Clinical trial NCT02689349: Esteem New Subject Enrollment Post Approval Study
Official title: Esteem Totally Implantable Hearing System New Subject Enrollment Post Approval Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sensorineural Hearing Loss
Keywords: hearing
implant
moderate degree
severe degree
Lead sponsor: Envoy Medical Corporation
Sponsor class: INDUSTRY
First posted: 2016-02-23
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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%?

Eligibility criteria: 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

Primary outcomes:
measure: Change in Speech Reception Threshold (SRT)
timeFrame: Change in SRT from Baseline Aided to 10-month post-activation with Esteem
measure: Change in Word Recognition Score (WRS)
timeFrame: Change in WRS from Baseline Aided to 10-month post-activation with Esteem
measure: Incidence of SADEs, Device Failures, & Replacements
timeFrame: Incidence at 10-month post-activation
measure: Incidence of Facial Pareses/Paralysis
timeFrame: Incidence at one month post-op
measure: Change in Bone Conduction Threshold (BCT) at 500 Hz
timeFrame: Change in BCT from Baseline to 10-month post-activation
measure: Change in Bone Conduction Threshold (BCT) at 1000 Hz
timeFrame: Change in BCT from Baseline to 10-month post-activation
measure: Change in Bone Conduction Threshold (BCT) at 2000 Hz
timeFrame: Change in BCT from Baseline to 10-month post-activation
measure: Change in Bone Conduction Threshold (BCT) at 4000 Hz
timeFrame: Change in BCT from Baseline to 10-month post-activation
Secondary outcomes:
measure: Change in Subjective Quality of Life as Measured With the Abbreviated Profile of Hearing Aid Benefit, or APHAB (Global Score)
timeFrame: Change from Baseline Aided to 10-month post-activation with Esteem
measure: Esteem Questionnaire Results
timeFrame: 10-month post-activation with Esteem
Other outcomes:
Locations:
city: Madison
country: United States
facility: North Alabama ENT Associates
state: Alabama
city: Los Altos
country: United States
facility: Pacific Hearing Service
state: California
city: Jupiter
country: United States
facility: Ear, Nose, & Throat Associates of South Florida
state: Florida
city: Atlanta
country: United States
facility: Ear Consultants of Georgia
state: Georgia
city: Woodridge
country: United States
facility: Loyola Center for Hearing
state: Illinois
city: Norman
country: United States
facility: Oklahoma Otolaryngology Associates
state: Oklahoma
Study officials:
affiliation: Loyola Center for Hearing, Woodridge IL
name: Sam Marzo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jupiter Medical Center, Jupiter FL
name: John Li, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pacific Hearing Service, Los Altos CA
name: Deborah Clark, AuD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oklahoma Otolaryngology Associates
name: Wayne Berryhill, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ear Consultants of Georgia
name: Sanjay Bhansali, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Arizona Ear Institute
name: Abraham Jacob, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lahey Hospital & Medical Center
name: Elizabeth Toh, MD
role: PRINCIPAL_INVESTIGATOR
References: