- CVS Health is set to shut down its foray into audiology services at the end of March as it positions itself to take advantage of the forthcoming over-the-counter hearing aid category of devices, Hearing Health & Technology Matters first reported. Fourty-nine standalone audiology centers in CVS retail locations and about 100 employees will be impacted by the decision.
- FDA is scheduled to issue a proposed rule outlining how it plans to implement the OTC hearing aid regulations in November, according to the Unified Agenda. It is required to issue the proposal by 2020 by the FDA Reauthorization Act of 2017, and then finalize the proposal within 180 days of the comment period closing.
- The decision by CVS may signal audiologist practices could face stiff headwinds when FDA issues its proposal. Hearing aid manufacturers such as Starkey Hearing Technologies have been lobbying the federal government in an effort to protect the industry.
FDA has made it clear it believes consumers should be able to take a more active role in managing hearing loss. In October, the agency authorized the first self-fitting hearing aid from Bose that consumers can program without assistance from a healthcare provider.
CVS Pharmacy started piloting audiology centers in 2015 at certain retail locations, but with new regulations on the horizon, the company is pivoting away from the experiment. The company said the decision was prompted by lower-cost devices entering the market in the "near future" that will "enable self-serve hearing testing and care."
"We are shifting our audiology strategy to better position CVS Pharmacy as a leader in offering clinically effective, lower priced hearing devices once the new over-the-counter category is approved by the FDA," CVS spokesperson Michael DeAngelis confirmed to MedTech Dive. "To help prepare for this shift, we are closing the standalone audiology centers in our retail locations, effective March 30, 2019."
The employees affected by the decision to close the centers will be paid through April 5 and be offered the opportunity to apply for other CVS positions, according to DeAngelis. Those that do not stay with the company will be "eligible for a transition package."
FDA announced in February it is planning to exempt certain hearing aids from 510(k) requirements in forthcoming rulemaking and will exercise enforcement discretion until such regulations are formally implemented.
Hearing aid manufacturers argue audiologists are a critical component of hearing care to maintain patient safety, but reports from the National Academies of Science, Engineering and Medicine and former President Barack Obama's President's Council of Advisors on Science and Technology argue OTC hearing aids will lower costs and expand consumer access.