Sensorineural Hearing LossNCT02689349

Esteem New Subject Enrollment Post Approval Study

A study testing Implantation of Esteem in people with Sensorineural Hearing Loss, run by Envoy Medical Corporation at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The New Enrollment Post-Approval Study is designed to evaluate the safety and efficacy of the Esteem Totally Implantable Hearing System in subjects suffering from moderate to severe hearing loss. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Sensorineural Hearing Loss
What is being tested?: Implantation of Esteem
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 117 participants
Where: 6 sitesUnited States
Study dates: Aug 2010to Sep 2021
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
Healthy volunteers accepted
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 moderate to severe sensorineural hearing loss in the ear to be implanted defined by pure tone average air-conduction threshold level.
Subject has an unaided maximum word recognition score of greater than or equal to 40% with recorded delivery using a phonetically balanced word list at SRT + 40 decibels (dB) or at maximum tolerable presentation level.
Subject is a current user of a properly functioning and appropriately fit hearing aid for at least one (1) month in the ear to be implanted.

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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.

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

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Ear Consultants of Georgia
Atlanta, Georgia, 30328
Ear, Nose, & Throat Associates of South Florida
Jupiter, Florida, 33458
Pacific Hearing Service
Los Altos, California, 94022
North Alabama ENT Associates
Madison, Alabama, 35758
Oklahoma Otolaryngology Associates
Norman, Oklahoma, 73072
Loyola Center for Hearing
Woodridge, Illinois, 60157

Other trials in United States

About this study

Official title: Esteem Totally Implantable Hearing System New Subject Enrollment Post Approval Study

The New Enrollment Post-Approval Study is designed to evaluate the safety and efficacy of the Esteem Totally Implantable Hearing System in subjects suffering from moderate to severe hearing loss.

Read the detailed description

Purpose:

To evaluate the long-term safety and efficacy of the Esteem Totally Implantable Hearing System (hereafter called Esteem) in subjects suffering from moderate to severe hearing loss.

Questions:

The following questions are to be answered:

Is Esteem effective through 1 year follow-up?
Is Esteem safe through 1 year follow-up?
Is the incidence of facial paresis/paralysis at 1 month follow-up no greater than 7%?

Conditions: Sensorineural Hearing Loss
Being tested: Implantation of Esteem
Keywords: hearing, implant, moderate degree, severe degree
Medical subject headings: Hearing Loss, Sensorineural

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Implantation of EsteemDevice
Subjects meeting indications are implanted with the Esteem Totally Implantable Hearing System

Study groups in NCT02689349
Study group	Role	What they receive
Esteem Implant Prospective Subjects	Experimental	Subjects followed through 1 year for both Safety and Efficacy endpoints Receives: Device: Implantation of Esteem
Esteem Implant Retrospective Chart Review Subjects	Other	Subjects providing Safety-only endpoint data through retrospective chart review, to be added to Prospective Subjects' Safety data Receives: Device: Implantation of Esteem

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Speech Reception Threshold (SRT)
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.
Measured: Change in SRT from Baseline Aided to 10-month post-activation with Esteem
Change in Word Recognition Score (WRS)
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%.
Measured: Change in WRS from Baseline Aided to 10-month post-activation with Esteem
Incidence of SADEs, Device Failures, & Replacements
The analysis of the incidence of Serious Adverse Device Effects (SADEs) and device failures and replacements
Measured: Incidence at 10-month post-activation
Incidence of Facial Pareses/Paralysis
The analysis of the incidence of facial pareses/paralysis at one month follow-up
Measured: Incidence at one month post-op
Change in Bone Conduction Threshold (BCT) at 500 Hz
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.
Measured: Change in BCT from Baseline to 10-month post-activation
Change in Bone Conduction Threshold (BCT) at 1000 Hz
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.
Measured: Change in BCT from Baseline to 10-month post-activation
Change in Bone Conduction Threshold (BCT) at 2000 Hz
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.
Measured: Change in BCT from Baseline to 10-month post-activation
Change in Bone Conduction Threshold (BCT) at 4000 Hz
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.
Measured: Change in BCT from Baseline to 10-month post-activation

Secondary outcomes (2)

Change in Subjective Quality of Life as Measured With the Abbreviated Profile of Hearing Aid Benefit, or APHAB (Global Score)
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.
Measured: Change from Baseline Aided to 10-month post-activation with Esteem
Esteem Questionnaire Results
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.
Measured: 10-month post-activation with Esteem

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2010Sep 2021

First posted23 Feb 2016 (estimated)
Study startAug 2010
Primary completionSep 2021
Study completionSep 2021

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 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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 117 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02689349
Sponsor's protocol ID: 0205
Status last verified: Jun 2022
First submitted: 8 Feb 2016
Last updated: 27 Jun 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Sensorineural Hearing Loss trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Esteem Totally Implantable Hearing System New Subject Enrollment Post Approval Study
ClinicalTrials.gov ID: NCT02689349
Acronym / sponsor ID: 0205
Conditions: Sensorineural Hearing Loss
Keywords: hearing, implant, moderate degree, severe degree
Study type: Interventional
Recruitment status: Completed
Enrolment: 117 participants (actual)
Lead sponsor: Envoy Medical CorporationIndustry (pharma, biotech, devices)
Study start: Aug 2010 (actual)
Primary completion: Sep 2021 (actual)
Study completion: Sep 2021 (actual)
First posted: 23 Feb 2016 (estimated)
Results: Posted 1 Jun 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The New Enrollment Post-Approval Study is designed to evaluate the safety and efficacy of the Esteem Totally Implantable Hearing System in subjects suffering from moderate to severe hearing loss.

