A year ago, the Food and Drug Administration (FDA) made an announcement regarding new regulations for over-the-counter hearing aids. The regulations aimed to make hearing aids more accessible and affordable for individuals with mild to moderate hearing loss. However, the current state of the O.T.C. hearing aid market remains confusing and chaotic for the older consumers it was intended to help. Despite this, manufacturers and retailers have made efforts to improve accessibility and affordability.
In the past year, there has been a renewed focus on treating hearing loss due to its impact on cognitive decline. A study conducted by Johns Hopkins University found that hearing aids can help reduce the pace of cognitive decline. Previous research had established a connection between hearing loss and cognitive decline, but the ACHIEVE study provided evidence that treating hearing loss can actually reduce cognitive loss.
The study involved nearly 1,000 individuals aged 70 to 84 with untreated mild to moderate hearing loss. Half of the participants received hearing assessments, were fitted with midpriced hearing aids, and received counseling on their usage. The other half participated in a health education program. Over the course of three years, the study found that hearing aids reduced the rate of cognitive decline by 48 percent compared to the control group for participants who were older and less affluent. These findings suggest that individuals at higher risk stand to benefit the most from treating hearing loss.
Further research is still needed to determine the effects of hearing-aid use on brain atrophy, social isolation, depression, and quality of life. Some experts are skeptical about emphasizing the connection between dementia and hearing loss, highlighting the importance of promoting hearing-aid use for its benefits on social interaction, cognition, and mental health.
While progress has been made in making hearing aids more accessible, acquiring quality hearing aids over the counter can still be challenging. The FDA has reviewed “self-fitting” hearing aids, which can be customized using a smartphone app, and found eight brands in compliance with regulations. A small study found that patients given a commercially available, self-fitting hearing aid performed as well as patients fitted by audiologists. However, not everyone feels comfortable with online sales and self-adjustments via apps. Devices that use preset controls do not undergo FDA review at all.
Misleading advertising and the wide range of price points further add to the confusion in the O.T.C. hearing aid market. Some marketers make false claims about their devices, such as restoring natural hearing. It’s important for consumers to be well-informed and aware of the options available. Progress is being made with self-fitting O.T.C. aids, which are now available at a lower cost compared to prescription devices. However, initial sales have been modest due to factors such as lack of awareness and affordability for older Americans.
Major manufacturers and distributors are expanding their offerings in the O.T.C. hearing aid market. Best Buy is increasing the number of stores carrying O.T.C. hearing aids, and EssilorLuxottica plans to introduce hearing aids embedded in eyeglass earpieces next year. Traditional manufacturers are also entering the O.T.C. market through partnerships with well-known consumer companies.
To guide consumers, companies like HearAdvisor, Wirecutter, and the Hearing Loss Association have evaluated and ranked hearing aids. HearAdvisor aims to be the trusted source for evaluating both prescription and O.T.C. hearing aids. They have awarded their “Expert Choice” to 13 devices, and generally find that O.T.C. devices priced at $1,000 or more perform well, while those sold online for under $500 are often low-quality.
While the United States is the first country to develop a regulated O.T.C. hearing aid market, there is still much progress to be made. Innovation and lower prices are expected in the future, but for now, the market is a work in progress.