Impact of Hearing Aid Service-delivery Model and Technology on Patient Outcomes
NCT ID: NCT03579563
Last Updated: 2024-10-10
Study Results
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View full resultsBasic Information
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COMPLETED
NA
290 participants
INTERVENTIONAL
2019-02-22
2023-12-22
Brief Summary
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Recently, over-the-counter (OTC) hearing aids have become available. These hearing aids are cheaper and easier to get because people can buy them directly and fit them on their own without seeing a doctor. This is called the OTC service model in this study. Another service model that could be great is a "hybrid" service model, where professionals help fit the OTC hearing aids. This hybrid model can make hearing aids both affordable and high quality.
Studies have shown that the OTC service model works as well as the AUD service model. Additionally, other research has found no big differences in how well high-end and low-end hearing aids work for patients. However, no one has studied the different service models and technology levels together in one study, and no one has looked at how well the hybrid service model (called the OTC+ service model in this study) works.
The goal of this study is to find out how the different ways of fitting hearing aids (AUD, OTC+, and OTC) and the different technology levels (high-end and low-end) affect patient outcomes. The study will take place at two sites and will be a randomized controlled trial. Participants will be randomly assigned to one of six groups, which are combinations of the three service models and two technology levels. Measurements will be taken before the hearing aids are fitted and again six to seven weeks after fitting to see how well the hearing aids are working for the patients.
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Detailed Description
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Additionally, a variety of technologies and features have been implemented in HAs, including multi-channel wide dynamic range compression, directional microphones, noise reduction algorithms, and wireless functionality. These technologies have evolved from basic algorithms into more sophisticated and complex designs. The high-end technologies and features often make HAs more expensive, further exacerbating the accessibility and affordability issues of traditional hearing healthcare.
In recent years, over-the-counter (OTC) HAs have emerged as an alternative to address some of the affordability and accessibility issues of the AUD service. This direct-to-consumer model enables users to self-determine hearing loss, self-fit OTC HAs, and self-manage the device without the need for professional support. This direct-to-consumer model is referred to as the OTC service model. Additionally, it has been advocated that a hybrid service model, where professionals fit OTC HAs (referred to as the OTC+ service model), could offer affordable and quality amplification interventions.
Previous clinical trials have shown that the OTC service model yields outcomes comparable to the AUD service model. Furthermore, prior research has found no statistically significant or clinically important differences in patient outcomes between high-end and low-end HAs. However, no prior research has systematically examined the effectiveness of HA fitting service models and HA technology levels in the same study. Additionally, no prior research has investigated the patient outcomes of the OTC+ service model.
The objective of the study is to determine the effect of HA fitting services (AUD, OTC+, and OTC) and technology levels (high-end and low-end) on patient outcomes. This is a two-site randomized controlled trial. Participants will be randomly assigned to one of six parallel arms, which are factorial combinations of three service models (AUD, OTC+, and OTC) and two HA technology levels (high-end and low-end). Baseline measures will be administered before HA fitting and patient outcomes will be assessed six to seven weeks post-HA fitting.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
DOUBLE
Study Groups
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AUD/High-end
In this group, the audiologist-based fitting will be used to provide high-end hearing aids.
AUD fitting
Prescription hearing aids will be fitted by audiologists using established procedures.
High-end HA
High-end hearing aids will be used.
OTC+/High-end
In this group, audiologists will provide brief services to fit high-end OTC hearing aids
OTC+ fitting
Audiology professionals provide brief services to fit preset-based OTC hearing aids, which are simulated using prescription hearing aids.
High-end HA
High-end hearing aids will be used.
OTC/High-end
In this group, high-end OTC hearing aids will be provided to subjects.
OTC fitting
In this group, preset-based OTC hearing aids, which are simulated using prescription hearing aids, will be provided to subjects. Subjects will take the full initiative and responsibility for learning and using hearing aids.
High-end HA
High-end hearing aids will be used.
AUD/Low-end
In this group, the audiologist-based fitting will be used to provide low-end hearing aids.
AUD fitting
Prescription hearing aids will be fitted by audiologists using established procedures.
Low-end HA
Low-end hearing aids will be used.
OTC+/Low-end
In this group, audiologists will provide brief services to fit low-end OTC hearing aids.
OTC+ fitting
Audiology professionals provide brief services to fit preset-based OTC hearing aids, which are simulated using prescription hearing aids.
Low-end HA
Low-end hearing aids will be used.
OTC/Low-end
In this group, low-end OTC hearing aids will be provided to subjects.
OTC fitting
In this group, preset-based OTC hearing aids, which are simulated using prescription hearing aids, will be provided to subjects. Subjects will take the full initiative and responsibility for learning and using hearing aids.
Low-end HA
Low-end hearing aids will be used.
Interventions
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AUD fitting
Prescription hearing aids will be fitted by audiologists using established procedures.
OTC+ fitting
Audiology professionals provide brief services to fit preset-based OTC hearing aids, which are simulated using prescription hearing aids.
OTC fitting
In this group, preset-based OTC hearing aids, which are simulated using prescription hearing aids, will be provided to subjects. Subjects will take the full initiative and responsibility for learning and using hearing aids.
High-end HA
High-end hearing aids will be used.
Low-end HA
Low-end hearing aids will be used.
Eligibility Criteria
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Inclusion Criteria
* Puretone average across 500, 1000, 2000, and 4000 Hz between 25 and 55 dB HL
* Thresholds from 500-4000 Hz no poorer than 65 dB HL, with up to 2 thresholds outside this criterion by \< 10 dB still being eligible.
* no previous hearing aid experience
Exclusion Criteria
55 Years
85 Years
ALL
No
Sponsors
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Vanderbilt University Medical Center
OTHER
National Institute on Deafness and Other Communication Disorders (NIDCD)
NIH
Yu-Hsiang Wu
OTHER
Responsible Party
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Yu-Hsiang Wu
Associate Professor
Principal Investigators
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Yu-Hsiang Wu, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Iowa
Locations
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University of Iowa
Iowa City, Iowa, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Countries
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References
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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. doi: 10.1097/00003446-199210000-00013.
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. No abstract available.
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. doi: 10.3766/jaaa.18.4.6.
Wu YH, Stangl E, Branscome K, Oleson J, Ricketts T. Hearing Aid Service Models, Technology, and Patient Outcomes: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2025 Jul 1;151(7):684-692. doi: 10.1001/jamaoto.2025.1008.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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201804771
Identifier Type: -
Identifier Source: org_study_id
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