Hearing Loss, SensorineuralNCT06499805
Barriers and Facilitators to OTC Hearing Aids Success
A study testing Audiologist-based fitting and Over-the-counter fitting in people with Hearing Loss, Sensorineural and Presbycusis, run by Yu-Hsiang Wu at 2 sites in United States.
Trial summary
Hearing aids can improve hearing, communication, and overall quality of life for people with hearing loss. However, not many people use hearing aids. A common reason is that hearing aids are expensive and hard to get. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Hearing Loss, Sensorineural, Presbycusis
- What is being tested?
- Audiologist-based fitting and Over-the-counter fitting
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Mar 2025to 1 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult-onset, perceived bilateral mild-to-moderate hearing loss
- no previous hearing aid experience
Who cannot join
- Non-native speaker of English
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Iowa
Iowa City, Iowa, 52242
Yu-Hsiang Wu, PhD
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Todd Ricketts, PhD
About this study
Hearing aids can improve hearing, communication, and overall quality of life for people with hearing loss. However, not many people use hearing aids. A common reason is that hearing aids are expensive and hard to get. The traditional way to get hearing aids involves multiple visits to licensed audiologists for identifying hearing loss, customizing the aids, and ongoing maintenance. This traditional method is called the AUD pathway.
Over-the-counter (OTC) hearing aids offer a different approach. They aim to make hearing aids more affordable and accessible, encouraging earlier use. In the OTC pathway, users diagnose their own hearing loss and fit and program the hearing aids themselves. Little is known about long-term effects of OTC hearing aids on users.
Read more
This study aims to compare the experiences of people who choose the OTC pathway with those who choose the AUD pathway. It takes place in two locations: Iowa City, IA, and Nashville, TN. Participants, who have mild-to-moderate hearing loss, choose their preferred pathway and are followed for 12 months. In the OTC pathway, participants buy their hearing aids directly from OTC companies or retailers. In the AUD pathway, prescription hearing aids and fitting services are provided by audiology clinics at the University of Iowa and Vanderbilt University Medical Center.
Participants are contacted 1, 6, and 12 months after starting to use their hearing aids. Researchers measure their satisfaction about hearing aids and other outcomes. If participants stop using their hearing aids, researchers assess their engagement with post-amplification hearing care. The results from both pathways are then compared.
Read the detailed description
Although hearing aids (HAs) can improve hearing ability, communication, social and emotional function, and quality of life for people with hearing loss, the adoption rate of HAs is low. A commonly reported barrier to HA uptake is that HAs are not affordable or accessible under the traditional service delivery model, which requires multiple visits to licensed audiologists for identification of hearing loss, customization of the HAs, and continual maintenance and fine-tuning. This hearing healthcare pathway is referred to as the AUD pathway. As an alternative, over-the-counter (OTC) HAs aim to promote earlier HA adoption and improve HA affordability and accessibility. In this healthcare pathway, referred to as the OTC pathway, users self-diagnose hearing loss and fit and program their OTC HAs. Although prior research has supported the feasibility of HA self-fitting and the OTC service-delivery model, little is known about how the OTC pathway impacts users' long-term well-being.
The goal of this study is to characterize the patient journey of individuals who opt for the OTC pathway in comparison to those who select the AUD pathway. The study is a two-site (Iowa City, IA, and Nashville, TN) longitudinal study in which participants choose their preferred healthcare pathways (OTC vs. AUD), and their HA outcomes are tracked for 12 months. Adults with bilateral mild-to-moderate hearing loss are recruited from the community. Upon entering the study, participants choose their preferred pathway and then proceed with the purchase of HAs. In the OTC pathway, participants purchase their chosen OTC HAs directly from OTC companies or retailers. In the AUD pathway, prescription HAs and fitting services are offered by the audiology clinics at the University of Iowa and Vanderbilt University Medical Center. Participants are contacted 1, 6, and 12 months after they begin using their HAs. During each contact, HA outcomes (e.g., HA satisfaction) are measured if participants continue using HAs. If participants have abandoned or under-utilized their HAs, their engagement with post-amplification hearing healthcare behaviors (e.g., seeking HAs again) is assessed. The data from the OTC and AUD pathways are then compared.
