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NCT02689349 · ClinicalTrials.gov registry record · NA
Esteem New Subject Enrollment Post Approval Study
A NA study, sponsored by Envoy Medical Corporation.
- Completed
- Registry status
- NA
- Development phase
- 117
- Enrollment target
NCT02689349: Completed NA study, sponsored by Envoy Medical Corporation.
NCT02689349 is a NA study that has completed, run by Envoy Medical Corporation. The registered enrollment target is 117 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02689349, a NA study, has completed, sponsored by Envoy Medical Corporation.
- COMPLETED
- Registry status
- NA
- Development phase
- 117 participants
- Enrollment target
Study Summary
The New Enrollment Post-Approval Study is designed to evaluate the safety and efficacy of the Esteem Totally Implantable Hearing System in subjects suffering from moderate to severe hearing loss.
Primary Outcome
Comparison of the speech reception threshold (SRT) using the Esteem System as compared to the pre-implant aided condition. The SRT is related to hearing sensitivity; lower numbers indicate better outcomes. Here, the difference in dB is reported; positive scores indicate improvement (lower SRT) with the Esteem relative to the pre-implant hearing aid. There are no specific minimum or maximum scores for this measure.
Interventions
- DEVICE Implantation of Esteem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 117 participants |
| Start Date | 2010-08 |
| Est. Completion | 2021-09 |
| Phase | NA |
What the finished NCT02689349 record still lists
NCT02689349 is an interventional study that assigns participants to a tested intervention. The registered 117 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which Implantation of Esteem is the first listed.
NCT02689349 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02689349 about?
NCT02689349 is a clinical study titled "Esteem New Subject Enrollment Post Approval Study". The New Enrollment Post-Approval Study is designed to evaluate the safety and efficacy of the Esteem Totally Implantable Hearing System in subjects suffering from moderate to severe hearing loss.
What is the current status of trial NCT02689349?
This trial is currently completed. It is a NA study. The enrollment target is 117 participants. The study started on 2010-08. Estimated completion is 2021-09.
What interventions are being tested in trial NCT02689349?
The interventions under investigation include: Implantation of Esteem (DEVICE).
Who is sponsoring clinical trial NCT02689349?
This trial is sponsored by Envoy Medical Corporation, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02689349's enrollment target sits among peer trials
117 807th of 2000 higher than 1,193 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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