Trial Outcomes & Findings for Esteem Totally Implantable Hearing System (NCT NCT01092910)

NCT ID: NCT01092910

Last Updated: 2020-01-02

Results Overview

Comparison of the speech reception threshold (SRT) using the Esteem System as compared to the pre-implant aided condition

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 57 participants
• Primary outcome timeframe: 4 Months Post Activation
• Results posted on: 2020-01-02

Participant Flow

Subjects were recruited at three different sites: The Ear Center of Greensboro Greensboro, NC 27401 Shohet Ear Associates Medical Group, Inc. Newport Beach, CA 92663 Lahey Clinic Burlington, MA 01805

Participant milestones

Measure	Esteem Implant Subjects are implanted with the Esteem Totally Implantable Hearing System Esteem Totally Implantable Hearing System: The Esteem System is a totally implantable hearing system designed to improve hearing in adult subjects suffering from mild to severe hearing loss that is sensorineural in origin.
Overall Study STARTED	57
Overall Study 4 Month Follow-up	54
Overall Study 10 Month Follow-up	52
Overall Study COMPLETED	52
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Esteem Totally Implantable Hearing System

Baseline characteristics by cohort

Measure	Esteem Implant n=57 Participants Subjects implanted with the Esteem Totally Implantable Hearing System
Age, Continuous	52.9 years STANDARD_DEVIATION 15.8 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	57 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	56 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 Months Post Activation

Comparison of the speech reception threshold (SRT) using the Esteem System as compared to the pre-implant aided condition

Outcome measures

Measure	Esteem Implant n=54 Participants Subjects implanted with the Esteem Totally Implantable Hearing System The Esteem System is a totally implantable hearing system designed to improve hearing in adult subjects suffering from mild to severe hearing loss that is sensorineural in origin.
SRT Change	10.6 dB Standard Error 1.6

PRIMARY outcome

Timeframe: 10 Months Post-Activation

Comparison of the speech reception threshold (SRT) using the Esteem System as compared to the pre-implant aided condition

Outcome measures

Measure	Esteem Implant n=54 Participants Subjects implanted with the Esteem Totally Implantable Hearing System The Esteem System is a totally implantable hearing system designed to improve hearing in adult subjects suffering from mild to severe hearing loss that is sensorineural in origin.
SRT Change	11.4 dB Standard Error 1.8

PRIMARY outcome

Timeframe: 4 Months Post Activation

Comparison of the word recognition score using the Esteem compared to the pre-implant aided condition

Outcome measures

Measure	Esteem Implant n=52 Participants Subjects implanted with the Esteem Totally Implantable Hearing System The Esteem System is a totally implantable hearing system designed to improve hearing in adult subjects suffering from mild to severe hearing loss that is sensorineural in origin.
Word Recognition Score Change	21.7 change in % correct Standard Error 4.2

PRIMARY outcome

Timeframe: 10 Months Post Activation

Comparison of the word recognition score using the Esteem compared to the pre-implant aided condition

Outcome measures

Measure	Esteem Implant n=52 Participants Subjects implanted with the Esteem Totally Implantable Hearing System The Esteem System is a totally implantable hearing system designed to improve hearing in adult subjects suffering from mild to severe hearing loss that is sensorineural in origin.
Word Recognition Score Change	19.8 change in % correct Standard Error 4.3

PRIMARY outcome

Timeframe: 10 Months Post-Activation

Population: Includes all events, cumulatively, from enrollment through 10-month followup

The incidence of Serious Adverse Device Effects (SADE) and the incidence rate of device failures and replacements

Outcome measures

Measure	Esteem Implant n=57 Participants Subjects implanted with the Esteem Totally Implantable Hearing System The Esteem System is a totally implantable hearing system designed to improve hearing in adult subjects suffering from mild to severe hearing loss that is sensorineural in origin.
SADEs	6 events

PRIMARY outcome

Timeframe: Baseline, 4-, and 10-Months Post-Activation

Population: 4-month and 10-month BC PTA (average 500, 1kHz, 2kHz) compared to baseline BC PTA

Comparison of bone conduction thresholds at the 4-month and 10-month post-activation follow-up, relative to the pre-implant baseline bone conduction thresholds. Lower thresholds represent better (more sensitive) outcomes.

