Envoy Medical reported that every patient enrolled in its pivotal trial of the Acclaim cochlear implant has completed the Activation Visit, the first step in turning the device on for the first time. The 56 patients who received the investigational implant have all undergone this critical procedural milestone, allowing the company to schedule the remaining follow‑up visits that will culminate in the 12‑month data set required for a Premarket Approval (PMA) submission to the U.S. Food and Drug Administration.
The activation milestone is a key regulatory hurdle. With all activation visits completed, the trial is now positioned to collect the 12‑month outcomes that will form the core of Envoy’s PMA application. The Acclaim device, which received Breakthrough Device designation in 2019, is the first fully implanted cochlear implant that offers no visible hardware on the patient’s head, a feature that could broaden adoption among individuals who are reluctant or unable to use external hearing devices.
Envoy’s Acclaim program builds on the company’s existing Esteem® active middle‑ear implant, which has been commercially available since 2010. By leveraging sensor technology from the Esteem platform, Acclaim represents a de‑risked, next‑generation solution that could address the unmet need of the roughly 6% of eligible patients who currently receive cochlear implants. Recent financing, including a public offering of up to $78 million, provides the runway to support the clinical and regulatory milestones required to bring the device to market.
CEO Brent Lucas said, “The conclusion of our trial studying the first‑of‑its‑kind fully implanted Acclaim® cochlear implant is now within sight. We believe the future of hearing solutions for those with severe to profound hearing loss will be fully implanted devices, and we are excited to be on the leading edge of that revolution.”
The completion of activation visits strengthens investor confidence in Envoy’s clinical trajectory and underscores the company’s progress toward regulatory approval. With the 12‑month data set on the horizon, Envoy is poised to advance the Acclaim program toward a PMA submission, potentially opening a new, high‑growth segment of the hearing‑aid market.
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