Washington, D.C. - Today, Congresswoman Fischbach introduced the Hearing Device Coverage Clarification Act, which clarifies that fully implanted active middle ear hearing devices are prosthetics that are not subject to the hearing aid coverage exclusion. The bill has wide bipartisan support amongst Minnesota's congressional delegation.

"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," said Rep. Fischbach (MN-07). "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."

“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,” said Rep. Craig (MN-02).  

Background: Unlike hearing aids, fully implanted middle ear hearing devices require surgery to replace the function of the middle ear and have no external components with microphones to pick up the sound or speakers to make the sound louder. Once the surgery is completed, the patient needs the device to hear and cannot “take off” the device without a surgical explant. According to the Food and Drug Administration (FDA), such devices are classified as prosthetics. And yet, CMS is still classifying them as hearing aids and, therefore, Medicare beneficiaries and those covered by private health insurance do not have access unless they pay out of pocket.