Sensorineural Hearing Loss
Conditions
Keywords
hearing, implant, moderate degree, severe degree
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%?
Interventions
DEVICEImplantation of Esteem
Subjects meeting indications are implanted with the Esteem Totally Implantable Hearing System
Sponsors
Envoy Medical Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Bone Conduction Threshold (BCT) at 4000 Hz | Change in BCT from Baseline to 10-month post-activation | 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 1000 Hz | Change in BCT from Baseline to 10-month post-activation | 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 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 Speech Reception Threshold (SRT) | 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. 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) | 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. 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 | Incidence at 10-month post-activation | The analysis of the incidence of Serious Adverse Device Effects (SADEs) and device failures and replacements |
| Incidence of Facial Pareses/Paralysis | Incidence at one month post-op | The analysis of the incidence of facial pareses/paralysis at one month follow-up |
| Change in Bone Conduction Threshold (BCT) at 500 Hz | Change in BCT from Baseline to 10-month post-activation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Esteem Questionnaire Results | 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. 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. |
| Change in Subjective Quality of Life as Measured With the Abbreviated Profile of Hearing Aid Benefit, or APHAB (Global Score) | Change from Baseline Aided to 10-month post-activation with Esteem | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Esteem Implant Prospective Subjects Subjects meeting indications for candidacy are followed through 1 year for both Safety and Efficacy endpoints | 59 |
| Esteem Implant Retrospective Chart Review Subjects Subjects meeting indications for candidacy for Safety endpoints provide Safety-only data via retrospective chart review, which will supplement the Prospective Subjects' Safety data in order to reach required N. | 58 |
| Total | 117 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Not implanted | 4 | 0 |
| Overall Study | Withdrawal by Subject | 9 | 0 |
Baseline characteristics
| Characteristic | Total | Esteem Implant Prospective Subjects | Esteem Implant Retrospective Chart Review Subjects |
|---|---|---|---|
| Age, Continuous | 60.4 years STANDARD_DEVIATION 17.6 | 60.4 years STANDARD_DEVIATION 17.6 | — |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | — |
| Race/Ethnicity, Customized Black/Non-Hispanic | 1 Participants | 1 Participants | — |
| Race/Ethnicity, Customized Hispanic | 0 Participants | 0 Participants | — |
| Race/Ethnicity, Customized White/Caucasian | 58 Participants | 58 Participants | — |
| Region of Enrollment United States | 117 participants | 59 participants | 58 participants |
| Sex: Female, Male Female | 17 Participants | 17 Participants | 0 Participants |
| Sex: Female, Male Male | 42 Participants | 42 Participants | 0 Participants |
| Work status did not answer | 2 Participants | 2 Participants | 0 Participants |
| Work status other | 7 Participants | 7 Participants | 0 Participants |
| Work status retired | 24 Participants | 24 Participants | 0 Participants |
| Work status unemployed | 3 Participants | 3 Participants | 0 Participants |
| Work status work full-time | 17 Participants | 17 Participants | 0 Participants |
| Work status work part-time | 6 Participants | 6 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 59 | 0 / 58 |
| other Total, other adverse events | 23 / 59 | 5 / 58 |
| serious Total, serious adverse events | 9 / 59 | 0 / 58 |
Outcome results
Primary
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.
Time frame: Change in BCT from Baseline to 10-month post-activation
Population: Change in Bone Conduction Threshold (BCT) at 1000 Hz was not collected from the Esteem Implant Retrospective Chart Review Subject Arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Esteem Implant Prospective Subjects | Change in Bone Conduction Threshold (BCT) at 1000 Hz | 1.8 dB | Standard Error 2.2 |
Primary
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.
Time frame: Change in BCT from Baseline to 10-month post-activation
Population: Change in Bone Conduction Threshold (BCT) at 2000 Hz was not collected from the Esteem Implant Retrospective Chart Review Subject Arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Esteem Implant Prospective Subjects | Change in Bone Conduction Threshold (BCT) at 2000 Hz | 2.3 dB | Standard Error 2.7 |
Primary
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.
