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Esteem New Subject Enrollment Post Approval Study

Esteem Totally Implantable Hearing System New Subject Enrollment Post Approval Study

NCT02689349•Envoy Medical Corporation

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.

Detailed Description

Purpose: To evaluate the long-term safety and efficacy of the Esteem Totally Implantable Hearing System (hereafter called Esteem) in subjects suffering from moderate to severe hearing loss. Questions: The following questions are to be answered: * Is Esteem effective through 1 year follow-up? * Is Esteem safe through 1 year follow-up? * Is the incidence of facial paresis/paralysis at 1 month follow-up no greater than 7%?

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Subject is ≥ 18 years old
•2. Subject understands the nature of the procedure and has signed the Subject Informed Consent Form prior to the procedure
•3. Subject is willing and able to comply with specified follow-up evaluations and understands the audiological test procedures and use of the Esteem® System.
•4. Subject has moderate to severe sensorineural hearing loss in the ear to be implanted defined by pure tone average air-conduction threshold level.
•5. Subject has an unaided maximum word recognition score of greater than or equal to 40% with recorded delivery using a phonetically balanced word list at SRT + 40 decibels (dB) or at maximum tolerable presentation level.
•6. Subject is a current user of a properly functioning and appropriately fit hearing aid for at least one (1) month in the ear to be implanted.
•7. Subject has normally functioning eustachian tube
•8. Subject has normal tympanic membrane
•9. Subject has a normal middle ear anatomy
•10. Subject has adequate space for Esteem® System implant determined via fine cut temporal bone CT scan
+1 more criteria

Exclusion Criteria

•1. Subject has a history of post-adolescent chronic middle ear infections, inner ear disorders or recurring vertigo requiring treatment, disorders such as mastoiditis, Hydrops or Meniere's syndrome or disease
•2. Subject has a history of otitis externa or eczema for the outer ear canal and the investigator believes this will affect the Esteem® System implantation
•3. Subject has cholesteatoma or destructive middle ear disease
•4. Subject has life expectancy of \< two (2) years due to other medical conditions
•5. Subject has retrocochlear or central auditory disorders
•6. Subject is known to be suffering from any psychological, developmental, physical, or emotional disorder that the investigator feels would interfere with the surgery or follow-up testing
•7. Subject has a known history of fluctuating air conduction and/or bone conduction hearing loss over a one-year period of 15 dB in either direction at 2 or more frequencies (from 500 - 4000 Hz)
•8. Subject has sudden hearing loss due to unknown cause
•9. Subject has a history of disabling tinnitus, defined as tinnitus which required treatment.
•10. Subject is unable to adequately perform audiological testing
+5 more criteria

Locations (6)

North Alabama ENT Associates

Madison, Alabama, United States

Pacific Hearing Service

Los Altos, California, United States

Ear, Nose, & Throat Associates of South Florida

Jupiter, Florida, United States

Ear Consultants of Georgia

Atlanta, Georgia, United States

Loyola Center for Hearing

Woodridge, Illinois, United States

Oklahoma Otolaryngology Associates

Norman, Oklahoma, United States

Key Dates

Start Date

August 1, 2010

Primary Completion Date

September 1, 2021

Completion Date

September 1, 2021

Last Updated

June 27, 2022

Enrollment

117

ACTUAL participants

Conditions

Sensorineural Hearing Loss

Interventions

Implantation of Esteem

DEVICE

Auditory Performances With Different Stimulation Depths in Cochlear Implanted Subjects Using a Fine Structure Strategy

NCT04591093

Sensorineural Hearing Loss, Bilateral

View study

RECRUITING

Vestibular and Postural Function in an Unselected Group of Children With Sensorineural Hearing Loss

NCT06229717

Children, OnlyVestibular Disorder+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 27, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Esteem New Subject Enrollment Post Approval Study

Inclusion Criteria

Exclusion Criteria

Auditory Performances With Different Stimulation Depths in Cochlear Implanted Subjects Using a Fine Structure Strategy

Vestibular and Postural Function in an Unselected Group of Children With Sensorineural Hearing Loss

Perceptual Adaptation Following Cochlear Implantation (Aim 3a)

Natural History in Children Up to 16 Years with Mild to Profound Hearing Loss Due to Mutations in GJB2 / OTOF Genes

Healthy heaAring for Healthy Ageing: Data-driven Hearing Rehabilitation Intervention to Promote Healthy Hearing

Optimizing Cochlear Implant Laterality in Patients With Unilateral Vestibular Weakness