Outcome measures

Measure	Esteem Implant n=52 Participants Subjects implanted with the Esteem Totally Implantable Hearing System The Esteem System is a totally implantable hearing system designed to improve hearing in adult subjects suffering from mild to severe hearing loss that is sensorineural in origin.
Assessment of Cochlear Function at 4-months and 10-months Post-activation, as Evidenced by Bone-conduction (BC) Thresholds. Baseline bone conduction PTA	55.6 dB HL Standard Error 1.3
Assessment of Cochlear Function at 4-months and 10-months Post-activation, as Evidenced by Bone-conduction (BC) Thresholds. 4 mo. bone conduction PTA	55.6 dB HL Standard Error 1.2
Assessment of Cochlear Function at 4-months and 10-months Post-activation, as Evidenced by Bone-conduction (BC) Thresholds. 10 mo. bone conduction PTA	55.3 dB HL Standard Error 1.4

SECONDARY outcome

Timeframe: 4 and 10 Months Post-Activation

Population: Data from entire subject cohort not available.

To assess whether the Esteem System improves Quality-of-Life, when compared to the baseline aided condition (pre-implant) as shown by the global Abbreviated Profile of Hearing Aid Benefit (APHAB) score. The APHAB is a 24-item self-assessment inventory in which patients report the amount of trouble they are having with communication in various everyday situations using a scale ranging from 0 to 100, with higher scores indicating less difficulty (or increased benefit). The Global Score is the average of 3 subscales.

Scores reported here are calculated by comparing the patient's reported difficulty in the baseline "unaided" condition with their amount of difficulty when using amplification (hearing aids or implant) -- i.e. Global Scores at pre-implant baseline subtracted from scores at aided baseline and at 4 and 10 months post-implant. Positive numbers denote increased benefit relative to unaided baseline, and the higher the number, the greater the benefit.

Outcome measures

Measure	Esteem Implant n=46 Participants Subjects implanted with the Esteem Totally Implantable Hearing System The Esteem System is a totally implantable hearing system designed to improve hearing in adult subjects suffering from mild to severe hearing loss that is sensorineural in origin.
Comparisons of Change in Global Score on Abbreviated Profile of Hearing Aid Benefit (APHAB) at 4 Months and at 10 Months Post-activation, Relative to Pre-implant Baseline Score Baseline Aided Global Score	35.0 score on a scale Standard Error 2.2
Comparisons of Change in Global Score on Abbreviated Profile of Hearing Aid Benefit (APHAB) at 4 Months and at 10 Months Post-activation, Relative to Pre-implant Baseline Score 4 mo.Global Score with Esteem	47.9 score on a scale Standard Error 3.1
Comparisons of Change in Global Score on Abbreviated Profile of Hearing Aid Benefit (APHAB) at 4 Months and at 10 Months Post-activation, Relative to Pre-implant Baseline Score 10 mo. Global Score with Esteem	46.6 score on a scale Standard Error 3.0

SECONDARY outcome

Timeframe: 4 and 10 Months Post Activation

To gain subject feedback on the use of the Esteem System relative to their pre-implant hearing aid (aided condition) as shown by the (unvalidated) Esteem Questionnaire. Subjects completed a 7-item questionnaire rating various subjective attributes concerning their experience with Esteem as compared to their previous hearing aid. Ratings were on a scale of 1 to 5, where 1 is "much worse," 3 is the same and 5 is "much better." Reported here are proportions of participants responding to each score (1 to 5) on the scale, for average scores across all 7 items for each subject.

Outcome measures

Measure	Esteem Implant n=49 Participants Subjects implanted with the Esteem Totally Implantable Hearing System The Esteem System is a totally implantable hearing system designed to improve hearing in adult subjects suffering from mild to severe hearing loss that is sensorineural in origin.
Scores on Esteem Questionnaire Response "1" - 4 mo average across items	2 Participants
Scores on Esteem Questionnaire Response "2" - 4 mo	5 Participants
Scores on Esteem Questionnaire Response "3" - 4 mo	4 Participants
Scores on Esteem Questionnaire Response "4" - 4 mo	15 Participants
Scores on Esteem Questionnaire Response "5" - 4 mo	23 Participants
Scores on Esteem Questionnaire Response "1" - 10 mo ave across items	2 Participants
Scores on Esteem Questionnaire Response "2" - 10 mo	3 Participants
Scores on Esteem Questionnaire Response "3" - 10 mo	5 Participants
Scores on Esteem Questionnaire Response "4" - 10 mo	12 Participants
Scores on Esteem Questionnaire Response "5" - 10 mo	24 Participants
Scores on Esteem Questionnaire Response Missing - 10 mo	3 Participants

SECONDARY outcome

Timeframe: 4 Months Post Activation

For each subject, the 4-month post-activation Air Conduction PTA (average of thresholds at three frequencies: 500, 1000, and 2000 Hz) was compared to the baseline unaided PTA. A negative mean difference (in dB) from baseline indicates improved hearing sensitivity with the Esteem, relative to baseline.

