Esteem Totally Implantable Hearing System Clinical Trial U.S. Pivotal Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 10
- 主要终点
- Word Recognition Score Change
研究概览
简要总结
To evaluate the safety and efficacy of the Esteem Totally Implantable Hearing System in subjects suffering from mild to severe hearing loss.
详细描述
Title: Esteem® Totally Implantable Hearing System Clinical Trial
Purpose: To evaluate the safety and efficacy of the Esteem® Totally Implantable Hearing System (hereafter called the Esteem® System) in subjects suffering from mild to severe hearing loss.
Trial Design: This pivotal trial is designed as a prospective, multi-center, non-randomized, clinical trial to evaluate the safety and efficacy of the Esteem® System. For this trial the subject will act as his or her own control.
This trial has been designed to meet the United States' regulatory requirements.
Enrollment Size: It is currently estimated that 50-60 subjects will be enrolled in this trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- 否
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 mild to severe sensorineural hearing loss between 500 and 4000 Hz in the ear to be implanted with pure tone air-conduction threshold levels within the limits of a Hearing Aid (HA) as follow:
- •Freq (Hz) 500 1000 2000 3000 4000 LL* (dB HL) 30 35 35 35 35 UL* (dB HL) 100 100 100 100 100
- •*LL = Lower Level; UL = Upper Level
- •Subject's air-bone gap is no greater than 10 dB at 4 of the 5 following frequencies: 500, 1000, 2000, 3000 and 4000 Hz.
- •Subject has an unaided maximum word recognition score of greater than or equal to 60% with recorded delivery using a phonetically balanced word list at SRT + 40 dB or at maximum tolerable presentation level.
- •Subject is a current user of a properly functioning and appropriately fit hearing aid. This is defined as the subject has used this aid for at least four (4) hours (average) per day (in the ear to be implanted) for at least three (3) months for a new aid or one (1) month for an adjusted aid.
- •Subject's hearing aid, in the ear to be implanted, shall appropriately fit optimally.
- •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.
- •Subject is a hearing aid user in the ear to be implanted.
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
Word Recognition Score Change
时间窗: 10 Months Post Activation
Comparison of the word recognition score using the Esteem compared to the pre-implant aided condition
SADEs
时间窗: 10 Months Post-Activation
The incidence of Serious Adverse Device Effects (SADE) and the incidence rate of device failures and replacements
Assessment of Cochlear Function at 4-months and 10-months Post-activation, as Evidenced by Bone-conduction (BC) Thresholds.
时间窗: Baseline, 4-, and 10-Months Post-Activation
Comparison of bone conduction thresholds at the 4-month and 10-month post-activation follow-up, relative to the pre-implant baseline bone conduction thresholds. Lower thresholds represent better (more sensitive) outcomes.
SRT Change
时间窗: 10 Months Post-Activation
Comparison of the speech reception threshold (SRT) using the Esteem System as compared to the pre-implant aided condition
次要结局
- Comparisons of Change in Global Score on Abbreviated Profile of Hearing Aid Benefit (APHAB) at 4 Months and at 10 Months Post-activation, Relative to Pre-implant Baseline Score(4 and 10 Months Post-Activation)
- Scores on Esteem Questionnaire(4 and 10 Months Post Activation)
- Change in Pure Tone Average (PTA) at 4 Months, Relative to Baseline Pre-implant(4 Months Post Activation)
- Difference in QuickSIN (Quick Speech-In-Noise Test) Score at 4 Months Relative to Baseline Aided Condition(4 Months Post Activation)