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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Esteem Implant Prospective Subjects | Experimental | Subjects followed through 1 year for both Safety and Efficacy endpoints |
|
| Esteem Implant Retrospective Chart Review Subjects | Other | Subjects providing Safety-only endpoint data through retrospective chart review, to be added to Prospective Subjects' Safety data |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantation of Esteem | Device | Subjects meeting indications are implanted with the Esteem Totally Implantable Hearing System |
|
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Alabama ENT Associates | Madison | Alabama | 35758 | United States | ||
| Pacific Hearing Service |
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| ID | Title | Description |
|---|---|---|
| FG000 | Esteem Implant Prospective Subjects | Implantation of Esteem: Subjects meeting indications are implanted with the Esteem Totally Implantable Hearing System and followed for both Efficacy and Safety endpoints. |
| FG001 | Esteem Implant Retrospective Chart Review Subjects | Subjects whose clinical data (Safety only) were obtained retrospectively to achieve required N for Safety endpoints |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Esteem Implant Prospective Subjects | Subjects meeting indications for candidacy are followed through 1 year for both Safety and Efficacy endpoints |
| BG001 | Esteem Implant Retrospective Chart Review Subjects |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Demographic data were not collected on Retrospective Chart Review subjects. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Change in Speech Reception Threshold (SRT) was not collected from the Esteem Implant Retrospective Chart Review Subject Arm. | Posted | Mean | Standard Error | dB | Change in SRT from Baseline Aided to 10-month post-activation with Esteem |
|
Adverse events reported here were those occurring within 10 months post-implantation
Adverse Event (AE): any undesirable clinical event occurring to a subject, during a clinical trial, whether or not it is considered related to the investigational product.
Serious Adverse Event (SAE) or Serious Adverse Device Effect (SADE): any adverse event that results in death, is life threatening, is disabling, involves cancer or congenital anomaly, requires or prolongs in-patient hospitalization (>24 hours) and/or requires intervention to prevent permanent impairment / damage.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Esteem Implant Prospective Subjects | Subjects meeting indications who were implanted with the Esteem Totally Implantable Hearing System and followed for both Efficacy and Safety endpoints. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fibrotic tissue in middle ear | Ear and labyrinth disorders | Non-systematic Assessment | Adjudicated as moderate procedure-related SAE in three cases, moderate device-related AE in one case, and as severe SADE in one case. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Incision discomfort | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Adjudicated as mild procedure-related AE |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Anderson, Ph.D. | Envoy Medical Corp. | (1) 651-788-3017 | landerson@envoymedical.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 20, 2019 | Mar 31, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| 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 |
| 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 |
| Los Altos |
| California |
| 94022 |
| United States |
| Ear, Nose, & Throat Associates of South Florida | Jupiter | Florida | 33458 | United States |
| Ear Consultants of Georgia | Atlanta | Georgia | 30328 | United States |
| Loyola Center for Hearing | Woodridge | Illinois | 60157 | United States |
| Oklahoma Otolaryngology Associates | Norman | Oklahoma | 73072 | United States |
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.
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Demographic data were not collected on Retrospective Chart Review subjects | Demographic data were not collected on Retrospective Chart Review subjects. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Baseline data were not collected on Retrospective Chart Review subjects | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Work status | Describes reported work status of participant, whether working full-time, part-time, retired, or unemployed. | Demographic data were not collected on subjects in retrospective chart review cohort. | Count of Participants | Participants |
|
|
|
| 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%. | Change in Word Recognition Score (WRS) was not collected from the Esteem Implant Retrospective Chart Review Subject Arm. | Posted | Mean | Standard Error | percent correct | Change in WRS from Baseline Aided to 10-month post-activation with Esteem |
|
|
|
| Primary | Incidence of SADEs, Device Failures, & Replacements | The analysis of the incidence of Serious Adverse Device Effects (SADEs) and device failures and replacements | Posted | Number | Number of events | Incidence at 10-month post-activation |
|
|
|
| Primary | Incidence of Facial Pareses/Paralysis | The analysis of the incidence of facial pareses/paralysis at one month follow-up | Posted | Count of Participants | Participants | Incidence at one month post-op |
|
|
|
