Esteem New Subject Enrollment Post Approval Study

Study Overview
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Brief Summary
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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
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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%?

Official Title
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Esteem Totally Implantable Hearing System New Subject Enrollment Post Approval Study

Conditions
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Sensorineural Hearing Loss

Intervention / Treatment
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* Device: Implantation of Esteem


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Esteem Implant Prospective Subjects<br>Subjects followed through 1 year for both Safety and Efficacy endpoints | Device: Implantation of Esteem<br>* Subjects meeting indications are implanted with the Esteem Totally Implantable Hearing System<br>|
| Other: Esteem Implant Retrospective Chart Review Subjects<br>Subjects providing Safety-only endpoint data through retrospective chart review, to be added to Prospective Subjects' Safety data | Device: Implantation of Esteem<br>* Subjects meeting indications are implanted with the Esteem Totally Implantable Hearing System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 SRT from Baseline Aided to 10-month post-activation with Esteem | 
| 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%. | Change in WRS from Baseline Aided to 10-month post-activation with Esteem | 
| Incidence of SADEs, Device Failures, & Replacements | The analysis of the incidence of Serious Adverse Device Effects (SADEs) and device failures and replacements | Incidence at 10-month post-activation | 
| Incidence of Facial Pareses/Paralysis | The analysis of the incidence of facial pareses/paralysis at one month follow-up | Incidence at one month post-op | 
| 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 BCT from Baseline to 10-month post-activation | 
| 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 BCT from Baseline to 10-month post-activation | 
| 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 BCT from Baseline to 10-month post-activation | 
| 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. | Change in BCT from Baseline to 10-month post-activation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change from Baseline Aided to 10-month post-activation with 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. | 10-month post-activation with Esteem | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hearing, implant, moderate degree, severe degree