderate hearing loss. Ear Hear. 2010 Feb;31(1):2-6. doi: 10.1097/AUD.0b013e3181cbc783.

Gopinath B, Schneider J, Hartley D, Teber E, McMahon CM, Leeder SR, Mitchell P. Incidence and predictors of hearing aid use and ownership among older adults with hearing loss. Ann Epidemiol. 2011 Jul;21(7):497-506. doi: 10.1016/j.annepidem.2011.03.005. Epub 2011 Apr 21.

Lin FR, Thorpe R, Gordon-Salant S, Ferrucci L. Hearing loss prevalence and risk factors among older adults in the United States. J Gerontol A Biol Sci Med Sci. 2011 May;66(5):582-90. doi: 10.1093/gerona/glr002. Epub 2011 Feb 27.

Takahashi G, Martinez CD, Beamer S, Bridges J, Noffsinger D, Sugiura K, Bratt GW, Williams DW. Subjective measures of hearing aid benefit and satisfaction in the NIDCD/VA follow-up study. J Am Acad Audiol. 2007 Apr;18(4):323-49.

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Responsible Party:	Yu-Hsiang Wu, Associate Professor, University of Iowa
ClinicalTrials.gov 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 27, 2021
Last Verified:	April 2021
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:


Presbycusis Hearing aid

Additional relevant MeSH terms:

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Presbycusis Hearing Loss, Sensorineural Hearing Loss Hearing Disorders Ear Diseases	Otorhinolaryngologic Diseases Sensation Disorders Neurologic Manifestations Nervous System Diseases

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