CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 57 enrolled
Drug / intervention
Esteem Totally Implantable Hearing Systemdevice
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/NCT01092910
NCT01092910N/ACompleted
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Esteem Totally Implantable Hearing System Clinical Trial U.S. Pivotal Trial

Envoy Medical Corporation·interventional·Posted Mar 25, 2010·Updated Jan 2, 2020

In Brief

A clinical study evaluating Esteem Totally Implantable Hearing System for Mild to Severe Sensorineural Hearing Loss. Completed, enrolled 57 participants across 5 sites.

Detailed Summary

To evaluate the safety and efficacy of the Esteem Totally Implantable Hearing System in subjects suffering from mild to severe hearing loss.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMild to Severe Sensorineural Hearing Loss
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 25, 2010
Enrollment StartJan 1, 2008
Primary CompletionJul 1, 2009
Study CompletionAug 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 16.3 years ago

Interventions

Esteem Totally Implantable Hearing Systemdevice

The Esteem System is a totally implantable hearing system designed to improve hearing in adult subjects suffering from mild to severe hearing loss that is sensorineural in origin.