Outcome measures

Measure	Esteem Implant n=53 Participants Subjects implanted with the Esteem Totally Implantable Hearing System The Esteem System is a totally implantable hearing system designed to improve hearing in adult subjects suffering from mild to severe hearing loss that is sensorineural in origin.
Change in Pure Tone Average (PTA) at 4 Months, Relative to Baseline Pre-implant	-27 dB Standard Error 1

SECONDARY outcome

Timeframe: 4 Months Post Activation

The Quick-SIN is a test of sentence recognition in varying levels of background noise. The score achieved is termed "SNR loss," and a higher score indicates poorer performance on the test. "SNR Loss" is defined as the dB increase in signal-to-noise ratio required by a hearing-impaired person to understand speech in noise, compared to someone with normal hearing. (The range of possible scores is -4.5 to 25.5, with lower scores indicating better performance.) For this study, baseline scores for each subject are subtracted from 4 month scores, providing a difference score. The mean difference across subjects is reported here, with 0 meaning no change and a negative difference indicating better performance with Esteem, compared to the pre-implant aided condition.

Outcome measures

Measure	Esteem Implant n=53 Participants Subjects implanted with the Esteem Totally Implantable Hearing System The Esteem System is a totally implantable hearing system designed to improve hearing in adult subjects suffering from mild to severe hearing loss that is sensorineural in origin.
Difference in QuickSIN (Quick Speech-In-Noise Test) Score at 4 Months Relative to Baseline Aided Condition	-1 score on a scale Standard Error 1

Adverse Events

Esteem Implant

Serious events: 6 serious events

Other events: 43 other events

Deaths: 0 deaths

Serious adverse events

Measure	Esteem Implant n=57 participants at risk Subjects implanted with the Esteem Totally Implantable Hearing System Esteem Totally Implantable Hearing System: The Esteem System is a totally implantable hearing system designed to improve hearing in adult subjects suffering from mild to severe hearing loss that is sensorineural in origin.
Ear and labyrinth disorders Limited benefit	5.3% 3/57 • Number of events 3 • Cumulative through 10 Month Post-Activation
Musculoskeletal and connective tissue disorders Incision Breakdown	3.5% 2/57 • Number of events 2 • Cumulative through 10 Month Post-Activation
Nervous system disorders Pain and Facial Weakness	1.8% 1/57 • Number of events 1 • Cumulative through 10 Month Post-Activation

Other adverse events

Measure	Esteem Implant n=57 participants at risk Subjects implanted with the Esteem Totally Implantable Hearing System Esteem Totally Implantable Hearing System: The Esteem System is a totally implantable hearing system designed to improve hearing in adult subjects suffering from mild to severe hearing loss that is sensorineural in origin.
Nervous system disorders Chorda Tympani/Taste Disturbance	40.4% 23/57 • Number of events 24 • Cumulative through 10 Month Post-Activation
Ear and labyrinth disorders Ear effusion/fluid	29.8% 17/57 • Number of events 17 • Cumulative through 10 Month Post-Activation
Ear and labyrinth disorders Tinnitus	14.0% 8/57 • Number of events 9 • Cumulative through 10 Month Post-Activation
Ear and labyrinth disorders Dizziness/vertigo	12.3% 7/57 • Number of events 7 • Cumulative through 10 Month Post-Activation
Skin and subcutaneous tissue disorders Incision discomfort/breakdown	10.5% 6/57 • Number of events 6 • Cumulative through 10 Month Post-Activation
Ear and labyrinth disorders Ear pain	7.0% 4/57 • Number of events 4 • Cumulative through 10 Month Post-Activation
Nervous system disorders Facial weakness/paralysis	7.0% 4/57 • Number of events 4 • Cumulative through 10 Month Post-Activation
General disorders Headache/Pain (post-op)	7.0% 4/57 • Number of events 4 • Cumulative through 10 Month Post-Activation
Ear and labyrinth disorders Ear cracking/roaring	5.3% 3/57 • Number of events 3 • Cumulative through 10 Month Post-Activation
Ear and labyrinth disorders Otitis externa/TM	5.3% 3/57 • Number of events 3 • Cumulative through 10 Month Post-Activation

Additional Information

Elizabeth Anderson, PhD

Envoy Medical Corp.

Phone: 651-361-8080

Email: landerson@envoymedical.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place