Evaluation of Revised Indicatons (ERID) for Cochlear Implant Candidacy for the Adult CMS Population (NCT02075229) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Revised Indicatons (ERID) for Cochlear Implant Candidacy for the Adult CMS Population
United States37 participantsStarted 2014-02
Plain-language summary
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.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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 dete…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
AzBio sentence score at Baseline/Pre-Surgery, 6 and 12 months