Accessible Hearing Care Interventions for Hearing Loss
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Alabama, Tuscaloosa
Disqualifiers: Severe cognitive impairment, others
No Placebo Group
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.
12345Is 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.
12367How 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.
12389Eligibility 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.
Trial 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
Participant Groups
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.
3Treatment groups
Experimental Treatment
Active Control
Group I: Audiology Best Practices plus Aural Rehabilitation (ABP+AR)Experimental Treatment3 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 Control2 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 Control2 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The University of AlabamaTuscaloosa, AL
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Who Is Running the Clinical Trial?
University of Alabama, TuscaloosaLead Sponsor
University of Alabama at BirminghamCollaborator
References
A Comparison of Personal Sound Amplification Products and Hearing Aids in Ecologically Relevant Test Environments. [2022]The aim of this study was to compare the benefit of self-adjusted personal sound amplification products (PSAPs) to audiologist-fitted hearing aids based on speech recognition, listening effort, and sound quality in ecologically relevant test conditions to estimate real-world effectiveness.
Clinical Performance Evaluation of a Personal Sound Amplification Product vs a Basic Hearing Aid and a Premium Hearing Aid. [2020]Hearing loss is a highly prevalent condition with multiple negative associated outcomes, yet few persons with hearing loss have hearing aids (HAs). Personal sound amplification products (PSAPs) could be an alternative low-cost solution to HAs, but data are lacking on the performance of PSAPs.
Applications of direct-to-consumer hearing devices for adults with hearing loss: a review. [2018]This systematic literature review is aimed at investigating applications of direct-to-consumer hearing devices for adults with hearing loss. This review discusses three categories of direct-to-consumer hearing devices: 1) personal sound amplification products (PSAPs), 2) direct-mail hearing aids, and 3) over-the-counter (OTC) hearing aids.
Feasibility of Personal Sound Amplification Products in Patients With Moderate Hearing Loss: A Pilot Study. [2022]This study was conducted to investigate the electroacoustic characteristics of personal sound amplification products (PSAPs), to identify whether PSAPs provide adequate gain and output for three common hearing loss (HL) configurations, and to compare the benefits of a representative PSAP (RPSAP) and a conventional hearing aid (HA) for clinical hearing outcomes as a pilot study.
Perception and expectations of personal sound amplification products in Korea: A hospital-based, multi-center, cross-sectional survey. [2022]The objective of this study was to investigate current perception and expected price of personal sound amplification products (PSAPs) and to analyze influencing factors through multi-center hospital-based surveys of outpatients, caregivers, and hearing experts.
Comparing Direct-to-Consumer Devices to Hearing Aids: Amplification Accuracy for Three Types of Hearing Loss. [2023]The U.S. Food and Drug Administration finalized regulations for over-the-counter hearing aids (OTC-HAs) on August 17, 2022. Little is known about the comparative performance of OTC-HAs and prescription HAs. This study compared amplification accuracy of prescription HAs and direct-to-consumer devices (DTCDs, including personal sound amplification products [PSAPs] and OTC-HAs).
Prioritizing research on over-the-counter (OTC) hearing aids for age-related hearing loss. [2023]Hearing aids are the most commonly used treatment for people with age-related hearing loss, however, hearing aid uptake is low, primarily due to high cost of the device, stigma, and a lack of perceived need. To address accessibility and affordability issues, the U.S. Food and Drug Administration created a new over-the-counter (OTC) hearing aid category. Various types of hearing devices are available for both individuals with hearing loss and for those with normal hearing, as hearing enhancement devices. Hearing aids (i.e., prescription hearing aids, self-fitting OTC hearing aids, and pre-set OTC hearing aids) are regulated by the FDA. The purpose of this article is to (a) provide a summary of existing research on direct-to-consumer (DTC) hearing devices such as Personal Sound Amplification Products (PSAPs) that informs OTC service delivery models; (b) provide an update on existing and ongoing randomized controlled trials on currently marketed OTC hearing aids; and (c) highlight the need for immediate research on OTC hearing aids and service delivery models to inform policy and clinical care. It remains to be seen what effect OTC hearing aids have on improving the uptake of hearing aids by individuals with mild-to-moderate hearing loss. However, there is scant research on all aspects of OTC hearing aids that are currently on the market. We conclude that high quality independent research must be prioritized to supplement evidence provided by the OTC hearing aid manufacturers for regulatory approval purposes.
Emerging Technologies, Market Segments, and MarkeTrak 10 Insights in Hearing Health Technology. [2021]Hearing health care is rapidly changing through innovation in technology, services, business models, and product categories. The introduction of hearables and over-the-counter (OTC) hearing aids in particular will change the market for hearing help and the role of the hearing care professionals (HCPs). This article focuses on how these products will be differentiated from HCP-fit hearing aids through their ability to address the unmet needs of different consumer segments within the population of people with hearing dysfunction. The unmet hearing needs of each segment are discussed, and the size of each segment estimated, demonstrating a large potential market for hearables and a smaller potential market for hearing aids than has been previously mentioned in the literature. The results from MarkeTrak 10's survey of consumers' attitudes toward an OTC model are reviewed, showing that approximately half of both hearing aid owners and nonowners are uncomfortable doing hearing- and hearing aid-related tasks on their own without the assistance of an HCP and would be unlikely to purchase OTC hearing aids if available today. MarkeTrak data are also shown that demonstrate that the majority of hearing aid and personal sound amplification product owners believe that the HCP helped or would have helped with their hearing devices. Finally, challenges to OTC hearing aids becoming successful are discussed.
Evaluation of the Self-Fitting Process with a Commercially Available Hearing Aid. [2022]Hearing aids and personal sound amplification products that are designed to be self-fitted by the user at home are becoming increasingly available in the online marketplace. While these devices are often marketed as a low-cost alternative to traditional hearing health-care, little is known about people's ability to successfully use and manage them. Previous research into the individual components of a simulated self-fitting procedure has been undertaken, but no study has evaluated performance of the procedure as a whole using a commercial product.