Clinical trial NCT03579563: Impact of Hearing Aid Service-delivery Model and Technology on Patient Outcomes
Official title: Impact of Hearing Aid Service-delivery Model and Technology on Patient Outcomes: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presbycusis
Keywords: Presbycusis
Hearing aid
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: Vanderbilt University Medical Center
name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2018-07-06
Enrollment: 290
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Age-related hearing loss is a big problem in the United States because many people have it and it affects their quality of life. Hearing aids can help, but not many people use them. One reason is that getting hearing aids can be expensive and difficult. People usually have to visit doctors, like audiologists, many times to get their hearing tested and have the hearing aids fitted and adjusted. This process is called the AUD service model in this study. Hearing aids come with different technologies and features, like directional microphones and noise reduction algorithms. These features can make hearing aids work better but also make them more expensive, which can be another barrier for people who need them.

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.

Detailed description: Age-related hearing loss presents a significant national challenge due to its high prevalence and significant quality-of-life consequences. Although hearing aids (HAs) are the primary choice for managing age-related hearing loss, their adoption rate remains low. One commonly reported reason for not adopting HAs is the financial and physical barriers associated with traditional hearing healthcare, which involves multiple visits to licensed professionals (such as audiologists) for diagnosis and a lengthy process of fitting and fine-tuning prescription HAs. This traditional service-delivery model is referred to as the AUD service model.

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.

Eligibility criteria: Inclusion Criteria:

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

  * 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:

* Non-native speaker of English

Primary outcomes:
measure: Hearing Aid Use Measured Using In-situ Glasgow Hearing Aid Benefit Profile (EMA-GHABP-Use)
timeFrame: 7-weeks post-intervention
measure: Hearing Aid Benefit Measured Using In-situ Glasgow Hearing Aid Benefit Profile (EMA-GHABP-Global)
timeFrame: 7-weeks post-intervention
Secondary outcomes:
measure: Change of Hearing Aid Performance Measured Using the Profile of Hearing Aid Performance (PHAP)
timeFrame: pre-intervention and 7 weeks post-intervention
measure: Change of Speech Recognition Performance as Measured by the Connected Speech Test (CST)
timeFrame: pre-intervention and 6 weeks post-intervention
measure: Change of Hearing Handicap Measured by Hearing Handicap Inventory for the Elderly (HHIE) or Hearing Handicap Inventory for Adults (HHIA)
timeFrame: pre-intervention and 7 weeks post-intervention
measure: Hearing Aid Use Measured Using Retrospective Glasgow Hearing Aid Benefit Profile (Retro-GHABP-Use)
timeFrame: 6-week post-intervention
measure: Hearing Aid Benefit Measured Using Retrospective Glasgow Hearing Aid Benefit Profile (Retro-GHABP-Global)
timeFrame: 6 weeks post-intervention
measure: Hearing Aid Satisfaction as Measured by the Satisfaction With Amplification in Daily Life (SADL)
timeFrame: 7-week post-intervention
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: University of Iowa
name: Yu-Hsiang Wu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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).
citation: 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.
citation: 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.
citation: 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.
citation: 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.