OTC vs Prescription Hearing Aids for Hearing Loss

Recruiting at 1 trial location

Overseen By Yu-Hsiang Wu, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yu-Hsiang Wu

Disqualifiers: Non-native English speaker

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

Compensation: Varies

Number of Visits: 4

360 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 5 6 7}

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. ^{2 3 8 9 10}

Research Team

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

Group I: OTC (over-the-counter) Experimental Treatment 1 Intervention

In this group, over-the-counter fitting will be used to provide over-the-counter hearing aids.

Group II: AUD (audiologist-based) Active Control 1 Intervention

In this group, the audiologist-based fitting will be used to provide prescription hearing aids.

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential Clinical and Economic Outcomes of Over-the-Counter Hearing Aids in the US. Borre, ED., Johri, M., Dubno, JR., et al.[2023]

A study involving 656 hearing aid users found no significant difference in overall satisfaction and benefit between those using over-the-counter (OTC) hearing aids and those using conventional hearing care professional (HCP) services.

While HCP users reported longer daily use of their hearing aids, OTC users experienced less difficulty in hearing situations where they wanted to hear better, suggesting that OTC hearing aids can provide comparable outcomes to traditional models.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing Hearing Aid Outcomes in Adults Using Over-the-Counter and Hearing Care Professional Service Delivery Models. Swanepoel, W., Oosthuizen, I., Graham, MA., et al.[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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Hearing Healthcare Professionals' Views about Over-The-Counter (OTC) Hearing Aids: Analysis of Retrospective Survey Data. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

Potential Clinical and Economic Outcomes of Over-the-Counter Hearing Aids in the US. [2023]

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

A Follow-Up Clinical Trial Evaluating the Consumer-Decides Service Delivery Model. [2020]

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

Pilot Comparison of Adjustment Protocols of Personal Sound Amplification Products. [2020]

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

Direct-to-Consumer Hearing Devices: Capabilities, Costs, and Cosmetics. [2020]

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

Disruptive Hearing Technologies and Mild Sensorineural Hearing Loss II: Current Research on Affordable Hearing Technologies and Direct-to-Consumer Models. [2020]

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

Comparing Hearing Aid Outcomes in Adults Using Over-the-Counter and Hearing Care Professional Service Delivery Models. [2023]

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

Over-the-Counter Hearing Aids: A Lost Decade for Change. [2018]

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

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