A year ago, the Food and Drug Administration (FDA) announced new regulations allowing the sale of over-the-counter (OTC) hearing aids and setting standards for their safety and effectiveness. This change aimed to make high-quality hearing aids more accessible and affordable for people with mild to moderate hearing loss. However, the OTC market is currently confusing and chaotic for older consumers who were supposed to benefit from these regulations.
Over the past year, there has been a renewed focus on the importance of treating hearing loss, particularly because it affects a significant number of people over the age of 70. Researchers at Johns Hopkins University conducted a randomized clinical trial that showed hearing aids can help reduce cognitive decline. This study, known as the ACHIEVE study, focused on older adults with untreated mild to moderate hearing loss. Half of the participants received hearing assessments, were fitted with midpriced hearing aids, and received counseling on how to use them. The study found that among older and less affluent participants, hearing aids reduced the rate of cognitive decline by 48% compared to the control group.
The researchers also plan to publish findings on how hearing-aid use affects brain atrophy, social isolation, depression, and quality of life. While some experts argue against emphasizing the connection between dementia and hearing loss, as it may deter people from seeking treatment, there are clear benefits to promoting hearing-aid use, such as enabling greater social interaction and reducing the risk of falls.
Despite these positive developments, the OTC market for hearing aids still faces challenges. The FDA has approved “self-fitting” hearing aids that users can customize with a smartphone app, but not all individuals feel comfortable with online sales and do-it-yourself adjustments. Additionally, devices that use preset controls and are not self-fitting do not undergo FDA review. Misleading advertising and a lack of price standardization further add to the confusion in the market.
However, progress has been made. Self-fitting OTC hearing aids that perform well are now available for around $1,000 a pair, while prescription hearing aids purchased through audiologists are significantly more expensive. Major manufacturers like Lexie Hearing have begun selling self-fitting OTC devices online and in stores, and other retailers like Best Buy have also started carrying OTC hearing aids. Traditional manufacturers are entering the OTC market and partnering with well-known consumer companies to promote brand recognition. Independent organizations like HearAdvisor are evaluating and ranking both prescription and OTC hearing aids to guide buyers.
While the US is the first country to develop a regulated OTC hearing aid market, there is still much room for innovation and lower prices in the future. Currently, the OTC hearing aid market is a work in progress, but with continued efforts and advancements, it has the potential to greatly benefit older individuals with hearing loss.
