The Esteem® Hearing Implant Post Approval Study

An observational study of Hearing Loss, run by Envoy Medical Corporation at 5 sites in United States.

Completed

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

Trial summary

The purpose of this study is to evaluate the long-term safety and efficacy of the Esteem® Hearing Implant in subjects suffering from moderate to severe hearing loss. Read more about this study

Who is it for?: Ages 18 to 90 yearsHealthy volunteers can take part
Conditions the study is for: Hearing Loss
What is being tested?: The Esteem Hearing Implant
Type of treatment: Medical device
How many people: 51 participants
Where: 5 sitesUnited States
Study dates: Aug 2010to Mar 2015
Phase: Observational
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 to 90 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: Persons suffering from moderate to severe hearing loss that is sensorineural in origin

Who may be able to join

Subject must meet all of the following criteria to be eligible for treatment in the trial:
Subject is at least 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 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 Lower Level (dB HL) 30 35 35 35 35 Upper Level (dB HL) 100 100 100 100 100

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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 40% with recorded delivery using a phonetically balanced word list at Speech Reception Threshold (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

Subjects will be excluded from the trial if any one of the following criteria is met:
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 external otitis 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 less than two (2) years due to other medical conditions
Subject has retrocochlear or central auditory disorders

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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

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

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

Other trials in United States

About this study

Official title: To Evaluate the Long-term Safety and Efficacy of the Esteem® Hearing Implant in Subjects Suffering From Moderate to Severe Hearing Loss

The purpose of this study is to evaluate the long-term safety and efficacy of the Esteem® Hearing Implant in subjects suffering from moderate to severe hearing loss.

Read the detailed description

The Post Approval Study is an extension of the pivotal clinical trial, which was 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 acts as his or her own control.

This trial has been designed to meet the United States' regulatory requirements.

The subjects included in this study include the 57 subjects implanted under the original Investigational Device Exemption (IDE) study and the five (5) subjects implanted under the continued access expansion approved by the FDA. Of these 62 subjects, all but one (explant) were available for continued follow-up. These subjects were re-consented for the 5 year Post Approval Study. No new subjects were enrolled and implanted in this study. The goal was to monitor a minimum of 45 subjects through their five (5) year follow-up. Ultimately, 51 subjects completed the study.

The following questions are to be answered:

Is the Esteem effective through 5 year follow-up?
Is the Esteem safe through 5 year follow-up?

Conditions: Hearing Loss
Being tested: The Esteem Hearing Implant
Keywords: hearing loss, sensorineural, hearing implant
Medical subject headings: Hearing Loss

What participants receive

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

The Esteem Hearing ImplantDevice
The Esteem® Hearing Implant is designed to improve hearing in subjects suffering from moderate to severe hearing loss that is sensorineural in origin. The Esteem® has been approved by FDA for the US market under Pre-Market Approval P090018 and this study fulfills the requirement for one of the Post Approval Studies.

What is being measured

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

Change From Baseline (Pre-implant Aided Condition) at Year 5 in Speech Reception Threshold (SRT)
ENDPOINT #1: SRT at baseline minus SRT at Year 5. Positive difference (i.e. lower value of SRT with the Esteem) indicates better outcome.
Measured: Baseline through Year 5 of Follow Up
Change From Baseline (Pre-implant Aided Condition) at Year 5 in Word Recognition Score (WRS) at 50 dB HL
ENDPOINT #2: WRS at Year 5 minus WRS at baseline. Positive difference (in % correct) indicates better outcome.
Measured: Baseline through Year 5 of Follow Up
Incidence of Serious Adverse Device Events (SADEs) and Device Failures and Replacements at Each Follow-up.
ENDPOINT #3: The analysis of the incidence of SADEs and device failures and replacements at each follow-up.
Measured: SADEs, PAS phase through Year 5 of Follow Up
Bone Conduction Stability
ENDPOINT #5: Difference between Baseline and 5 Year Pure-Tone Average (PTA; average of 500, 1000, 2000 Hz thresholds); calculated as PTA at Year 5 minus PTA at baseline. Smaller magnitude dB difference indicates better outcome.
Measured: Baseline through 5 Year Follow-Up

Secondary outcomes (1)

Improvement in Quality of Life as Reflected by Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire
APHAB results were obtained from baseline aided condition through Year 5 of follow up. The APHAB responses are in terms of percent of time an individual experiences problems, on a scale of 0-100%; lower scores indicate fewer problems.Compared scores with Esteem to scores in baseline aided condition, calculated as APHAB Global score at baseline minus APHAB Global score at Year 5, giving a "difference in benefit" score. The Global Score is the mean of the scores (% of problems) for Ease of Communication (EC), Reverberation (RV), and Background Noise (BN) subscales of the APHAB. A positive difference in benefit score indicates more benefit with Esteem.
Measured: Baseline through Year 5 of Follow Up

Timeline

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

Aug 2010Mar 2015

First posted28 Jan 2016 (estimated)
Study startAug 2010
Primary completionAug 2014
Study completionMar 2015

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 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02666222
Sponsor's protocol ID: 0204 Post-Approval Study (PAS)
Status last verified: Jan 2016
First submitted: 8 Jul 2011
Last updated: 4 May 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
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 Hearing Loss trials

Study at a glance

From the registry record, last updated by the sponsor on 4 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: To Evaluate the Long-term Safety and Efficacy of the Esteem® Hearing Implant in Subjects Suffering From Moderate to Severe Hearing Loss
ClinicalTrials.gov ID: NCT02666222
Acronym / sponsor ID: 0204 Post-Approval Study (PAS)
Conditions: Hearing Loss
Keywords: hearing loss, sensorineural, hearing implant
Study type: Observational
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: Envoy Medical CorporationIndustry (pharma, biotech, devices)
Study start: Aug 2010
Primary completion: Aug 2014 (actual)
Study completion: Mar 2015 (actual)
First posted: 28 Jan 2016 (estimated)
Results: Posted 4 May 2016

Clinical summary

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

The purpose of this study is to evaluate the long-term safety and efficacy of the Esteem® Hearing Implant in subjects suffering from moderate to severe hearing loss.

