Esteem New Subject Enrollment Post Approval Study

Sensorineural Hearing Loss Clinical Trial

Official title:

Esteem Totally Implantable Hearing System New Subject Enrollment Post Approval Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02689349
• Other study ID #: 0205
• Status: Completed
• Phase: N/A
• Start date: August 2010
• Est. completion date: September 2021

Study information

• Verified date: June 2022
• Source: Envoy Medical Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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%?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: September 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subject is = 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 in the ear to be implanted defined by pure tone average air-conduction threshold level.

5. 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.

6. 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.

7. Subject has normally functioning eustachian tube

8. Subject has normal tympanic membrane

9. Subject has a normal middle ear anatomy

10. Subject has adequate space for Esteem® System implant determined via fine cut temporal bone CT scan

11. Subject is a native speaker of the English language.

Exclusion Criteria:

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 otitis externa 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 < 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

Related Conditions & MeSH terms

• Hearing Loss
• Hearing Loss, Sensorineural
• Sensorineural Hearing Loss

Intervention

Device:
• Implantation of Esteem
Subjects meeting indications are implanted with the Esteem Totally Implantable Hearing System

Locations

Country	Name	City	State
United States	Ear Consultants of Georgia	Atlanta	Georgia
United States	Ear, Nose, & Throat Associates of South Florida	Jupiter	Florida
United States	Pacific Hearing Service	Los Altos	California
United States	North Alabama ENT Associates	Madison	Alabama
United States	Oklahoma Otolaryngology Associates	Norman	Oklahoma
United States	Loyola Center for Hearing	Woodridge	Illinois

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	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.	Change in SRT from Baseline Aided to 10-month post-activation with Esteem
Primary	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%.	Change in WRS from Baseline Aided to 10-month post-activation with Esteem
Primary	Incidence of SADEs, Device Failures, & Replacements	The analysis of the incidence of Serious Adverse Device Effects (SADEs) and device failures and replacements	Incidence at 10-month post-activation
Primary	Incidence of Facial Pareses/Paralysis	The analysis of the incidence of facial pareses/paralysis at one month follow-up	Incidence at one month post-op
Primary	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.	Change in BCT from Baseline to 10-month post-activation
Primary	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.	Change in BCT from Baseline to 10-month post-activation
Primary	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.	Change in BCT from Baseline to 10-month post-activation
Primary	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.	Change in BCT from Baseline to 10-month post-activation
Secondary	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.	Change from Baseline Aided to 10-month post-activation with Esteem
Secondary	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.	10-month post-activation with Esteem