Hearing Loss, Adult-OnsetNCT07288463
Hearing Loss and Brain Health Study
A study testing Over-The-Counter (OTC) hearing aid in people with Hearing Loss, Adult-Onset and Dementia, run by University of Southern California at 1 site in United States.
Trial summary
Hearing loss is a prevalent and modifiable risk factor for cognitive decline and dementia in older adults, yet access to hearing care remains limited. Over-the-counter (OTC) hearing aids represent a promising and scalable strategy to expand access, particularly for individuals at elevated risk for dementia who may… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Hearing Loss, Adult-Onset, Dementia
- What is being tested?
- Over-The-Counter (OTC) hearing aid
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2027to 30 Jun 2031
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >= 50 years
- Known APOE status
- Bilateral mild to moderate sensorineural hearing loss
- No current use of hearing aids or cochlear implants
- No diagnosis of dementia and able to provide informed consent
- Able to complete questionnaires and follow instructions in English
- Willing and able to comply with study procedures, follow-up visits, and hearing-aid use
Who cannot join
- Clinical diagnosis of dementia
- Severe or profound hearing loss
- Self-reported congenital hearing loss
- Absence of an ear canal due to medical conditions or prior surgical procedures
- unwillingness to wear OTC hearing aids regularly (>=4 hours/day)
- medical contraindication to use hearing aids (e.g., actively draining ear)
- Known retrocochlear pathology
- Severe uncorrected visual impairment or significant manual dexterity limitations that prevent handling the device
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Southern California
Los Angeles, California, 90066
Janet Choi, MD, 323-790-6788, choilab@usc.edu
About this study
Hearing loss is a prevalent and modifiable risk factor for cognitive decline and dementia in older adults, yet access to hearing care remains limited. Over-the-counter (OTC) hearing aids represent a promising and scalable strategy to expand access, particularly for individuals at elevated risk for dementia who may benefit most from earlier intervention. This pilot study aims to evaluate the feasibility and acceptability of OTC hearing aid use among older adults. Participants aged ≥50 years will undergo standardized hearing screening to identify bilateral, mild-to-moderate hearing loss. Eligible participants will be randomized to one of two sequences: (1) immediate intervention: 3-mo using OTC hearing aids or (2) waitlist control: 3-mo without devices followed by OTC hearing aid use after 3 months. Feasibility outcomes include study enrollment and retention, protocol adherence, and average daily device use determined by data-logging. Acceptability outcomes will be assessed using the International Outcome Inventory for Hearing Aids (IOI-HA), device satisfaction ratings, and participant intention to continue hearing-aid use. Hearing outcomes include validated questionnaires on hearing and listening efforts. Findings will inform the design of larger trials aimed at improving access to hearing care and promoting cognitive health.
- Conditions
- Hearing Loss, Adult-Onset, Dementia
- Being tested
- Over-The-Counter (OTC) hearing aid
- Medical subject headings
- Hearing Loss, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Over-The-Counter (OTC) hearing aidDevice
Over-The-Counter (OTC) hearing aid
| Study group | Role | What they receive |
|---|---|---|
| Immediate Intervention | Experimental | Immediate Intervention: 3-month of OTC hearing aid use Receives: Device: Over-The-Counter (OTC) hearing aid |
| Waitlist control | Active comparator | Waitlist control: Basic patient education on hearing loss without OTC hearing aid for 3 months, followed by OTC hearing aid fitting Receives: Device: Over-The-Counter (OTC) hearing aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility- Proportion of enrolled participants who complete all study periods
Feasibility- Proportion of enrolled participants who complete all study periods
Measured: Baseline, 3 months, and 6 months follow-up
Feasibility - Enrollment rate (% eligible who consent)
Feasibility - Enrollment rate (% eligible who consent)
Measured: Baseline
Feasibility - Study visit completion rate (% of planned visits completed)
Feasibility - Study visit completion rate (% of planned visits completed)
Measured: Baseline, 3 months, and 6 months follow-up
Feasibility - Frequency of device troubleshooting encounters
Feasibility - Frequency of device troubleshooting encounters
Measured: Baseline, 3 months, and 6 months follow-up
Feasibility - Percentage achieving >= 6hours/day of objective wear time
Feasibility - Percentage achieving >= 4hours/day of objective wear time
Measured: Baseline, 3 months, and 6 months follow-up
Feasibility - Hearing aid use adherence (mean daily wear time from data-logging)
Feasibility - Hearing aid use adherence (mean daily wear time from data-logging)
Measured: Baseline, 3 months, and 6 months follow-up
Feasibility - Protocol adherence rate (% completing scheduled assessments)
Feasibility - Protocol adherence rate (% completing scheduled assessments)
Measured: Baseline, 3 months, and 6 months follow-up
Feasibility - Retention rate (% completing follow-up visits)
Feasibility - Retention rate (% completing follow-up visits)
Measured: Baseline, 3 months, and 6 months follow-up
Acceptability - International Outcome Inventory for Hearing Aids
International Outcome Inventory for Hearing Aids (IOI-HA) The IOI-HA is a 7-item self-report questionnaire assessing hearing aid outcomes across domains including daily use, benefit, residual activity limitation, satisfaction, residual participation restriction, impact on others, and quality of life. Each item is scored on a 5-point Likert scale, with total scores ranging from 7 to 35. Higher scores indicate better hearing aid outcomes and greater perceived benefit/satisfaction.
