Longitudinal Outcomes of Hearing Aids

Longitudinal Outcomes of Over-the-Counter Hearing Aids

Age-related hearing loss is a substantial national problem due to its high prevalence and significant psychosocial consequences. Although hearing aids (HAs) are the primary intervention for the management of age-related hearing loss, only 15-30% of those who could benefit from HAs actually seek them out. HA adoption rates are even worse for people with lower income and for racial and ethnic minorities. One of the most commonly reported reasons for people not seeking HA intervention is the high cost of HAs and the associated audiological fitting services. Because HAs fitted using the audiologist-based service-delivery model are unaffordable, more and more Americans (1.5 million in 2010) purchase amplification devices via over-the-counter (OTC) service-delivery 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, although there is some evidence supporting the effectiveness of OTC HAs, all previous studies measured short-term outcomes (e.g., 6 weeks). It is unknown what the long-term outcomes of OTC HAs would look like. The outcomes could improve across time because users may eventually figure out how to use HAs. On the other hand, the outcomes of OTC HAs could become poorer across time because, unlike traditional HA fitting, users do not have professionals to support them. Therefore, the overall goal of this project is to examine the longitudinal changes in OTC HA outcomes over 3 months.

Study Overview

• Status: Completed
• Conditions: Presbycusis
• Intervention / Treatment: Device: Over-the-counter fitting

Detailed Description

Although hearing aids (HAs) are the first treatment of choice for age-related hearing loss, only 15-30% of those older Americans who could benefit, actually seek HAs out and use them. HA adoption rates are even lower for people with lower income and for racial and ethnic minorities. Although the answer to why so few older adults seek or use amplification is multidimensional, one common thread is that many people believe that HAs fitted using the audiologist-based model cost too much. Therefore, it is not surprising that there has been increased advocacy for a variety of over-the-counter (OTC) service-delivery models, which have increasingly been identified as important options for managing mild-to-moderate age-related hearing loss.

Is the amplification intervention delivered using the OTC model an appropriate solution for age-related hearing loss? Although there is some evidence supporting the effectiveness of OTC HAs, all previous studies measured short-term outcomes (e.g., 6 weeks). It is unknown what the long-term outcomes of OTC HAs would look like. The purpose of this project is to examine the longitudinal changes in OTC HA outcomes over 3 months. Older adults with age-related hearing loss will be recruited. Pre-configured hearing aids (that simulate OTC hearing aids) will be provided to subjects. Subjects will take the full initiative and responsibility for learning and using hearing aids. HA outcomes will be measured at 6-week and 12-week post intervention.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Non-native speaker of English

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OTC Group; In this group, the over-the-counter fitting will be used to provide hearing aids.	Device: Over-the-counter fitting; In this group, pre-configured hearing aids, which simulate over-the-counter hearing aids, will be provided to subjects. Subjects will take the full initiative and responsibility for learning and using hearing aids.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hearing Aid Benefit as Measured by the Glasgow Hearing Aid Benefit Profile (GHABP)	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 score ranges from 0 (no benefit) to 5 (lots of benefit). The score at 1-week, 6-week and 12-week post intervention is the primary outcome.	1-week, 6-week, and 12-week post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hearing Aid Performance/Benefit as Measured Using the Profile of Hearing Aid Performance (PHAP)	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).	1-week, 6-week, and 12-week post-intervention
Hearing Handicap as Measured by Hearing Handicap Inventory for the Elderly (HHIE) or Hearing Handicap Inventory for Adults (HHIA)	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 100 (more handicap).	1-week, 6-week, and 12-week post-intervention
Hearing Aid Satisfaction as Measured by the Hearing Aid Satisfaction Survey (HASS)	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).	1-week, 6-week, and 12-week post-intervention
Willingness-to-pay	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-week and 12-week post intervention
Quality of Life as Measured by the World Health Organization's Disability Assessment Schedule 2.0 (WHODAS 2.0)	The WHODAS is a questionnaire designed to measure quality of life. The summary score ranges from 0 (No disability) to 100 (Full disability).	1-week, 6-week, and 12-week post-intervention
Hearing Aid Satisfaction as Measured by the Satisfaction With Amplification in Daily Life (SADL)	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).	1-week, 6-week, and 12-week post-intervention
Speech Recognition Performance as Measured by the Connected Speech Test (CST)	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).	1-week, 6-week, and 12-week post-intervention

Collaborators and Investigators

• Sponsor: Yu-Hsiang Wu
• Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)
• Investigators: Principal Investigator: Yu-Hsiang Wu, PhD, University of Iowa

Publications and helpful links

General Publications

• 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.
• Brody L, Wu YH, Stangl E. A Comparison of Personal Sound Amplification Products and Hearing Aids in Ecologically Relevant Test Environments. Am J Audiol. 2018 Dec 6;27(4):581-593. doi: 10.1044/2018_AJA-18-0027.
• Humes LE, Rogers SE, Quigley TM, Main AK, Kinney DL, Herring C. The Effects of Service-Delivery Model and Purchase Price on Hearing-Aid Outcomes in Older Adults: A Randomized Double-Blind Placebo-Controlled Clinical Trial. Am J Audiol. 2017 Mar 1;26(1):53-79. doi: 10.1044/2017_AJA-16-0111. Erratum In: Am J Audiol. 2019 Sep 13;28(3):730. doi: 10.1044/2019_AJA-19-0087.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): September 1, 2022

Study Registration Dates

• First Submitted: July 19, 2019
• First Submitted That Met QC Criteria: July 22, 2019
• First Posted (Actual): July 23, 2019

Study Record Updates

• Last Update Posted (Actual): August 13, 2024
• Last Update Submitted That Met QC Criteria: August 12, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Presbycusis; Hearing aid
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss, Sensorineural; Hearing Loss; Presbycusis
• Other Study ID Numbers: 201905847; R01DC015997-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The proposed research will include data from a total of 45 participants with hearing loss recruited State of Iowa 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.
• IPD Sharing Time Frame: The date will be available starting 6 months after publication of the main findings of the trial.
• IPD Sharing 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No