Hearing Aids for Hearing Loss

(IHAT Trial)

Recruiting at 1 trial location

Overseen By Preeti Pandey, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Severe hearing loss, Middle ear disorders, Neurological conditions, others

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

Compensation: Varies

Number of Visits: 6

Duration: 6 months

280 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different types of hearing aids, including over-the-counter (OTC) and prescription models, impact individuals with mild to moderate hearing loss. Researchers aim to assess how these hearing aids influence users' daily experiences, cognitive skills, and overall hearing-related brain activity. By comparing the costs and user preferences for various hearing aid options, the study seeks to provide valuable insights for healthcare providers and policymakers. Suitable participants for this trial have mild to moderate hearing loss in both ears, can read and understand English materials, and own a smartphone. As an unphased trial, this study offers participants the chance to contribute to important research that could shape future hearing aid options and accessibility.

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 prior data suggests that these hearing aid options are safe for individuals with hearing loss?

Research shows that over-the-counter (OTC) hearing aids, like those tested in this study, are generally safe to use. Studies have found that these hearing aids meet the same FDA standards as prescription models. The FDA carefully reviews them before sale and checks them afterward to ensure ongoing safety.

However, a past study found some concerns. About 75.9% of hearing healthcare professionals reported possible issues with OTC hearing aids. These issues might include discomfort or a poor fit, but they usually do not involve serious health risks.

Overall, OTC hearing aids are designed to be easy to use and help improve hearing without major side effects. They offer a more affordable and accessible option compared to traditional prescription hearing aids. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the treatments HA-HCP, OTC-HCP, OTC-R, and OTC-SF for hearing loss because they introduce new ways to access and use hearing aids. HA-HCP involves hearing aids provided by healthcare professionals, which are often tailored to individual needs. In contrast, OTC-HCP, OTC-R, and OTC-SF are over-the-counter options, making hearing aids more accessible and potentially more affordable for users who might not have easy access to professional fitting services. This trial explores the effectiveness and user satisfaction of these different access methods, aiming to broaden the availability and customization of hearing aid solutions.

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

This trial will compare different types of hearing aids for hearing loss. Studies have shown that over-the-counter (OTC) hearing aids can be a good choice for people with mild to moderate hearing loss. Research indicates that users often feel just as satisfied and experience similar benefits as those using prescription hearing aids fitted by a professional. One study found that after using hearing aids for six weeks, there were no major differences in satisfaction or hearing improvement between self-fitted OTC aids and those fitted by an audiologist. This finding suggests that OTC hearing aids, like the OTC-HCP and OTC-R models tested in this trial, might work just as well for many people. Overall, OTC hearing aids can provide a more affordable and accessible way for individuals to manage their hearing loss. ^{6 7 8 9 10}

Who Is on the Research Team?

Vinaya Manchaiah, AuD, MBA, PhD

Principal Investigator

University of Colorado, Denver

Anu Sharma, PhD

Principal Investigator

University of Colorado, Boulder

Are You a Good Fit for This Trial?

The IHAT study is for individuals with mild to moderate hearing loss. It's designed to compare different ways of getting hearing aids, including over-the-counter options and those fitted by specialists.

Inclusion Criteria

No previous hearing aid experience greater than 3 months

I have adult-onset hearing loss in both ears, confirmed by a hearing test.

I am willing to be assigned to any treatment group.

Exclusion Criteria

I have hearing loss that is worse in one ear.

I have a middle ear disorder.

I have a neurological condition like dementia or Parkinson's, or scored below 25 on a cognitive test.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive different service delivery models of over-the-counter (OTC) hearing aids or prescription hearing aids fitted by specialists

6 months

Multiple visits (in-person and remote)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Follow-up assessments at 6 and 12 months post intervention

What Are the Treatments Tested in This Trial?

Interventions

• HA-HCP
• OTC-HCP
• OTC-R
• OTC-SF

Trial Overview This trial tests four service models for providing hearing aids: HA-HCP (prescription), OTC-R (regular over-the-counter), OTC-HCP (over-the-counter with healthcare professional advice), and OTC-SF (self-fitting). The impact on user experience, behavior, cognition, and brain activity will be evaluated.

How Is the Trial Designed?

Group I: OTC-R Experimental Treatment 1 Intervention

Group II: OTC-HCP Experimental Treatment 1 Intervention

Group III: HA-HCP Active Control 1 Intervention

Group IV: OTC-SF Active Control 1 Intervention

HA-HCP is already approved in United States, European Union for the following indications:

Approved in United States as OTC Hearing Aids for:

• Mild to moderate hearing loss

Approved in United States as Prescription Hearing Aids for:

• Mild to profound hearing loss

Approved in European Union as Hearing Aids for:

• Mild to profound hearing loss

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

Published Research Related to This Trial

A survey of 1,037 US residents over 50 years old revealed that 84% preferred in-person hearing health care (HHC) over direct-to-consumer (DTC) models, indicating a significant discomfort with online options for obtaining hearing aids.

Factors such as older age, higher income, and lack of interest in hearing aids were associated with a lower likelihood of pursuing HHC online, while previous experience with DTC healthcare increased the likelihood of choosing online options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of Consumer Attitudes Following Recent Changes in the US Hearing Health Care Market. Singh, J., Dhar, S.[2023]

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 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]

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]

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]

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]

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, as mandated by the FDA Reauthorization Act of 2017, allows nearly 30 million people with hearing loss to access these devices without needing a medical evaluation or audiologist appointment.

Collaboration between pharmacists and audiologists is essential for maximizing the benefits of OTC hearing aids, as pharmacists are likely to be the first point of contact for patients seeking guidance on these devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

OTC hearing aids: An opportunity for collaborative working relationships between pharmacists and audiologists. Berenbrok, LA., DeRuiter, M., Mormer, E.[2022]

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/2833823

Hearing Aid Service Models, Technology, and Patient ... In the OTC service model, users self-assess their hearing difficulties and self-fit/adjust devices without professional support, thereby ...

3. 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 associated ...

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

Over-the-counter hearing aids: implementations and ... Modern digital prescription hearing aids, recognized as safe and effective medical devices ... While most potential OTC hearing aid users have high-frequency or ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06499805

Barriers and Facilitators to OTC Hearing Aids Success Over-the-counter (OTC) hearing aids offer a different approach. They aim ... The final dataset will include self-reported hearing aid outcome data. All ...

6. 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 ...

7. 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 ...

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. consumerreports.org consumerreports.org/health/hearing-aids/complete-guide-to-over-the-counter-hearing-aids-a3898239010/

A Complete Guide to Over-the-Counter Hearing Aids Prescription Hearing Aids vs. Over-the-Counter Hearing Aids. Prescription hearing aids and OTC devices function in essentially the same way.

10. mdpi.com mdpi.com/2039-4349/13/2/18

Hearing Healthcare Professionals' Views about Over-The- ... OTC hearing aids were initiated to improve affordability, accessibility, and hearing aid uptake and are currently a rapidly emerging category of hearing devices ...