Summary: Envoy Medical has received approval from the American Medical Association (AMA) for five Category III CPT codes for its Esteem Fully Implanted Active Middle Ear Implant, potentially enabling broader market adoption and insurance reimbursement for this groundbreaking hearing device.
Takeaways:
- The approval of five new Category III CPT codes marks a major milestone for Envoy Medical’s FDA-approved Esteem Fully Implanted Active Middle Ear Implant, facilitating a pathway for reimbursement.
- Previously, the lack of specific CPT codes limited access and market adoption of totally implantable hearing devices, a barrier that could now be addressed with the new codes.
- The Esteem FI-AMEI offers 24/7 hearing capability without the need for external components, providing a breakthrough solution for individuals with moderate to severe sensorineural hearing loss.
Envoy Medical, a hearing health company focused on fully implanted hearing systems, announced that the American Medical Association (AMA) Current Procedural Terminology (CPT) Editorial Panel has approved five Category III CPT codes for totally implantable active middle ear implants (AMEI), a crucial development for the company’s already FDA-approved Esteem product.
This marks the first time that there will be CPT codes for totally implantable active middle ear hearing implants like the Esteem device, the company says. The previous lack of CPT codes effectively limited market adoption of and prevented access to these groundbreaking, fully implanted hearing devices. With a new set of CPT codes, a path to reimbursement for the breakthrough Esteem Fully Implanted Active Middle Ear Implant (FI-AMEI) may begin to take shape.
How CPT Codes Work
CPT codes are used by healthcare professionals and insurers to identify, track, and pay for medical services and procedures. If a medical service or procedure does not have coding, insurance reimbursement can be challenging.
“Today’s announcement is a seminal moment for Envoy Medical and one that we will work to capitalize on for patients suffering with hearing loss who want access to groundbreaking technologies,” says Brent Lucas, CEO of Envoy Medical, “We have a breakthrough hearing device in our Esteem fully implanted active middle ear implant. We know it is a device more people with hearing loss want to pursue. Today brings us one step closer to altering the hearing healthcare landscape by providing hearing loss patients with another viable solution.”
What is a Category III CPT
Category III CPT codes are temporary codes for emerging technologies, services, and procedures. The inclusion of a descriptor and its associated code number in the CPT code set does not represent endorsement by the American Medical Association of any particular diagnostic or therapeutic procedure/service. Inclusion or exclusion of a procedure/service does not imply any health insurance coverage or reimbursement policy.
Further reading: Envoy Medical Secures Patent for Safe Recharge Tech in Fully Implanted Hearing Devices
“The Esteem product is a viable hearing solution for the right candidate and we look forward to reinvigorating our efforts around this product now that the codes have been approved,” says Lucas. “We have some exciting ideas about improvements to the Esteem device and look forward to furthering our lead in fully implanted hearing technologies. We will continue to act as a disrupter and push the industry forward, which we believe will lead to more innovation and meaningful change.”
Category III codes that were approved at the September 2024 meeting will be posted to the AMA CPT website by January 1, 2025 with an effective implementation date of July 1, 2025.
About the Esteem Fully Implanted Active Middle Ear Implant (FI-AMEI)
The Esteem fully implanted active middle ear implant (FI-AMEI) is the only FDA-approved, fully implanted* hearing device for adults diagnosed with moderate to severe sensorineural hearing loss allowing for 24/7 hearing capability using the ear’s natural anatomy. The Esteem FI-AMEI hearing implant is invisible and requires no externally worn components and nothing is placed in the ear canal for it to function, the company says.
*Once activated, the external Esteem FI-AMEI Personal Programmer is not required for daily use.
Image of the The Esteem Implant from www.envoymedical.com
