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The Esteem® Hearing Implant Post Approval Study

NCT02666222 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 51

Last updated 2016-05-04

Study results available
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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.

Conditions

Interventions

DEVICE

The Esteem Hearing Implant

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.

Sponsors & Collaborators

  • Envoy Medical Corporation

    lead INDUSTRY

Principal Investigators

  • Jack A Shohet, MD · Hoag Memorial Hospital

  • Elizabeth H Toh, MBBS; MD · Lahey Clinic Medical Center

  • Eric M Kraus, MD, MS, FACS · Moses H. Cone Memorial Hospital

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2014-08-31
Completion
2015-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02666222 on ClinicalTrials.gov