Measured: Baseline, 3 months, and 6 months follow-up
Acceptability - Intention to continue use after study completion
Acceptability - Intention to continue use after study completion Participant-reported intention to continue hearing aid use after study completion will be assessed using a Likert-scale questionnaire. Responses are scored on a 5-point scale ranging from 1 to 5, with higher scores indicating greater willingness and acceptability for continued hearing aid use. Minimum score: 1; maximum score: 5. Higher scores represent better outcomes (greater intention to continue use).
Measured: Baseline, 3 months, and 6 months follow-up
Secondary outcomes (2)
Hearing Handicap Inventory - Screening Version
Hearing Handicap Inventory for the Elderly - Screening Version (HHIE-S) The HHIE-S is a 10-item self-report questionnaire assessing the emotional and social/situational effects of hearing loss in older adults. Total scores range from 0 to 40, with higher scores indicating greater perceived hearing handicap and worse hearing-related quality of life. Minimum score: 0; maximum score: 40. Higher scores represent worse outcomes.
Measured: Baseline, 3 months, and 6 months follow-up
Vanderbilt fatigue scale
Vanderbilt Fatigue Scale - Adult Hearing Loss (VFS-AHL) The Vanderbilt Fatigue Scale - Adult Hearing Loss (VFS-AHL) is a self-report measure assessing listening-related fatigue in adults with hearing loss. Scores are derived using item-response theory-based scoring and are typically transformed to a standardized scale ranging from approximately -2 to +2 logits, with higher scores indicating greater fatigue and worse outcomes. Higher scores represent worse listening-related fatigue.
Measured: Baseline, 3 months, and 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start1 Jul 2027 (estimated)
- Primary completion30 Jun 2030 (estimated)
- Study completion30 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, Adult-OnsetStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Janet Choi, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07288463
- Sponsor's protocol ID
- APP-25-05793
- Status last verified
- May 2026
- First submitted
- 15 Dec 2025
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: At this time, individual participant data (IPD) will not be shared. Because this is a small feasibility pilot study involving a high-risk population, and the primary study outcomes are feasibility and acceptability metrics rather than clinical endpoints, we do not anticipate that sharing individual-level data would provide meaningful scientific value.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hearing Loss and Brain Health Study
- ClinicalTrials.gov ID
- NCT07288463
- Acronym / sponsor ID
- APP-25-05793
- Conditions
- Hearing Loss, Adult-Onset, Dementia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 1 Jul 2027 (estimated)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 30 Jun 2031 (estimated)
- First posted
- 17 Dec 2025 (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 loss is a prevalent and modifiable risk factor for cognitive decline and dementia in older adults, yet access to hearing care remains limited. Over-the-counter (OTC) hearing aids represent a promising and scalable strategy to expand access, particularly for individuals at elevated risk for dementia who may benefit most from earlier intervention. This pilot study aims to evaluate the feasibility and acceptability of OTC hearing aid use among older adults. Participants aged ≥50 years will undergo standardized hearing screening to identify bilateral, mild-to-moderate hearing loss. Eligible participants will be randomized to one of two sequences: (1) immediate intervention: 3-mo using OTC hearing aids or (2) waitlist control: 3-mo without devices followed by OTC hearing aid use after 3 months. Feasibility outcomes include study enrollment and retention, protocol adherence, and average daily device use determined by data-logging. Acceptability outcomes will be assessed using the International Outcome Inventory for Hearing Aids (IOI-HA), device satisfaction ratings, and participant intention to continue hearing-aid use. Hearing outcomes include validated questionnaires on hearing and listening efforts. Findings will inform the design of larger trials aimed at improving access to hearing care and promoting cognitive health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Intervention | Experimental | Device: Over-The-Counter (OTC) hearing aidImmediate Intervention: 3-month of OTC hearing aid use |
| Waitlist control | Active comparator | Device: Over-The-Counter (OTC) hearing aidWaitlist control: Basic patient education on hearing loss without OTC hearing aid for 3 months, followed by OTC hearing aid fitting |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age >= 50 years
- Known APOE status
