The Esteem® Hearing Implant Post Approval Study

Hearing Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02666222
• Other study ID #: 0204 PAS
• Status: Completed
• Phase: Phase 4
• First received: July 8, 2011
• Last updated: January 26, 2016
• Start date: March 2011
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: Envoy Medical Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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.

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 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) are available for continued follow-up. These subjects will be re-consented for the 5 year Post Approval Study. No new subjects will be enrolled and implanted in this study. The goal will be to monitor the 61 remaining subjects through their five (5) year follow-up.

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: January 2016
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Deafness
• Hearing Loss

Intervention

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.

Locations

Country	Name	City	State
United States	Lahey Clinic, Inc.	Burlington	Massachusetts
United States	Surgical Care Affiliates	Greensboro	North Carolina
United States	The Ear Center of Greensboro	Greensboro	North Carolina
United States	Hoag Memorial Hospital Presbyterian	Newport Beach	California
United States	Shohet Ear Associates	Newport Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
Envoy Medical Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the speech reception threshold (SRT) using the Esteem® System as compared to the pre-implant aided condition.	ENDPOINT #1:Comparison of the speech reception threshold (SRT) using the Esteem® System as compared to the pre-implant aided condition.	Baseline through Year 5 of Follow Up	No
Primary	Comparison of the word recognition score using the Esteem® compared to the pre-implant aided condition.	ENDPOINT #2: Comparison of the word recognition score using the Esteem® compared to the pre-implant aided condition.	Baseline through Year 5 of Follow Up	No
Primary	Incidence of 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.	Baseline through Year 5 of Follow Up	Yes
Primary	Incidence of facial pareses/paralysis at 1 month follow-up.	ENDPOINT #4: The analysis of the incidence of facial pareses/paralysis at 1 month follow-up.	Baseline through 1 Month Post-Implant	Yes
Primary	Comparison of bone conduction threshold (BC) using forehead placement post activation compared to the pre-implant BC threshold.	ENDPOINT #5: Comparison of bone conduction threshold (BC) using forehead placement post activation compared to the pre-implant BC threshold.	Baseline through Year 5 of Follow Up	Yes
Secondary	Improvement in Quality-of-Life with APHAB	Gather Abbreviated Profile of Hearing Aid Benefit results form baseline aided through year 5 of follow up	Baseline through Year 5 of Follow Up	No
Secondary	Improvement in Quality-of-Life with Esteem® Questionnaire	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	Baseline through Year 5 of Follow Up	No

External Links

•   Invisible Hearing with Esteem®