360 Participants Needed

OTC vs Prescription Hearing Aids for Hearing Loss

Recruiting at 1 trial location
ES
YW
Overseen ByYu-Hsiang Wu, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Yu-Hsiang Wu
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

Hearing aids can improve hearing, communication, and overall quality of life for people with hearing loss. However, not many people use hearing aids. A common reason is that hearing aids are expensive and hard to get. The traditional way to get hearing aids involves multiple visits to licensed audiologists for identifying hearing loss, customizing the aids, and ongoing maintenance. This traditional method is called the AUD pathway. Over-the-counter (OTC) hearing aids offer a different approach. They aim to make hearing aids more affordable and accessible, encouraging earlier use. In the OTC pathway, users diagnose their own hearing loss and fit and program the hearing aids themselves. Little is known about long-term effects of OTC hearing aids on users. This study aims to compare the experiences of people who choose the OTC pathway with those who choose the AUD pathway. It takes place in two locations: Iowa City, IA, and Nashville, TN. Participants, who have mild-to-moderate hearing loss, choose their preferred pathway and are followed for 12 months. In the OTC pathway, participants buy their hearing aids directly from OTC companies or retailers. In the AUD pathway, prescription hearing aids and fitting services are provided by audiology clinics at the University of Iowa and Vanderbilt University Medical Center. Participants are contacted 1, 6, and 12 months after starting to use their hearing aids. Researchers measure their satisfaction about hearing aids and other outcomes. If participants stop using their hearing aids, researchers assess their engagement with post-amplification hearing care. The results from both pathways are then compared.

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 the treatment Audiologist-based fitting, Over-the-counter fitting for hearing loss?

Research suggests that over-the-counter (OTC) hearing aids can increase accessibility and affordability for people with mild-to-moderate hearing loss, and a consumer-decides approach to selecting hearing aids has shown positive outcomes. However, audiologist-driven models tend to provide better results, indicating that professional guidance may enhance the effectiveness of OTC hearing aids.12345

Are over-the-counter (OTC) hearing aids safe for humans?

There are concerns about the safety of OTC hearing aids, as hearing healthcare professionals have expressed worries about issues like counseling and audiological care. Some devices may deliver poor sound quality and uncomfortably loud sounds, which could be unsafe.12567

How do over-the-counter hearing aids differ from prescription hearing aids for hearing loss?

Over-the-counter (OTC) hearing aids are unique because they can be purchased directly by consumers without a prescription or fitting by an audiologist, making them more accessible and affordable compared to traditional prescription hearing aids. This new category aims to address barriers like high costs and stigma associated with hearing aid use, although there is limited research on their real-world effectiveness.238910

Research Team

YW

Yu-Hsiang Wu, PhD

Principal Investigator

University of Iowa

Eligibility Criteria

This trial is for individuals with mild-to-moderate hearing loss, including sensorineural and age-related types. Participants can choose to fit their own over-the-counter (OTC) hearing aids or have them fitted by an audiologist. The study excludes certain people based on criteria not specified here.

Inclusion Criteria

I have mild to moderate hearing loss that started in adulthood.
No previous hearing aid experience

Exclusion Criteria

English is not my first language.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pathway Selection and Hearing Aid Acquisition

Participants choose their preferred pathway (OTC or AUD) and acquire hearing aids

1-2 weeks

Initial Use and Adjustment

Participants begin using their hearing aids and adjust to them

1 month
1 visit (in-person or virtual)

Follow-up

Participants are monitored for satisfaction and outcomes at 1, 6, and 12 months

12 months
3 visits (virtual or in-person)

Treatment Details

Interventions

  • Audiologist-based fitting
  • Over-the-counter fitting
Trial Overview The study compares user experiences between self-fitted OTC hearing aids and those fitted by audiologists (AUD pathway). It tracks participant satisfaction over a year in Iowa City, IA, and Nashville, TN, with check-ins at 1, 6, and 12 months.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: OTC (over-the-counter)Experimental Treatment1 Intervention
In this group, over-the-counter fitting will be used to provide over-the-counter hearing aids.
Group II: AUD (audiologist-based)Active Control1 Intervention
In this group, the audiologist-based fitting will be used to provide prescription hearing aids.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Yu-Hsiang Wu

Lead Sponsor

Trials
4
Recruited
710+

Vanderbilt University Medical Center

Collaborator

Trials
922
Recruited
939,000+

University of Manchester

Collaborator

Trials
370
Recruited
621,000+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials
377
Recruited
190,000+

Findings from Research

A survey of 730 hearing healthcare professionals revealed that over 70% expressed significant concerns about over-the-counter (OTC) hearing aids, particularly regarding safety, counseling, and the quality of audiological care.
While nearly half of the professionals indicated they would support patients using OTC hearing aids, the responses were divided into two groups: 'OTC averse' who had strong concerns, and 'OTC apprehensive' who had mixed feelings, highlighting the need for further education and support for both HHPs and consumers.
Hearing Healthcare Professionals' Views about Over-The-Counter (OTC) Hearing Aids: Analysis of Retrospective Survey Data.Manchaiah, V., Sharma, A., Rodrigo, H., 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.
Prioritizing research on over-the-counter (OTC) hearing aids for age-related hearing loss.Manchaiah, V., Swanepoel, W., Sharma, A.[2023]
Over-the-counter (OTC) hearing aids can lead to higher uptake rates among adults with mild to moderate hearing loss and are associated with similar quality-adjusted life years (QALYs) as traditional hearing aids, making them a viable option for hearing intervention.
OTC hearing aids are significantly more cost-effective, costing only 5%-38% of traditional hearing aids, and are considered cost-effective if they provide at least 55% of the quality of life benefits of traditional devices.
Potential Clinical and Economic Outcomes of Over-the-Counter Hearing Aids in the US.Borre, ED., Johri, M., Dubno, JR., et al.[2023]

References

Hearing Healthcare Professionals' Views about Over-The-Counter (OTC) Hearing Aids: Analysis of Retrospective Survey Data. [2023]
Prioritizing research on over-the-counter (OTC) hearing aids for age-related hearing loss. [2023]
Potential Clinical and Economic Outcomes of Over-the-Counter Hearing Aids in the US. [2023]
A Follow-Up Clinical Trial Evaluating the Consumer-Decides Service Delivery Model. [2020]
Pilot Comparison of Adjustment Protocols of Personal Sound Amplification Products. [2020]
Direct-to-Consumer Hearing Devices: Capabilities, Costs, and Cosmetics. [2020]
Disruptive Hearing Technologies and Mild Sensorineural Hearing Loss II: Current Research on Affordable Hearing Technologies and Direct-to-Consumer Models. [2020]
Comparing Hearing Aid Outcomes in Adults Using Over-the-Counter and Hearing Care Professional Service Delivery Models. [2023]
Over-the-Counter Hearing Aids: A Lost Decade for Change. [2018]
10.United Statespubmed.ncbi.nlm.nih.gov
Emerging Technologies, Market Segments, and MarkeTrak 10 Insights in Hearing Health Technology. [2021]
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