- Bilateral mild to moderate sensorineural hearing loss
- No current use of hearing aids or cochlear implants
- No diagnosis of dementia and able to provide informed consent
Key exclusion criteria (8 listed)
- Clinical diagnosis of dementia
- Severe or profound hearing loss
- Self-reported congenital hearing loss
- Absence of an ear canal due to medical conditions or prior surgical procedures
- unwillingness to wear OTC hearing aids regularly (>=4 hours/day)
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 (OTC) hearing aidOver-The-Counter (OTC) hearing aid | Device | Immediate Intervention, Waitlist control |
Primary outcome
Feasibility- Proportion of enrolled participants who complete all study periods
Time frame: Baseline, 3 months, and 6 months follow-up
Feasibility- Proportion of enrolled participants who complete all study periods
Feasibility - Enrollment rate (% eligible who consent)
Time frame: Baseline
Feasibility - Enrollment rate (% eligible who consent)
Feasibility - Study visit completion rate (% of planned visits completed)
Time frame: Baseline, 3 months, and 6 months follow-up
Feasibility - Study visit completion rate (% of planned visits completed)
Feasibility - Frequency of device troubleshooting encounters
Time frame: Baseline, 3 months, and 6 months follow-up
Feasibility - Frequency of device troubleshooting encounters
Feasibility - Percentage achieving >= 6hours/day of objective wear time
Time frame: Baseline, 3 months, and 6 months follow-up
Feasibility - Percentage achieving >= 4hours/day of objective wear time
Feasibility - Hearing aid use adherence (mean daily wear time from data-logging)
Time frame: Baseline, 3 months, and 6 months follow-up
Feasibility - Hearing aid use adherence (mean daily wear time from data-logging)
Feasibility - Protocol adherence rate (% completing scheduled assessments)
Time frame: Baseline, 3 months, and 6 months follow-up
Feasibility - Protocol adherence rate (% completing scheduled assessments)
Feasibility - Retention rate (% completing follow-up visits)
Time frame: Baseline, 3 months, and 6 months follow-up
Feasibility - Retention rate (% completing follow-up visits)
Acceptability - International Outcome Inventory for Hearing Aids
Time frame: Baseline, 3 months, and 6 months follow-up
International Outcome Inventory for Hearing Aids (IOI-HA) The IOI-HA is a 7-item self-report questionnaire assessing hearing aid outcomes across domains including daily use, benefit, residual activity limitation, satisfaction, residual participation restriction, impact on others, and quality of life. Each item is scored on a 5-point Likert scale, with total scores ranging from 7 to 35. Higher scores indicate better hearing aid outcomes and greater perceived benefit/satisfaction.
Acceptability - Intention to continue use after study completion
Time frame: Baseline, 3 months, and 6 months follow-up
Acceptability - Intention to continue use after study completion Participant-reported intention to continue hearing aid use after study completion will be assessed using a Likert-scale questionnaire. Responses are scored on a 5-point scale ranging from 1 to 5, with higher scores indicating greater willingness and acceptability for continued hearing aid use. Minimum score: 1; maximum score: 5. Higher scores represent better outcomes (greater intention to continue use).
2 secondary outcomes
Hearing Handicap Inventory - Screening Version
Time frame: Baseline, 3 months, and 6 months follow-up
Vanderbilt fatigue scale
Time frame: Baseline, 3 months, and 6 months follow-up
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 8 May 2026.
- Individual participant dataSharing planned: Undecided. At this time, individual participant data (IPD) will not be shared. Because this is a small feasibility pilot study involving a high-risk population, and the primary study outcomes are feasibility and acceptability metrics rather than clinical endpoints, we do not anticipate that sharing individual-level data would provide meaningful scientific value.
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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.
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 (OTC) hearing aid in people with Hearing Loss, Adult-Onset and Dementia, run by University of Southern California 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 7 inclusion and 8 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: opening soon, as of the sponsor's last update on 8 May 2026. 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?
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 Janet Choi, MD (323-790-6788, choilab@usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility- Proportion of enrolled participants who complete all study periods (time frame: Baseline, 3 months, and 6 months follow-up). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 May 2026.