NEW RULE IS MUSIC TO MANY CONSUMERS’ EARS

Close to 30 million adults in the United States could benefit from hearingaid use, according to the U.S. Food and Drug Administration . However, hearing aids traditionally required a prescription—and came with a price tag too high for many consumers.

But on Aug. 16, 2022, the FDA issued a final rule establishing a new category of over-the-counter hearing aids. The action, which went into effect on Oct. 10, 2022, allows consumers with a perceived mildto-moderate hearing impairment to purchase hearing aids directly from stores or from online retailers without the need for a medical exam, prescription or a fitting adjustment by an audiologist, the agency noted.

The rule is expected to lower the cost of hearing aids. It’s also designed to ensure the safety and effectiveness of OTC hearing aids while fostering innovation and competition in the hearingaid technology marketplace, FDA said. The OTC category established in the rule applies to certain airconduction hearing aids intended for people 18 years of age and older.

“Hearing loss is a critical public health issue that affects the ability of millions of Americans to effectively communicate in their daily social interactions,” said FDA Commissioner Robert M. Califf., M.D. “Establishing this new regulatory category will allow people with perceived mild-to-moderate hearing loss to have convenient access to an array of safe, effective and affordable hearing aids from their neighborhood store or online.”

“Additionally, daily stressors, including smart phones, sunlight and screens, can impact the eyes,” he pointed out. “And as people age, the natural filter—macula— in the eyes may weaken and leave the eyes more vulnerable to stress.”

To help here, Bausch + Lomb offers enhanced Ocuvite Adult 50+ eye vitamins with vitamin D. The vitamins’ key nutrients help protect eye health, particularly as consumers age, Gordon noted.

And the company has more innovation in the works, he said. This year will bring line extensions to the Biotrue brand, including Biotrue Hydration Boost contact lens rehydrating drops, and the company’s eye health vitamins lineup.

“The company will also launch Lumify Eye Illuminations, a new line of specialty products designed for the sensitive eye area,” Gordon added.

Ear Care Getting More Attention

Consumers’ desire for self-care is a driver within the OTC ear care segment as well. The trend toward self-care often escalates during periods of economic uncertainty, explained Will Righeimer, CEO of Los Angeles-based Hyland’s Naturals.

“So, what we are seeing from consumers right now is a very proactive attempt to manage their health to the best of their ability,” he said. “They are researching preventive vitamins and supplements to support ear care and addressing common issues like swimmer’s ear and itchy, dry ear using OTC solutions.”

Two other trends within the segment are safer products and the prevalence of videos of the inner ear on social media, said Edward Wagner, CEO of Portland, Ore.-based Blue Echo Care. On the product safety front, consumer education is pushing a trend toward safer devices—similar to what’s used by audiologists— for wax removal and more. As for the latter trend, video-enabled otoscopes are allowing recording of the inner ear.

“One of my favorite bits of data I like to share with retailers is how mindblowingly popular ear wax videos are online,” he said. “For example, there are currently 8.4 billion views on TikTok at #earwaxremoval and another 10.5 billion views at #earwax. … These products are utilizing new technology, integrating into the realm of social media and building on an established product like the otoscope. I’m very excited about their potential moving forward.”

The ear care category overall is also getting more attention, thanks to the introduction of OTC hearing aids (see the sidebar, “New Rule is Music to Many Consumers’ Ears”).

“With more people introduced to and interacting with the category, there’s a potential for an influx in sales and buyer interest,” said Elyse Dickerson, CEO of Eosera Inc., Fort Worth, Texas.

That’s already happened for the WaxRx ear washer, a product of Doctor Easy Medical Products, Orange Park, Fla. Although the product has been around for 25 years, the increased demand for self-care and the success of other professionalgrade offerings have propelled the product to “a leading consumer ear care product,” noted the company’s president, Marsha Garcia. Modeled after professional ear washers, it’s the first OTC ear wax removal product able to remove even impacted ear wax.

