Accessible Hearing Care Interventions for Hearing Loss

Overseen By Marcia J Hay-McCutcheon, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama, Tuscaloosa

Disqualifiers: Severe cognitive impairment, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 14 weeks

210 Participants Needed

Trial Summary

What is the purpose of this trial?

This project will address quality of care issues associated with hearing loss in adults who have mild-to-moderate hearing loss and who have no access to hearing healthcare. Through the use of three different interventions involving over-the-counter hearing aids, it will lead to options that will increase access and affordability of hearing healthcare for adults with mild-to-moderate hearing loss.

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 data supports the effectiveness of this treatment for hearing loss?

Research shows that personal sound amplification products (PSAPs) and over-the-counter (OTC) hearing aids can be effective alternatives to traditional hearing aids, providing benefits in speech recognition and sound quality in real-world settings. These devices offer a low-cost solution for individuals with hearing loss, making hearing care more accessible. ^{1 2 3 4 5}

Is there any safety data available for over-the-counter hearing aids and personal sound amplification products?

The research articles provided do not contain specific safety data for over-the-counter hearing aids or personal sound amplification products. They focus on performance, effectiveness, and regulatory aspects. ^{1 2 3 6 7}

How is the treatment of hearing loss with PSAPs different from other treatments?

The treatment using Personal Sound Amplification Products (PSAPs) is unique because it offers a low-cost, over-the-counter option for individuals with hearing loss, allowing them to self-fit and adjust the devices without needing a professional audiologist. This makes it more accessible compared to traditional hearing aids, which typically require fitting and adjustment by a hearing care professional. ^{1 2 3 8 9}

Research Team

Marcia J Hay-McCutcheon, PhD

Principal Investigator

The University of Alabama, Tuscaloosa

Eligibility Criteria

This trial is for adults over 40 living in West Central or South Alabama who have mild-to-moderate hearing loss. It's not open to those with severe cognitive impairments from conditions like stroke, head injury, dementia, or Alzheimer's disease.

Inclusion Criteria

I am 40 years old or older.

I have some difficulty hearing.

You live in West Central or South Alabama.

Exclusion Criteria

I do not have severe cognitive issues from conditions like stroke or Alzheimer's.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive over-the-counter hearing aids and participate in aural rehabilitation programs as per their assigned group

14 weeks

Multiple visits for hearing evaluations and interventions

Follow-up

Participants are monitored for changes in hearing aid outcomes and quality of life

1 year

Annual assessment

Extension

Participants who complete the study in years 1 and 2 are invited back for additional testing

1 year

Treatment Details

Interventions

• Four Weeks of Aural Rehabilitation
• Hearing Evaluation
• Personal Sound Amplification Product (PSAP) Fitting and Orientation
• Provision of Personal Sound Amplification Products (PSAPs)

Trial Overview The study tests three interventions: providing personal sound amplification products (PSAPs), a four-week aural rehabilitation program, and PSAP fitting/orientation alongside regular hearing evaluations to improve hearing healthcare access and affordability.

Participant Groups

Group I: Audiology Best Practices plus Aural Rehabilitation (ABP+AR) Experimental Treatment 3 Interventions

This experimental group will receive a hearing evaluation, an over-the-counter hearing aid fitting and orientation, and four-weeks of an aural rehabilitation program conducted by specially-trained community health workers. Additionally, these adults will complete pre- and post-questionnaires and speech perception testing.

Group II: Over-the-Counter Only (OTC-Only) Active Control 2 Interventions

This comparison group of adults with hearing loss will receive a hearing evaluation. They will be provided with over-the-counter hearing aids but the audiologist will not assist with fitting the aids or providing an orientation. This arm mimics what would happen when a consumer privately purchases over-the-counter hearing aids. They will complete pre- and post-questionnaires and speech perception testing.

Group III: Audiology Best Practices (ABP) Active Control 2 Interventions

This comparison group of adults with hearing loss will receive a hearing evaluation and over-the-counter hearing aid fitting and orientation. The aural rehabilitation program will not be provided initially. These participants will complete pre- and post-questionnaires and speech perception testing.

Hearing Evaluation is already approved in United States for the following indications:

Approved in United States as OTC Hearing Aids for:

• Mild to moderate hearing loss in adults 18 years and older

Who Is Running the Clinical Trial?

University of Alabama, Tuscaloosa

Lead Sponsor

Trials

49

Recruited

17,900+

University of Alabama at Birmingham

Collaborator

Trials

1,677

Recruited

2,458,000+

Findings from Research

In a study involving 25 older adults with mild-to-moderate hearing loss, audiologist-fitted hearing aids provided significantly better speech recognition and reduced listening effort compared to self-adjusted personal sound amplification products (PSAPs).

While hearing aids offered superior audibility and performance, all PSAPs still improved speech recognition and listening effort compared to no amplification, making them a potential budget-friendly alternative for those unable to afford traditional hearing aids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comparison of Personal Sound Amplification Products and Hearing Aids in Ecologically Relevant Test Environments. Brody, L., Wu, YH., Stangl, E.[2022]

In a study of 56 participants with varying degrees of hearing loss, personal sound amplification products (PSAPs) performed similarly to basic and premium hearing aids (HAs) for individuals with mild to moderate hearing impairment, suggesting PSAPs could be a cost-effective alternative.