- Conditions
- Hearing Loss, Sensorineural, Presbycusis
- Being tested
- Audiologist-based fitting, Over-the-counter fitting
- Medical subject headings
- Hearing Loss, Sensorineural, Presbycusis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audiologist-based fittingDevice
Description hearing aids will be fitted by audiologists using established procedures.
Over-the-counter fittingDevice
In this group, over-the-counter hearing aids will be used by subjects. Subjects will take the full initiative and responsibility for learning and using hearing aids.
| Study group | Role | What they receive |
|---|---|---|
| AUD (audiologist-based) | Active comparator | In this group, the audiologist-based fitting will be used to provide prescription hearing aids. Receives: Device: Audiologist-based fitting |
| OTC (over-the-counter) | Experimental | In this group, over-the-counter fitting will be used to provide over-the-counter 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 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-, 6-, and 12-month post-intervention
Secondary outcomes (5)
Overall hearing aid outcome as measured by the International Outcome Inventory for Hearing Aids (IOI-HA)
The IOI-HA is a questionnaire designed to measures hearing aid outcome across multiple domains, including hearing aid use time and satisfaction. The score ranges from 1 (poor outcome) to 5 (great outcome).
Measured: 1-, 6-, and 12-month post-intervention
Aided hearing-specific quality of life as measured by the the Revised Hearing Handicap Inventory (RHHI).
The RHHI is designed to measure subject's hearing-specific quality of life (i.e., perceived hearing handicap). The score ranges from 0 (no handicap) to 24 (more handicap).
Measured: 1-, 6-, and 12-month post-intervention
Hearing aid related issues as measured by the Hearing Aid Issues Survey
This questionnaire asks participants to report the frequency of occurrence of 15 common device-related issues (e.g., "whistles", "device hurts ear", and ?too loud?) using a 5-point Likert scale. The score ranges from 15 (no issues) to 75 (more issue).
Measured: 1-, 6-, and 12-month post-intervention
Hearing aid success as measured by the HA Use Questionnaire
This instrument has three hearing aid use patterns to choose from: full-time use (whenever hearing aids are needed, score=3), part-time use (occasional use, score=2), and non-use (score=1).
Measured: 1-, 6-, and 12-month post-intervention
Engagement with post-amplification hearing healthcare behaviors measured by the Hearing Healthcare Behavior Questionnaire
This questionnaire measures the participants' engagement with hearing healthcare behaviors after they have abandoned or under-utilized the study HAs (e.g., seeking HAs again). The score ranges from 0 (no engagement) to 1 (full engagement).
Measured: 1-, 6-, and 12-month post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start15 Mar 2025
- Primary completion1 Apr 2029 (estimated)
- Study completion1 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Hearing Loss, SensorineuralStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yu-Hsiang Wu
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), Vanderbilt University Medical Center, University of Manchester
- 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
- NCT06499805
- Sponsor's protocol ID
- 202404595
- Other IDs
- R01DC015997
- Status last verified
- Oct 2026
- First submitted
- 5 Jul 2024
- Last updated
- 2 Nov 2026
- Results posted
- No
- 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 360 participants with hearing loss recruited State of Iowa, State of Tennessee and surrounding areas. The final dataset will include self-reported hearing aid outcome data. All datasets and metadata that can be shared will be deposited in the Inter-University Consortium for Political and Social Research (ICPSR).
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.
PubMed 30458521Chien W, Lin FR. Prevalence of hearing aid use among older adults in the United States. Arch Intern Med. 2012 Feb 13;172(3):292-3. doi: 10.1001/archinternmed.2011.1408. No abstract available.
PubMed 22332170Gopinath 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 21514179Humes 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 28252160Lin FR, Niparko JK, Ferrucci L. Hearing loss prevalence in the United States. Arch Intern Med. 2011 Nov 14;171(20):1851-2. doi: 10.1001/archinternmed.2011.506. No abstract available.
