Envoy Medical completed the three-month follow-up for all 56 patients in the pivotal Acclaim cochlear implant trial, advancing toward an FDA PMA submission.
Written By: Fariha Sameen, PharmD
Reviewed By: Pharmacally Editorial Team
Envoy Medical has completed the three-month follow-up for all 56 participants enrolled in its pivotal clinical trial evaluating the investigational Acclaim® fully implanted cochlear implant, marking a key development milestone as the company moves toward a planned Premarket Approval (PMA) submission to the U.S. Food and Drug Administration.
The milestone indicates that every enrolled patient has now completed the initial three-month assessment, allowing the company to continue collecting longer-term safety and performance data required to support its PMA application. Envoy expects all participants to reach the six-month follow-up by late 2026 and complete the 12-month evaluation by April 2027.
Fully Implanted Cochlear Implant Targets Severe Hearing Loss
The Acclaim cochlear implant is an investigational, fully implanted hearing device intended for adults with severe to profound sensorineural hearing loss that is not adequately managed with hearing aids. Unlike conventional cochlear implants, which rely on externally worn microphones and processors, the Acclaim system uses an implanted sensor that captures sound through the ear’s natural anatomy.
By eliminating external components, the technology could provide continuous hearing capability while improving convenience, cosmetic acceptance, and device compliance. The FDA granted the Acclaim cochlear implant Breakthrough Device Designation in 2019, recognizing its potential to address an unmet clinical need.
The device remains investigational and is currently limited to clinical study use in the United States.
Pivotal Trial Continues to Generate Safety Data
Envoy Medical’s ongoing pivotal study (NCT06699797) enrolled 56 patients and continues to evaluate the safety and overall performance of the Acclaim cochlear implant. Although the company did not disclose efficacy results or endpoint data in the latest update, it confirmed that safety and other study measures are being collected throughout the trial and will form part of the planned PMA submission.
Completion of the three-month milestone represents an important operational achievement, ensuring that every participant has progressed through the early postoperative evaluation period before entering longer-term follow-up.
Additional clinical data from the six- and twelve-month visits are expected to provide the evidence needed to support regulatory review.
Company Moves Closer to PMA Submission
Chief Executive Officer Brent Lucas said the latest milestone reflects the company’s continued execution of its clinical development strategy and brings Envoy Medical closer to submitting its PMA application to the FDA. He noted that each completed milestone advances the company’s objective of introducing a fully implanted cochlear implant to patients in the United States.
Building on Experience with Fully Implanted Hearing Technology
Envoy Medical has previous experience developing implantable hearing devices through its Esteem® Fully Implanted Active Middle Ear Implant, which has been commercially available in the United States since 2010. The Esteem system remains the only FDA-approved fully implanted hearing implant for adults with moderate to severe sensorineural hearing loss and operates without externally worn components during routine daily use.
If approved, the Acclaim cochlear implant would expand the company’s fully implanted hearing technology platform into patients with more advanced hearing loss, potentially offering an alternative to conventional cochlear implant systems that require external hardware.
With enrollment completed and all participants reaching the first major follow-up milestone, the pivotal trial has entered the next phase of long-term evaluation as Envoy Medical advances toward its anticipated FDA PMA submission.
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About the Writer
Fariha Sameen, PharmD (LinkedIn), is a clinical pharmacy professional with hands-on experience in patient counselling, medication review, therapeutic monitoring, and clinical documentation across multiple departments. She has experience identifying and assessing drug-related problems and supporting medication safety practices. Her interests include pharmacovigilance, ADR reporting, clinical research, and medical writing focused on clear, evidence-based communication.
