Back to resultsEsteem New Subject Enrollment Post Approval Study
Primary Purpose
Sensorineural Hearing Loss
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Implantation of Esteem
Sponsored by
About this trial
This is an interventional treatment trial for Sensorineural Hearing Loss focused on measuring hearing, implant, moderate degree, severe degree
Eligibility Criteria
Inclusion Criteria:
- Subject is ≥ 18 years old
- Subject understands the nature of the procedure and has signed the Subject Informed Consent Form prior to the procedure
- Subject is willing and able to comply with specified follow-up evaluations and understands the audiological test procedures and use of the Esteem® System.
- Subject has moderate to severe sensorineural hearing loss in the ear to be implanted defined by pure tone average air-conduction threshold level.
- 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.
- 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.
- Subject has normally functioning eustachian tube
- Subject has normal tympanic membrane
- Subject has a normal middle ear anatomy
- Subject has adequate space for Esteem® System implant determined via fine cut temporal bone CT scan
- Subject is a native speaker of the English language.
Exclusion Criteria:
- 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
- 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
- Subject has cholesteatoma or destructive middle ear disease
- Subject has life expectancy of < two (2) years due to other medical conditions
- Subject has retrocochlear or central auditory disorders
- 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
- 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)
- Subject has sudden hearing loss due to unknown cause
- Subject has a history of disabling tinnitus, defined as tinnitus which required treatment.
- Subject is unable to adequately perform audiological testing
- 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.
- 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
- Subject is pregnant at the time of device implant
- Subject has a history of keloid formation
- Subject has known hypersensitivity to silicone rubber, polyurethane, stainless steel, titanium and/or gold
Sites / Locations
- North Alabama ENT Associates
- Pacific Hearing Service
- Ear, Nose, & Throat Associates of South Florida
- Ear Consultants of Georgia
- Loyola Center for Hearing
- Oklahoma Otolaryngology Associates
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Esteem Implant Prospective Subjects
Esteem Implant Retrospective Chart Review Subjects
Arm Description
Subjects followed through 1 year for both Safety and Efficacy endpoints
Subjects providing Safety-only endpoint data through retrospective chart review, to be added to Prospective Subjects' Safety data
Outcomes
Primary Outcome Measures
Change in Speech Reception Threshold (SRT)
Comparison of the speech reception threshold (SRT) using the Esteem System as compared to the pre-implant aided condition. The SRT is related to hearing sensitivity; lower numbers indicate better outcomes. Here, the difference in dB is reported; positive scores indicate improvement (lower SRT) with the Esteem relative to the pre-implant hearing aid. There are no specific minimum or maximum scores for this measure.
Change in Word Recognition Score (WRS)
Comparison of the word recognition score using the Esteem compared to the pre-implant aided condition. For WRS, a higher score indicates a better outcome. Here, the difference in % correct is reported; positive scores indicate better performance with the Esteem relative to the pre-implant hearing aid. Scores on this test range from 0 to 100%.
Incidence of SADEs, Device Failures, & Replacements
The analysis of the incidence of Serious Adverse Device Effects (SADEs) and device failures and replacements
Incidence of Facial Pareses/Paralysis
The analysis of the incidence of facial pareses/paralysis at one month follow-up
Change in Bone Conduction Threshold (BCT) at 500 Hz
Comparison of bone conduction (BC) threshold at 500 Hz post activation compared to the pre-implant BC threshold. Change in Bone Conduction is used to determine whether residual cochlear function has declined following implant of the Esteem. Positive numbers indicate higher (i.e., poorer) bone conduction thresholds post-implant, relative to pre-implant.
Change in Bone Conduction Threshold (BCT) at 1000 Hz
Change in BCT from Baseline to 10-month post-activation. Change in Bone Conduction is used to determine whether residual cochlear function has declined following implant of the Esteem. Positive numbers indicate higher (i.e., poorer) bone conduction thresholds post-implant, relative to pre-implant.
Change in Bone Conduction Threshold (BCT) at 2000 Hz
Change in BCT from Baseline to 10-month post-activation. Change in Bone Conduction is used to determine whether residual cochlear function has declined following implant of the Esteem. Positive numbers indicate higher (i.e., poorer) bone conduction thresholds post-implant, relative to pre-implant.
