NCT02075229

Evaluation of Revised Indicatons (ERID) for Cochlear Implant Candidacy for the Adult CMS Population

Official Title:

A Proposal to Evaluate Revised Indications for Cochlear Implant Candidacy for the Adult CMS Population

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.

Eligibility

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 determine if there are any disabling cognitive limitations that would prevent the patient from providing reliable data for this study.

Disease(s) and\or Condition(s)

Bilateral Sensorineural Hearing Loss

Primary Purpose
Intervention/Treatment
    • Type: DEVICE
    • Name: Cochlear implant
    • Description: A cochlear implant consists of an implantable device that electrically stimulates surviving nerve fibers within the inner ear to produce perceptions of sound in patients with significant sensorineural hearing loss.. The implanted device is controlled by an external sound processor that converts acoustic sound signals into patterns of electrical stimulation that result in sound perception for the user.
    • Arm Group Labels: Group A, Group B
Sponsor
  • American Cochlear Implant Alliance