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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods for obtaining hearing aids for mild-to-moderate hearing loss. One method involves purchasing over-the-counter (OTC) hearing aids, where individuals manage the selection and fitting themselves. The other method involves consulting an audiologist for fitting prescription hearing aids (audiologist-based fitting). The study evaluates participants' satisfaction with their hearing aids and their usage over a year. It seeks individuals who have noticed hearing loss in both ears and have not previously used hearing aids. As an unphased trial, this study provides a unique opportunity to explore different hearing aid options and determine the most effective approach.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that over-the-counter (OTC) hearing aids are generally safe for adults with mild-to-moderate hearing loss. The FDA evaluates these devices before sale and continues to monitor them for safety. However, some studies indicate that about 75.9% of hearing healthcare providers have concerns about their safety, mainly because they are new to the market.

Users of OTC hearing aids should be aware that they need to diagnose their own hearing needs and fit the aids themselves. Achieving the best fit and sound quality might require some practice. Minor issues may arise as users adjust, but these are usually easy to manage. Overall, OTC hearing aids offer a safe and more affordable option for those seeking to improve their hearing without the higher costs of prescription hearing aids. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about comparing over-the-counter (OTC) hearing aids to prescription ones because of the potential to make hearing aids more accessible and affordable. Unlike traditional prescription hearing aids, which require fitting by an audiologist, OTC hearing aids can be purchased and fitted directly by the user. This approach could significantly reduce costs and increase convenience for people with hearing loss, making it easier for more individuals to improve their hearing without the need for a specialist appointment. By evaluating both OTC and prescription options, researchers aim to understand the effectiveness and user satisfaction of each approach, potentially leading to broader access to hearing solutions.

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

This trial will compare over-the-counter (OTC) hearing aids with prescription hearing aids. Studies have shown mixed results regarding the effectiveness of OTC hearing aids. Some research indicates that people using OTC hearing aids feel less fatigued after prolonged listening. However, detailed studies comparing OTC hearing aids to prescription ones are limited. Participants in the OTC arm of this trial will use over-the-counter fitting for their hearing aids. In contrast, those in the prescription arm will receive audiologist-based fitting for prescription hearing aids, which have a longer history of proven success in improving hearing and communication. While OTC hearing aids are more affordable and accessible, prescription aids might offer better overall performance. More research is needed to fully understand how OTC aids compare to traditional options. ^{4 6 7 8 9}

Who Is on the Research Team?

Yu-Hsiang Wu, PhD

Principal Investigator

University of Iowa

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10102918/

Effectiveness of an Over-the-Counter Self-fitting Hearing ... However, clinical effectiveness studies of available OTC hearing aids using the existing devices in the market are limited. Objective. To ...

2. jamanetwork.com jamanetwork.com/journals/jamaotolaryngology/fullarticle/2803832

Effectiveness of an Over-the-Counter Self-fitting Hearing ... However, clinical effectiveness studies of available OTC hearing aids using the existing devices in the market are limited. Objective To compare ...

3. audiologyonline.com audiologyonline.com/articles/research-quick-takes-volume-10-29477

Research Quick Takes Volume 10: An Update on OTC ... OTC hearing aid buyers also reported taking up hearing aids because of listening fatigue 2.3 times more often. On the other hand, prescription ...

4. frontiersin.org frontiersin.org/journals/audiology-and-otology/articles/10.3389/fauot.2024.1347437/full

Over-the-counter hearing aids: implementations and ... Only 2% of American adults aged 40 and older with hearing difficulties reported purchasing an OTC hearing aid in the last 6 months, and just 4% may buy one in ...

5. pubs.asha.org pubs.asha.org/doi/10.1044/2022_AJA-22-00130

Comparing Hearing Aid Outcomes in Adults Using Over- ... More affordable hearing aids are now available due to over-the-counter (OTC) hearing aid regulations. ... Outcomes research for OTC hearing devices and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11594523/

A Retrospective Study of the Adverse Events Associated ... As with all newly introduced devices, there are concerns regarding the safety profile of OTC hearing aids, with 75.9% of hearing healthcare ...

7. fda.gov fda.gov/medical-devices/hearing-aids/otc-hearing-aids-what-you-should-know

OTC Hearing Aids: What You Should Know Over-the-Counter (OTC) Hearing Aids. A hearing aid is a medical device that is intended to help with hearing loss and is worn behind or within ...

8. gao.gov gao.gov/products/gao-24-106854

Over-the-Counter Hearing Aids: Information on the New ... OTC hearing aids are subject to the same FDA premarket reviews and postmarket oversight as other medical devices. For example, FDA conducts ...

9. pubs.asha.org pubs.asha.org/doi/10.1044/2022_PERSP-22-00117

Over-the-Counter Hearing Aids: What the Practicing ... Another potential advantage of improving accessibility with OTC hearing aids is the possibility that individuals with hearing loss will access devices sooner ...