By mid-October, hearing aids will start filling up retail shelves for the first time thanks to the recent Food and Drug Administration (FDA) decision to allow over-the-counter sales. It's a long-awaited outcome, as the federal Over-The-Counter Hearing Aid Act passed in 2017. The bill required the FDA to designate a category of over-the-counter hearing aids for mild to moderate hearing loss, and that work that is now complete.It's a boon for businesses looking to create and sell OTC hearing aids, as 15% of American adults report hearing loss. Soon, this often-forgotten, unglamorous space could be buzzing with technological innovation as hearing aids enter the realm of mass-market consumer technology.“My single biggest concern is that we as an industry botch it," says Christian Gormsen, CEO of hearing aid manufacturer Eargo, which was founded in 2010 and has $342 million in funding. He's referring to the potential for retailers that have never sold hearing aids before, like CVS or Walmart, to sell cheap products without proper patient support. Eargo's 'invisible' hearing aid.An explosion of new products and retailers also opens the door for the spread of online misinformation, counterfeit products, and unauthorized personal data collection, raising concerns of scamming and hacking. While the FDA decision is a positive move—a breakthrough, even—understanding the state of the industry and mitigating risks is paramount to the initiative's long-term success.Technology Reinvents Hearing AidsIn the past few years, startups have recognized the potential to disrupt the hearing aid industry. Mobile apps, artificial intelligence, Bluetooth, and virtual screenings are just a few of the many innovations replacing the typical process for acquiring and using a hearing aid. Prior to the FDA decision, an audiologist needed to prescribe patients a hearing aid. During a typical visit, patients take a hearing loss test, which reveals the frequencies a patient struggles with, the percentage of words they recognize, and a few more speech- and hearing-related tests. A man undergoes an audiologist exam."The brain relies more on high frequencies than lower to distinguish between consonants, which is unfortunately what people lose when they’re older," said Dr. Andrew Resnick, Au.D., who has been practicing audiology in New York City for 25 years. "The difference between a P and a T sound can be tricky, for example. The way our brain tells those apart is by hearing high frequencies. So if you can’t hear those, the word 'pick' and 'tick' might sound the same."An audiologist configures a hearing aid to address the weaknesses discovered in the tests. This occurs via software created by a hearing aid manufacturer, which is likely one of five major companies that control 90% of hearing aid sales.Newer entrants in the market, like Eargo, offer similar services without an in-person audiologist visit. By playing tones on a phone call or through an app, they believe they can acquire enough information to configure the hearing aid (or allow the patient to configure it in the app.) Plus, the device itself is not as bulky as traditional hearing aids. "No one wants to wear a traditional beige, banana-like hearing aid. Absolutely no one," Eargo CEO Gormsen says. Signia's hearing aid appArtificial intelligence is another focus that may solve common complaints like high-pitched feedback and over-amplified background noise. Startup Whisper uses AI to autonomously optimize sound quality. In a loud restaurant, for example, the hearing aid might automatically reduce background noise while amplifying the closest voice. It comes with a mobile app, a pair of hearing aids, and the "Whisper Brain," a small device and dedicated processor that runs the AI technology and enables software updates.The Signia hearing aid app, meanwhile, allows users to adjust volume balance, view battery life, and even toggle on "mask mode" to better hear people wearing face masks.Here Come the Hackers?It's hard to imagine any hearing aid wearer would object to these technological improvements at face value, but behind the scenes they create the same cesspool of data collection issues we've seen in other industries. Hearing aid companies will log user data collected in the app, as well as sound and volume information, which they will use to improve the products. “We do monitor hearing aid data," Gormsen explains. “But privacy is essential in healthcare. When we introduced the mobile app, we made sure we were compliant with HIPAA, CCP, and GDPR." These regulations protect patient health records (HIPAA) and online privacy (via the CCP in California and GDPR in Europe). All FDA-registered OTC hearing aids must be compliant.But selling personal data to third parties for advertising is a $455 billion industry, The Wall Street Journal reports. In the wrong hands, this could lead to targeted scams via social media, robocalls, and spam texts for hearing aid users, many of whom are elderly. On top of that, OTC status will allow for a flood of profits that some bad