Core Points - The Hearing Device Coverage Clarification Act has been reintroduced in both the U.S. House and Senate to clarify that certain hearing implants are considered prosthetics, potentially allowing for Medicare coverage [1][2][4] - The House version of the bill, H.R. 1921, was reintroduced by Representatives Michelle Fischbach and Angie Craig, while the Senate version, S. 983, was reintroduced by Senators Amy Klobuchar and James Lankford, with expectations of bipartisan support [3] - The Act aims to provide Medicare coverage for fully implanted active middle ear hearing devices, distinguishing them from traditional hearing aids, which could benefit companies like Envoy Medical that produce such devices [4][5] Company Insights - Envoy Medical, a company specializing in fully implanted hearing systems, has received FDA PMA approval for its Esteem® device since 2010 and is one of the few companies with a fully implanted active middle ear implant [5][6] - The company believes that the passage of the Hearing Device Coverage Clarification Act would create more well-paying jobs in the U.S. and enhance competitiveness in the hearing implant industry, which is currently dominated by foreign players [5][6] - Envoy Medical's Acclaim Cochlear Implant is designed for severe to profound sensorineural hearing loss and received Breakthrough Device Designation from the FDA in 2019, indicating its innovative nature [6][8]
Hearing Device Coverage Clarification Act Reintroduced in House and Senate