For participants with moderately severe hearing loss, premium HAs significantly outperformed both PSAPs and basic HAs, indicating that more advanced hearing aids are necessary for effective management of severe hearing loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Performance Evaluation of a Personal Sound Amplification Product vs a Basic Hearing Aid and a Premium Hearing Aid. Cho, YS., Park, SY., Seol, HY., et al.[2020]

Some direct-to-consumer hearing devices, like personal sound amplification products (PSAPs) and over-the-counter (OTC) hearing aids, can produce dangerously high sound levels, which may pose safety risks for users.

Despite lower satisfaction rates compared to professionally purchased hearing aids, OTC devices show potential benefits, especially when supported by hearing health care professionals, indicating a need for further research to better understand their efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applications of direct-to-consumer hearing devices for adults with hearing loss: a review. Manchaiah, V., Taylor, B., Dockens, AL., et al.[2018]

Some personal sound amplification products (PSAPs) can provide adequate amplification for common types of hearing loss, with two high-end PSAPs meeting all necessary electroacoustic tolerances in a controlled study.

In clinical tests, a representative PSAP (RPSAP) improved hearing compared to no device but performed slightly worse than conventional hearing aids, suggesting it may be a useful alternative for individuals with moderate hearing loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Personal Sound Amplification Products in Patients With Moderate Hearing Loss: A Pilot Study. Kim, GY., Kim, JS., Jo, M., et al.[2022]

The study revealed that the overall perception of personal sound amplification products (PSAPs) among 197 outpatient visitors was low, with a perception score of only 3.04 out of 5, indicating a need for better awareness and understanding of these devices.

There was a significant discrepancy in the expected price of PSAPs, with patients and caregivers expecting to pay around $933.9 per ear, while hearing specialists estimated the price to be much lower at $291.3 per ear, highlighting a gap in communication and expectations between these groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perception and expectations of personal sound amplification products in Korea: A hospital-based, multi-center, cross-sectional survey. Han, JS., Kim, Y., Park, MK., et al.[2022]

Over-the-counter hearing aids (OTC-HAs) and personal sound amplification products (PSAPs) showed larger deviations from amplification targets compared to prescription hearing aids (HAs), particularly for moderate to severe hearing loss, indicating they may be less effective for those with more significant hearing impairments.

For mild hearing loss, OTC-HAs and PSAPs could meet some prescriptive targets, but overall, half of these devices did not consistently perform well, suggesting that while they may be accessible, their efficacy compared to prescription devices is limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing Direct-to-Consumer Devices to Hearing Aids: Amplification Accuracy for Three Types of Hearing Loss. Sheffield, SW., Jacobs, M., Ellis, C., et al.[2023]

The introduction of over-the-counter (OTC) hearing aids by the FDA aims to improve accessibility and affordability for individuals with age-related hearing loss, addressing barriers like high costs and stigma.

Current research on OTC hearing aids is limited, highlighting the urgent need for independent studies to evaluate their effectiveness and inform clinical practices, especially for individuals with mild-to-moderate hearing loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prioritizing research on over-the-counter (OTC) hearing aids for age-related hearing loss. Manchaiah, V., Swanepoel, W., Sharma, A.[2023]

The introduction of hearables and over-the-counter (OTC) hearing aids is expected to significantly change the hearing health care market by addressing the unmet needs of various consumer segments, indicating a large potential market for hearables.

Despite the potential for OTC hearing aids, a survey revealed that about half of current and potential users are uncomfortable managing hearing-related tasks without professional help, suggesting that hearing care professionals will still play a crucial role in the adoption and success of these products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emerging Technologies, Market Segments, and MarkeTrak 10 Insights in Hearing Health Technology. Edwards, B.[2021]

In a study involving 40 adults with mild to moderately severe hearing loss, 55% successfully completed the self-fitting procedure for commercially available hearing aids, indicating a moderate level of efficacy for these devices.

Errors during the self-fitting process varied by experience level, with experienced users making more mistakes related to the hearing test and fine-tuning, while new users struggled more with physical customization and insertion, suggesting that tailored support and improved instructions could enhance user success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Self-Fitting Process with a Commercially Available Hearing Aid. Convery, E., Keidser, G., Seeto, M., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

A Comparison of Personal Sound Amplification Products and Hearing Aids in Ecologically Relevant Test Environments. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Clinical Performance Evaluation of a Personal Sound Amplification Product vs a Basic Hearing Aid and a Premium Hearing Aid. [2020]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Applications of direct-to-consumer hearing devices for adults with hearing loss: a review. [2018]

4. Korea (South) pubmed.ncbi.nlm.nih.gov

Feasibility of Personal Sound Amplification Products in Patients With Moderate Hearing Loss: A Pilot Study. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Perception and expectations of personal sound amplification products in Korea: A hospital-based, multi-center, cross-sectional survey. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Comparing Direct-to-Consumer Devices to Hearing Aids: Amplification Accuracy for Three Types of Hearing Loss. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Prioritizing research on over-the-counter (OTC) hearing aids for age-related hearing loss. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Emerging Technologies, Market Segments, and MarkeTrak 10 Insights in Hearing Health Technology. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Evaluation of the Self-Fitting Process with a Commercially Available Hearing Aid. [2022]