AMA Approves New CPT Codes for Active Middle Ear Hearing Implants

Someone was listening: Active middle ear implants have new CPT codes for the first time.

The American Medical Association’s (AMA) Current Procedural Terminology (CPT) Editorial Panel has approved five Category III CPT codes for totally implantable active middle ear implants (AMEI), a key development for products like Envoy Medical Inc.’s U.S. Food and Drug Administration (FDA)-approved Esteem device.

The previous lack of CPT codes effectively limited market adoption of and prevented access to fully implanted hearing devices, according to Envoy Medical. With a new set of CPT codes, a path to reimbursement for the Esteem Fully Implanted Active Middle Ear Implant (FI-AMEI) may begin to take shape.

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.

“[This] 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,” Envoy Medical CEO Brent Lucas said. “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. [This] brings us one step closer to altering the hearing healthcare landscape by providing hearing loss patients with another viable solution.”

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.

“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,” Lucas stated. “We have some 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 approved earlier this fall will be posted to the AMA CPT website by Jan. 1, 2025, with a July 1, 2025, implementation date.

The Esteem fully implanted active middle ear implant (FI-AMEI) is billed as the only FDA-approved, fully implanted* hearing device for adults diagnosed with moderate to severe sensorineural hearing loss that allows 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.

Envoy Medical is confident its fully implanted Acclaim Cochlear Implant will be a first-of-its-kind fully implanted cochlear implant. Envoy Medical’s fully implanted technology includes a sensor designed to leverage the natural anatomy of the ear instead of a microphone to capture sound. The Acclaim CI is designed to address severe to profound sensorineural hearing loss that is not adequately addressed by hearing aids. The Acclaim CI is expected to be indicated for adults who have been deemed adequate candidates by a qualified physician.

The Acclaim Cochlear Implant received FDA Breakthrough Device Designation in 2019; it was the first hearing-focused device to receive such a designation.

The Acclaim Cochlear Implant is an investigational device limited by U.S. law to investigational use.

*Once activated, the external Esteem FI-AMEI Personal Programmer is not required for daily use.