PubMed 22083573Nelson PB, Perry TT, Gregan M, VanTasell D. Self-Adjusted Amplification Parameters Produce Large Between-Subject Variability and Preserve Speech Intelligibility. Trends Hear. 2018 Jan-Dec;22:2331216518798264. doi: 10.1177/2331216518798264.
PubMed 30191767Urbanski D, Hernandez H, Oleson J, Wu YH. Toward a New Evidence-Based Fitting Paradigm for Over-the-Counter Hearing Aids. Am J Audiol. 2021 Mar 10;30(1):43-66. doi: 10.1044/2020_AJA-20-00085. Epub 2020 Dec 1.
PubMed 33264578
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Barriers and Facilitators to OTC Hearing Aids Success
- ClinicalTrials.gov ID
- NCT06499805
- Acronym / sponsor ID
- 202404595
- Conditions
- Hearing Loss, Sensorineural, Presbycusis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Yu-Hsiang WuUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD), Vanderbilt University Medical Center, University of Manchester
- Study start
- 15 Mar 2025 (actual)
- Primary completion
- 1 Apr 2029 (estimated)
- Study completion
- 1 Apr 2029 (estimated)
- First posted
- 12 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hearing aids can improve hearing, communication, and overall quality of life for people with hearing loss. However, not many people use hearing aids. A common reason is that hearing aids are expensive and hard to get. The traditional way to get hearing aids involves multiple visits to licensed audiologists for identifying hearing loss, customizing the aids, and ongoing maintenance. This traditional method is called the AUD pathway.
Over-the-counter (OTC) hearing aids offer a different approach. They aim to make hearing aids more affordable and accessible, encouraging earlier use. In the OTC pathway, users diagnose their own hearing loss and fit and program the hearing aids themselves. Little is known about long-term effects of OTC hearing aids on users.
This study aims to compare the experiences of people who choose the OTC pathway with those who choose the AUD pathway. It takes place in two locations: Iowa City, IA, and Nashville, TN. Participants, who have mild-to-moderate hearing loss, choose their preferred pathway and are followed for 12 months. In the OTC pathway, participants buy their hearing aids directly from OTC companies or retailers. In the AUD pathway, prescription hearing aids and fitting services are provided by audiology clinics at the University of Iowa and Vanderbilt University Medical Center.
Participants are contacted 1, 6, and 12 months after starting to use their hearing aids. Researchers measure their satisfaction about hearing aids and other outcomes. If participants stop using their hearing aids, researchers assess their engagement with post-amplification hearing care. The results from both pathways are then compared.
Detailed description
Although hearing aids (HAs) can improve hearing ability, communication, social and emotional function, and quality of life for people with hearing loss, the adoption rate of HAs is low. A commonly reported barrier to HA uptake is that HAs are not affordable or accessible under the traditional service delivery model, which requires multiple visits to licensed audiologists for identification of hearing loss, customization of the HAs, and continual maintenance and fine-tuning. This hearing healthcare pathway is referred to as the AUD pathway. As an alternative, over-the-counter (OTC) HAs aim to promote earlier HA adoption and improve HA affordability and accessibility. In this healthcare pathway, referred to as the OTC pathway, users self-diagnose hearing loss and fit and program their OTC HAs. Although prior research has supported the feasibility of HA self-fitting and the OTC service-delivery model, little is known about how the OTC pathway impacts users' long-term well-being.
