Trial Outcomes & Findings for Esteem New Subject Enrollment Post Approval Study (NCT NCT02689349)

Last Updated: 2022-06-27

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

117 participants

Primary outcome timeframe

Change in SRT from Baseline Aided to 10-month post-activation with Esteem

Results posted on

2022-06-27

Participant Flow

Participant milestones

Participant milestones
Measure	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.	Esteem Implant Retrospective Chart Review Subjects Subjects whose clinical data (Safety only) were obtained retrospectively to achieve required N for Safety endpoints
Overall Study STARTED	59	58
Overall Study COMPLETED	46	58
Overall Study NOT COMPLETED	13	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	Esteem Implant Retrospective Chart Review Subjects Subjects whose clinical data (Safety only) were obtained retrospectively to achieve required N for Safety endpoints
Overall Study Not implanted	4	0
Overall Study Withdrawal by Subject	9	0

Baseline Characteristics

Demographic data were not collected on Retrospective Chart Review subjects.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Esteem Implant Prospective Subjects n=59 Participants Subjects meeting indications for candidacy are followed through 1 year for both Safety and Efficacy endpoints	Esteem Implant Retrospective Chart Review Subjects n=58 Participants 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.	Total n=117 Participants Total of all reporting groups
Age, Continuous	60.4 years STANDARD_DEVIATION 17.6 • n=59 Participants • Demographic data were not collected on Retrospective Chart Review subjects.	—	60.4 years STANDARD_DEVIATION 17.6 • n=59 Participants • Demographic data were not collected on Retrospective Chart Review subjects.
Sex: Female, Male Female	17 Participants n=59 Participants • Demographic data were not collected on Retrospective Chart Review subjects.	0 Participants Demographic data were not collected on Retrospective Chart Review subjects.	17 Participants n=59 Participants • Demographic data were not collected on Retrospective Chart Review subjects.
Sex: Female, Male Male	42 Participants n=59 Participants • Demographic data were not collected on Retrospective Chart Review subjects.	0 Participants Demographic data were not collected on Retrospective Chart Review subjects.	42 Participants n=59 Participants • Demographic data were not collected on Retrospective Chart Review subjects.
Race/Ethnicity, Customized White/Caucasian	58 Participants n=59 Participants • Baseline data were not collected on Retrospective Chart Review subjects	—	58 Participants n=59 Participants • Baseline data were not collected on Retrospective Chart Review subjects
Race/Ethnicity, Customized Black/Non-Hispanic	1 Participants n=59 Participants • Baseline data were not collected on Retrospective Chart Review subjects	—	1 Participants n=59 Participants • Baseline data were not collected on Retrospective Chart Review subjects
Race/Ethnicity, Customized Hispanic	0 Participants n=59 Participants • Baseline data were not collected on Retrospective Chart Review subjects	—	0 Participants n=59 Participants • Baseline data were not collected on Retrospective Chart Review subjects
Race/Ethnicity, Customized Asian	0 Participants n=59 Participants • Baseline data were not collected on Retrospective Chart Review subjects	—	0 Participants n=59 Participants • Baseline data were not collected on Retrospective Chart Review subjects
Region of Enrollment United States	59 participants n=59 Participants	58 participants n=58 Participants	117 participants n=117 Participants
Work status work full-time	17 Participants n=59 Participants • Demographic data were not collected on subjects in retrospective chart review cohort.	0 Participants Demographic data were not collected on subjects in retrospective chart review cohort.	17 Participants n=59 Participants • Demographic data were not collected on subjects in retrospective chart review cohort.
Work status work part-time	6 Participants n=59 Participants • Demographic data were not collected on subjects in retrospective chart review cohort.	0 Participants Demographic data were not collected on subjects in retrospective chart review cohort.	6 Participants n=59 Participants • Demographic data were not collected on subjects in retrospective chart review cohort.
Work status retired	24 Participants n=59 Participants • Demographic data were not collected on subjects in retrospective chart review cohort.	0 Participants Demographic data were not collected on subjects in retrospective chart review cohort.	24 Participants n=59 Participants • Demographic data were not collected on subjects in retrospective chart review cohort.
Work status unemployed	3 Participants n=59 Participants • Demographic data were not collected on subjects in retrospective chart review cohort.	0 Participants Demographic data were not collected on subjects in retrospective chart review cohort.	3 Participants n=59 Participants • Demographic data were not collected on subjects in retrospective chart review cohort.
Work status other	7 Participants n=59 Participants • Demographic data were not collected on subjects in retrospective chart review cohort.	0 Participants Demographic data were not collected on subjects in retrospective chart review cohort.	7 Participants n=59 Participants • Demographic data were not collected on subjects in retrospective chart review cohort.
Work status did not answer	2 Participants n=59 Participants • Demographic data were not collected on subjects in retrospective chart review cohort.	0 Participants Demographic data were not collected on subjects in retrospective chart review cohort.	2 Participants n=59 Participants • Demographic data were not collected on subjects in retrospective chart review cohort.

