Longitudinal Outcomes of Hearing Aids
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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 Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Change of Hearing aid benefit as measured by the Glasgow Hearing Aid Benefit Profile (GHABP) [Change between 6-week post intervention and 12-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 an ecological momentary assessment methodology. The name of the mobile device app is AudioSense2. The score ranges from 0 (no benefit) to 5 (lots of benefit). The change in the score between 6-week and 12-week post intervention is the primary outcome.
Secondary Outcome Measures
- Change of Hearing aid performance/benefit as measured using the Profile of Hearing Aid Performance / Profile of Hearing Aid Benefit (PHAP / PHAB) [Change between 6-week post intervention and 12-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). The score difference between two PHAP (i.e., 6-week post intervention and 12-week post-intervention) is PHAB.
- Change of Hearing handicap as measured by Hearing Handicap Inventory for the Elderly (HHIE) or Hearing Handicap Inventory for Adults (HHIA) [Change between 6-week post intervention and 12-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).
- Change of Hearing aid satisfaction as measured by the Hearing Aid Satisfaction Survey (HASS) [Change between 6-week post intervention and 12-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 [12-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.
- Change of Quality of life as measured by the World Health Organization's Disability Assessment Schedule 2.0 (WHODAS 2.0) [Change between 6-week post intervention and 12-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).
- Change of Hearing aid satisfaction as measured by the Satisfaction with Amplification in Daily Life (SADL) [Change between 6-week post intervention and 12-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).
- Change of Speech recognition performance as measured by the Connected Speech Test (CST) [Change between 6-week post intervention and 12-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).
- Change of Hearing aid benefit as measured by the Glasgow Hearing Aid Benefit Profile (GHABP) (paper-and-pencil administration) [Change between 6-week post intervention and 12-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 paper-and-pencil format. he score ranges from 0 (no benefit) to 5 (lots of benefit). The change in the score between 6-week and 12-week post intervention is the primary outcome.
Eligibility Criteria
Criteria
Inclusion Criteria:
- adult-onset, bilateral, mild-to-moderately severe sensorineural hearing loss
Exclusion Criteria:
- Non-native speaker of English
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Iowa | Iowa City | Iowa | United States | 52242 |
Sponsors and Collaborators
- Yu-Hsiang Wu
- National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
- Principal Investigator: Yu-Hsiang Wu, PhD, University of Iowa
Study Documents (Full-Text)
More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 201905847
- R01DC015997-01A1