Esteem Totally Implantable Hearing System New Subject Enrollment Post Approval Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 117
- 试验地点
- 12
- 主要终点
- Change in Bone Conduction Threshold (BCT) at 1000 Hz
研究概览
简要总结
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.
详细描述
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%?
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Change in Bone Conduction Threshold (BCT) at 1000 Hz
时间窗: Change in BCT from Baseline to 10-month post-activation
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 Word Recognition Score (WRS)
时间窗: Change in WRS from Baseline Aided to 10-month post-activation with Esteem
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%.
Incidence of Facial Pareses/Paralysis
时间窗: Incidence at one month post-op
The analysis of the incidence of facial pareses/paralysis at one month follow-up
Change in Bone Conduction Threshold (BCT) at 2000 Hz
时间窗: Change in BCT from Baseline to 10-month post-activation
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.
Incidence of SADEs, Device Failures, & Replacements
时间窗: Incidence at 10-month post-activation
The analysis of the incidence of Serious Adverse Device Effects (SADEs) and device failures and replacements
Change in Bone Conduction Threshold (BCT) at 4000 Hz
时间窗: Change in BCT from Baseline to 10-month post-activation
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 Speech Reception Threshold (SRT)
时间窗: Change in SRT from Baseline Aided to 10-month post-activation with Esteem
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 Bone Conduction Threshold (BCT) at 500 Hz
时间窗: Change in BCT from Baseline to 10-month post-activation
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.
次要结局
- 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)