Company Applauds FDA for Increased Access and Innovation
SAN JOSE, Calif., Aug. 17, 2022 (GLOBE NEWSWIRE) — Eargo, Inc. (Nasdaq: EAR) (“Eargo” or the “Company”), a medical device company with a mission to improve hearing health, announced its support for the new regulatory category of over-the-counter (“OTC”) hearing aids, as finalized by the Food and Drug Administration (the “FDA”) on Wednesday, August 17, 2022.
Christian Gormsen, President and CEO, said, “This decision aligns directly with Eargo’s mission. By making hearing aids more accessible and affordable while maintaining safety standards, the industry will finally be driven by consumer demand for higher quality products.
Mr. Gormsen continued: “Based on our initial review of the final rule, we believe that Eargos can continue to be sold under existing regulations and classified as over-the-counter hearing aids, subject to compliance with the labeling and other requirements of the final rule. For example, we believe that Eargo hearing aids currently on the market meet FDA exit and insertion depth requirements. We also believe that the FDA’s removal of certain sales restrictions for over-the-counter hearing aids will allow Eargo to expand how we serve customers by adding full retail outlets and physical locations in a streamlined way. and scalable, which will allow Eargo to meet customers more widely. hearing health needs. We plan to add partner physical locations to our online experience in 2022 and 2023. That said, we will need to dedicate time and resources to evaluating the final rule and ensuring our devices and processes comply with the new requirements.
Mr. Gormsen concluded, “This industry milestone will drive innovation and provide the kinds of user-friendly hearing care experiences the industry needs. The hearing aid industry has traditionally been stagnant and slow to adapt to changing consumer needs. Stigma is the biggest barrier to people’s decision to wear hearing aids. Eargo launched its first product six years ago to overcome stigma with its virtually invisible hearing aids. Our differentiated product and consumer-focused approach, which includes lifetime remote customer service, empowers people to take control of their own hearing well-being. Eargo wholeheartedly supports the FDA’s decision to take this monumental step forward to promote accessibility, and we look forward to the positive changes this will have on the future of hearing health.
The new ruling, which is expected to take effect in October 2022, is expected to increase access to products for the approximately 45 million American adults who have some degree of hearing loss. Only one in four people who would benefit from wearing a hearing aid have worn one. The over-the-counter hearing aid regulatory category aims to make hearing aids more affordable and attractive to consumers while meeting reasonable standards of safety and effectiveness.
The final rule will be effective 60 days after it is published in the Federal Register. Based on the current regulatory classification of Eargo hearing aids as Class I or Class II exempt air conduction hearing aids, we believe that Eargo will have 240 days after the date of publication in the Federal Register to comply with new or revised requirements, including labeling requirements. . However, if any of our current devices require 510(k) clearance to comply with the final rule, we will need to obtain clearance for those devices prior to the effective date of the final rule.
Eargo is a medical device company with a mission to improve hearing health. Our innovative product and go-to-market approach addresses key challenges to traditional hearing aid adoption, including social stigma, accessibility and cost. We believe our Eargo hearing aids are the first virtually invisible, rechargeable, fully-in-the-canal, FDA-regulated, Class I or Class II exempt devices indicated to compensate for mild to moderate hearing loss. Our differentiated, consumer-centric approach empowers consumers to take control of their hearing. Consumers can purchase Eargo hearing aids online or over the phone and receive personalized, hands-on consultation and support from hearing care professionals via phone, text, email or video chat. Eargo hearing aids are offered to consumers at approximately half the price of competing hearing aids purchased through traditional channels in the United States.
Eargo’s sixth-generation device, Eargo 6, is an FDA Class II exempt hearing aid featuring Sound Adjust technology that automatically optimizes the soundscape as the user moves between environments. http://eargo.com
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical fact contained in this press release are forward-looking statements, including statements regarding the future effects of the FDA rule for over-the-counter hearing aids, the company’s ability to add complete, physical retail locations in a simplified and scalable way. , and the impact of the FDA’s final rule and the company’s assessment, ability and timing to comply with the new requirements. Forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions that could cause actual results and events to differ materially from those anticipated, including, but not limited to , the risks, uncertainties and assumptions relating to: the rights offering; the extent to which the Company may be able to validate processes to support the submission of claims from the FEHB program or other insurance programs in the future, if applicable, and the Company’s ability to maintain or increase Eargo hearing aid insurance coverage; the timing or results of ongoing claims audits and reviews of medical records by third-party payers; the extent of losses of hearing aids delivered to customers from September 21, 2021 to December 8, 2021; the impact of third-party payer audits and the hearing aid regulatory landscape on the Company’s business and results of operations; the Company’s expectations regarding additional orders from existing customers; the Company’s expectations regarding the size of the potential market and the size of potential consumer populations for its products and any future products, including increased insurance coverage for Eargo hearing aids; the Company’s ability to market new hearing aids and the anticipated features of such hearing aids; developments and projections regarding the Company’s competitors and its industry, including competing products; the Company’s ability to maintain its competitive technological advantages in the face of new entrants to its industry; the price of the Company’s hearing aids; the Company’s expectations regarding the ability to make certain claims related to the performance of its hearing aids over competing products; the Company’s expectations regarding changes in the regulatory landscape for hearing aids, including the implementation of the over-the-counter hearing aid regulatory framework and the Company’s assessment, ability and timing to comply with the new requirements ; and the Company’s estimates regarding the COVID-19 pandemic, including, but not limited to, its duration and impact on the Company’s business and results of operations. These and other risks are described in greater detail in the section titled “Risk Factors” contained in the Company’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and other documents filed with the United States Securities and Exchange Commission. All forward-looking statements contained in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, are based on current expectations, forecasts and assumptions, and speak only as of the date of this Press release. Except as required by law, the Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.
Senior Vice President of Corporate Strategy and Investor Relations