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

Trial Summary

What is the purpose of this trial?

The research will explore outcomes of different service delivery models of over-the-counter (OTC) hearing aids by comparing them to prescription hearing aids fitted by specialists in individuals with mild to moderate hearing loss. The investigators will examine how each type affects users' experiences, behavior, thinking skills, and brain activity related to hearing. Additionally, the study will focus on what types of people prefer each hearing aid option, what helps or hinders these choices, and compare the costs of four different service options. This approach will help transition from research findings into real-world practice, providing useful information for healthcare providers and policymakers about OTC hearing aid options.

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 Hearing Aids for Hearing Loss?

Research shows that over-the-counter (OTC) hearing aids, which are more affordable, have been validated in laboratory settings, although real-world benefits are still being studied. Comparisons between OTC and prescription hearing aids indicate that both can be effective, but many users feel more comfortable with professional guidance. ^{1 2 3 4 5}

Are over-the-counter hearing aids safe for humans?

There are concerns about the safety of over-the-counter hearing aids, as hearing healthcare professionals have expressed worries about issues like counseling and audiological care. ^{1 2 4 6 7}

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

Over-the-counter (OTC) hearing aids are unique because they allow individuals to purchase and fit hearing aids themselves without needing a prescription or professional fitting, making them more accessible and affordable compared to traditional hearing aids that require a hearing care professional (HCP). This approach can meet the needs of those who prefer a more direct and potentially less costly option for managing hearing loss. ^{1 2 5 6 8}

Research Team

Vinaya Manchaiah, AuD, MBA, PhD

Principal Investigator

University of Colorado, Denver

Anu Sharma, PhD

Principal Investigator

University of Colorado, Boulder

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

References

1. 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]

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

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

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

Comparing Direct-to-Consumer Devices to Hearing Aids: Amplification Accuracy for Three Types of Hearing Loss. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

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

5. New Zealand pubmed.ncbi.nlm.nih.gov

Applications of direct-to-consumer hearing devices for adults with hearing loss: a review. [2018]

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

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

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

OTC hearing aids: An opportunity for collaborative working relationships between pharmacists and audiologists. [2022]

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

Assessment of Consumer Attitudes Following Recent Changes in the US Hearing Health Care Market. [2023]