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Starkey - Next Level - August 2022

Starkey Responds to FDA Proposed Ruling on Over-the-Counter Hearing Aids


Eden Prairie, Minnesota (October 19, 2021) – Starkey President and CEO Brandon Sawalich has issued a statement regarding the recent proposed ruling by the Federal Food and Drug Administration (FDA) outlining a new category of hearing aids that can be sold over the counter (OTC). Consumers will be able to buy these devices directly from a retailer, without visiting a trained and licensed hearing healthcare professional. Starkey, in conjunction with the Hearing Industries Association (HIA), is currently reviewing the ruling to ensure it is in the best interest of patients and will submit comments accordingly.

“Starkey wishes to thank the FDA for meticulously following a process of open dialogue with every stakeholder: manufacturers, hearing professionals, industry groups and, most importantly, patients and their families,” said Sawalich. “As the largest American-owned hearing aid manufacturer, Starkey has taken a leadership role in working with policymakers to ensure policies are created with the patient at the forefront. We believe it is important for their voices to be heard not only now, but in the future. It is imperative for the public to understand that hearing healthcare professionals are an essential resource, as they determine not only which products are right for each patient’s unique hearing loss, but also to prevent more damage to their hearing.”

To ensure new policies are in the best interests of patients, Starkey created Listen Carefully, an initiative aimed at bridging the conversation between hearing healthcare professionals, individuals with hearing loss, and policymakers in Washington, D.C. In reviewing the proposed ruling, Starkey will continue to solicit feedback from industry leaders, hearing professionals and patients regarding the regulations, and encourage people to share their thoughts directly with the FDA via the public comment process.

For more information about Listen Carefully, click here. For more information about Starkey, click here.


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