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Esteem Totally Implantable Hearing System

Primary Purpose

Mild to Severe Sensorineural Hearing Loss

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Esteem Totally Implantable Hearing System
Sponsored by
Envoy Medical Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild to Severe Sensorineural Hearing Loss focused on measuring Sensorineural, Hearing Loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject is 18 years old
  • Subject understands the nature of the procedure and has signed the Subject Informed Consent Form prior to the procedure
  • Subject is willing and able to comply with specified follow-up evaluations and understands the audiological test procedures and use of the Esteem System.
  • Subject has mild to severe sensorineural hearing loss between 500 and 4000 Hz in the ear to be implanted with pure tone air-conduction threshold levels within the limits of a Hearing Aid (HA) as follow:

Freq (Hz) 500 1000 2000 3000 4000 LL* (dB HL) 30 35 35 35 35 UL* (dB HL) 100 100 100 100 100

*LL = Lower Level; UL = Upper Level

  • Subject's air-bone gap is no greater than 10 dB at 4 of the 5 following frequencies: 500, 1000, 2000, 3000 and 4000 Hz.
  • Subject has an unaided maximum word recognition score of greater than or equal to 60% with recorded delivery using a phonetically balanced word list at SRT + 40 dB or at maximum tolerable presentation level.
  • Subject is a current user of a properly functioning and appropriately fit hearing aid. This is defined as the subject has used this aid for at least four (4) hours (average) per day (in the ear to be implanted) for at least three (3) months for a new aid or one (1) month for an adjusted aid.
  • Subject's hearing aid, in the ear to be implanted, shall appropriately fit optimally.
  • Subject has normally functioning eustachian tube
  • Subject has normal tympanic membrane
  • Subject has a normal middle ear anatomy
  • Subject has adequate space for Esteem System implant determined via fine cut temporal bone CT scan
  • Subject is a native speaker of the English language.
  • Subject is a hearing aid user in the ear to be implanted.

Exclusion Criteria:

  • 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
  • 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
  • Subject has cholesteatoma or destructive middle ear disease
  • Subject has life expectancy of two (2) years due to other medical conditions
  • Subject has retrocochlear or central auditory disorders
  • 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
  • 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)
  • Subject has sudden hearing loss due to unknown cause
  • Subject has a history of disabling tinnitus, defined as tinnitus which required treatment.
  • Subject is unable to adequately perform audiological testing
  • 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.
  • 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
  • Subject is pregnant at the time of device implant
  • Subject has a history of keloid formation
  • Subject has known hypersensitivity to silicone rubber, polyurethane, stainless steel, titanium and/or gold

Sites / Locations

  • Hoag Memorial Hospital Presbyterian
  • Shohet Ear Associates
  • Lahey Clinic, Inc.
  • Surgical Care Affiliates
  • The Ear Center of Greensboro

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Esteem Implant

Arm Description

Subjects are implanted with the Esteem Totally Implantable Hearing System

Outcomes

Primary Outcome Measures

SRT Change
Comparison of the speech reception threshold (SRT) using the Esteem System as compared to the pre-implant aided condition
SRT Change
Comparison of the speech reception threshold (SRT) using the Esteem System as compared to the pre-implant aided condition
Word Recognition Score Change
Comparison of the word recognition score using the Esteem compared to the pre-implant aided condition
Word Recognition Score Change
Comparison of the word recognition score using the Esteem compared to the pre-implant aided condition
SADEs
The incidence of Serious Adverse Device Effects (SADE) and the incidence rate of device failures and replacements
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.

Secondary Outcome Measures

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
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.
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.
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.
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.

