A Proposal to Evaluate Revised Indications for Cochlear Implant Candidacy for the Adult CMS Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 19
- 主要终点
- AzBio sentence score at Baseline/Pre-Surgery, 6 and 12 months
研究概览
简要总结
Purpose: The purpose of this study is 1) to evaluate the safety and efficacy of currently available multichannel cochlear implant systems for newly implanted adults with an indication based on open-set sentence recognition that expand criteria currently used by Center for Medicare & Medicaid Services (CMS), and 2) to assess the correlation between measures of speech recognition in candidates for cochlear implants and their utility in predicting audiologic and quality of life outcomes after implantation.
Participants: Adults (≥ 65 years of age) and CMS-eligible as a primary source of medical insurance coverage.
Procedures (methods): Evaluate objective and subjective outcomes of cochlear implantation in a patient population that does not meet current CMS candidacy criteria.
详细描述
Informed Consent will be obtained prior to enrollment in the study, and will include an interview to discuss study expectations, potential risks and benefits and the study evaluation schedule. The Informed Consent Form may be taken home and reviewed by the candidate and the candidate will be given the opportunity to ask questions about it and/or the study prior to signing the form. The candidate will then be given a copy of the signed Informed Consent Form.
The Informed Consent Forms will include a detailed list of procedures included in the pre-operative evaluation process. The Informed Consent document will be reviewed and signed by the relevant parties prior to any study-related evaluation taking place. Testing completed as part of normal clinical practice, such as the audiogram is acceptable prior to signing the consent form.
Information regarding each participant's hearing history will be collected and may be obtained from the participant directly or from their medical record.
The Preoperative evaluation includes:
- Assessment of the candidate's suitability for the study
- Establishment of baseline data if the candidate proves to be appropriate for study inclusion.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Sixty-five years of age or older at the time of the study and CMS-eligible as primary source of medical insurance coverage.
- •Bilateral moderate to profound hearing loss in the low frequencies (up to 1000 Hz) and profound sensorineural hearing loss in the high frequencies (3000 Hz and above).
- •Preoperative aided sentence score in quiet greater than or equal to 40% correct but less than or equal to 60% correct in the best aided condition on recorded AzBio sentences.
- •English spoken as the primary language.
排除标准
- •Congenital hearing loss (for the purpose of this study, onset pror to 2 years-of-age).
- •Preoperative aided sentence score less than 40% or greater than 60% correct in the best aided condition on AzBio sentences in quiet
- •Ossification, absence of cochlear development or any other cochlear anomaly that might prevent complete insertion of the electrode array.
- •Hearing loss of neural or central origin (e.g., deafness due to lesions on the acoustic nerve or central auditory pathway).
- •Active middle-ear infection.
- •The audiologist and/or surgeon will review the study protocol with the patient prior to having him/her sign the consent form. If the patient indicates he/she is unwilling or unable to comply with all investigational requirements, he/she will not be enrolled in the study.
- •Using best clinical judgment based on professional interaction with the patient and his/her family, the managing audiologist and surgeon will determine if there are any disabling cognitive limitations that would prevent the patient from providing reliable data for this study.
结局指标
主要结局
AzBio sentence score at Baseline/Pre-Surgery, 6 and 12 months
时间窗: up to 12 months post-cochlear implant.
A list of recorded sentences presented to subjects prior to receiving a cochlear implant while they use hearing aids. Subjects repeat each word of the sentence that they can understand and are given a percent correct score based on the percentage of words correctly understood. The test is administered again after receiving a cochlear implant to determine if their ability to recognize words in sentences has improved.
次要结局
- CNC Word Test at Baseline/Pre-Surgery, 6 and 12 months(Prior to receiving a cochlear implant and 6 and 12 months post- cochlear implant.)
- Health Utility Index Mark 3 (HUI3) Questionnaire at Baseline/Pre-Surgery, 6 and 12 months(Prior to receiving a cochlear implant and 6 and 12 months post- cochlear implant.)
- Abbreviated Profile of Hearing Aid Benefit (APHAB)(Prior to receiving a cochlear implant and 6 and 12 months post- cochlear implant.)
- Short Form Health Survey (SF-36) with utility transforms at Baseline/Pre-Surgery, 6 and 12 months(6 and 12 months post- cochlear implant.)
研究者
Teresa A. Zwolan, PhD
Professor and Director, University of Michigan Cochlear Implant Program
American Cochlear Implant Alliance