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Pivotal Clinical Trial Evaluating the Safety and Efficacy of the Fully Implanted Acclaim Cochlear Implant

NCT06699797 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2026-03-16

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if the Acclaim CI works to treat severe to profound sensorineural hearing loss in adults. It was also learn about the safety of the Acclaim CI implant. The main questions it aims to answer are:

* Does the Acclaim CI device help participants hear words better compared to before the implants?
* What medical problems do participants have after the Acclaim CI device was implanted?

Participants will:

* Have the Acclaim CI implanted; and
* Visit the clinical site for checkups and tests at 1-Month, 3-Months, 6-Months, and at 1-year and 2-years after the device has been turned on.

Conditions

  • Sensori-Neural Deafness
  • Sensorineural Hearing Loss
  • Sensorineural Hearing Loss (Disorder)
  • Sensorineural Hearing Loss, Bilateral
  • Sensorineural Hearing Loss, Profound
  • Sensorineural Hearing Loss, Severe

Interventions

DEVICE

Acclaim Cochlear Implant

Participants with the Acclaim CI device will be tested during follow-up with their hearing results compared to baseline (before the device implant procedure).

Sponsors & Collaborators

  • Envoy Medical Corporation

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-06
Primary Completion
2027-04-30
Completion
2028-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06699797 on ClinicalTrials.gov