N/A
Completed N=117
Esteem New Subject Enrollment Post Approval Study
Source: ClinicalTrials.gov NCT02689349 ↗Enrolled (actual)
117
Serious AEs
7.7%
Results posted
Jun 2022
Primary outcomePrimary: Change in Speech Reception Threshold (SRT) — 5.3 dB
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Speech Reception Threshold (SRT) |
5.3 | — |
| PRIMARY Change in Word Recognition Score (WRS) |
5.5 | — |
| PRIMARY Incidence of SADEs, Device Failures, & Replacements |
3; 0 | — |
| PRIMARY Incidence of Facial Pareses/Paralysis |
3; 0 | — |
| PRIMARY Change in Bone Conduction Threshold (BCT) at 500 Hz |
1.4 | — |
| PRIMARY Change in Bone Conduction Threshold (BCT) at 1000 Hz |
1.8 | — |
| PRIMARY Change in Bone Conduction Threshold (BCT) at 2000 Hz |
2.3 | — |
| PRIMARY Change in Bone Conduction Threshold (BCT) at 4000 Hz |
-3.4 | — |
| SECONDARY Change in Subjective Quality of Life as Measured With the Abbreviated Profile of Hearing Aid Benefit, or APHAB (Global Score) |
5.8 | — |
| SECONDARY Esteem Questionnaire Results |
37; 33; 36; 36; 38; 41 | — |
Eligibility Criteria
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
- 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.
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
- 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
Data sourced from ClinicalTrials.gov (NCT02689349). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.