Pivotal Clinical Trial Evaluating the Safety and Efficacy of the Fully Implanted Acclaim Cochlear Implant
← catalyst calendarNCT06699797 · readout ≤ 254 d
Sponsored by Envoy Medical Corporation (industry) · COCH — their whole pipeline →.
Phase
Not applicable
Status
Active, not recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
56estimated
Sites
7
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-02-06 | actual | When the study began enrolling |
| Primary completion | Apr 2027 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Apr 2028 | estimated | The whole study's end, after follow-up |
| First posted | 2024-11-21 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-03-16 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Sensori-Neural Deafness
- Sensorineural Hearing Loss
- Sensorineural Hearing Loss (Disorder)
- Sensorineural Hearing Loss, Bilateral
- Sensorineural Hearing Loss, Profound
- Sensorineural Hearing Loss, Severe
Intervention
- Device: Acclaim Cochlear Implant
Primary outcomes
what the primary-completion date above is the date OFIn the Safety Set, frequency and severity of device and procedure related adverse events, including device deficiencies, reported through 12-Month post-activation
measured From consent to the 1-year follow-up visit
In the Full Analysis Set, within-subject difference between CNC word score obtained at 12-months post-activation in the Acclaim Only condition and the pre-operative aided score in the ear to be implanted
measured From consent to the 1-year follow-up visit
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