Longitudinal Outcomes of Hearing Aids

Presbycusis Clinical Trial

Official title:

Longitudinal Outcomes of Over-the-Counter Hearing Aids

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04030299
• Other study ID #: 201905847
• Secondary ID: R01DC015997-01A1
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: May 1, 2024

Study information

• Verified date: May 2023
• Source: University of Iowa
• Contact: Yu-Hsiang Wu, PhD
• Phone: 319-335-8728
• Email: yu-hsiang-wu[@]uiowa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Non-native speaker of English

Related Conditions & MeSH terms

• Presbycusis

Intervention

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.

Locations

Country	Name	City	State
United States	University of Iowa	Iowa City	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
Yu-Hsiang Wu	National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

References & Publications (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. — View 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. — View 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. — View Citation

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of 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 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.	Change between 6-week post intervention and 12-week post-intervention
Secondary	Change of Hearing aid performance/benefit as measured using the Profile of Hearing Aid Performance / Profile of Hearing Aid Benefit (PHAP / PHAB)	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 between 6-week post intervention and 12-week post-intervention
Secondary	Change of 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 24 (more handicap).	Change between 6-week post intervention and 12-week post-intervention
Secondary	Change of 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).	Change between 6-week post intervention and 12-week post-intervention
Secondary	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.	12-week post intervention
Secondary	Change of 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).	Change between 6-week post intervention and 12-week post-intervention
Secondary	Change of 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).	Change between 6-week post intervention and 12-week post-intervention
Secondary	Change of 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).	Change between 6-week post intervention and 12-week post-intervention
Secondary	Change of Hearing aid benefit as measured by the Glasgow Hearing Aid Benefit Profile (GHABP) (paper-and-pencil administration)	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.	Change between 6-week post intervention and 12-week post-intervention