Mild to Severe Sensorineural Hearing LossNCT01092910
Esteem Totally Implantable Hearing System
A study testing Esteem Totally Implantable Hearing System in people with Mild to Severe Sensorineural Hearing Loss, run by Envoy Medical Corporation at 5 sites in United States.
Trial summary
To evaluate the safety and efficacy of the Esteem Totally Implantable Hearing System in subjects suffering from mild to severe hearing loss. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mild to Severe Sensorineural Hearing Loss
- What is being tested?
- Esteem Totally Implantable Hearing System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 5 sitesUnited States
- Study dates
- Jan 2008to Aug 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Lahey Clinic, Inc.
Burlington, Massachusetts, 01805
Surgical Care Affiliates
Greensboro, North Carolina, 27401
The Ear Center of Greensboro
Greensboro, North Carolina, 27401
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92658
Shohet Ear Associates
Newport Beach, California, 92663
About this study
Official title: Esteem Totally Implantable Hearing System Clinical Trial U.S. Pivotal Trial
To evaluate the safety and efficacy of the Esteem Totally Implantable Hearing System in subjects suffering from mild to severe hearing loss.
Read the 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.
- Being tested
- Esteem Totally Implantable Hearing System
- Keywords
- Sensorineural, Hearing Loss
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esteem Totally Implantable Hearing SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Esteem Implant | Experimental | Subjects are implanted with the Esteem Totally Implantable Hearing System Receives: Device: Esteem Totally Implantable Hearing System |
What is being measured
The primary outcome is the main question the study is designed to answer.
SRT Change
Comparison of the speech reception threshold (SRT) using the Esteem System as compared to the pre-implant aided condition
Measured: 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
Measured: 10 Months Post-Activation
Word Recognition Score Change
Comparison of the word recognition score using the Esteem compared to the pre-implant aided condition
Measured: 4 Months Post Activation
Word Recognition Score Change
Comparison of the word recognition score using the Esteem compared to the pre-implant aided condition
Measured: 10 Months Post Activation
SADEs
The incidence of Serious Adverse Device Effects (SADE) and the incidence rate of device failures and replacements
Measured: 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.
Measured: Baseline, 4-, and 10-Months Post-Activation
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 Months Post Activation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2010 (estimated)
- Study startJan 2008
- Primary completionJul 2009
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mild to Severe Sensorineural Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Envoy Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jack A. Shohet, M.D., Principal investigatorEric M. Kraus, M.D., M.S., Principal investigator, F.A.C.S.Peter J. Catalano, M.D., Principal investigator, F.A.C.S.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01092910
- Sponsor's protocol ID
- 0204
- Status last verified
- Jan 2016
- First submitted
- 19 Mar 2010
- Last updated
- 2 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esteem Totally Implantable Hearing System Clinical Trial U.S. Pivotal Trial
- ClinicalTrials.gov ID
- NCT01092910
- Acronym / sponsor ID
- 0204
- Keywords
- Sensorineural, Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Envoy Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 25 Mar 2010 (estimated)
- Results
- Posted 23 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Esteem Implant | Experimental | Device: Esteem Totally Implantable Hearing SystemSubjects are implanted with the Esteem Totally Implantable Hearing System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Esteem Totally Implantable Hearing SystemThe 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. | Device | Esteem Implant |
Primary outcome
SRT Change
Time frame: 4 Months Post Activation
Comparison of the speech reception threshold (SRT) using the Esteem System as compared to the pre-implant aided condition
SRT Change
Time frame: 10 Months Post-Activation
Comparison of the speech reception threshold (SRT) using the Esteem System as compared to the pre-implant aided condition
Word Recognition Score Change
Time frame: 4 Months Post Activation
Comparison of the word recognition score using the Esteem compared to the pre-implant aided condition
Word Recognition Score Change
Time frame: 10 Months Post Activation
Comparison of the word recognition score using the Esteem compared to the pre-implant aided condition
SADEs
Time frame: 10 Months Post-Activation
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.
Time frame: Baseline, 4-, and 10-Months Post-Activation
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.
4 secondary outcomes
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
Time frame: 4 and 10 Months Post-Activation
Scores on Esteem Questionnaire
Time frame: 4 and 10 Months Post Activation
Change in Pure Tone Average (PTA) at 4 Months, Relative to Baseline Pre-implant
Time frame: 4 Months Post Activation
Difference in QuickSIN (Quick Speech-In-Noise Test) Score at 4 Months Relative to Baseline Aided Condition
Time frame: 4 Months Post Activation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Envoy Medical Corporation Official Web SiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jack A. Shohet, M.D. principal investigator
Eric M. Kraus, M.D., M.S. principal investigator
F.A.C.S.
Peter J. Catalano, M.D. principal investigator
F.A.C.S.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Esteem Totally Implantable Hearing System in people with Mild to Severe Sensorineural Hearing Loss, run by Envoy Medical Corporation at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SRT Change (time frame: 4 Months Post Activation). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2020.