Detailed description

Purpose:

To evaluate the long-term safety and efficacy of the Esteem Totally Implantable Hearing System (hereafter called Esteem) in subjects suffering from moderate to severe hearing loss.

Questions:

The following questions are to be answered:

Is Esteem effective through 1 year follow-up?
Is Esteem safe through 1 year follow-up?
Is the incidence of facial paresis/paralysis at 1 month follow-up no greater than 7%?

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Esteem Implant Prospective Subjects	Experimental	Device: Implantation of EsteemSubjects followed through 1 year for both Safety and Efficacy endpoints
Esteem Implant Retrospective Chart Review Subjects	Other	Device: Implantation of EsteemSubjects providing Safety-only endpoint data through retrospective chart review, to be added to Prospective Subjects' Safety data

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 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 moderate to severe sensorineural hearing loss in the ear to be implanted defined by pure tone average air-conduction threshold level.
Subject has an unaided maximum word recognition score of greater than or equal to 40% with recorded delivery using a phonetically balanced word list at SRT + 40 decibels (dB) or at maximum tolerable presentation level.

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
Implantation of EsteemSubjects meeting indications are implanted with the Esteem Totally Implantable Hearing System	Device	Esteem Implant Prospective Subjects, Esteem Implant Retrospective Chart Review Subjects

Primary outcome

Change in Speech Reception Threshold (SRT)
Time frame: Change in SRT from Baseline Aided to 10-month post-activation with Esteem
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.
Change in Word Recognition Score (WRS)
Time frame: Change in WRS from Baseline Aided to 10-month post-activation with Esteem
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%.
Incidence of SADEs, Device Failures, & Replacements
Time frame: Incidence at 10-month post-activation
The analysis of the incidence of Serious Adverse Device Effects (SADEs) and device failures and replacements
Incidence of Facial Pareses/Paralysis
Time frame: Incidence at one month post-op
The analysis of the incidence of facial pareses/paralysis at one month follow-up
Change in Bone Conduction Threshold (BCT) at 500 Hz
Time frame: Change in BCT from Baseline to 10-month post-activation
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.
Change in Bone Conduction Threshold (BCT) at 1000 Hz
Time frame: Change in BCT from Baseline to 10-month post-activation
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.
Change in Bone Conduction Threshold (BCT) at 2000 Hz
Time frame: Change in BCT from Baseline to 10-month post-activation
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.
Change in Bone Conduction Threshold (BCT) at 4000 Hz
Time frame: Change in BCT from Baseline to 10-month post-activation
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.

2 secondary outcomes

Change in Subjective Quality of Life as Measured With the Abbreviated Profile of Hearing Aid Benefit, or APHAB (Global Score)
Time frame: Change from Baseline Aided to 10-month post-activation with Esteem
Esteem Questionnaire Results
Time frame: 10-month post-activation with Esteem

Results and safety

Results posted to the registry on 1 Jun 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Esteem Implant Prospective Subjects	59	46
Esteem Implant Retrospective Chart Review Subjects	58	58

Primary outcome: Change in Speech Reception Threshold (SRT)

Time frame: Change in SRT from Baseline Aided to 10-month post-activation with Esteem. Mean (Standard Error). Unit: dB

Measure	Esteem Implant Prospective Subjects n = 46
Value	5.3 (2.4)

Population analysed: Change in Speech Reception Threshold (SRT) was not collected from the Esteem Implant Retrospective Chart Review Subject Arm.

Primary outcome: Change in Word Recognition Score (WRS)

Time frame: Change in WRS from Baseline Aided to 10-month post-activation with Esteem. Mean (Standard Error). Unit: percent correct

Measure	Esteem Implant Prospective Subjects n = 46
Value	5.5 (3.8)

Population analysed: Change in Word Recognition Score (WRS) was not collected from the Esteem Implant Retrospective Chart Review Subject Arm.

Primary outcome: Incidence of SADEs, Device Failures, & Replacements

Time frame: Incidence at 10-month post-activation. Number. Unit: Number of events

Measure	Esteem Implant Prospective Subjects n = 46	Esteem Implant Retrospective Chart Review Subjects n = 58
Value	3	0

Primary outcome: Incidence of Facial Pareses/Paralysis

Time frame: Incidence at one month post-op. Count of participants. Unit: Participants

Measure	Esteem Implant Prospective Subjects n = 46	Esteem Implant Retrospective Chart Review Subjects n = 58
Value	3	0

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events reported here were those occurring within 10 months post-implantation. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Esteem Implant Prospective Subjects	9 of 59 (15.3%)	23 of 59 (39%)	0 of 59
Esteem Implant Retrospective Chart Review Subjects	0 of 58 (0%)	5 of 58 (8.6%)	0 of 58

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Sensorineural Hearing Loss

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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.

Sam Marzo, MD principal investigator

Loyola Center for Hearing, Woodridge IL

John Li, MD principal investigator

Jupiter Medical Center, Jupiter FL

Deborah Clark, AuD principal investigator

Pacific Hearing Service, Los Altos CA

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Implantation of Esteem in people with Sensorineural Hearing Loss, run by Envoy Medical Corporation at 6 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 11 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 27 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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 1 Jun 2022). 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?

Change in Speech Reception Threshold (SRT) (time frame: Change in SRT from Baseline Aided to 10-month post-activation with Esteem). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02689349.

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 27 Jun 2022.