While a lot of health tech shown at CES is doomed to become vaporware, there’s reason to believe that 2022 is going to be a big year for hearables. Case in point: Eargo, a CES regular since 2015, is announcing the Eargo 6. The buds are the sixth iteration of the company’s smart hearing aids and feature nifty new tech that automatically adjusts sound levels on the go.
Hearing aids work by converting sound picked up by a microphone into a digital signal that’s then amplified. They can also amplify certain sounds, like your voice, while also dampening background noise. Eargo’s are registered as an FDA Class II exempt device, meaning they are a medium-risk device with specialized controls.
Given that this is Eargo’s sixth version of its hearing aids, some of the updates are iterative. For instance, the new Eargo 6 is better at masking background noise and “noise between pauses in speech.” It’s also got improved IPX7 water resistance. And Eargo added a “mask mode,” which allows the device to more accurately compensate for how masks dampen a speaker’s voice. But the big update this year is a new feature Eargo dubs Sound Adjust.
Sound Adjust builds upon the Eargo 5’s Sound Match feature, which plays sounds in each ear at different volumes and pitches. That creates a personalized hearing profile that can be used to tune the device based on a specific environment, be it a loud restaurant or a meeting. The only issue with the Eargo 5 Sound Match feature was that the initial test to create a personalized hearing profile took 8–10 minutes, and if you ever wanted to update that profile, it requires putting them in the charger and waiting up to five minutes. For temporary adjustments on the go, you’d have to pull out your phone or tap your ear. Eargo says the new Sound Adjust feature builds on this tech via a proprietary algorithm to identify your environment without user input and then automatically modify the hearing aids’ settings. In a nutshell, it’s going from manual to auto.
While I wasn’t able to try the Eargo 6 in person, I did get to see a demo over Zoom. The Eargo buds are quite small, to the point where you can’t tell if someone’s actually wearing one. Since I couldn’t try one for myself, I’m not able to say how well the device works for someone like me — let alone someone with hearing loss. That said, the discreet design is notable. A major reason so many people don’t use hearing aids is the social stigma attached to wearing one. The National Institute on Deafness and Other Communication Disorders believes roughly a third of people aged 65–74 suffer from hearing loss. That jumps to 50 percent for those over 75. However, only 30 percent of people over 70 who could benefit from hearing aids have used one. That number plummets to 16 percent for adults aged 20–69.
Eargo CEO Christian Gormsen told The Verge that the Eargo 6 is aimed at people with mild to moderate hearing loss, a group that has thus far been underserved due to the cumbersome process of getting hearing aids. There are several steps involved, including getting a hearing test, clearance from your doctor, an appointment with an audiologist, and follow-ups. Another problem is hearing aids are expensive. According to Consumer Affairs, the average cost of one digital hearing aid ranges from $1,000 to $4,000, with the cheapest costing between $500 and $3,000. Even Eargo’s models are pricey at $2,950 for a pair (though the company offers a 45-day trial period and financing and says customers all receive lifetime support.) While Medicaid and some private insurance may cover some or all of the cost, most plans — including Medicare — generally don’t.
Other brands like Nuheara, Olive Union, and Signia have also showcased their hearable tech at CES over the years. But there’s a good reason why 2022 might be a watershed year for hearing tech. Earlier in October, the FDA proposed a rule that will allow people to buy hearing aids over-the-counter without needing a medical exam. The FDA also issued updated guidance for personal sound amplification products (PSAPs), electronic devices that act as amplifiers for all sounds. The agency is expected to finalize that proposal in the next few months. This has huge implications for accessibility, as it’s expected to result in much more affordable products and reduce the number of steps needed to get a hearing aid in the first place.
Bigger tech companies have also been adding more hearing-related features to their gadgets. In May, Bose launched its FDA-cleared SoundControl Hearing Aids, which don’t require seeing an audiologist and cost $849.95. The catch is that they’re only available in five states, though Bose does have plans to roll out the device nationally eventually. Apple also recently added a new Conversation Boost accessibility feature to its AirPods Pro. Samsung added Voice Detect in early 2021 to the Galaxy Buds Pro and Buds 2. The feature works by activating Samsung’s Ambient Noise mode, allowing sounds from your environment to filter through whenever it identifies you speaking. The idea is so that you don’t have to take out your buds or switch modes when interacting with people.
So far, the biggest hurdle in developing innovative health tech is navigating the FDA’s clearance process. Running clinical trials, though necessary, requires resources that smaller startups may not have access to. In theory, allowing over-the-counter hearing aids could not only grant greater access and autonomy for people who need them but also encourage further developments in hearing tech.
At the same time, audiologists have raised concerns that over-the-counter hearing aids could cause harm by encouraging people to skip professional assessments. Hearing aids aren’t diagnostic and can’t fully replace doctors visits. Additionally, it’s not a given that factory presets on over-the-counter aids would be effective when everyone’s hearing is unique. The American Academy of Audiology’s official position on the matter states that while audiologists should offer support to people pursuing over-the-counter hearing aid tech, it believes consumers are “best served when they receive a comprehensive audiologic assessment prior to the use of any hearing aid.” For its part, Eargo says it employs over 40 licensed audiologists on staff to help users set up and customize their hearing aids — but that may not be the case for every company that decides to make over-the-counter hearing aids.
This is a common quandary with many health-related gadgets, and the medical community is still coming to terms with how to handle people taking their health into their own hands. EyeQue Vision Check, a winner of the CES 2019 Innovation Award, is another example of an FDA-registered gadget that lets users skip an in-person vision test. I tested it — and while I did get a more accurate pair of glasses, my vision was still noticeably blurrier than the pair I got after finally visiting my doctor. Although some measurements were comparable, it wasn’t ideal for someone like me with severe astigmatism and myopia.
Regardless of how it all shakes out, there’s also no guarantee that existing direct-to-consumer companies like Eargo will opt to take the over-the-counter route. When asked, Eargo spokesperson Grace Schwartzstein told The Verge that it was “anxiously awaiting the FDA announcement” and that it would “plan to evaluate accordingly.”