Envoy Medical, a hearing health company focused on fully implanted hearing systems, 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 says it believes the classification resulted in breakthrough hearing technologies not being available to Medicare beneficiaries.

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

“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,” says 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.”

Further reading: Envoy Medical Awarded New Patent for Implantable Cochlear Systems

Fully Implanted Active Middle Ear Hearing Devices are not hearing aids for a variety of reasons, according to Envoy Medical. They are fully implanted and do not use external microphones to pick up sound. As fully implanted medical devices, they come to market through a significantly different regulatory pathway than hearing aids. 

“Every day, Minnesota-based med tech companies are creating brand new technologies, like the Esteem, that have the potential to bring immense benefits to Minnesotans and Americans across the country – but only if they are accessible. That’s why I’m working with my colleague Rep. Michelle Fischbach on this bipartisan bill to correct the misclassification of these hearing technologies and ensure Minnesotans are receiving the coverage they need to access these life-changing devices,” says Representative Craig.

The implant requires a surgical procedure by a skilled ear surgeon where part of the middle ear is bypassed or replaced to compensate for the damaged inner ear. Once positioned, fully implanted active middle ear devices become the patient’s hearing pathway and is something they cannot remove themselves.

“The FDA has approved the fully implanted hearing devices as prosthetics, not simple hearing aids, and yet CMS has been classifying them as a hearing aid, meaning its implantation cannot be covered by Medicare,” says Representative Fischbach. “These devices could help countless people regain their hearing, but CMS wants to price so many of them out of taking that monumental step for their well-being. I am proud to introduce legislation that will enable more people to gain access to these life-changing products.”

Envoy Medical believes that this legislation would not only provide access to an important technology, but also would encourage more innovation and competition.

“Passage of this bill will absolutely result in more competition and more innovation. Envoy Medical is just one of many companies that would begin to reinvest into the fully implanted active middle ear hearing device segment,” Lucas says. “That would mean more innovation, more competition, more well-paying jobs here in America, and, most importantly, more solutions for the nearly 40 million Americans who suffer from disabling hearing loss.”