Newly Introduced Bipartisan Bill Seeks to Clarify Fully Implanted Active Middle Ear Hearing Devices as Prosthetics, Not Hearing Aids, Making Them Eligible for Medicare Coverage

Envoy Medical’s FDA Approved Esteem Fully Implanted Active Middle Ear Hearing Device May Now Have an Opportunity to be a Coverable Benefit

WHITE BEAR LAKE, Minnesota, Feb. 07, 2024 (GLOBE NEWSWIRE) -- Envoy Medical, Inc. (“Envoy Medical”) (NASDAQ: “COCH”), a revolutionary hearing health company focused on fully implanted hearing systems, today announced the introduction of a new bipartisan Congressional bill, titled the Hearing Device Coverage Clarification Act. The bill seeks to clarify that fully implanted active middle ear hearing devices are prosthetics and not subject to the current Medicare hearing aid coverage exclusion.

The Social Security Act of 1965 excluded hearing aids, eyeglasses, and dental care from being coverable benefits under Medicare and Medicaid. The Center for Medicare and Medicaid Services (“CMS”) has broadly interpreted what a “hearing aid” is to include devices that are not hearing aids. Envoy Medical believes this inappropriate classification has resulted in breakthrough hearing technologies not being available to Medicare beneficiaries and has hindered innovation and competition in the hearing device marketplace.

The legislation was introduced on February 6, 2024 in the U.S. House of Representatives by Representatives Michelle Fischbach (R-MN) and Angie Craig (D-MN). The legislation is expected to gain additional bipartisan support following the bill’s introduction.

“The Hearing Device Coverage Clarification Act is a big step in the right direction for hearing loss patients who deserve access to more options. Hearing aids are wonderful technologies – we are in no way suggesting otherwise – but they are not for everyone suffering from disabling hearing loss. We have seen discouraged longtime hearing aid users rejoin life with our fully implanted Esteem hearing device, and we believe more Medicare beneficiaries deserve that opportunity,” said Envoy Medical CEO Brent Lucas. “We are thrilled that Representatives Fischbach and Craig are committed to bringing this issue forward for the benefit of their constituents’ health by leading the effort to correct what we believe to be an administrative mistake. Both Representatives Fischbach and Craig, along with their amazing staff, have taken the time to learn about this issue, the technology, and understand why it is important. We are also grateful for the other members of the U.S. House and Senate who have offered their support and we look forward to working with them as we proceed.”