Over-The-Counter Hearing Aids for Hearing Loss
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests over-the-counter (OTC) hearing aids to determine their effectiveness for older adults with mild-to-moderate hearing loss, who face a higher risk of dementia. The study aims to assess the ease of use and satisfaction with these hearing aids. Participants will either begin using the hearing aids immediately or after a short wait. Suitable candidates are individuals aged 50 and older with mild-to-moderate hearing loss in both ears, who carry the APOE ε4 gene, and do not currently use hearing aids. As an unphased trial, this study offers participants the chance to contribute to important research that could enhance hearing aid accessibility and satisfaction for many.
What prior data suggests that over-the-counter hearing aids are safe for older adults?
Studies have shown that over-the-counter (OTC) hearing aids are generally safe for adults with mild to moderate hearing loss. The FDA has approved these devices, confirming they meet safety standards for public use. Research indicates that issues, such as the device malfunctioning, are rare. Most problems relate to the device's construction, like it falling apart. However, these issues do not appear to pose significant health risks. Overall, OTC hearing aids are considered safe and comparable to prescription hearing aids, though they may be slightly less effective.1234
Why are researchers excited about this trial?
Unlike traditional hearing aids, which often require a prescription and professional fitting, over-the-counter (OTC) hearing aids offer a more accessible and affordable option for those with hearing loss. Researchers are excited about these devices because they empower individuals to manage their hearing health without the need for a specialist, making them especially appealing to those who might face barriers to traditional care. Additionally, by providing immediate intervention, these hearing aids could potentially enhance hearing ability and quality of life more quickly than waiting for specialist appointments.
What evidence suggests that over-the-counter hearing aids are effective for hearing loss?
Research has shown that over-the-counter (OTC) hearing aids can effectively assist people with mild to moderate hearing loss. One study found that self-fitting OTC hearing aids performed as well as those fitted by professionals, particularly in enhancing speech understanding and user satisfaction. Another study found that while OTC hearing aids might not match the effectiveness of prescription ones, they still significantly improve hearing. These devices are also considered safe, making them a viable option for many. Overall, OTC hearing aids can be a helpful solution for better hearing, especially for those at risk of memory and thinking problems. Participants in this trial will either receive immediate intervention with OTC hearing aids or join a waitlist control group that will use OTC hearing aids after an initial period.35678
Are You a Good Fit for This Trial?
This trial is for adults aged 50 or older who are at increased risk for dementia and have mild-to-moderate hearing loss in both ears. Participants must be willing to use over-the-counter hearing aids and complete various assessments. Those with conditions that could interfere with the study or who cannot follow the protocol may not qualify.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Immediate Intervention
Participants use OTC hearing aids for 4 months
Waitlist Control
Participants receive basic patient education on hearing loss without OTC hearing aid for 2 months, followed by 4 months of OTC hearing aid use
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Over-The-Counter (OTC) hearing aid
Trial Overview
The study tests if using over-the-counter hearing aids can help people at risk of dementia. Half will start using the hearing aids right away, while the other half waits two months before starting. The study measures how well participants stick to wearing these devices and their satisfaction with them.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Immediate Intervention: 4-month of OTC hearing aid use
Waitlist control: Basic patient education on hearing loss without OTC hearing aid for 2 months, followed by 4 months of OTC hearing aid use
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Southern California
Lead Sponsor
Citations
Effectiveness of an Over-the-Counter Self-fitting Hearing ...
These findings suggest that self-fitting OTC hearing aids may provide an effective intervention for mild to moderate hearing loss. Trial ...
Comparing Hearing Aid Outcomes in Adults Using Over- ...
This study compared hearing aid outcomes reported by clients from OTC and conventional hearing care professional (HCP) service delivery models.
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aao-hnsfjournals.onlinelibrary.wiley.com
aao-hnsfjournals.onlinelibrary.wiley.com/doi/10.1002/ohn.817Over‐The‐Counter Hearing Aids: Are They Safe and Effective?
OTC and prescription hearing aids are comparably safe, though OTC hearing aids are slightly less efficacious. Further evaluation of the OTC ...
Research Quick Takes Volume 10: An Update on OTC ...
Comparing Hearing Aid Outcomes in Adults Using Over-the-Counter and Hearing Care Professional Service Delivery Models (Swanepoel et al., 2023).
Performance and Effectiveness of a Self-fitting Over-the- ...
Recent clinical trials suggest that OTC hearing aids can deliver similar benefits to professionally fitted ones in speech recognition and self-reported outcomes ...
OTC Hearing Aids: What You Should Know
The FDA established a new category of over-the-counter (OTC) hearing aids for adults 18 years of age and older with perceived mild to moderate hearing loss.
A Retrospective Study of the Adverse Events Associated ...
There is a low reported incidence of adverse events associated with OTC hearing aids. Possible poor construction of the device and its falling apart, resulting ...
Evaluating the Safety and Usability of an Over-the-Counter ...
This study describes the safety and usability of an over-the- counter hearing aid for adults with mild to moderate hearing loss. Based on ...
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