CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 117 enrolled
Drug / intervention
Implantation of Esteemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02689349
NCT02689349N/ACompleted
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Esteem Totally Implantable Hearing System New Subject Enrollment Post Approval Study

Envoy Medical Corporation·interventional·Posted Feb 23, 2016·Updated Jun 27, 2022

In Brief

A clinical study evaluating Implantation of Esteem for Sensorineural Hearing Loss. Completed, enrolled 117 participants across 6 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSensorineural Hearing Loss
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 23, 2016
Enrollment StartAug 1, 2010
Primary CompletionSep 1, 2021
TodayJul 2, 2026
Enrollment to primary: 11.1 yearsPosted 10.4 years ago

Interventions

Implantation of Esteemdevice

Subjects meeting indications are implanted with the Esteem Totally Implantable Hearing System