June 22, 2023
By Rebecca Glasner
Recent moves by US regulators to allow over-the-counter (OTC) sales of some hearing aid devices have highlighted the need for careful human factors engineering (HFE) and usability processes among manufacturers of qualifying products.
Final US FDA Rule: Over-the-counter (OTC) hearing aids
In August 2022, the US Food and Drug Administration (FDA) released a final rule, “Establishing Over-the-Counter Hearing Aids.” The final rule allows some hearing aids to be sold OTC rather than via prescription (FDA Guidance Document). This new OTC category has the potential to improve hearing aid access for Americans over 18 years of age with perceived mild to moderate hearing loss.
Hearing loss can impact many aspects of a person’s life, including feelings of social isolation and an increased risk of dementia. Presently, 28.8 million Americans could benefit from using a hearing aid; however, four out of five of those who could benefit from a hearing aid do not currently use one.
Over-the-counter hearing aids might be less expensive than traditional hearing aids and do not require a medical exam or fitting by an audiologist. Instead, people can buy these devices with little to no guidance from a healthcare professional. One requirement per the FDA ruling is that OTC hearing aids must include package labeling displaying the words “hearing aid” and “OTC” to differentiate the device from a personal sound amplification product (PSAP) – a non-medical device that amplifies sound for certain situations such as bird watching.
While the FDA is allowing for some hearing aids to be sold OTC, hearing aid manufacturers should still consider the regulatory pathway. Some hearing aids might be exempt from a premarket submission, but many will still require a 510(K) submission for FDA clearance.
Human factors considerations for OTC hearing aids
OTC hearing aids have the potential to help people struggling with hearing loss but might present new usability and user experience challenges not encountered with traditional, prescription hearing aids. While reading glasses are similarly available for consumers to purchase without a prescription, OTC hearing aids have some important differences that will lead them to be a more nuanced purchase than reading glasses. Manufacturers entering the OTC hearing aid space will be well served by performing human factors research to ensure a potential user can safely select, set up and use their new device.
Users will need to self-select at the point of purchase and determine whether they are eligible to use OTC hearing aids; in particular, whether they have mild to medium hearing loss. They may also need to consider if they are purchasing a “connected device” and whether they own a compatible device, such as a smartphone. Similarly, users (and potentially, retail workers) will need to be able to differentiate between PSAP devices and OTC hearing aids. Some additional human factors considerations are that new versus existing hearing aid users might have different expectations of or approaches to hearing aid selection that should be accounted for in OTC product, packaging, and labeling design.
While prescription hearing aids can be professionally adjusted or customized, OTC hearing aid users will likely need to set up their new hearing aids on their own, or perhaps with the help of a relative or friend. Such setup tasks might involve changing settings on a smartphone or on the device itself. Additionally, hearing aids require the brain to adapt to new sounds and may not immediately resolve hearing issues, thus, new users may experience dissatisfaction or confusion if they are unaware of the adjustment period.
Users will also need to correctly place their hearing aid in or around their ears. Medical devices that go into the ear may have additional safety-related placement considerations, such as not going too deep into the ear canal to avoid damaging the inner ear. Because over-the-counter product users may not have a health care professional to rely on, manufacturers of OTChearing aids should consider ways to support people with proper positioning, such as with a training video and/or positioning guidance in the instructions.
Conclusion: The importance of human factors engineering in OTC hearing aid manufacturing
Manufacturers of all hearing aids, though especially OTC products, will benefit from conducting early research to get a better understanding of users’ device design and labeling needs and expectations. Then, conducting iterative formative evaluations throughout development will help form the final product design in a way that enables safe, effective and satisfying use by hearing aid users.
If we can help you evaluate your device, or identify the best regulatory pathway for your product, contact our global team to help you scale your human factors program and conduct HF activities, or, sign up for a complimentary account with OPUS, our software platform that provides HFE training, tools and templates.
Rebecca Glasner is Human Factors Associate at Emergo by UL.
Griffiths TD, Lad M, Kumar S, Holmes E, McMurray B, Maguire EA, Billig AJ, Sedley W. How Can Hearing Loss Cause Dementia? Neuron. 2020 Nov 11;108(3):401-412. doi: 10.1016/j.neuron.2020.08.003. Epub 2020 Aug 31. PMID: 32871106; PMCID: PMC7664986.
National Institute on Deafness and Other Communication Disorders: Quick Statistics About Hearing
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