Envoy Medical Inc. has released 12-month results from the first 10 participants in a pivotal trial for its fully implanted Acclaim cochlear implant [1].

This development represents a potential shift in auditory prosthetics by removing the need for external hardware. Traditional cochlear implants require a processor worn behind the ear, which can be cumbersome or impractical for some users.

The company said that the Stage 1 trial focused on the safety and efficacy of the internalized system [1]. The follow-up period for these initial participants lasted 12 months [1]. By moving the entire system inside the body, the company aims to provide a more seamless integration for those with severe hearing loss.

Parallel to the Acclaim trials, researchers have demonstrated a prototype for an implantable microphone. According to data released July 2, 2024, this prototype performed on par with commercial hearing aids [2]. The goal of this technology is to eliminate the external microphones that currently characterize most hearing devices.

These advancements in the U.S. are part of a broader effort to explore fully internalized hearing solutions [1]. While the Acclaim system focuses on the cochlear implant, the microphone prototype addresses the broader challenge of sound capture without external equipment [2].

The integration of these two technologies—the fully implanted processor and a high-performance internal microphone—could eventually lead to a completely invisible hearing solution. The researchers said that the microphone's performance was comparable to existing commercial standards [2].

“Envoy Medical released 12-month results from the first 10 participants in Stage 1 of its pivotal trial.”

The transition from semi-implantable to fully implantable auditory devices reduces the risk of external hardware damage and removes the social stigma associated with visible hearing aids. If the Acclaim system and the implantable microphone prototype achieve widespread clinical success, it would mark a fundamental change in how deafness is treated, moving from a managed disability with external tools to a biologically integrated sensory restoration.