---
title: "EXCLUSIVE: Envoy Medical Builds Momentum With Improved Cochlear Implant Trial Results"
type: "News"
locale: "en"
url: "https://longbridge.com/en/news/292633477.md"
description: "Envoy Medical reported improved 12-month hearing results for its Acclaim cochlear implant, with mean CNC word recognition scores rising to 53.2% from a 15.2% baseline. Nine of ten participants showed positive responses, and no serious adverse events were recorded. The company has completed Stage 2 enrollment and plans to submit for FDA Premarket Approval in late 2027 or early 2028."
datetime: "2026-07-14T13:01:05.000Z"
locales:
  - [zh-CN](https://longbridge.com/zh-CN/news/292633477.md)
  - [en](https://longbridge.com/en/news/292633477.md)
  - [zh-HK](https://longbridge.com/zh-HK/news/292633477.md)
generator: "portal-rs"
---

# EXCLUSIVE: Envoy Medical Builds Momentum With Improved Cochlear Implant Trial Results

**Envoy Medical Inc.** (NASDAQ:COCH) on Tuesday reported 12-month results from the first 10 participants in Stage 1 of its pivotal clinical trial evaluating the investigational fully implanted Acclaim cochlear implant, with hearing performance continuing to improve over previously reported six-month data.

The company said participants achieved a mean Consonant-Nucleus-Consonant (CNC) word recognition score of 53.2% at the 12-month mark, compared with a pre-implantation baseline of 15.2%.

The 38.0 percentage point improvement exceeded the 24.0 percentage point gain reported after six months, when the cohort posted a mean score of 39.2%.

 **Read Also: EXCLUSIVE: Envoy Medical Hits Trial Milestone For Cochlear Implant Designed To Work With Natural Ear** 

The 12-month data will serve as the primary efficacy endpoint for the Acclaim pivotal clinical study.

## Majority Of Patients Showed Positive Response

Nine of the 10 Stage 1 participants demonstrated hearing improvements consistent with the overall trend, while one participant was identified as a potential non-responder. Envoy Medical said it is reviewing the underlying cause of that outcome.

Excluding the potential non-responder, the remaining nine participants recorded a mean CNC word recognition score of 59.1% at 12 months, representing a 42.2 percentage point improvement from baseline.

On the safety front, the company reported no serious adverse events, as defined by the study protocol, among the first 10 participants through their 12-month follow-up visits.

## **Envoy Medical** Says Stage 2 Enrollment Complete

The completion of the 12-month assessments marks the end of primary endpoint follow-up for Stage 1 of Envoy Medical’s two-stage pivotal trial.

Following FDA authorization to expand the study, the company moved into Stage 2, which is now fully enrolled. All participants have completed their one-month visits, while many have also reached their three- and six-month follow-up milestones.

The company is collecting additional study measures and will include them in its planned FDA Premarket Approval submission.

Envoy Medical expects all Stage 2 participants to complete their 12-month follow-up by the early second quarter of 2027, with a Premarket Approval submission planned several months later.

**COCH Price Action:** Envoy Medical shares were down 3.24% at $0.67 during premarket trading on Tuesday, according to Benzinga Pro data.

 **Read Also: Mohamed El-Erian Says Kevin Warsh Is 'Serious' About Reforming the Fed, Restoring Political Independence** 

*Photo by PeopleImages via Shutterstock*

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> **Disclaimer: This article is for reference only and does not constitute any investment advice.**