The FDA’s publication this week of a rule creating a new category of over-the-counter hearing aids has been met with widespread praise from consumers, patient advocacy groups, politicians and others. Many of them have praised the ruling’s potential to vastly lower the costs of hearing aids.
Many devicemakers, too, have shown their support for the agency’s move, since it allows them to market their products directly to consumers, cutting out multiple middlemen and potentially bringing their hearing aids to more people.
Among those doling out praise are Eargo, GN Hearing and Nuheara, all of which are now making preparations to put their best feet forward when the rule takes effect in mid-October. At that point, adults with mild to moderate hearing impairment will be able to purchase air-conduction hearing aids both online and in stores from retail giants like CVS, Walgreens and Best Buy—no prescription needed.
In a statement this week, Eargo CEO Christian Gormsen applauded the ruling and its potential to spark more innovation, saying, “By making hearing aids more accessible and affordable while maintaining safety standards, the industry will now finally be driven by consumer demand for superior products.”
Gormsen added that while the California-based company believes its devices already fit the new criteria, Eargo is setting aside time and resources for “evaluating the final rule and ensuring that our devices and processes come into compliance with the new requirements.”
According to the FDA, makers of air-conduction hearing aids—which are worn either behind or inside the ear, without requiring an implant—that have already been cleared by the agency have about eight months to ensure their devices comply with the new standards.
Gormsen also noted that the OTC ruling will help Eargo expand its footprint to reach consumers both virtually and in person. The company is now planning on “adding partnered physical locations to our online experience in 2022 and 2023,” he said in the statement.
Denmark-based GN, meanwhile, was similarly welcoming of the news, laying out plans to register its next wireless hearing aid in the newly created OTC category.
The Jabra Enhance Plus earbuds are half the size of the brand’s current smallest offerings. They’re designed to enhance hearing while also acting as headphones to stream music and take phone calls, all of which can be controlled through an app on a user’s smartphone.
According to GN’s announcement, selling the miniaturized in-ear hearing aids through the OTC pathway will compound its ability to reach new audiences. The company said it’s already started to achieve this, given that it estimates the audience for Jabra Enhance Plus is, on average, 18 years younger than users of its prescription hearing aids.
The Eargo and Jabra devices will be among those sold by retailers as early as mid-October. CVS and Walgreens have confirmed that they’ll be offering hearing aids at that time, while Best Buy outlined this week an entirely “new experience” it’ll begin offering in stores and online for hearing device shoppers.
That includes an online hearing assessment consumers can access either through the retail giant’s website or via QR code in its stores. Both the assessment and Best Buy’s employees will be able to guide buyers to the right device for their needs. Its offerings will include those from Eargo, Jabra, Lucid Hearing and Lexie Hearing, which recently took on Bose’s range of direct-to-consumer hearing aids.
Also potentially joining that group this fall is Nuheara, an Australian company developing earbuds that cancel out ambient noise to help users focus on a specific source. The self-fitting version of its technology is undergoing FDA review. Once secured, the hearing aids will be sold at Best Buy with HP branding, thanks to a trademark license agreement Nuheara inked with the consumer tech giant earlier this year, its U.S. CEO John Luna said in a release (PDF).