Change in Bone Conduction Threshold (BCT) at 4000 Hz
Change in BCT from Baseline to 10-month post-activation. Change in Bone Conduction is used to determine whether residual cochlear function has declined following implant of the Esteem. Positive numbers indicate higher (i.e., poorer) bone conduction thresholds post-implant, relative to pre-implant.
Secondary Outcome Measures
Change in Subjective Quality of Life as Measured With the Abbreviated Profile of Hearing Aid Benefit, or APHAB (Global Score)
Quality of Life measured with the APHAB comparison between the pre-implant aided condition and 10-month post-activation. In general, a lower score indicates better performance. The range of scores for each subscale (including the Global score, reported here) is 1 to 99. Here, mean difference in benefit score with the Esteem implant vs. pre-implant aided condition is reported. A positive difference score indicates more benefit with the Esteem.
Esteem Questionnaire Results
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. Subjects rated each item as "Is much worse", "Somewhat worse", "Is about the same", "Is somewhat better", or "Is much better" with the Esteem. Reported here are the cumulative number of respondents indicating "Same", "Somewhat better", or "Much better" for the given question.
Full Information
NCT ID
NCT02689349
First Posted
February 8, 2016
Last Updated
June 1, 2022
Sponsor
Envoy Medical Corporation
1. Study Identification
Unique Protocol Identification Number
NCT02689349
Brief Title
Esteem New Subject Enrollment Post Approval Study
Official Title
Esteem Totally Implantable Hearing System New Subject Enrollment Post Approval Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
August 2010 (Actual)
Primary Completion Date
September 2021 (Actual)
Study Completion Date
September 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Envoy Medical Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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%?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sensorineural Hearing Loss
Keywords
hearing, implant, moderate degree, severe degree
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
117 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Esteem Implant Prospective Subjects
Arm Type
Experimental
Arm Description
Subjects followed through 1 year for both Safety and Efficacy endpoints
Arm Title
Esteem Implant Retrospective Chart Review Subjects
Arm Type
Other
Arm Description
Subjects providing Safety-only endpoint data through retrospective chart review, to be added to Prospective Subjects' Safety data
Intervention Type
Device
Intervention Name(s)
Implantation of Esteem
Intervention Description
Subjects meeting indications are implanted with the Esteem Totally Implantable Hearing System
Primary Outcome Measure Information:
Title
Change in Speech Reception Threshold (SRT)
Description
Comparison of the speech reception threshold (SRT) using the Esteem System as compared to the pre-implant aided condition. The SRT is related to hearing sensitivity; lower numbers indicate better outcomes. Here, the difference in dB is reported; positive scores indicate improvement (lower SRT) with the Esteem relative to the pre-implant hearing aid. There are no specific minimum or maximum scores for this measure.
Time Frame
Change in SRT from Baseline Aided to 10-month post-activation with Esteem
Title
Change in Word Recognition Score (WRS)
Description
Comparison of the word recognition score using the Esteem compared to the pre-implant aided condition. For WRS, a higher score indicates a better outcome. Here, the difference in % correct is reported; positive scores indicate better performance with the Esteem relative to the pre-implant hearing aid. Scores on this test range from 0 to 100%.
Time Frame
Change in WRS from Baseline Aided to 10-month post-activation with Esteem
Title
Incidence of SADEs, Device Failures, & Replacements
Description
The analysis of the incidence of Serious Adverse Device Effects (SADEs) and device failures and replacements
Time Frame
Incidence at 10-month post-activation
Title
Incidence of Facial Pareses/Paralysis
Description
The analysis of the incidence of facial pareses/paralysis at one month follow-up
Time Frame
Incidence at one month post-op
Title
Change in Bone Conduction Threshold (BCT) at 500 Hz
Description
Comparison of bone conduction (BC) threshold at 500 Hz post activation compared to the pre-implant BC threshold. Change in Bone Conduction is used to determine whether residual cochlear function has declined following implant of the Esteem. Positive numbers indicate higher (i.e., poorer) bone conduction thresholds post-implant, relative to pre-implant.
Time Frame
Change in BCT from Baseline to 10-month post-activation
Title
Change in Bone Conduction Threshold (BCT) at 1000 Hz
Description
Change in BCT from Baseline to 10-month post-activation. Change in Bone Conduction is used to determine whether residual cochlear function has declined following implant of the Esteem. Positive numbers indicate higher (i.e., poorer) bone conduction thresholds post-implant, relative to pre-implant.
