Age-related Hearing ImpairmentK-HEARSNCT06803394
Hearing Health Equity Through Accessible Research and Solutions for Korean Americans
A study testing K-HEARS Intervention and K-HEARS Sound Amplifier Intervention in people with Age-related Hearing Impairment and Personal Communication, run by Johns Hopkins University at 1 site in United States.
Trial summary
The objective of this study is to test the effect of a community-delivered, affordable, and accessible hearing care intervention on improving communication function and health-related quality of life among older Korean Americans (KA) and the older Korean American's care partners that integrates a low-cost… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Age-related Hearing Impairment, Personal Communication, Hearing Impairment
- What is being tested?
- K-HEARS Intervention and K-HEARS Sound Amplifier Intervention
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 800 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2025to 30 Sep 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
PARTICIPANT CRITERIA Participant inclusion criteria
- Self-identified as first-generation KA in the target region
- Age 60 years or older
- Has a communication partner who lives in the same household or has at least weekly interactions
- Screening audiometry Pure-tone audiometry (PTA)1,2,4 kilohertz (kHz) >25 decibel (dB) hearing loss (HL) in better ear
- Hearing handicap as measured by HHIE-S score >=8 Participant exclusion criteria
- Current use of hearing aid
- Medical contraindications to use amplification device (e.g., draining ear)
- Plan to move from the area within 6 months
- Active treatment for a terminal illness or in hospice
COMMUNICATION PARTNER CRITERIA Communication Partner inclusion criteria
- Age 18 years or older
- Able to read and speak Korean
- Lives with the older adult or has at least weekly interactions Communication Partner exclusion criteria
- Plan to move from the area within 6 months
- Active treatment for a terminal illness or in hospice
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
Johns Hopkins School of Nursing
Baltimore, Maryland, 21205
About this study
The objective of this study is to test the effect of a community-delivered, affordable, and accessible hearing care intervention on improving communication function and health-related quality of life among older Korean Americans (KA) and the older Korean American's care partners that integrates a low-cost over-the-counter amplification device and hearing rehabilitation in comparison to a 6-month delayed treatment group through a cluster randomized controlled study.
- Conditions
- Age-related Hearing Impairment, Personal Communication, Hearing Impairment, Hearing Loss, Community-dwelling Seniors, Korean
- Being tested
- K-HEARS Intervention, K-HEARS Sound Amplifier Intervention
- Medical subject headings
- Communication, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
K-HEARS InterventionBehavioural
Tailored aural rehabilitation for participant and care partner
K-HEARS Sound Amplifier InterventionDevice
Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Treatment Site | Experimental | Study site assigned to immediate treatment of K-HEARS intervention Receives: Behavioral: K-HEARS Intervention; Device: K-HEARS Sound Amplifier Intervention |
| Delayed Treatment Site | Placebo comparator | Study site assigned to 6-month delayed treatment of K-HEARS intervention Receives: Behavioral: K-HEARS Intervention; Device: K-HEARS Sound Amplifier Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hearing Handicap Inventory for the Elderly (HHIE-S) score
Score range 0-40. 0-8 suggests no hearing handicap 10-24 suggests mild-moderate hearing handicap 26-40 suggests significant hearing handicap.
Measured: Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group)
Secondary outcomes (2)
Third Party Disability as assessed by the Significant Other Scale for Hearing Disability (SOS-HEAR)
Third-party disability will be measured in communication partners using the Significant Other Scale for Hearing Disability (SOS-HEAR). Score range 0-104, with higher score more disability.
Measured: Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group)
Relationship Quality as assessed by the Mutuality Scale
Relationship quality will be measured using the Mutuality Scale among participants and communication partners. Score range 0-60, with higher score better relationship quality.
Measured: Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start9 Feb 2025
- Primary completion1 Feb 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-related Hearing ImpairmentStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
- Investigators
- Hae-Ra Han, PhD,RN, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06803394
- Sponsor's protocol ID
- IRB00406742
- Other IDs
- R01DC019686
- Acronym
- K-HEARS
- Status last verified
- Mar 2026
- First submitted
- 27 Jan 2025
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hearing Health Equity Through Accessible Research and Solutions for Korean Americans
- ClinicalTrials.gov ID
- NCT06803394
- Acronym / sponsor ID
- K-HEARS / IRB00406742
- Conditions
- Age-related Hearing Impairment, Personal Communication, Hearing Impairment, Hearing Loss, Community-dwelling Seniors, Korean
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 9 Feb 2025 (actual)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 31 Jan 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.
The objective of this study is to test the effect of a community-delivered, affordable, and accessible hearing care intervention on improving communication function and health-related quality of life among older Korean Americans (KA) and the older Korean American's care partners that integrates a low-cost over-the-counter amplification device and hearing rehabilitation in comparison to a 6-month delayed treatment group through a cluster randomized controlled study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Treatment Site | Experimental | Behavioral: K-HEARS Intervention, Device: K-HEARS Sound Amplifier InterventionStudy site assigned to immediate treatment of K-HEARS intervention |
| Delayed Treatment Site | Placebo comparator | Behavioral: K-HEARS Intervention, Device: K-HEARS Sound Amplifier InterventionStudy site assigned to 6-month delayed treatment of K-HEARS intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| K-HEARS InterventionTailored aural rehabilitation for participant and care partner | Behavioural | Delayed Treatment Site, Immediate Treatment Site |
| K-HEARS Sound Amplifier InterventionTailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation. | Device | Delayed Treatment Site, Immediate Treatment Site |
Primary outcome
Hearing Handicap Inventory for the Elderly (HHIE-S) score
Time frame: Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group)
Score range 0-40. 0-8 suggests no hearing handicap 10-24 suggests mild-moderate hearing handicap 26-40 suggests significant hearing handicap.
2 secondary outcomes
Third Party Disability as assessed by the Significant Other Scale for Hearing Disability (SOS-HEAR)
Time frame: Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group)
Relationship Quality as assessed by the Mutuality Scale
Time frame: Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group)
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 12 Mar 2026.
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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.
Hae-Ra Han, PhD,RN principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing K-HEARS Intervention and K-HEARS Sound Amplifier Intervention in people with Age-related Hearing Impairment and Personal Communication, run by Johns Hopkins University 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?
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: enrolling by invitation, as of the sponsor's last update on 12 Mar 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. Some participants in this study may receive a placebo. 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?
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 Handicap Inventory for the Elderly (HHIE-S) score (time frame: Baseline, 6 months post-intervention (Immediate Group). 6 months post-baseline (Delayed Group)). 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 12 Mar 2026.