Esteem New Subject Enrollment Post Approval Study

NCT ID: NCT02689349

Last Updated: 2022-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 117 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2021-09-30

Brief 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%?

Conditions

Sensorineural Hearing Loss

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Esteem Implant Prospective Subjects

Subjects followed through 1 year for both Safety and Efficacy endpoints

Group Type: EXPERIMENTAL

Implantation of Esteem

Intervention Type: DEVICE

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

Esteem Implant Retrospective Chart Review Subjects

Subjects providing Safety-only endpoint data through retrospective chart review, to be added to Prospective Subjects' Safety data

Group Type: OTHER

Implantation of Esteem

Intervention Type: DEVICE

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

Interventions

Implantation of Esteem

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

Intervention Type: DEVICE

Eligibility Criteria

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

11. Subject is a native speaker of the English language.

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

11. Subject has a medical condition or undergoing a treatment that may affect healing and the investigator does not believe the subject is a good candidate for the trial.

12. Subject has diabetes that is not well controlled with medication or diet and the investigator does not believe in his best medical judgment that the subject would be a good candidate for the trial

13. Subject is pregnant at the time of device implant

14. Subject has a history of keloid formation

15. Subject has known hypersensitivity to silicone rubber, polyurethane, stainless steel, titanium and/or gold

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Envoy Medical Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sam Marzo, MD

Role: PRINCIPAL_INVESTIGATOR

Loyola Center for Hearing, Woodridge IL

John Li, MD

Role: PRINCIPAL_INVESTIGATOR

Jupiter Medical Center, Jupiter FL

Deborah Clark, AuD

Role: PRINCIPAL_INVESTIGATOR

Pacific Hearing Service, Los Altos CA

Wayne Berryhill, MD

Role: PRINCIPAL_INVESTIGATOR

Oklahoma Otolaryngology Associates

Sanjay Bhansali, MD

Role: PRINCIPAL_INVESTIGATOR

Ear Consultants of Georgia

Abraham Jacob, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arizona Ear Institute

Elizabeth Toh, MD

Role: PRINCIPAL_INVESTIGATOR

Lahey Hospital & Medical Center

Locations

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

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

0205

Identifier Type: -

Identifier Source: org_study_id