US-based Envoy Medical has received approval from the US Food and Drug Administration (FDA) for its investigational device exemption (IDE) application to commence a study of the Acclaim cochlear implant (Acclaim CI).

This implant is tailored for adults who suffer from severe to profound sensorineural hearing loss and who are not adequately served by hearing aids.

The FDA's approval of the IDE application allows Envoy Medical to gather initial clinical data from a subset of patients before expanding enrolment to the full subject cohort.

The Acclaim CI technology has an implanted sensor that utilises the physical anatomy of the ear to capture sound.

Envoy Medical plans to collaborate with various cochlear implant institutions in the US for the investigational study, which will serve as investigational study sites.

Envoy Medical CEO Brent Lucas said: “Receiving FDA approval to initiate this pivotal study marks a significant milestone in our efforts to bring this breakthrough hearing device to more people with severe to profound hearing loss.

“Last week marked the American Medical Association’s approval of new CPT codes for totally implantable active middle ear implants, which opens new opportunities for our already FDA-approved Esteem device. This week, we are celebrating IDE approval to start a pivotal study for our investigational Acclaim device.”

The Acclaim CI was granted the breakthrough device designation by the FDA in 2019.

Another Envoy device, the Esteem fully implanted active middle ear implant (FI-AMEI), is approved by the FDA for use in adults with moderate to severe sensorineural hearing loss.

The FI-AME is designed to be invisible, with no external components or ear canal insertions required.