Hearing Aids for Hearing Loss
(IHAT Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Colorado, Denver
Disqualifiers: Severe hearing loss, Middle ear disorders, Neurological conditions, others
No Placebo Group
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.
12345Are 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.
12467How 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.
12568Eligibility 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.
+3 more
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.
+2 more
Trial 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
Participant Groups
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.
4Treatment groups
Experimental Treatment
Active Control
Group I: OTC-RExperimental Treatment1 Intervention
Group II: OTC-HCPExperimental Treatment1 Intervention
Group III: HA-HCPActive Control1 Intervention
Group IV: OTC-SFActive Control1 Intervention
HA-HCP is already approved in United States, 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Colorado School of MedicineAurora, CO
University of Colorado BoulderBoulder, CO
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Who Is Running the Clinical Trial?
University of Colorado, DenverLead Sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)Collaborator
References
Comparing Hearing Aid Outcomes in Adults Using Over-the-Counter and Hearing Care Professional Service Delivery Models. [2023]More affordable hearing aids are now available due to over-the-counter (OTC) hearing aid regulations. Although laboratory studies have validated many OTC hearing technologies, there are limited real-world benefit studies. This study compared hearing aid outcomes reported by clients from OTC and conventional hearing care professional (HCP) service delivery models.
Emerging Technologies, Market Segments, and MarkeTrak 10 Insights in Hearing Health Technology. [2021]Hearing health care is rapidly changing through innovation in technology, services, business models, and product categories. The introduction of hearables and over-the-counter (OTC) hearing aids in particular will change the market for hearing help and the role of the hearing care professionals (HCPs). This article focuses on how these products will be differentiated from HCP-fit hearing aids through their ability to address the unmet needs of different consumer segments within the population of people with hearing dysfunction. The unmet hearing needs of each segment are discussed, and the size of each segment estimated, demonstrating a large potential market for hearables and a smaller potential market for hearing aids than has been previously mentioned in the literature. The results from MarkeTrak 10's survey of consumers' attitudes toward an OTC model are reviewed, showing that approximately half of both hearing aid owners and nonowners are uncomfortable doing hearing- and hearing aid-related tasks on their own without the assistance of an HCP and would be unlikely to purchase OTC hearing aids if available today. MarkeTrak data are also shown that demonstrate that the majority of hearing aid and personal sound amplification product owners believe that the HCP helped or would have helped with their hearing devices. Finally, challenges to OTC hearing aids becoming successful are discussed.
Comparing Direct-to-Consumer Devices to Hearing Aids: Amplification Accuracy for Three Types of Hearing Loss. [2023]The U.S. Food and Drug Administration finalized regulations for over-the-counter hearing aids (OTC-HAs) on August 17, 2022. Little is known about the comparative performance of OTC-HAs and prescription HAs. This study compared amplification accuracy of prescription HAs and direct-to-consumer devices (DTCDs, including personal sound amplification products [PSAPs] and OTC-HAs).
Hearing Healthcare Professionals' Views about Over-The-Counter (OTC) Hearing Aids: Analysis of Retrospective Survey Data. [2023]Over-the-counter hearing aids have been available to consumers in the US since 17 October 2022 following a ruling by the Food and Drug Administration. However, their reception by hearing healthcare professionals (HHP) has been mixed, and concerns have been expressed by many HHPs. The aim of this study was to examine the concerns that HHPs have towards over-the-counter (OTC) hearing aids. The study used a retrospective survey design. The survey data of HHPs (n = 730) was obtained from Hearing Tracker. A 22-item structured questionnaire was administered using a Question Scout platform. Descriptive analyses examined reported areas of concern and a Fisher's exact test examined the relationship between demographics and responses. A cluster analysis with partitioning around medoids (PAM) was used to identify a sub-group of participants based on responses. Nearly half of HHPs who participated reported that they will support patients with OTC hearing aids purchased elsewhere, whereas a quarter reported that they will sell OTC hearing aids in their clinic or website. HHPs expressed over 70% agreement in 'concern' statements in 14 of the 17 items. Issues about safety, counseling, and audiological care were the key concerns expressed by HHPs about OTC hearing aids. Some demographics (i.e., profession, primary position) were associated with responses to some statements. Two groups were identified based on the responses to concern statements. The HHPs in the first cluster 'OTC averse' (51%) agreed on all the 17 concern statements, whereas the second cluster 'OTC apprehensive' (49%) had some items rated as disagree (i.e., consumers will give up on amplification) and neither agree nor disagree (i.e., do not provide good value, warranties and return periods will be worse), and remaining items were rated as agree. OTC hearing aids were initiated to improve affordability, accessibility, and hearing aid uptake and are currently a rapidly emerging category of hearing devices. Overall, the results of the current study indicate that HHPs have serious concerns about OTC hearing aids. HHP concerns cited in this study provide useful feedback to stakeholders (e.g., HHP professional agencies, FDA, industry, and insurance payers) involved in improving OTC hearing aid implementation.
Applications of direct-to-consumer hearing devices for adults with hearing loss: a review. [2018]This systematic literature review is aimed at investigating applications of direct-to-consumer hearing devices for adults with hearing loss. This review discusses three categories of direct-to-consumer hearing devices: 1) personal sound amplification products (PSAPs), 2) direct-mail hearing aids, and 3) over-the-counter (OTC) hearing aids.
Potential Clinical and Economic Outcomes of Over-the-Counter Hearing Aids in the US. [2023]Over-the-counter (OTC) hearing aids are now available in the US; however, their clinical and economic outcomes are unknown.
OTC hearing aids: An opportunity for collaborative working relationships between pharmacists and audiologists. [2022]In 2017, the United States Food and Drug Administration Reauthorization Act created a new category of hearing aids to be sold over the counter (OTC), disrupting how nearly 30 million persons with hearing loss will seek and purchase hearing aids. Laws and regulations do not require a medical evaluation or an appointment with an audiologist prior to purchasing OTC hearing aids. However, it is likely that patients will approach pharmacists with questions about OTC hearing aids when considering these devices available at the community pharmacy. The objective of this commentary is to discuss the opportunity for collaborative working relationships between pharmacists and audiologists in the context of OTC hearing aids. The most relevant barriers to pharmacist/audiologist collaboration are turf concerns, lack of trust, and distance between practice sites. OTC hearing aids can positively impact hearing health care across the nation with successful collaboration between the professions of pharmacy and audiology.
Assessment of Consumer Attitudes Following Recent Changes in the US Hearing Health Care Market. [2023]The addition of over-the-counter hearing aid (HA) options has transformed the way individuals can access hearing health care (HHC). However, although critical to their adoption and use, consumer attitudes and opinions about direct-to-consumer (DTC) models of health care are often understudied.