Eargo celebrates one year anniversary of OTC hearing aid regulations

Eargo celebrates the one-year anniversary of the creation of an over-the-counter hearing aid category in the US. This important advancement by the US Food & Drug Administration, following a bipartisan mandate from Congress, was meant to reduce costs, increase competition, improve access, and drive innovation in the hearing aid category, resulting in more widespread adoption of hearing technology. This firmly aligns with Eargo’s founding mission. The FDA has noted that the use of hearing aids has been associated with health benefits, improved social participation, and a better quality of life. The revised regulations were intended to encourage more widespread adoption of hearing aids. Eargo is proud to have actively supported the FDA’s rulemaking in establishing this nascent category, though Eargo believes much remains to realize its true intent. Eargo recently surveyed its customers who purchased an OTC self-fitting hearing aid available in the brand’s portfolio of offerings in the year since the regulations have been in effect. Nearly 900 Eargo customers responded. Survey highlights affirm the spirit of the FDA’s objectives of accessibility, affordability, competition, innovation, and effectiveness are being met through direct-to-consumer delivery models like Eargo’s. Approximately 70% of survey respondents were new to hearing aids when they purchased a device from Eargo. Of those survey respondents, the average time from when individuals recognized they had hearing loss to getting their first hearing aid was approximately 4 years. This is much shorter than a 2019 study estimate of 8.9 years. Eargo’s hearing aids are virtually invisible when worn and rechargeable without custom earmolds, which we believe is unique among hearing aids. Only half of the survey respondents were still certain they would get a hearing aid if only visible options were available. The new OTC regulations allow us to more broadly market and sell a hearing aid that encourages people not to let their condition go untreated. Approximately 77% of Eargo users surveyed indicated that buying devices directly online is more affordable or about the same cost as buying in person. Approximately 75% of Eargo survey respondents who had previously worn a traditional hearing aid indicated that Eargo’s performance was equal to or better than their traditional hearing aid. Eargo believes that realizing the intent of the OTC mandate requires further efforts to enable access to hearing aids for adults with hearing loss, such as third-party payment assistance via insurance plan hearing aid benefits. Ahead of the 2024 plan year, Eargo is heartened to see some progressive health plans providing coverage for OTC hearing aids and hopes this is indicative of a trend in coverage for future benefit years. Leaders like UnitedHealthcare are adding benefits for OTC hearing aids across its Medicare Advantage plans and other lines of business. This offers to improve access to OTC hearing aids for the tens of millions of Americans covered by such plans. To date, most plans have made no changes to the hearing aid benefits offered, and a handful of plans exclude coverage of OTC hearing aids. By covering hearing aids-including FDA-cleared self-fitting OTC hearing aids-in high-risk populations without significant administrative hurdles, third-party payors could improve the health of their members while reducing costs of downstream comorbidities that are associated with untreated hearing loss. As Eargo marks the one-year anniversary of the FDA’s launch of the OTC hearing aid category, the company remains focused on providing a discreet and supported experience to counteract the stigma associated with hearing loss, empowering individuals to take control of their hearing wellness journey on their own terms. Eargo’s commitment to accessibility and innovation envisions a future where hearing care is transformative and accessible to all Americans who need it.