Time Frame
Change in BCT from Baseline to 10-month post-activation
Title
Change in Bone Conduction Threshold (BCT) at 2000 Hz
Description
Change in BCT from Baseline to 10-month post-activation. Change in Bone Conduction is used to determine whether residual cochlear function has declined following implant of the Esteem. Positive numbers indicate higher (i.e., poorer) bone conduction thresholds post-implant, relative to pre-implant.
Time Frame
Change in BCT from Baseline to 10-month post-activation
Title
Change in Bone Conduction Threshold (BCT) at 4000 Hz
Description
Change in BCT from Baseline to 10-month post-activation. Change in Bone Conduction is used to determine whether residual cochlear function has declined following implant of the Esteem. Positive numbers indicate higher (i.e., poorer) bone conduction thresholds post-implant, relative to pre-implant.
Time Frame
Change in BCT from Baseline to 10-month post-activation
Secondary Outcome Measure Information:
Title
Change in Subjective Quality of Life as Measured With the Abbreviated Profile of Hearing Aid Benefit, or APHAB (Global Score)
Description
Quality of Life measured with the APHAB comparison between the pre-implant aided condition and 10-month post-activation. In general, a lower score indicates better performance. The range of scores for each subscale (including the Global score, reported here) is 1 to 99. Here, mean difference in benefit score with the Esteem implant vs. pre-implant aided condition is reported. A positive difference score indicates more benefit with the Esteem.
Time Frame
Change from Baseline Aided to 10-month post-activation with Esteem
Title
Esteem Questionnaire Results
Description
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. Subjects rated each item as "Is much worse", "Somewhat worse", "Is about the same", "Is somewhat better", or "Is much better" with the Esteem. Reported here are the cumulative number of respondents indicating "Same", "Somewhat better", or "Much better" for the given question.
Time Frame
10-month post-activation with Esteem
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subject is ≥ 18 years old
Subject understands the nature of the procedure and has signed the Subject Informed Consent Form prior to the procedure
Subject is willing and able to comply with specified follow-up evaluations and understands the audiological test procedures and use of the Esteem® System.
Subject has moderate to severe sensorineural hearing loss in the ear to be implanted defined by pure tone average air-conduction threshold level.
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.
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.
Subject has normally functioning eustachian tube
Subject has normal tympanic membrane
Subject has a normal middle ear anatomy
Subject has adequate space for Esteem® System implant determined via fine cut temporal bone CT scan
Subject is a native speaker of the English language.
Exclusion Criteria:
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
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
Subject has cholesteatoma or destructive middle ear disease
Subject has life expectancy of < two (2) years due to other medical conditions
Subject has retrocochlear or central auditory disorders
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
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)
Subject has sudden hearing loss due to unknown cause
Subject has a history of disabling tinnitus, defined as tinnitus which required treatment.
Subject is unable to adequately perform audiological testing
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.
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
Subject is pregnant at the time of device implant
Subject has a history of keloid formation
Subject has known hypersensitivity to silicone rubber, polyurethane, stainless steel, titanium and/or gold
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sam Marzo, MD
Organizational Affiliation
Loyola Center for Hearing, Woodridge IL
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John Li, MD
Organizational Affiliation
Jupiter Medical Center, Jupiter FL
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Deborah Clark, AuD
Organizational Affiliation
Pacific Hearing Service, Los Altos CA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wayne Berryhill, MD
Organizational Affiliation
Oklahoma Otolaryngology Associates
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sanjay Bhansali, MD
Organizational Affiliation
Ear Consultants of Georgia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Abraham Jacob, MD
Organizational Affiliation
University of Arizona Ear Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elizabeth Toh, MD
Organizational Affiliation
Lahey Hospital & Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Alabama ENT Associates
City
Madison
State/Province
Alabama
ZIP/Postal Code
35758
Country
United States
Facility Name
Pacific Hearing Service
City
Los Altos
State/Province
California
ZIP/Postal Code
94022
Country
United States
Facility Name
Ear, Nose, & Throat Associates of South Florida
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Ear Consultants of Georgia
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Loyola Center for Hearing
City
Woodridge
State/Province
Illinois
ZIP/Postal Code
60157
Country
United States
Facility Name
Oklahoma Otolaryngology Associates
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73072
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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