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

Launched by AMERICAN COCHLEAR IMPLANT ALLIANCE · Feb 28, 2014

Keywords

ClinConnect Summary

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 C...

Gender

ALL

Eligibility criteria

• 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.