Esteem New Subject Enrollment Post Approval Study

NCT02689349 | Completed Results

• 1 other identifier: 0205
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Sensorineural Hearing Loss

Keywords

hearing; implant; moderate degree; severe degree

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (2)

• Change in Subjective Quality of Life as Measured With the Abbreviated Profile of Hearing Aid Benefit, or APHAB (Global Score)

  Change from Baseline Aided to 10-month post-activation with Esteem

• Esteem Questionnaire Results

  10-month post-activation with Esteem

Study Arms (2)

Esteem Implant Prospective Subjects

EXPERIMENTAL

Subjects followed through 1 year for both Safety and Efficacy endpoints

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

Device: Implantation of Esteem

Interventions

Implantation of Esteem DEVICE

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

Esteem Implant Prospective Subjects; Esteem Implant Retrospective Chart Review Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Envoy Medical Corporation: lead

Study Sites (6)

North Alabama ENT Associates

Madison, Alabama, 35758, United States

Location

Pacific Hearing Service

Los Altos, California, 94022, United States

Location

Ear, Nose, & Throat Associates of South Florida

Jupiter, Florida, 33458, United States

Location

Ear Consultants of Georgia

Atlanta, Georgia, 30328, United States

Location

Loyola Center for Hearing

Woodridge, Illinois, 60157, United States

Location

Oklahoma Otolaryngology Associates

Norman, Oklahoma, 73072, United States

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Elizabeth Anderson, Ph.D.
• Organization: Envoy Medical Corp.

landerson@envoymedical.com

(1) 651-788-3017

Study Officials

• Sam Marzo, MD

  Loyola Center for Hearing, Woodridge IL

  PRINCIPAL INVESTIGATOR

• John Li, MD

  Jupiter Medical Center, Jupiter FL

  PRINCIPAL INVESTIGATOR

• Deborah Clark, AuD

  Pacific Hearing Service, Los Altos CA

  PRINCIPAL INVESTIGATOR

• Wayne Berryhill, MD

  Oklahoma Otolaryngology Associates

  PRINCIPAL INVESTIGATOR

• Sanjay Bhansali, MD

  Ear Consultants of Georgia

  PRINCIPAL INVESTIGATOR

• Abraham Jacob, MD

  University of Arizona Ear Institute

  PRINCIPAL INVESTIGATOR

• Elizabeth Toh, MD

  Lahey Hospital & Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2016
• First Posted: February 23, 2016
• Study Start: August 1, 2010
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: June 27, 2022
• Results First Posted: June 1, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)