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Esteem New Subject Enrollment Post Approval Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02689349
Recruitment Status : Active, not recruiting
First Posted : February 23, 2016
Last Update Posted : April 9, 2021
Sponsor:
Information provided by (Responsible Party):
Envoy Medical Corporation

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.

Condition or disease Intervention/treatment Phase
Sensorineural Hearing Loss Device: Implantation of Esteem Not Applicable

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%?

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Esteem Totally Implantable Hearing System New Subject Enrollment Post Approval Study
Study Start Date : August 2010
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Esteem Implant
Implantation of Esteem
Device: Implantation of Esteem
Subjects meeting indications are implanted with the Esteem Totally Implantable Hearing System




Primary Outcome Measures :
  1. Change in Speech Reception Threshold (SRT) [ Time Frame: Change in SRT from Baseline Aided to 10-month post-activation with Esteem ]
    Comparison of the speech reception threshold (SRT) using the Esteem System as compared to the pre-implant aided condition

  2. Change in Word Recognition Score (WRS) [ Time Frame: Change in WRS from Baseline Aided to 10-month post-activation with Esteem ]
    Comparison of the word recognition score using the Esteem compared to the pre-implant aided condition

  3. Incidence of SADEs, Device Failures, & Replacements [ Time Frame: Incidence at 10-month post-activation ]
    The analysis of the incidence of Serious Adverse Device Effects (SADEs) and device failures and replacements

  4. Incidence of Facial Pareses/Paralysis [ Time Frame: Incidence at one month post-op ]
    The analysis of the incidence of facial pareses/paralysis at one month follow-up

  5. Change in Bone Conduction Threshold (BCT) [ Time Frame: Change in BCT from Baseline to 10-month post-activation ]
    Comparison of bone conduction (BC) threshold post activation compared to the pre-implant BC threshold


Secondary Outcome Measures :
  1. Change in Subjective Quality of Life as Measured with APHAB [ Time Frame: Change from Baseline Aided to 10-month post-activation with Esteem ]
    To show that the Esteem System improves Quality of Life when compared to the pre-implant aided condition, as shown by Abbreviated Profile of Hearing Aid Benefit (APHAB) results

  2. Esteem Questionnaire Results [ Time Frame: 10-month post-activation with Esteem ]
    To gather subject feedback and comments on the use of the Esteem System through subject ratings on questionnaire items specifically focusing on factors such as the clarity of sound, the user's ability to understand speech in background noise, naturalness of sound, benefits of the system, etc. -- relative to the pre-implant aided condition



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02689349


Locations
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United States, Alabama
North Alabama ENT Associates
Madison, Alabama, United States, 35758
United States, California
Pacific Hearing Service
Los Altos, California, United States, 94022
United States, Florida
Ear, Nose, & Throat Associates of South Florida
Jupiter, Florida, United States, 33458
United States, Georgia
Ear Consultants of Georgia
Atlanta, Georgia, United States, 30328
United States, Illinois
Loyola Center for Hearing
Woodridge, Illinois, United States, 60157
United States, Oklahoma
Oklahoma Otolaryngology Associates
Norman, Oklahoma, United States, 73072
Sponsors and Collaborators
Envoy Medical Corporation
Investigators
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Principal Investigator: Sam Marzo, MD Loyola Center for Hearing, Woodridge IL
Principal Investigator: John Li, MD Jupiter Medical Center, Jupiter FL
Principal Investigator: Deborah Clark, AuD Pacific Hearing Service, Los Altos CA
Principal Investigator: Wayne Berryhill, MD Oklahoma Otolaryngology Associates
Principal Investigator: Sanjay Bhansali, MD Ear Consultants of Georgia
Principal Investigator: Abraham Jacob, MD University of Arizona Ear Institute
Principal Investigator: Elizabeth Toh, MD Lahey Hospital & Medical Center
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Responsible Party: Envoy Medical Corporation
ClinicalTrials.gov Identifier: NCT02689349    
Other Study ID Numbers: 0205
First Posted: February 23, 2016    Key Record Dates
Last Update Posted: April 9, 2021
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Envoy Medical Corporation:
hearing
implant
moderate degree
severe degree
Additional relevant MeSH terms:
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Hearing Loss
Hearing Loss, Sensorineural
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases