The below statement from Starkey President Brandon Sawalich addresses President Biden’s announcement following his meeting with the White House Competition Council, a group established by the July 2021 Promoting Competition in the American Economy executive order advancing US economic competition; the Council met for the second time on Monday, January 24, at a moment when high prices related to inflation are affecting Americans. According to Starkey, the company supports “increasing hearing aid accessibility, but not at the cost of patient safety.” In remarks posted online, Biden includes the FDA’s proposed rule on OTC hearing aids as a talking point, saying, “We expect this is going to lower costs for hearing aids from thousands of dollars to — literally to hundreds of dollars, saving people hundreds and hundreds of dollars. And people will — can pick them up at a local pharmacy, saving time and money, and helping the tens of million people with hearing loss who don’t have hearing aids now.”
Hearing aids are a medical device. They are built with the technology of a medical device and regulated as such by the FDA. I have been in the hearing healthcare industry for nearly 30 years, and competition in this market has never been stronger. Hearing aids are manufactured by more than 80 FDA registered companies, and manufacturers continue to not only push the limits of hearing aid technology for the betterment of the patient, but each offers devices at a variety of price points. Starkey has, and will continue to, support an increased access to hearing healthcare. Since 2017, when Congress created this new category of OTC hearing aids, Starkey has worked tirelessly to ensure these new devices protect patient safety and satisfaction.
Unfortunately, at the behest of a few consumer electronics companies putting profit over patients, this administration is trying to commoditize a hearing aid as a consumer electronics device.
I would welcome the opportunity to meet with President Biden and his team on this issue. As a leader in the hearing industry for more than 50 years, all of us at Starkey look forward to working with his administration toward one common goal of helping people hear better.
President & CEO