Envoy Medical presented the first interim results from the pivotal study of its Acclaim cochlear implant at the American Academy of Audiology and the Combined Otolaryngology Spring Meetings held in late April 2026. The company’s presentation highlighted safety and performance signals from the first 10 patients who completed six‑month follow‑up visits.
The interim analysis showed that participants wore the implant for a median of 24 hours per day, up from a pre‑operative average of 15.5 hours with hearing aids. Speech recognition scores improved from 15.2 % pre‑implant to 39.2 % at six months, a 24‑percentage‑point gain, while tinnitus‑related quality‑of‑life scores dropped from a mean of 24.5 to 6.25. Ninety percent of patients reported a preference for an invisible, fully implanted device, and 80 % had previously declined traditional cochlear implants because of the external processor.
Envoy will continue to share data at upcoming events: the American Cochlear Implant Alliance conference on May 8, the International Conference on Cochlear Implants and Other Implantable Technologies on May 11, and a fireside chat on April 29 to discuss the findings in depth.
CEO Brent Lucas said the data “reinforces our belief in the clinical and commercial promise of a fully implanted approach” and noted that the study’s success “demonstrates strong interest in a solution that eliminates the external hardware barrier.” He added that the company’s breakthrough device designation and the completion of activation visits for all 56 enrolled subjects position Envoy to file a pre‑market approval submission in 2027.
The fully implanted design addresses a key adoption barrier for traditional cochlear implants, potentially expanding the addressable market. With 80 % of participants previously declining conventional devices, the Acclaim implant could capture a segment of patients who value discretion and ease of use. The company’s progress toward FDA approval and the positive interim data suggest a favorable trajectory for future regulatory milestones and market entry.
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