OTC Hearing Aids: Reflecting on the Evolution of Hearing Technology

November 6, 2023

In a landmark decision in October 2022, the U.S. Food and Drug Administration (FDA) established a new category of over-the-counter (OTC) hearing aids. This decision allowed millions of Americans with mild-to-moderate hearing loss to have easier access to hearing aids. Subsequently, hearing technology brands have brought innovative, accessible, and potentially life-changing OTC hearing aid solutions to the consumer market over the past 12 months.

There is no question that the FDA ruling bolsters a new era for hearing health technologies, with OTC hearing aids clearly illustrating the massive evolution from early devices like ear trumpets and analog hearing aids. The OTC devices take discrete form, comparable to today’s receiver-in-canal hearing aids and true wireless earbuds, and are designed for usability, comfort and performance.

Yet, the potential of the category remains largely untapped. One year later, we’re reflecting on the impact and implications of the OTC hearing aid ruling, the possibilities for the category, and our vision for supporting the future of accessible hearing solutions for all.

Hearing Loss is High-Prevalence, High-Risk

The National Institute on Deafness & Other Communication Disorders estimates that 15% of American adults report some trouble hearing and reports that while about 28.8 million US adults could benefit from hearing aids, only 16% of that group uses them due to a variety of barriers: cost, stigma, affordability, and awareness.

One of the major concerns associated with hearing loss is a lack of overall protection. Hearing loss can result from a single, short exposure to loud sound, or long or repeated exposures. Existing hearing damage can also be made worse over time if proper protective measures are not taken to limit exposure.

Even at mild levels, the risks associated with untreated hearing loss go beyond the ability to perceive sound. Research from Johns Hopkins Medicine reports that processing sound is essential to balance and day-to-day movement, and when hearing is hindered, the risk of falls or injury is increased. Individuals with mild hearing loss may also mishear important sounds such as alarms, posing a safety risk.

Untreated hearing loss can also increase the risk of cognitive and emotional health problems. It can be incredibly challenging for someone who is experiencing hearing loss to maintain basic communication. The American Academy of Audiology reports that this can lead to feelings of social isolation, depression, and low self-esteem. Long-term, hearing loss has also been associated with brain atrophy, cognitive decline and dementia when left untreated.

How OTC Hearing Aids Can Help

The best way to learn about and treat hearing loss will always be an audiology visit, as audiologists diagnose and treat hearing problems. However, the availability of over-the-counter hearing aids is a revolutionary opportunity to support those with hearing loss who may otherwise be limited by the adoption barriers mentioned before. Increasing awareness around the benefits of the category is the first step to promoting early intervention and helping decrease the risks associated with hearing loss over time.

While affordability has been a long-cited barrier to hearing aid use, a broader spectrum of accessible hearing health products can make a significant difference

From a market standpoint, the availability of OTC options enhances consumer choice. The competition in the market has brought a variety of solutions for consumers to choose from, ensuring that users can select from a range of hearing aids with different features and price points that cater to their individual preferences. With the advent of self-programming apps and self-hearing tests, users now have the tools to fine-tune their hearing experiences like never before. This newfound control allows them to tailor their hearing aids precisely to their needs.

While current solutions may be expensive, with devices ranging up to thousands of dollars, many consumer technology brands have set out to make OTC devices more affordable, combining their audio expertise with personalization tools and FDA-approved hearing support. Since the ruling, many brands have come to market with high-quality, comfortable OTC hearing aids for a broader range of consumers. JLab, for example, unveiled its concept for $99 OTC hearing aids at CES 2023.

Similarly, many leaders in headphone design have entered the OTC hearing aid market, including Jabra, Bose, and Sony. The designs from these brands are helping to advance awareness around features that many consumers will find not only helpful for hearing health but also enticing from an experiential standpoint. With built-in Bluetooth for music and podcast streaming, health tracking, and even hearing personalization features, OTC hearing aid users can enjoy enhanced hearing with the added benefits they expect from their wireless sound technologies.

This increased availability and range of options can help individuals seek assistance at the earliest signs of hearing loss, leading to timely intervention and better outcomes. The growing awareness and diversity in the market have also begun to destigmatize hearing loss, which encourages more individuals to seek help and support for their hearing needs.

Over 75 Years in Ears

In the 1950s, Hugh Knowles and his team revolutionized the hearing aid industry by creating balanced armatures. At that time, they couldn't have predicted how much their technology would advance. Today, Knowles is still leading the way in developing high-performance components for hearing health solutions, remaining the world's largest producer of transducers for hearing aids.

A long-time supporter of hearing health solutions and premium sound, last year Knowles developed new solutions to better serve the rise of OTC hearing aid designs – including three balanced armature models and two MEMS microphones specialized for hearing health devices. Paired with Knowles' high-volume manufacturing process, we’ve worked to support the production of new hearing technologies and support brands delivering consumer products to meet the demand. The Wall Street Journal recently published an article highlighting the top OTC hearing aids for consumers, which referred to the NCOA ratings. We are incredibly proud that Knowles technologies have been incorporated into this list of seven top products.

Balanced armatures have been crucial in hearing aids for decades and are now essential in premium sound solutions like in-ear monitors and earphones. As the worlds of exceptional audio solutions and hearing health converge, a realm of personal, accessible, and enjoyable listening experiences is open to explore. The innovation is bridging the gap between those seeking premium audio quality and those needing hearing assistance -- and with the availability of OTC hearing aids and hearing enhancement tools, it's more accessible than ever.

As the hearing health opportunity evolves, we’re proud to continue to empower individuals with the best hearing solutions in sound quality, accessibility, and personalization. The future of hearing augmentation and premium audio is promising, and we envision a world where every individual can enjoy a world of sound that is just right for every ear, everywhere.