To evaluate the safety and efficacy of the Esteem Totally Implantable Hearing System in subjects suffering from mild to severe hearing loss.
Title: Esteem® Totally Implantable Hearing System Clinical Trial Purpose: To evaluate the safety and efficacy of the Esteem® Totally Implantable Hearing System (hereafter called the Esteem® System) in subjects suffering from mild to severe hearing loss. Trial Design: This pivotal trial is designed as a prospective, multi-center, non-randomized, clinical trial to evaluate the safety and efficacy of the Esteem® System. For this trial the subject will act as his or her own control. This trial has been designed to meet the United States' regulatory requirements. Enrollment Size: It is currently estimated that 50-60 subjects will be enrolled in this trial. Subject Population: Adult subjects who have mild to severe sensorineural hearing loss, have a healthy middle ear, have a speech discrimination score of equal to or better than 40%, and have previously worn a hearing aid for a minimum of 3 months with an average daily use rate of at least 4 hours are eligible for inclusion in the trial. See detailed inclusion/exclusion criteria for specifics. Primary Objectives: 1. To demonstrate that the Esteem® System improves the speech threshold of sensitivity for hearing and identifying speech signals as well as or better than the pre-implant hearing aid (aided condition). Endpoint: Comparison of the speech reception threshold (SRT) using the Esteem® System (4 months post activation) as compared to the pre-implant aided condition. 2. To demonstrate that the Esteem® System at the 4 months post- activation visit is as effective as or better than the hearing aid for improving speech discrimination (intelligibility) as shown by the word recognition score at 50 dB. Endpoint: Comparison of the word recognition score using the Esteem® at 4 months post-activation compared to the pre-implant aided condition. 3. To determine the incidence of Serious Adverse Device Effects (SADE) and the incidence rate of device failures and replacements. Endpoint: The analysis of the incidence of SADEs and device failures and replacements at each follow-up. 4. To demonstrate that the subjects' cochlear function remains unchanged with the Esteem® System as shown by comparison of the subjects' pre-implant baseline bone conduction threshold versus the subjects' 4 month post-activation visit bone conduction threshold. Endpoint: Comparison of bone conduction threshold (BC) using forehead placement at 4 months post activation compared to the pre-implant BC threshold. Secondary Objectives: 1. To demonstrate that the Esteem® System at the 4 months post activation visit improves the 3-frequency (500, 1000, and 2000 Hz) pure tone average (PTA) when compared to the baseline unaided condition. 2. To demonstrate that the Esteem® System at the 4 months post-activation visit is as effective as or better than the hearing aid for improving speech discrimination (intelligibility) as shown by the QuickSIN (speech in noise) test results. 3. To show that the Esteem® System improves Quality-of-Life when compared to the baseline aided condition as shown by APHAB results. 4. To gather subject feedback and comments on the use of the Esteem® System relative to the pre-implant hearing aid (aided condition) as shown by the Esteem® Questionnaire.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
57
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.
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
Shohet Ear Associates
Newport Beach, California, United States
Lahey Clinic, Inc.
Burlington, Massachusetts, United States
Surgical Care Affiliates
Greensboro, North Carolina, United States
SRT Change
Comparison of the speech reception threshold (SRT) using the Esteem System as compared to the pre-implant aided condition
Time frame: 4 Months Post Activation
SRT Change
Comparison of the speech reception threshold (SRT) using the Esteem System as compared to the pre-implant aided condition
Time frame: 10 Months Post-Activation
Word Recognition Score Change
Comparison of the word recognition score using the Esteem compared to the pre-implant aided condition
Time frame: 4 Months Post Activation
Word Recognition Score Change
Comparison of the word recognition score using the Esteem compared to the pre-implant aided condition
Time frame: 10 Months Post Activation
SADEs
The incidence of Serious Adverse Device Effects (SADE) and the incidence rate of device failures and replacements
Time frame: 10 Months Post-Activation
Assessment of Cochlear Function at 4-months and 10-months Post-activation, as Evidenced by Bone-conduction (BC) Thresholds.
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.
Time frame: Baseline, 4-, and 10-Months Post-Activation
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
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The Ear Center of Greensboro
Greensboro, North Carolina, United States
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.
Time frame: 4 and 10 Months Post-Activation
Scores on Esteem Questionnaire
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.
Time frame: 4 and 10 Months Post Activation
Change in Pure Tone Average (PTA) at 4 Months, Relative to Baseline Pre-implant
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.
Time frame: 4 Months Post Activation
Difference in QuickSIN (Quick Speech-In-Noise Test) Score at 4 Months Relative to Baseline Aided Condition
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.
Time frame: 4 Months Post Activation