Innovation Aplenty

Heightened interest in the ear care category on the part of consumers means room for new, innovative OTC products. One such product is Hyland’s Naturals Dry Ear Relief Oil. According to Righeimer, the natural product combines oils such as aloe vera, jojoba seed and hemp seed to soothe dry ears.

“We are seeing an uptick in interest for dry ear treatment options,” he noted. “We believe this is a byproduct of the fact that so many more people are using earphones for work calls, and hearing aids are now available over the counter so more people are trying them.”

Safety has been a priority in new product development for Blue Echo Care. The company’s ear wax removal kit and electronic ear wax remover allow consumers to purchase the same devices used in doctor’s offices, for example, Wagner said. And the company recently introduced a Bluetooth-enabled otoscope for all Android and Apple devices.

“We’ve recently made all of these products [and others] available as private label as well, following the trend of retailers growing their own brands,” he added.

For its part, Eosera recently introduced Ear Pain MD, which contains the strongest concentration of lidocaine available over the counter—4%—to provide relief of ear pain, Dickerson said.

“It’s great for the warm months when swimmer’s ear season is prevalent and kids are in and out of the water,” she explained. “Ear Pain MD is not intended to treat infection [but] is a great product to use while systemic medication kicks in.”

This summer, the company also will be launching Ear Dryer MD. An electric, rechargeable ear dryer that features a warming function, the product will be a “must have” for swimmer’s ear season, Dickerson said, as warm, wet ears are breeding grounds for bacteria to grow.

New Options for Hearing Loss

Some of the newest ear care innovations are in the OTC hearing aid space.

“It has never been easier for customers to receive support for their hearing loss,” said Christian Gormsen, CEO of Eargo, San Jose, Calif.

Although Eargo continues to see the introduction of hearing aids resembling earbud-style headphones, it’s focusing on “practically invisible” options to meet the needs of consumers who want a “more discreet device,” Gormsen said. The company’s latest OTC innovation—the self-fitting Eargo 7, which features Sound Adjust+ technology to mimic how natural hearing adapts to changing environments—debuted in January 2023.

“It combines the high tech and high touch of high-end devices at a more affordable price point, without compromising quality or user experience,” he said. “Eargo 7 is designed for discretion, measuring the size of a thumbnail … virtually invisible when in the ear and easily removed with a transparent pull tab.”

Charlotte Schrøder, senior manager of business development, Lifestyle Hearing for Jabra/GN Group in Copenhagen, Denmark, notes that her company continues to see more classic consumer electronics players entering the OTC hearing aid space.

“With this, new form factors and new features drawing on traditional consumer electronics experiences will emerge,” she said. “Tele-audiology and software-based services are being used to differentiate products. We also continue to see more focus on the use of AI to provide better user experiences.”

For its part, Jabra/GN Group recently introduced the Jabra Enhance Plus to the OTC hearing aid market.

“At $799 a pair, this is 80% cheaper than the average price paid today for a pair of traditional hearing aids purchased in a clinic, greatly expanding accessibility,” Schrøder said. “It’s important to note, however, that OTC is not a replacement of hearing aids as we know them today. Our Jabra Enhance Plus device provides a solution for those looking to begin their hearing health journey.”

Since OTC hearing aids hit the market, Eargo has noticed a positive trend, Gormsen noted: more conversations around general hearing wellness.

“Despite this, some customers are having a difficult time navigating what OTC hearing aids are and where they can purchase them, which is why we offer education and support every step along their journey,” he said.

Gormsen also encourages drug stores to consider the customer experience when it comes to planning and merchandising the OTC hearing aid assortment.

“Ease of access to affordable and high-quality hearing aids and comfort should be the top priority,” he said. “Simply placing a product … on the shelf is not enough. If the drug store is offering OTC hearing aids in a self-service station, the entire experience needs to be well thought out and intuitive for customers to avoid confusion and frustration.” dsn