Full Information

First Posted
March 19, 2010
Last Updated
December 13, 2019
Sponsor
Envoy Medical Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01092910
Brief Title
Esteem Totally Implantable Hearing System
Official Title
Esteem Totally Implantable Hearing System Clinical Trial U.S. Pivotal Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Envoy Medical Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To evaluate the safety and efficacy of the Esteem Totally Implantable Hearing System in subjects suffering from mild to severe hearing loss.
Detailed Description
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: 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. 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. 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. 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: 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. 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. To show that the Esteem® System improves Quality-of-Life when compared to the baseline aided condition as shown by APHAB results. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild to Severe Sensorineural Hearing Loss
Keywords
Sensorineural, Hearing Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Esteem Implant
Arm Type
Experimental
Arm Description
Subjects are implanted with the Esteem Totally Implantable Hearing System
Intervention Type
Device
Intervention Name(s)
Esteem Totally Implantable Hearing System
Intervention Description
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.
Primary Outcome Measure Information:
Title
SRT Change
Description
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
Title
SRT Change
Description
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
Title
Word Recognition Score Change
Description
Comparison of the word recognition score using the Esteem compared to the pre-implant aided condition
Time Frame
4 Months Post Activation
Title
Word Recognition Score Change
Description
Comparison of the word recognition score using the Esteem compared to the pre-implant aided condition
Time Frame
10 Months Post Activation
Title
SADEs
Description
The incidence of Serious Adverse Device Effects (SADE) and the incidence rate of device failures and replacements
Time Frame
10 Months Post-Activation
Title
Assessment of Cochlear Function at 4-months and 10-months Post-activation, as Evidenced by Bone-conduction (BC) Thresholds.
Description
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
Secondary Outcome Measure Information:
Title
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
Description
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
Title
Scores on Esteem Questionnaire
Description
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
Title
Change in Pure Tone Average (PTA) at 4 Months, Relative to Baseline Pre-implant
Description
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
Title
Difference in QuickSIN (Quick Speech-In-Noise Test) Score at 4 Months Relative to Baseline Aided Condition
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is 18 years old Subject understands the nature of the procedure and has signed the Subject Informed Consent Form prior to the procedure Subject is willing and able to comply with specified follow-up evaluations and understands the audiological test procedures and use of the Esteem System. Subject has mild to severe sensorineural hearing loss between 500 and 4000 Hz in the ear to be implanted with pure tone air-conduction threshold levels within the limits of a Hearing Aid (HA) as follow: Freq (Hz) 500 1000 2000 3000 4000 LL* (dB HL) 30 35 35 35 35 UL* (dB HL) 100 100 100 100 100 *LL = Lower Level; UL = Upper Level Subject's air-bone gap is no greater than 10 dB at 4 of the 5 following frequencies: 500, 1000, 2000, 3000 and 4000 Hz. Subject has an unaided maximum word recognition score of greater than or equal to 60% with recorded delivery using a phonetically balanced word list at SRT + 40 dB or at maximum tolerable presentation level. Subject is a current user of a properly functioning and appropriately fit hearing aid. This is defined as the subject has used this aid for at least four (4) hours (average) per day (in the ear to be implanted) for at least three (3) months for a new aid or one (1) month for an adjusted aid. Subject's hearing aid, in the ear to be implanted, shall appropriately fit optimally. Subject has normally functioning eustachian tube Subject has normal tympanic membrane Subject has a normal middle ear anatomy Subject has adequate space for Esteem System implant determined via fine cut temporal bone CT scan Subject is a native speaker of the English language. Subject is a hearing aid user in the ear to be implanted. Exclusion Criteria: 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 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 Subject has cholesteatoma or destructive middle ear disease Subject has life expectancy of two (2) years due to other medical conditions Subject has retrocochlear or central auditory disorders 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 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) Subject has sudden hearing loss due to unknown cause Subject has a history of disabling tinnitus, defined as tinnitus which required treatment. Subject is unable to adequately perform audiological testing 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. 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 Subject is pregnant at the time of device implant Subject has a history of keloid formation Subject has known hypersensitivity to silicone rubber, polyurethane, stainless steel, titanium and/or gold
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jack A. Shohet, M.D.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eric M. Kraus, M.D., M.S.
Organizational Affiliation
F.A.C.S.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter J. Catalano, M.D.
Organizational Affiliation
F.A.C.S.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hoag Memorial Hospital Presbyterian
City
Newport Beach
State/Province
California
ZIP/Postal Code
92658
Country
United States
Facility Name
Shohet Ear Associates
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Lahey Clinic, Inc.
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
Surgical Care Affiliates
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
The Ear Center of Greensboro
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.envoymedical.com
Description
Envoy Medical Corporation Official Web Site

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Esteem Totally Implantable Hearing System

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