Time frame: Change in BCT from Baseline to 10-month post-activation
Population: Change in Bone Conduction Threshold (BCT) at 4000 Hz was not collected from the Esteem Implant Retrospective Chart Review Subject Arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Esteem Implant Prospective Subjects | Change in Bone Conduction Threshold (BCT) at 4000 Hz | -3.4 dB | Standard Error 2 |
Primary
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.
Time frame: Change in BCT from Baseline to 10-month post-activation
Population: Change in Bone Conduction Threshold (BCT) at 500 Hz was not collected from the Esteem Implant Retrospective Chart Review Subject Arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Esteem Implant Prospective Subjects | Change in Bone Conduction Threshold (BCT) at 500 Hz | 1.4 dB | Standard Error 2 |
Primary
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.
Time frame: Change in SRT from Baseline Aided to 10-month post-activation with Esteem
Population: Change in Speech Reception Threshold (SRT) was not collected from the Esteem Implant Retrospective Chart Review Subject Arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Esteem Implant Prospective Subjects | Change in Speech Reception Threshold (SRT) | 5.3 dB | Standard Error 2.4 |
Primary
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%.
Time frame: Change in WRS from Baseline Aided to 10-month post-activation with Esteem
Population: Change in Word Recognition Score (WRS) was not collected from the Esteem Implant Retrospective Chart Review Subject Arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Esteem Implant Prospective Subjects | Change in Word Recognition Score (WRS) | 5.5 percent correct | Standard Error 3.8 |
Primary
Incidence of Facial Pareses/Paralysis
The analysis of the incidence of facial pareses/paralysis at one month follow-up
Time frame: Incidence at one month post-op
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Esteem Implant Prospective Subjects | Incidence of Facial Pareses/Paralysis | 3 Participants |
| Esteem Implant Retrospective Chart Review Subjects | Incidence of Facial Pareses/Paralysis | 0 Participants |
Primary
Incidence of SADEs, Device Failures, & Replacements
The analysis of the incidence of Serious Adverse Device Effects (SADEs) and device failures and replacements
Time frame: Incidence at 10-month post-activation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Esteem Implant Prospective Subjects | Incidence of SADEs, Device Failures, & Replacements | 3 Number of events |
| Esteem Implant Retrospective Chart Review Subjects | Incidence of SADEs, Device Failures, & Replacements | 0 Number of events |
Secondary
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.
Time frame: Change from Baseline Aided to 10-month post-activation with Esteem
Population: Questionnaire data available from only 41 of 46 subjects. The APHAB (Global Score) was not collected from the Esteem Implant Retrospective Chart Review Subject Arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Esteem Implant Prospective Subjects | Change in Subjective Quality of Life as Measured With the Abbreviated Profile of Hearing Aid Benefit, or APHAB (Global Score) | 5.8 score on a scale | Standard Error 3.1 |
Secondary
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.
Time frame: 10-month post-activation with Esteem
Population: Esteem Questionnaire Results were not collected from the Esteem Implant Retrospective Chart Review Subject Arm. Three subjects did not complete the Esteem Questionnaire at the 10-month visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Esteem Implant Prospective Subjects | Esteem Questionnaire Results | How confident do you feel with the Esteem compared to your hearing aid? | 41 Participants |
| Esteem Implant Prospective Subjects | Esteem Questionnaire Results | 1. How do you rate the clarity of the sound you hear with the Esteem compared to your hearing aid? | 37 Participants |
| Esteem Implant Prospective Subjects | Esteem Questionnaire Results | How do you rate your ability to understand speech in background noise ... ? | 33 Participants |
| Esteem Implant Prospective Subjects | Esteem Questionnaire Results | How natural sounding are voices and other sounds compared to your hearing aid? | 36 Participants |
| Esteem Implant Prospective Subjects | Esteem Questionnaire Results | How do you rate the benefit of the entire system being invisible ... compared to your hearing aid? | 36 Participants |
| Esteem Implant Prospective Subjects | Esteem Questionnaire Results | How well do you understand conversation with your Esteem even when several people are talking ...? | 38 Participants |
| Esteem Implant Prospective Subjects | Esteem Questionnaire Results | Does the Esteem allow you to live a more active lifestyle? | 43 Participants |