Audiology Services via Telehealth for Hearing Loss in Aging

(ACHIEVE-HIFU Trial)

No longer recruiting at 3 trial locations

Overseen By Christine Mitchell, ScM

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Disability in ADLs, Vision impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 18

Duration: 1 year

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether telehealth (remote healthcare services) can improve hearing aid use and communication compared to traditional in-person visits. It involves two groups: one receiving hearing care through telehealth audiological rehabilitative service delivery and the other through clinic-based audiological rehabilitative service delivery. Both groups will have access to both methods over time. The trial seeks participants who have previously been part of the ACHIEVE study, are already using hearing aids, and agree to try either telehealth or in-person care. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance hearing care for many.

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 these audiological rehabilitative service delivery models are safe for older adults with hearing loss?

Research has shown that both telehealth and in-person audiology services are generally safe and well-received for hearing loss care. Telehealth enables remote appointments and provides results similar to in-person visits, effectively supporting hearing aid users without additional risks. Studies confirm that telehealth offers reliable hearing tests and treatments.

Traditional clinic visits remain a common method for managing hearing loss and are widely accepted in healthcare. They provide face-to-face interaction, which some patients prefer for personalized care. Both telehealth and clinic visits have demonstrated safety, giving patients the flexibility to choose their preferred method of receiving hearing care. No major problems have been reported with either approach. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it's exploring the use of telehealth to deliver audiology services for hearing loss in older adults. Unlike traditional methods where patients must visit the clinic for every session, telehealth allows for remote access to care, making it more convenient and accessible, especially for those with mobility issues or living in remote areas. This approach aims to maintain or even improve the quality of care while providing flexibility and reducing the need for frequent in-person visits. The trial could potentially reshape how audiological care is delivered by integrating modern technology into routine healthcare practices.

What evidence suggests that this trial's treatments could be effective for hearing loss in aging?

This trial compares clinic-based audiological rehabilitative service delivery with telehealth audiological rehabilitative service delivery for managing hearing loss in older adults. Research has shown that receiving hearing care at a clinic helps older adults manage hearing loss effectively, improving communication and boosting overall health. Studies have also found that telehealth services for hearing care are generally safe and work as well as in-person visits, providing reliable results for hearing tests and treatments. Both clinic visits and telehealth effectively address hearing issues, making either a good choice for managing hearing loss. ^{1 3 6 7 8}

Who Is on the Research Team?

Frank R Lin, MD, PhD

Principal Investigator

Johns Hopkins University

Victoria A Sanchez, AuD, PhD

Principal Investigator

University of South Florida

Are You a Good Fit for This Trial?

This trial is for older adults aged 70-84 with adult-onset hearing loss who previously participated in the ACHIEVE trial. They must have a mild to moderate hearing impairment and be open to using telehealth or clinic-based hearing care. Exclusions include severe vision impairment, recent use of hearing aids, unwillingness to wear them daily, certain ear conditions, and significant disability in daily activities.

Inclusion Criteria

I was part of the hearing intervention in the ACHIEVE trial.

You have moderate to severe hearing loss in your better ear.

Availability of participant in area for study duration

Exclusion Criteria

I am not willing to wear hearing aids every day.

I have hearing loss where sounds don't reach my inner ear well in both ears.

You have used a hearing aid in the last year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either telehealth or conventional clinic-based hearing healthcare services

1 year

Clinic-based visits every 6 months

Crossover

Participants in the conventional HHC arm cross-over to receive telehealth HHC

1 year

Clinic-based visits every 6 months

Follow-up

Participants are monitored for hearing aid use and communication outcomes

2 years

Data collection follow-up visits every 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Clinic-based audiological rehabilitative service delivery
• Telehealth audiological rehabilitative service delivery

Trial Overview The study compares two ways of delivering hearing healthcare: traditional in-clinic visits versus telehealth services. It aims to see if telehealth can improve how often older adults use their hearing aids and other communication outcomes compared to standard clinic visits.

How Is the Trial Designed?

Group I: Telehealth hearing healthcare group Experimental Treatment 1 Intervention

The telehealth hearing healthcare group will have clinic-based visits every 6 months for the duration of the 2-year study. This group will receive telehealth audiological rehabilitative service delivery and be able to utilize telehealth options, in addition to conventional options, to address any unanticipated needs that arise during both years of the study.

Group II: Conventional hearing healthcare group Experimental Treatment 2 Interventions

The conventional hearing healthcare group will have clinic-based visits every 6 months for the duration of the 2-year study. During Year 1, this group will receive clinic-based audiological rehabilitative service delivery and be able to use conventional options to address any unanticipated needs that arise, and then during Year 2, this group will also receive telehealth audiological rehabilitative service delivery and be able to utilize telehealth options, in addition to conventional options, to address any unanticipated needs that arise.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

NYU Langone Health

Collaborator

Trials

1,431

Recruited

838,000+

Wake Forest University

Collaborator

Trials

193

Recruited

151,000+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

University of North Carolina

Collaborator

Trials

174

Recruited

1,457,000+

University of South Florida

Collaborator

Trials

433

Recruited

198,000+

University of Mississippi Medical Center

Collaborator

Trials

185

Recruited

200,000+

University of Minnesota

Collaborator

Trials

1,459

Recruited

1,623,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12123699/

Age-Related Hearing Loss: Evidence-Based Strategies for ... Nationally, two-thirds of adults 70 years and older have a clinically significant hearing loss, increasing to >95% among individuals 90 years ...

2. withpower.com withpower.com/trial/phase-hearing-loss-9-2021-70ec1

Audiology Services via Telehealth for Hearing Loss in Aging Research shows that telehealth in audiology is generally safe and effective, providing reliable results for hearing tests and treatments similar to ...

3. researchprotocols.org researchprotocols.org/2025/1/e64115

Protocol for Randomized Controlled Trial Conclusions: The findings of this study will provide evidence for the impact and cost-effectiveness of a community-based auditory or hearing ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0020748925000598

Effects on health outcomes following a nurse-led hearing ... The sustained communication ability improvements at 3-month follow-up suggest hearing loss management programs positively impact the health of older adults with ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11010415/

Remote or in-clinic? The effect of service delivery mode on ... This study will investigate whether remote hearing aid fittings can provide clinically equivalent outcomes when compared to current, in-clinic, best practice ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK616586/

Outcomes for Hearing Health Interventions The most common treatment for sensorineural hearing loss involves amplifying the incoming signal to improve hearing function. This is accomplished most often ...

7. pubs.asha.org pubs.asha.org/doi/10.1044/2024_PERSP-23-00169

Navigating the Role of Mobile Audiology in Public Health Mobile audiology services may play a vital role in public health programs and initiatives by bringing hearing health care to underserved communities.

8. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/29/NCT05070429/Prot_000.pdf

Randomized Trial of Telehealth vs. Conventional Hearing ... The telehealth HHC service delivery model allows for remote access to HHC services and continuous support of participants' hearing loss needs ...