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Esteem Implant Prospective Subjects n=46 Participants Subjects meeting indications are implanted with the Esteem Totally Implantable Hearing System and followed for both Safety and Efficacy endpoints for 1 year.	Esteem Implant Retrospective Chart Review Subjects Subjects whose clinical data (Safety only) were obtained retrospectively to achieve required N for Safety endpoints
Change in Speech Reception Threshold (SRT)	5.3 dB Standard Error 2.4	—

PRIMARY outcome

Timeframe: 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.

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%.

Outcome measures

Outcome measures
Measure	Esteem Implant Prospective Subjects n=46 Participants Subjects meeting indications are implanted with the Esteem Totally Implantable Hearing System and followed for both Safety and Efficacy endpoints for 1 year.	Esteem Implant Retrospective Chart Review Subjects Subjects whose clinical data (Safety only) were obtained retrospectively to achieve required N for Safety endpoints
Change in Word Recognition Score (WRS)	5.5 percent correct Standard Error 3.8	—

PRIMARY outcome

Timeframe: Incidence at 10-month post-activation

The analysis of the incidence of Serious Adverse Device Effects (SADEs) and device failures and replacements

Outcome measures

Outcome measures
Measure	Esteem Implant Prospective Subjects n=46 Participants Subjects meeting indications are implanted with the Esteem Totally Implantable Hearing System and followed for both Safety and Efficacy endpoints for 1 year.	Esteem Implant Retrospective Chart Review Subjects n=58 Participants Subjects whose clinical data (Safety only) were obtained retrospectively to achieve required N for Safety endpoints
Incidence of SADEs, Device Failures, & Replacements	3 Number of events	0 Number of events

PRIMARY outcome

Timeframe: Incidence at one month post-op

The analysis of the incidence of facial pareses/paralysis at one month follow-up

Outcome measures

Outcome measures
Measure	Esteem Implant Prospective Subjects n=46 Participants Subjects meeting indications are implanted with the Esteem Totally Implantable Hearing System and followed for both Safety and Efficacy endpoints for 1 year.	Esteem Implant Retrospective Chart Review Subjects n=58 Participants Subjects whose clinical data (Safety only) were obtained retrospectively to achieve required N for Safety endpoints
Incidence of Facial Pareses/Paralysis	3 Participants	0 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Esteem Implant Prospective Subjects n=46 Participants Subjects meeting indications are implanted with the Esteem Totally Implantable Hearing System and followed for both Safety and Efficacy endpoints for 1 year.	Esteem Implant Retrospective Chart Review Subjects Subjects whose clinical data (Safety only) were obtained retrospectively to achieve required N for Safety endpoints
Change in Bone Conduction Threshold (BCT) at 500 Hz	1.4 dB Standard Error 2.0	—