The goal of this study is to characterize the patient journey of individuals who opt for the OTC pathway in comparison to those who select the AUD pathway. The study is a two-site (Iowa City, IA, and Nashville, TN) longitudinal study in which participants choose their preferred healthcare pathways (OTC vs. AUD), and their HA outcomes are tracked for 12 months. Adults with bilateral mild-to-moderate hearing loss are recruited from the community. Upon entering the study, participants choose their preferred pathway and then proceed with the purchase of HAs. In the OTC pathway, participants purchase their chosen OTC HAs directly from OTC companies or retailers. In the AUD pathway, prescription HAs and fitting services are offered by the audiology clinics at the University of Iowa and Vanderbilt University Medical Center. Participants are contacted 1, 6, and 12 months after they begin using their HAs. During each contact, HA outcomes (e.g., HA satisfaction) are measured if participants continue using HAs. If participants have abandoned or under-utilized their HAs, their engagement with post-amplification hearing healthcare behaviors (e.g., seeking HAs again) is assessed. The data from the OTC and AUD pathways are then compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AUD (audiologist-based) | Active comparator | Device: Audiologist-based fittingIn this group, the audiologist-based fitting will be used to provide prescription hearing aids. |
| OTC (over-the-counter) | Experimental | Device: Over-the-counter fittingIn this group, over-the-counter fitting will be used to provide over-the-counter hearing aids. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adult-onset, perceived bilateral mild-to-moderate hearing loss
- no previous hearing aid experience
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 |
|---|---|---|
| Audiologist-based fittingDescription hearing aids will be fitted by audiologists using established procedures. | Device | AUD (audiologist-based) |
| Over-the-counter fittingIn this group, over-the-counter hearing aids will be used by subjects. Subjects will take the full initiative and responsibility for learning and using hearing aids. | Device | OTC (over-the-counter) |
Primary outcome
Hearing aid satisfaction as measured by the Satisfaction with Amplification in Daily Life (SADL)
Time frame: 1-, 6-, and 12-month 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).
5 secondary outcomes
Overall hearing aid outcome as measured by the International Outcome Inventory for Hearing Aids (IOI-HA)
Time frame: 1-, 6-, and 12-month post-intervention
Aided hearing-specific quality of life as measured by the the Revised Hearing Handicap Inventory (RHHI).
Time frame: 1-, 6-, and 12-month post-intervention
Hearing aid related issues as measured by the Hearing Aid Issues Survey
Time frame: 1-, 6-, and 12-month post-intervention
Hearing aid success as measured by the HA Use Questionnaire
Time frame: 1-, 6-, and 12-month post-intervention
Engagement with post-amplification hearing healthcare behaviors measured by the Hearing Healthcare Behavior Questionnaire
Time frame: 1-, 6-, and 12-month post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- 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 22332170Chien W, Lin FR. Prevalence of hearing aid use among older adults in the United States. Arch Intern Med. 2012 Feb 13;172(3):292-3. doi: 10.1001/archinternmed.2011.1408. No abstract available.
- 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.
- 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 22083573Lin FR, Niparko JK, Ferrucci L. Hearing loss prevalence in the United States. Arch Intern Med. 2011 Nov 14;171(20):1851-2. doi: 10.1001/archinternmed.2011.506. No abstract available.
- Background: PubMed 30191767Nelson PB, Perry TT, Gregan M, VanTasell D. Self-Adjusted Amplification Parameters Produce Large Between-Subject Variability and Preserve Speech Intelligibility. Trends Hear. 2018 Jan-Dec;22:2331216518798264. doi: 10.1177/2331216518798264.
- Background: PubMed 33264578Urbanski D, Hernandez H, Oleson J, Wu YH. Toward a New Evidence-Based Fitting Paradigm for Over-the-Counter Hearing Aids. Am J Audiol. 2021 Mar 10;30(1):43-66. doi: 10.1044/2020_AJA-20-00085. Epub 2020 Dec 1.
- Individual participant dataSharing planned: Yes. The proposed research will include data from a total of 360 participants with hearing loss recruited State of Iowa, State of Tennessee and surrounding areas. The final dataset will include self-reported hearing aid outcome data. All datasets and metadata that can be shared will be deposited in the Inter-University Consortium for Political and Social Research (ICPSR).
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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.
Yu-Hsiang Wu, PhD principal investigator
University of Iowa
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Audiologist-based fitting and Over-the-counter fitting in people with Hearing Loss, Sensorineural and Presbycusis, run by Yu-Hsiang Wu at 2 sites 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 2 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: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yu-Hsiang Wu, PhD (319-335-8728, yu-hsiang-wu@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hearing aid satisfaction as measured by the Satisfaction with Amplification in Daily Life (SADL) (time frame: 1-, 6-, and 12-month 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 NCT06499805, which also lists 7 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 2 Nov 2026.