Detailed description

This trial has been designed to meet the United States' regulatory requirements.

The following questions are to be answered:

Is the Esteem effective through 5 year follow-up?
Is the Esteem safe through 5 year follow-up?

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Persons suffering from moderate to severe hearing loss that is sensorineural in origin

Key inclusion criteria (16 listed)

Subject must meet all of the following criteria to be eligible for treatment in the trial:
Subject is at least 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 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:

Key exclusion criteria (16 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 external otitis 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 less than 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
The Esteem Hearing ImplantThe Esteem® Hearing Implant is designed to improve hearing in subjects suffering from moderate to severe hearing loss that is sensorineural in origin. The Esteem® has been approved by FDA for the US market under Pre-Market Approval P090018 and this study fulfills the requirement for one of the Post Approval Studies.	Device	–

Primary outcome

Change From Baseline (Pre-implant Aided Condition) at Year 5 in Speech Reception Threshold (SRT)
Time frame: Baseline through Year 5 of Follow Up
ENDPOINT #1: SRT at baseline minus SRT at Year 5. Positive difference (i.e. lower value of SRT with the Esteem) indicates better outcome.
Change From Baseline (Pre-implant Aided Condition) at Year 5 in Word Recognition Score (WRS) at 50 dB HL
Time frame: Baseline through Year 5 of Follow Up
ENDPOINT #2: WRS at Year 5 minus WRS at baseline. Positive difference (in % correct) indicates better outcome.
Incidence of Serious Adverse Device Events (SADEs) and Device Failures and Replacements at Each Follow-up.
Time frame: SADEs, PAS phase through Year 5 of Follow Up
ENDPOINT #3: The analysis of the incidence of SADEs and device failures and replacements at each follow-up.
Bone Conduction Stability
Time frame: Baseline through 5 Year Follow-Up
ENDPOINT #5: Difference between Baseline and 5 Year Pure-Tone Average (PTA; average of 500, 1000, 2000 Hz thresholds); calculated as PTA at Year 5 minus PTA at baseline. Smaller magnitude dB difference indicates better outcome.

1 secondary outcome

Improvement in Quality of Life as Reflected by Abbreviated Profile of Hearing Aid Benefit (APHAB) Questionnaire
Time frame: Baseline through Year 5 of Follow Up

Results and safety

Results posted to the registry on 4 May 2016, 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	51	49

Primary outcome: Change From Baseline (Pre-implant Aided Condition) at Year 5 in Speech Reception Threshold (SRT)

Time frame: Baseline through Year 5 of Follow Up. Mean (Standard Error). Unit: dB

Measure	Esteem Implant n = 49
Value	4.8 (2)

Population analysed: 5 Year Follow-up

Primary outcome: Change From Baseline (Pre-implant Aided Condition) at Year 5 in Word Recognition Score (WRS) at 50 dB HL

Time frame: Baseline through Year 5 of Follow Up. Mean (Standard Error). Unit: percentage of correct responses

Measure	Esteem Implant n = 49
Value	17 (4.2)

Population analysed: 5 Year Follow-up Visit

Primary outcome: Incidence of Serious Adverse Device Events (SADEs) and Device Failures and Replacements at Each Follow-up.

Time frame: SADEs, PAS phase through Year 5 of Follow Up. Number. Unit: participants

Measure	Esteem Implant n = 51
Value	3

Population analysed: Cumulative through 5-Year Follow-up

Primary outcome: Bone Conduction Stability

Time frame: Baseline through 5 Year Follow-Up. Mean (Standard Error). Unit: dB

Measure	Esteem Implant n = 49
Value	3.7 (1.1)

Population analysed: Difference between Baseline and 5 Year PTA (average of 500, 1000, 2000 Hz thresholds)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: PAS phase through 5 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Esteem Implant	14 of 51 (27.5%)	42 of 51 (82.4%)	Not reported

Limitations and caveats (from the sponsor): 1. Study endpoints do not account for natural progression of hearing loss over 5-year follow-up. 2. Fitting methods for pre-implant hearing aid were not strictly controlled in the protocol.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Invisible Hearing with Esteem®Link provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Hearing Loss

Not yet recruiting
Automated Text Message Reminders to Promote Hearing Aid Adoption
Hearing Loss
Enrolling by invitationObservational study
Post-Market Registry Study for Vibrant Hearing Solutions
Conductive Hearing Loss, Mixed Hearing Loss
Recruiting
Investigating Auditory Processing in the Users of Auditory Brainstem and Cochlear Implants
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RecruitingObservational study
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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.

Jack A Shohet, MD principal investigator

Hoag Memorial Hospital

Elizabeth H Toh, MBBS; MD principal investigator

Lahey Clinic Medical Center

Eric M Kraus, MD, MS, FACS principal investigator

Moses H. Cone Memorial Hospital

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

Questions about this trial

What is this clinical trial studying?

An observational study of 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 16 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 4 May 2016. 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 4 May 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?

Change From Baseline (Pre-implant Aided Condition) at Year 5 in Speech Reception Threshold (SRT) (time frame: Baseline through Year 5 of Follow Up). The study lists 4 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 NCT02666222.

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 4 May 2016.