Esteem New Subject Enrollment Post Approval Study (NCT02689349) | Clinical Trial Compass
CompletedNot Applicable
Esteem New Subject Enrollment Post Approval Study
United States117 participantsStarted 2010-08
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
Exclusion criteria
✕. 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
What they're measuring
1
Change in Speech Reception Threshold (SRT)
Timeframe: Change in SRT from Baseline Aided to 10-month post-activation with Esteem
2
Change in Word Recognition Score (WRS)
Timeframe: Change in WRS from Baseline Aided to 10-month post-activation with Esteem
3
Incidence of SADEs, Device Failures, & Replacements
Timeframe: Incidence at 10-month post-activation
4
Incidence of Facial Pareses/Paralysis
Timeframe: Incidence at one month post-op
5
Change in Bone Conduction Threshold (BCT) at 500 Hz
Timeframe: Change in BCT from Baseline to 10-month post-activation
6
Change in Bone Conduction Threshold (BCT) at 1000 Hz
Timeframe: Change in BCT from Baseline to 10-month post-activation
7
Change in Bone Conduction Threshold (BCT) at 2000 Hz
Timeframe: Change in BCT from Baseline to 10-month post-activation
8
Change in Bone Conduction Threshold (BCT) at 4000 Hz