K-HEARS Interventions for Age-Related Hearing Loss

(K-HEARS Trial)

Overseen By Carrie L Nieman, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Current hearing aid use, Terminal illness, Others

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new hearing care method for older Korean Americans with hearing loss. The goal is to determine if a community-delivered program, which includes a low-cost hearing device (K-HEARS Sound Amplifier Intervention) and rehabilitation, can improve communication and enhance quality of life. Participants will begin treatment immediately or after six months, allowing researchers to compare outcomes. First-generation Korean Americans aged 60 or older with hearing loss who do not currently use a hearing aid might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to innovative hearing care solutions tailored for the community.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the K-HEARS interventions are safe for age-related hearing loss?

Studies have shown that hearing rehabilitation programs, such as the K-HEARS Intervention, help people use hearing aids more effectively and feel less impacted by hearing loss. Participants generally find these programs easy to handle, with few reports of serious side effects. Research has shown similar positive results for the K-HEARS Sound Amplifier Intervention. Specifically, a study found that older adults with hearing loss could use sound amplification devices safely, without major problems. Overall, these treatments appear safe and manageable for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for age-related hearing loss rely on hearing aids or cochlear implants to amplify sound or directly stimulate the auditory nerve. However, the K-HEARS interventions are unique because they focus on enhancing the natural hearing process through innovative sound amplification technology. Researchers are excited about these treatments because they could offer a more seamless and potentially less invasive alternative to traditional hearing aids. The K-HEARS Sound Amplifier Intervention, in particular, promises to provide customized sound enhancement, which may improve the overall listening experience for users compared to standard devices.

What evidence suggests that the K-HEARS interventions are effective for age-related hearing loss?

Studies have shown that the K-HEARS program can greatly improve communication and quality of life for older adults with hearing loss. Research indicates that hearing programs like K-HEARS help people hear better and feel less isolated. In this trial, participants will receive assignments to either an immediate treatment site or a delayed treatment site for the K-HEARS intervention. For the K-HEARS Sound Amplifier, studies show that these devices can make hearing problems seem less severe and improve emotional well-being. Hearing rehabilitation programs, including these, have proven to positively affect those with age-related hearing loss. ^{1 4 6 7 8}

Who Is on the Research Team?

Hae-Ra Han, PhD,RN

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for older Korean Americans and their care partners who are experiencing age-related hearing loss. Participants should be community-dwelling seniors interested in improving communication function and quality of life through a new hearing intervention.

Inclusion Criteria

Self-identified as first-generation KA in the target region

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

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Immediate Treatment

Participants receive the K-HEARS intervention immediately, which includes a low-cost over-the-counter amplification device and hearing rehabilitation

6 months

Regular community visits

Delayed Treatment

Participants receive the K-HEARS intervention after a 6-month delay, which includes a low-cost over-the-counter amplification device and hearing rehabilitation

6 months

Regular community visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• K-HEARS Intervention
• K-HEARS Sound Amplifier Intervention

Trial Overview The study tests the 'K-HEARS Intervention,' which includes an affordable over-the-counter sound amplifier and hearing rehabilitation, against a delayed treatment group to see if it improves communication and life quality.

How Is the Trial Designed?

Group I: Immediate Treatment Site Experimental Treatment 2 Interventions

Study site assigned to immediate treatment of K-HEARS intervention

Group II: Delayed Treatment Site Placebo Group 2 Interventions

Study site assigned to 6-month delayed treatment of K-HEARS intervention

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

Published Research Related to This Trial

The SMART study involves 145 participants aged 50 and older, assessing the impact of hearing aids and cochlear implants on various health outcomes related to hearing loss.

Participants with cochlear implants reported higher levels of loneliness and social isolation, as well as poorer hearing and communication abilities compared to those using hearing aids, highlighting the need for effective rehabilitative therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Studying Multiple Outcomes After Aural Rehabilitative Treatment Study: Study Design and Baseline Results. Li, L., Blake, C., Sung, Y., et al.[2020]

Citations

1. withpower.com withpower.com/trial/phase-age-related-hearing-impairment-2-2025-0acec

K-HEARS Interventions for Age-Related Hearing Loss ... The objective of this study is to test the effect of a community-delivered, affordable, and accessible hearing care intervention on improving communication ...

2. reporter.nih.gov reporter.nih.gov/project-details/8750157

Age-related hearing loss: Health services utilization and ... This project will use medical care administrative insurance billing data from older adults to compare accepted medical care quality measures between propensity- ...

3. academic.oup.com academic.oup.com/innovateage/article/8/Supplement_1/133/7936175

ADVANCING AFFORDABLE, ACCESSIBLE HEARING CARE ... The efficacy of the HEARS intervention was assessed through a randomized controlled trial (RCT) (JAMA, 2022) that demonstrated the intervention ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2826555

A Hearing Intervention and Health-Related Quality of Life ... Treatment of hearing loss could potentially improve health-related quality of life among older adults with hearing loss. The effect of hearing ...

5. frontiersin.org frontiersin.org/journals/aging/articles/10.3389/fragi.2024.1299964/full

Impact of hearing rehabilitation programs on presbycusis ... Hearing rehabilitation programs improve outcomes for hearing aid users with presbycusis, but their efficacy is influenced by various factors, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11532099/

Impact of hearing rehabilitation programs on presbycusis ... Hearing rehabilitation programs significantly improve hearing aid outcomes, reduce self-perceived hearing impairment, and alleviate negative emotional states ...

7. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT04030299

NCT04030299 | Longitudinal Outcomes of Hearing Aids 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 ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10849199/

Age-related hearing loss: An updated and comprehensive ... This paper reviews the updated literature, which targets current interventions for age-related hearing loss.