2024-05-19 04:45:09 ET
Summary
- Envoy Medical is a hearing device company that offers fully implantable devices for people with moderate to severe hearing loss.
- The company's second device, Acclaim, has been granted Breakthrough Device status and is about to begin clinical trials for FDA approval.
- Envoy's devices offer advantages such as no external device, no cleaning required, no risk of costly replacement, and 24/7 usage.
Envoy Medical ( COCH ) is a hearing device company for people with moderate to severe hearing loss. It is the only company that offers an FDA approved active fully implantable device, the Esteem Active Middle Ear implant. This device has lacked commercial success due to its Medicaid classification as a hearing aid, which is not eligible for coverage. Private insurance companies typically follow Medicaid reimbursement policies. Few people are capable or willing to cover the cost of the Esteem device, about $25 K, without insurance reimbursement.
The company's second fully implantable device, the Acclaim , has been granted Breakthrough Device status and is about to begin clinical trials for FDA approval. The company estimates that Acclaim will be commercially available in 2026. The device is a cochlea implant which is covered by Medicare. Meanwhile, The Hearing Device Coverage Clarification Ac t, introduced in February, seeks to clarify that fully implanted middle ear devices, such as the Esteem, are prosthetics and not hearing aids, therefore eligible for Medicaid coverage....
Read the full article on Seeking Alpha
For further details see:
Envoy Medical Is Pursuing Filling A Hearing Industry Void