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Esteem Implant Prospective Subjects n=46 Participants Subjects meeting indications are implanted with the Esteem Totally Implantable Hearing System and followed for both Safety and Efficacy endpoints for 1 year.	Esteem Implant Retrospective Chart Review Subjects Subjects whose clinical data (Safety only) were obtained retrospectively to achieve required N for Safety endpoints
Change in Bone Conduction Threshold (BCT) at 1000 Hz	1.8 dB Standard Error 2.2	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Esteem Implant Prospective Subjects n=46 Participants Subjects meeting indications are implanted with the Esteem Totally Implantable Hearing System and followed for both Safety and Efficacy endpoints for 1 year.	Esteem Implant Retrospective Chart Review Subjects Subjects whose clinical data (Safety only) were obtained retrospectively to achieve required N for Safety endpoints
Change in Bone Conduction Threshold (BCT) at 2000 Hz	2.3 dB Standard Error 2.7	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Esteem Implant Prospective Subjects n=46 Participants Subjects meeting indications are implanted with the Esteem Totally Implantable Hearing System and followed for both Safety and Efficacy endpoints for 1 year.	Esteem Implant Retrospective Chart Review Subjects Subjects whose clinical data (Safety only) were obtained retrospectively to achieve required N for Safety endpoints
Change in Bone Conduction Threshold (BCT) at 4000 Hz	-3.4 dB Standard Error 2.0	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Esteem Implant Prospective Subjects n=41 Participants Subjects meeting indications are implanted with the Esteem Totally Implantable Hearing System and followed for both Safety and Efficacy endpoints for 1 year.	Esteem Implant Retrospective Chart Review Subjects Subjects whose clinical data (Safety only) were obtained retrospectively to achieve required N for Safety endpoints
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 outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Esteem Implant Prospective Subjects n=43 Participants Subjects meeting indications are implanted with the Esteem Totally Implantable Hearing System and followed for both Safety and Efficacy endpoints for 1 year.	Esteem Implant Retrospective Chart Review Subjects Subjects whose clinical data (Safety only) were obtained retrospectively to achieve required N for Safety endpoints
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 Questionnaire Results How do you rate your ability to understand speech in background noise ... ?	33 Participants	—
Esteem Questionnaire Results How natural sounding are voices and other sounds compared to your hearing aid?	36 Participants	—
Esteem Questionnaire Results How do you rate the benefit of the entire system being invisible ... compared to your hearing aid?	36 Participants	—
Esteem Questionnaire Results How well do you understand conversation with your Esteem even when several people are talking ...?	38 Participants	—
Esteem Questionnaire Results How confident do you feel with the Esteem compared to your hearing aid?	41 Participants	—
Esteem Questionnaire Results Does the Esteem allow you to live a more active lifestyle?	43 Participants	—

Adverse Events

Esteem Implant Prospective Subjects

Serious events: 9 serious events

Other events: 23 other events

Deaths: 0 deaths

Esteem Implant Retrospective Chart Review Subjects

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Esteem Implant Prospective Subjects n=59 participants at risk Subjects meeting indications who were implanted with the Esteem Totally Implantable Hearing System and followed for both Efficacy and Safety endpoints.	Esteem Implant Retrospective Chart Review Subjects n=58 participants at risk Subjects whose clinical data (Safety only) were obtained retrospectively to achieve required N for Safety endpoints
Ear and labyrinth disorders Fibrotic tissue in middle ear	5.1% 3/59 • Number of events 3 • 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.	0.00% 0/58 • 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.
Injury, poisoning and procedural complications Facial weakness/paresis	5.1% 3/59 • Number of events 3 • 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.	0.00% 0/58 • 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.
Skin and subcutaneous tissue disorders Incision breakdown	1.7% 1/59 • Number of events 1 • 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.	0.00% 0/58 • 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.
Skin and subcutaneous tissue disorders Silicone erosion	1.7% 1/59 • Number of events 1 • 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.	0.00% 0/58 • 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.
Infections and infestations Infection	1.7% 1/59 • Number of events 1 • 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.	0.00% 0/58 • 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.

Other adverse events

Additional Information

Elizabeth Anderson, Ph.D.

Envoy Medical Corp.

Phone: (1) 651-788-3017

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place