At a glance
ClinicalIndex Comparison RecordN/ACompleted· 51 enrolled
Drug / intervention
The Esteem Hearing Implantdevice
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.
To Evaluate the Long-term Safety and Efficacy of the Esteem® Hearing Implant in Subjects Suffering From Moderate to Severe Hearing Loss
In Brief
An observational study evaluating The Esteem Hearing Implant for Hearing Loss. Completed, enrolled 51 participants across 5 sites.
Detailed Summary
The purpose of this study is to evaluate the long-term safety and efficacy of the Esteem® Hearing Implant in subjects suffering from moderate to severe hearing loss.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsHearing Loss
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartAug 2010
Primary CompletionAug 2014
Study CompletionMar 2015
First PostedJan 2016
TodayJul 2026
First PostedJan 28, 2016
Enrollment StartAug 1, 2010
Primary CompletionAug 1, 2014
Study CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 10.4 years ago
Interventions
The Esteem Hearing Implantdevice
The Esteem® Hearing Implant is designed to improve hearing in subjects suffering from moderate to severe hearing loss that is sensorineural in origin. The Esteem® has been approved by FDA for the US market under Pre-Market Approval P090018 and this study fulfills the requirement for one of the Post Approval Studies.