The Esteem® Hearing Implant Post Approval Study

• ClinicalTrials.gov Identifier: NCT02666222
• Recruitment Status: Completed
• First Posted: January 28, 2016
• Results First Posted: May 4, 2016
• Last Update Posted: May 4, 2016
• Sponsor: Envoy Medical Corporation
• Information provided by (Responsible Party): Envoy Medical Corporation

Study Description

Brief 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.

Condition or disease	Intervention/treatment
Hearing Loss	Device: The Esteem Hearing Implant

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?

Study Design

• Study Type: Observational
• Actual Enrollment: 51 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: To Evaluate the Long-term Safety and Efficacy of the Esteem® Hearing Implant in Subjects Suffering From Moderate to Severe Hearing Loss
• Study Start Date: August 2010
• Actual Primary Completion Date: August 2014
• Actual Study Completion Date: March 2015

Groups and Cohorts

Intervention Details:

• Device: The Esteem Hearing Implant
  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.

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.

Secondary Outcome Measures :

1. 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 ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

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

Criteria

Inclusion Criteria:

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

1. Subject is at least 18 years old
2. Subject understands the nature of the procedure and has signed the Subject Informed Consent Form prior to the procedure
3. Subject is willing and able to comply with specified follow-up evaluations and understands the audiological test procedures and use of the Esteem® System.

4. 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

5. 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.
6. 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.
7. 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.
8. Subject's hearing aid, in the ear to be implanted, shall appropriately fit optimally.
9. Subject has normally functioning eustachian tube
10. Subject has normal tympanic membrane
11. Subject has a normal middle ear anatomy
12. Subject has adequate space for Esteem® System implant determined via fine cut temporal bone CT scan
13. Subject is a native speaker of the English language.
14. Subject is a hearing aid user in the ear to be implanted

Exclusion Criteria:

Subjects will be excluded from the trial if any one of the following criteria is met:

1. 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
2. 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
3. Subject has cholesteatoma or destructive middle ear disease
4. Subject has life expectancy of less than two (2) years due to other medical conditions
5. Subject has retrocochlear or central auditory disorders
6. 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
7. 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)
8. Subject has sudden hearing loss due to unknown cause
9. Subject has a history of disabling tinnitus, defined as tinnitus which required treatment.
10. Subject is unable to adequately perform audiological testing
11. 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.
12. 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
13. Subject is pregnant at the time of device implant
14. Subject has a history of keloid formation
15. Subject has known hypersensitivity to silicone rubber, polyurethane, stainless steel, titanium and/or gold

Contacts and Locations

Locations

United States, California

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States, 92658

Shohet Ear Associates

Newport Beach, California, United States, 92663

United States, Massachusetts

Lahey Clinic, Inc.

Burlington, Massachusetts, United States, 01805

United States, North Carolina

Surgical Care Affiliates

Greensboro, North Carolina, United States, 27401

The Ear Center of Greensboro

Greensboro, North Carolina, United States, 27401

Sponsors and Collaborators

Envoy Medical Corporation

Investigators

• Principal Investigator: Jack A Shohet, MD; Hoag Memorial Hospital
• Principal Investigator: Elizabeth H Toh, MBBS; MD; Lahey Clinic Medical Center
• Principal Investigator: Eric M Kraus, MD, MS, FACS; Moses H. Cone Memorial Hospital

More Information

Additional Information:

Invisible Hearing with Esteem® 

• Responsible Party: Envoy Medical Corporation
• ClinicalTrials.gov Identifier: NCT02666222
• Other Study ID Numbers: 0204 Post-Approval Study (PAS)
• First Posted: January 28, 2016
• Results First Posted: May 4, 2016
• Last Update Posted: May 4, 2016
• Last Verified: January 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Envoy Medical Corporation:

hearing loss; sensorineural; hearing implant

Additional relevant MeSH terms:

Hearing Loss; Deafness; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases