This week, Apple announced its entry into the OTC hearing aid market with the launch of its new AirPods Pro 2 true wireless earbuds. It’s been nearly two years since the U.S. Food & Drug Administration announced its Over-The-Counter hearing aid regulations. OTC means companies can sell approved hearing aids directly to consumers nationwide.
To find out more about the OTC sector and what sort of impact Apple might have on the hearing aid market, I spoke with Andrew Bellavia, who spent a considerable part of his career with the Knowles Corporation, the world’s foremost manufacturer of balanced armatures, the mini speakers used in hearing aids. Bellavia is also the founder of the hearing and communications accessibility consultancy AuraFuturity and co-hosts the This Week in Hearing podcast. He also speaks and writes about innovations in hearing care.
Under the new regulations, OTC hearing aids must meet a suite of performance and labeling requirements. The idea behind the regulations was to lower the price of hearing aids, spur innovation and boost access to hearing devices. So far, the results have been mixed. The best-performing units are not much different from traditional hearing aids, while others are simply hearing aids repackaged with OTC software at lower prices. While access to hearing aids has increased, innovation has remained modest, only a fraction of the unmet need has been satisfied by the current crop of products.
I asked Andrew Bellavia what is stopping companies just selling earbuds that can double as hearing aids.
“In the U.S., hearing aids are a regulated medical device for several reasons. One is safety, especially to prevent consumers from inadvertently exposing themselves to immediately dangerous sound levels through improper programming. This is why OTC hearing aids are intended only for mild to moderate losses that can be served with a device that doesn’t have potentially dangerous output levels.”
“Another reason for the regulation is to make sure that users aren’t suffering from a medical condition that could affect their hearing but is the result of a more serious issue. A hearing care professional can check for this, but in the OTC case, the labeling needs to explain who the device is for as well as who it is not for. The labeling also needs to identify the conditions for which a person should seek medical attention.”
The regulations for OTC are here now, but I asked Bellavia who OTC hearing devices were aimed at and how many people suffer from that level of hearing loss. Is hearing loss on the increase?
“Globally, nearly 1.6 billion people experience some degree of hearing loss: that’s about 20% of the total population. According to the World Health Organization, the number of people with hearing loss is expected to increase to nearly 2.5 billion people by 2050. The WHO estimates today’s global direct and indirect economic costs of untreated hearing loss is around $980 billion. Untreated hearing loss is a serious issue with large-scale human and economic costs.”
“Despite those numbers, only about 24 million hearing aids are dispensed each year. Given that most people wear two aids, and assuming the average life of a hearing aid is five years, only about 60 million people are using hearing aids at any given moment. This is an adoption rate of just a few percent. Even allowing for populations with other conditions that prevent the effective use of hearing aids, this is a very low number.”
“Most hearing aids are dispensed in economically developed countries so the adoption rate is much higher there at around 20 – 40%. In other countries, some of which have less than one audiologist per million people, the adoption rates are far lower.”
“Of the total population with hearing loss, about 1.4 billion are in the mild to moderate range. Mild can be misleading because, even at that level, hearing loss can cause changes in how the brain processes sound, leading to other comorbidities. Mild hearing loss can affect work performance and enjoyment of social situations.”
“The true promise of OTC hearing aids is that they could become available on a global basis. Much work is needed to make them appropriately available and maintained with due respect for regional needs. As has been demonstrated in the U.S., OTC hearing aids can be safely supplied either on a direct basis or via health professionals in local clinics.”
Apple has announced its entry into the OTC hearing aid market with a software update coming to AirPods Pro 2 earbuds later this year. Will Apple’s move boost the market as a whole and be a catalyst that the OTC sector needs? I asked Bellavia how big an impact Apple’s entry into hearing aids would have on other players.
“Hearing loss severity is strongly correlated with age. People with mild to moderate hearing loss skew younger. Hearing aid adoption rates are lower in this population for several reasons. One is the stigma around the perception that hearing aids make a person look old. This is exacerbated by real or perceived ageism, especially in the workplace.”
“Another reason is that at milder losses, people may feel they hear well in quiet situations. They might need situational help in noisy social settings but they are fine at home. An all-day prescription hearing aid that is perceived as being too expensive tends to be less attractive to people in this group.”
“Apple’s AirPods have been able to provide hearing assistance for more than two years. At present, it’s a little cumbersome to set up which may explain why Apple has remained relatively silent about the hearing features already built into its AirPods. How much Apple benefits from official OTC status depends on several factors, including performance. The company must also make a concerted effort to educate people about the ill effects of untreated hearing loss and how AirPods can help.”
“Part of this campaign must include highly visible messages that AirPods are also for helping people to hear friends and family better and not just for isolating oneself from disturbing noise or people. This would break down the “reverse stigma” that makes both the wearer and their companions feel uneasy about wearing earbuds in social situations.”
“The direct impact of marketing AirPods as OTC hearing aids will depend on how many regions of the world are offered this capability. It will depend on the regulatory environment in each location around the world. While Apple referred to “over 100 countries” in its press release, it remains to be seen where the company can offer the update.”
I asked Bellavia where he believes Apple will end up taking the OTC hearing aid market.
“Apple’s longer-term impact could be seismic. With the company’s massive market share and its marketing prowess, it could alter the entire conversation about hearing care and encourage millions of people to address their hearing loss for the first time. Those who are happy with the result will get an immediate benefit and will hopefully be less hesitant about seeking professional care later, should they need it. Others may not go the AirPods route but may be influenced to seek professional care straight away. In either case, the result will be positive.”
Will we eventually see earbuds and OTC hearing aids merge into a single category? Will there soon be OTC features built into all earbuds in a way that ANC is with Qualcomm’s Bluetooth earbud chipsets?
“Consumer earbud chipsets are increasingly able to provide OTC hearing aid capability using software alone. Other companies are embedding specialized circuits for hearing aid functionality while leaving more memory and processing power for other functions like active noise cancellation while reducing power consumption. For example, at CES last January, software company Absolute Audio Labs and chip maker Renesas announced a partnership to enable software-based earbuds with hearing aid capability and all-day battery life. I expect we will see more announcements now that Apple has legitimized the market.”
“Regulatory requirements will probably prevent a complete merging between earbuds and hearing aids. In the short term, I expect Apple’s move will prompt others to offer OTC functionality, either standard or as an option, in a similarly closed ecosystem. But as intelligent consumer earbuds, often called “hearables,” become increasingly powerful and programmable, it is an open question what the regulatory bodies can do once users can load a hearing aid app from a third party into their earbuds.”
What does Apple’s move mean for the big names in hearing aid manufacturing like Switzerland’s Sonova AG or Denmark’s GN?
“To date, the major hearing aid companies have delivered hearing aids with increasingly sophisticated and intelligent functionality in discrete, comfortable, all-day devices using purpose-built chips. I don’t see this going away any time soon for people with severe hearing loss.
On the other hand, we may be at the dawn of a consumer-OTC revolution, where effective devices for both situational and all-day wear are available from the top audio brands as a feature alongside adaptive ANC and excellent music quality at consumer prices. This could be good for everybody as mass-market adoption of OTC hearing devices accelerates. More people will get the hearing care they need, and those people may be more comfortable migrating to prescription devices later. Consumers, OTC manufacturers, prescription hearing aid companies, and hearing care providers will all benefit as a result.”