| 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. | Change in Bone Conduction Threshold (BCT) at 500 Hz was not collected from the Esteem Implant Retrospective Chart Review Subject Arm. | Posted | Mean | Standard Error | dB | Change in BCT from Baseline to 10-month post-activation |
|
|
|
| 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. | Change in Bone Conduction Threshold (BCT) at 1000 Hz was not collected from the Esteem Implant Retrospective Chart Review Subject Arm. | Posted | Mean | Standard Error | dB | Change in BCT from Baseline to 10-month post-activation |
|
|
|
| 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. | Change in Bone Conduction Threshold (BCT) at 2000 Hz was not collected from the Esteem Implant Retrospective Chart Review Subject Arm. | Posted | Mean | Standard Error | dB | Change in BCT from Baseline to 10-month post-activation |
|
|
|
| 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. | Change in Bone Conduction Threshold (BCT) at 4000 Hz was not collected from the Esteem Implant Retrospective Chart Review Subject Arm. | Posted | Mean | Standard Error | dB | Change in BCT from Baseline to 10-month post-activation |
|
|
|
| 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. | 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. | Posted | Mean | Standard Error | score on a scale | Change from Baseline Aided to 10-month post-activation with Esteem |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | 10-month post-activation with Esteem |
|
|
|
| 0 |
| 59 |
| 9 |
| 59 |
| 23 |
| 59 |
| EG001 | Esteem Implant Retrospective Chart Review Subjects | Subjects whose clinical data (Safety only) were obtained retrospectively to achieve required N for Safety endpoints | 0 | 58 | 0 | 58 | 5 | 58 |
|
| Facial weakness/paresis | Injury, poisoning and procedural complications | Non-systematic Assessment | Procedure-related SAE, mild in one case and moderate in two cases. |
|
| Incision breakdown | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Adjudicated as procedure-related SAE of moderate severity. |
|
| Silicone erosion | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Adjudicated as moderate device-related SAE |
|
| Infection | Infections and infestations | Non-systematic Assessment | Adjudicated as moderate procedure-related SAE |
|
|
| Taste disturbance | Injury, poisoning and procedural complications | Non-systematic Assessment | Adjudicated as mild procedure-related AE |
|
| Uncomfortable sound | Ear and labyrinth disorders | Non-systematic Assessment | Adjudicated as mild device-related AE. |
|
| Eustachian tube dysfunction | Ear and labyrinth disorders | Non-systematic Assessment | Adjudicated as mild AE |
|
| Numbness | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Adjudicated as mild procedure-related AE |
|
| Air bubble over implant | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Adjudicated as mild procedure-related AE |
|
| Device cuts out | Ear and labyrinth disorders | Non-systematic Assessment | Adjudicated as procedure-related AE |
|
| Disequilibrium | Ear and labyrinth disorders | Non-systematic Assessment | Adjudicated as mild, procedure-related AE |
|
| Tinnitus | Ear and labyrinth disorders | Non-systematic Assessment | Adjudicated as mild AE |
|
| Noise or audible artifact | Ear and labyrinth disorders | Non-systematic Assessment | Adjudicated as mild AE |
|
| Clarity or sound quality | Ear and labyrinth disorders | Non-systematic Assessment | Adjudicated as mild, device-related AE |
|
| Suction feeling at implant site | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Adjudicated as moderate, procedure-related AE |
|
| Non-implant hearing aid sound quality | Ear and labyrinth disorders | Non-systematic Assessment | Adjudicated as mild AE |
|
| Lump at implant site | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Adjudicated as mild device-related AE |
|
| Fell and hit head | Injury, poisoning and procedural complications | Non-systematic Assessment | Adjudicated as moderate AE |
|
| Middle ear effusion | Ear and labyrinth disorders | Non-systematic Assessment | Adjudicated as mild, procedure-related AE in two cases, and moderate, procedure-related AE in one case. |
|
| Ear drainage | Ear and labyrinth disorders | Non-systematic Assessment | Adjudicated as mild, procedure-related AE. |
|
| Keloids | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Adjudicated as mild, procedure-related AE |
|
| Incision breakdown | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Adjudicated as mild, procedure-related AE |
|
| High capacitance measurement | Product Issues | Non-systematic Assessment | Device-related AE |
|
| Personal Programmer malfunction | Product Issues | Non-systematic Assessment | Device-related AE |
|
| Limited benefit | Ear and labyrinth disorders | Non-systematic Assessment | Based on post-market surveillance complaint. Per site, "resolved with medication - no device deficiency noted." |
|
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| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
|
| How do you rate the benefit of the entire system being invisible ... compared to your hearing aid? |
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| How well do you understand conversation with your Esteem even when several people are talking ...? |
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| How confident do you feel with the Esteem compared to your hearing aid? |
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| Does the Esteem allow you to live a more active lifestyle? |
|