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Esteem New Subject Enrollment Post Approval Study

NCT02689349 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2022-06-27

Study results available
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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.

Conditions

  • Sensorineural Hearing Loss

Interventions

DEVICE

Implantation of Esteem

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

Sponsors & Collaborators

  • Envoy Medical Corporation

    lead INDUSTRY

Principal Investigators

  • Sam Marzo, MD · Loyola Center for Hearing, Woodridge IL

  • John Li, MD · Jupiter Medical Center, Jupiter FL

  • Deborah Clark, AuD · Pacific Hearing Service, Los Altos CA

  • Wayne Berryhill, MD · Oklahoma Otolaryngology Associates

  • Sanjay Bhansali, MD · Ear Consultants of Georgia

  • Abraham Jacob, MD · University of Arizona Ear Institute

  • Elizabeth Toh, MD · Lahey Hospital & Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2021-09-30
Completion
2021-09-30

Countries

  • United States

Study Locations

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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 NCT02689349 on ClinicalTrials.gov