Impact of Hearing Aid Service-delivery Model and Technology on Patient Outcomes

NCT03579563 | Completed Results FDA Device

• 2 other identifiers: 2018047711R01DC015997-01A1
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 2

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.

Conditions

Presbycusis

Keywords

Presbycusis; Hearing aid

Outcome Measures

Primary Outcomes (2)

• Hearing Aid Use Measured Using In-situ Glasgow Hearing Aid Benefit Profile (EMA-GHABP-Use)

  The GHABP is a questionnaire that measures hearing aid (HA) users' listening experience in four situations: TV listening, small conversation in quiet, conversation in noise, and group conversation. The GHABP will be administered using smartphone-based Ecological Momentary Assessment (EMA) to collect in-situ reports. Scores from the items that evaluate patient's HA use are averaged across the four situations to form the EMA-GHABP-Use score. The score ranges from 1 (not use HA at all) to 5 (use HA all the time).

  7-weeks post-intervention

• Hearing Aid Benefit Measured Using In-situ Glasgow Hearing Aid Benefit Profile (EMA-GHABP-Global)

  The GHABP is a questionnaire that measures hearing aid (HA) users' listening experience in four situations: TV listening, small conversation in quiet, conversation in noise, and group conversation. The GHABP will be administered using smartphone-based Ecological Momentary Assessment (EMA) to collect in-situ reports. Scores from the items that evaluate a patient's hearing disability, hearing handicap, HA benefit, and HA satisfaction are averaged across the four situations to form the EMA-GHABP-Global score. The score ranges from 1 (poorer outcome) to 5 (better outcome).

  7-weeks post-intervention

Secondary Outcomes (6)

• Change of Hearing Aid Performance Measured Using the Profile of Hearing Aid Performance (PHAP)

  pre-intervention and 7 weeks post-intervention

• Change of Speech Recognition Performance as Measured by the Connected Speech Test (CST)

  pre-intervention and 6 weeks post-intervention

• Change of Hearing Handicap Measured by Hearing Handicap Inventory for the Elderly (HHIE) or Hearing Handicap Inventory for Adults (HHIA)

  pre-intervention and 7 weeks post-intervention

• Hearing Aid Use Measured Using Retrospective Glasgow Hearing Aid Benefit Profile (Retro-GHABP-Use)

  6-week post-intervention

• Hearing Aid Benefit Measured Using Retrospective Glasgow Hearing Aid Benefit Profile (Retro-GHABP-Global)

  6 weeks post-intervention

Study Arms (6)

AUD/High-end

ACTIVE COMPARATOR

In this group, the audiologist-based fitting will be used to provide high-end hearing aids.

Other: AUD fitting; Device: High-end HA

OTC+/High-end

EXPERIMENTAL

In this group, audiologists will provide brief services to fit high-end OTC hearing aids

Other: OTC+ fitting; Device: High-end HA

OTC/High-end

EXPERIMENTAL

In this group, high-end OTC hearing aids will be provided to subjects.

Other: OTC fitting; Device: High-end HA

AUD/Low-end

ACTIVE COMPARATOR

In this group, the audiologist-based fitting will be used to provide low-end hearing aids.

Other: AUD fitting; Device: Low-end HA

OTC+/Low-end

EXPERIMENTAL

In this group, audiologists will provide brief services to fit low-end OTC hearing aids.

Other: OTC+ fitting; Device: Low-end HA

OTC/Low-end

EXPERIMENTAL

In this group, low-end OTC hearing aids will be provided to subjects.

Other: OTC fitting; Device: Low-end HA

Interventions

AUD fitting OTHER

Prescription hearing aids will be fitted by audiologists using established procedures.

AUD/High-end; AUD/Low-end

OTC fitting OTHER

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.

OTC/High-end; OTC/Low-end

High-end HA DEVICE

High-end hearing aids will be used.

AUD/High-end; OTC+/High-end; OTC/High-end

Low-end HA DEVICE

Low-end hearing aids will be used.

AUD/Low-end; OTC+/Low-end; OTC/Low-end

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Non-native speaker of English

Sponsors & Collaborators

• Yu-Hsiang Wu: lead
• Vanderbilt University Medical Center: collaborator
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (2)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (9)

• 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.

  PMID: 23169194 BACKGROUND

• 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.

  PMID: 1487096 BACKGROUND

• 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.

  PMID: 24521924 BACKGROUND

• 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).

  PMID: 18519576 BACKGROUND

• 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.

  PMID: 20040828 BACKGROUND

• 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.

  PMID: 21514179 BACKGROUND

• 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.

  PMID: 21357188 BACKGROUND

• 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.

  PMID: 17580727 BACKGROUND

• 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.

  PMID: 40372746 DERIVED

MeSH Terms

Conditions

Presbycusis

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Firstly, the study used only one preset-based over-the-counter (OTC) device by simulation, which may not capture the variability and range of OTC hearing aids available on the market. Additionally, because participants were randomly assigned to intervention groups in the study, our OTC participants may not represent real-world users who actively choose OTC hearing aids. These limitations could affect the generalizability of study's findings.

Results Point of Contact

• Title: Dr. Yu-Hsiang Wu
• Organization: The University of Iowa

yu-hsiang-wu@uiowa.edu

319-3359758

Study Officials

• Yu-Hsiang Wu, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 25, 2018
• First Posted: July 6, 2018
• Study Start: February 22, 2019
• Primary Completion: December 22, 2023
• Study Completion: December 22, 2023
• Last Updated: October 10, 2024
• Results First Posted: October 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• 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.

Locations

US (2)