PresbycusisNCT04030299
Longitudinal Outcomes of Hearing Aids
A study testing Over-the-counter fitting in people with Presbycusis, run by Yu-Hsiang Wu at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Presbycusis
- What is being tested?
- Over-the-counter fitting
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2019to 1 Sep 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult-onset, bilateral, mild-to-moderately severe sensorineural hearing loss
Who cannot join
- Non-native speaker of English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Presbycusis
- Being tested
- Over-the-counter fitting
- Keywords
- Presbycusis, Hearing aid
- Medical subject headings
- Presbycusis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Over-the-counter fittingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| OTC Group | Experimental | In this group, the over-the-counter fitting will be used to provide hearing aids. Receives: Device: Over-the-counter fitting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-week, 6-week, and 12-week post-intervention
Secondary outcomes (7)
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).
Measured: 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).
Measured: 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).
Measured: 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..
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 1-week, 6-week, and 12-week post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study start1 Sep 2019
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for PresbycusisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yu-Hsiang Wu
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor-investigator, Yu-Hsiang Wu, University of Iowa
- Investigators
- Yu-Hsiang Wu, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04030299
- Sponsor's protocol ID
- 201905847
- Other IDs
- R01DC015997-01A1
- Status last verified
- Aug 2024
- First submitted
- 19 Jul 2019
- Last updated
- 13 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
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.
PubMed 20040828Lin 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.
PubMed 21357188Humes 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.
PubMed 28252160Brody 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.
PubMed 30458521Takahashi 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.
PubMed 17580727Gopinath 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.
PubMed 21514179
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Outcomes of Over-the-Counter Hearing Aids
- ClinicalTrials.gov ID
- NCT04030299
- Acronym / sponsor ID
- 201905847
- Conditions
- Presbycusis
- Keywords
- Presbycusis, Hearing aid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Yu-Hsiang WuUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 23 Jul 2019 (actual)
- Results
- Posted 13 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OTC Group | Experimental | Device: Over-the-counter fittingIn this group, the over-the-counter fitting will be used to provide hearing aids. |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult-onset, bilateral, mild-to-moderately severe sensorineural hearing loss
Key exclusion criteria (1 listed)
- Non-native speaker of English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Over-the-counter fittingIn 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. | Device | OTC Group |
Primary outcome
Hearing Aid Benefit as Measured by the Glasgow Hearing Aid Benefit Profile (GHABP)
Time frame: 1-week, 6-week, 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 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.
7 secondary outcomes
Hearing Aid Performance/Benefit as Measured Using the Profile of Hearing Aid Performance (PHAP)
Time frame: 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)
Time frame: 1-week, 6-week, and 12-week post-intervention
Hearing Aid Satisfaction as Measured by the Hearing Aid Satisfaction Survey (HASS)
Time frame: 1-week, 6-week, and 12-week post-intervention
Willingness-to-pay
Time frame: 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)
Time frame: 1-week, 6-week, and 12-week post-intervention
Hearing Aid Satisfaction as Measured by the Satisfaction With Amplification in Daily Life (SADL)
Time frame: 1-week, 6-week, and 12-week post-intervention
Speech Recognition Performance as Measured by the Connected Speech Test (CST)
Time frame: 1-week, 6-week, and 12-week post-intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20040828Donahue 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.
- Background: PubMed 21357188Lin 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.
- Background: PubMed 28252160Humes 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.
- Background: PubMed 30458521Brody 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.
- Background: PubMed 17580727Takahashi 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.
- Background: PubMed 21514179Gopinath 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu-Hsiang Wu, PhD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Over-the-counter fitting in people with Presbycusis, run by Yu-Hsiang Wu at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hearing Aid Benefit as Measured by the Glasgow Hearing Aid Benefit Profile (GHABP) (time frame: 1-week, 6-week, and 12-week post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04030299, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2024.