actors will inevitably try to exploit.Tech and AccessibilityMore sophisticated features could bar certain users who are uncomfortable navigating new technology on their own, especially for such an important device. The highest prevalence of hearing loss is among those 80 years and older, affecting 80% of people in this age group, according to the AARP. "You have to remember that we’re dealing with an older population—some of whom are quite tech-savvy—but the use of apps is already an issue and it's definitely a potential source of confusion and problems going forward," says Dr. Resnick. "For example, Bluetooth can be wonky, and now we get calls about hearing aids not connecting successfully to phones. It's a whole new realm of what we have to do as audiologists." Others disagree with the idea that elderly patients are categorically tech-averse. "Many older adults are becoming more tech savvy, based on AARP’s polling from its latest Tech Trends and 50+ study," says Lina Walker, VP of Health Security in AARP’s Public Policy Institute. "Three in four people over 50 rely on tech to stay connected and that’s true even for those in their 70s and above.  There’s a significant rise in the use of smartphones and tablets for many activities, including health services."Still, Gormsen reports that 80% of Eargo customers choose to speak to one of their specialists even though it's not required for purchase. “They can help answer questions like: 'Is it sitting the right way in my ear? How do I use the programs? How do I use my mobile app? How can I fit it to my specific hearing loss?'” he says. Buying an OTC, tech-heavy, expensive product may be unappealing for certain people, driving them back to the audiologist for support.Where Will OTC Hearing Aids Be Sold?The primary benefit of the FDA decision is the explosion of access to hearing aids, both in stores and online. Just a few days after the Biden administration released a statement, Best Buy announced it will sell hearing aids in its stores. All products must have an official, FDA-approved OTC label, so check for that before buying. "The labels also include warnings and other information you should know before buying or when using the hearing aid, such as signs that indicate that you should see a doctor," the National Institute on Deafness and Other Communication Disorders reports. Apple's Air Pod Pro earbuds expand the definition of a traditional hearing aid by offering basic sound amplification features to everyday users."If you Google hearing aids today and in the past decade, 95% of what comes up is not a hearing aid," says Gormsen. "They’re not even registered with the FDA." He fears that OTC sales will bring more counterfeit products to market, especially with online retailers.Many retailers will be looking for the lowest cost product as well, as hearing aids typically range from $2,000 to $8,000, Goodrx reports. Bose's new $850 hearing aids are evidence of this trend. Apple's AirPods Pro earbuds contain sound-boosting technology and customizable settings, although they are not officially called "hearing aids." As such, OTC hearing aids will likely be simplistic and geared toward the most common, mass market hearing issues. “From what I understand, the devices that will be available over the counter will not be programmable to accommodate somebody’s specific hearing loss configuration," says Dr. Resnick. “I think there’s a good chance a lot of people will have underserved needs from their hearing loss with over-the-counter devices." Both he and Gormsen agree there is a risk that OTC hearing aids may ironically sour customers on the concept. It remains to be seen if stores like Best Buy or Walmart will have on-site testing or sales support; Costco hearing centers offer an example for others to consider.Predictions Going ForwardIn the next few years, expect to see hearing aids on the shelves of local drug stores and big box retailers. Expect more casual conversation about hearing aids, and hopefully more people wearing them who need them.Don't expect audiologists to go out of business. People with severe hearing loss or those dissatisfied with the OTC experience will still rely on these experts. In terms of the types of products and full slate of retailers who will offer hearing aids, that remains to be seen. Some cheaper products may be extremely basic, taking in sounds and amplifying them indiscriminately. Others may have more sophisticated, tech-heavy features like AI and accompanying mobile apps to customize sound amplification. Hopefully, a Google search for "hearing aids" will return fewer counterfeit products as the OTC label becomes widely recognized, but regulation of online activity—including data collection—has been notoriously elusive. Providing robust customer service and mitigating concerns like privacy, security, and accessibility will be paramount to the success of the FDA decision in the coming years as a more mass market, innovative version of the industry takes hold.

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