Single-Sided Deafness in the Medicare Population

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and effectiveness of cochlear implantation in adults 65 years of age and older.

Detailed Description
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The study will be conducted as a single-subject, repeated measures, multi center study at 3 sites. Fifteen subjects will be enrolled in this study. Three centers in the United States and Canada will recruit subjects into this study. Study subjects will be followed for 12 months post-implantation of the device.

Official Title
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Cochlear Implantation in the Single-Sided Deafness in the Medicare Population

Conditions
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Hearing Loss, Unilateral

Intervention / Treatment
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* Device: MED-EL Cochlear Implant System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 65 years of age or older at the time of implantation Unilateral profound hearing loss, as defined by a pure-tone average (500, 1000, 2000, and 4000 Hz) of 90 dB or greater in the ear to be implanted Sensorineural hearing loss in the ear to be implanted, as defined by an air-bone gap less than or equal to 10 dB at two or more frequencies out of 500, 1000, 2000, and 4000 Hz Normal or near-normal hearing in the non-implanted ear, as defined by a pure-tone average (500, 1000, 2000, and 4000 Hz) of 30 dB or less Word recognition in the ear to be implanted of 5% or less on CNC word score in quiet Previous experience with an appropriately-fit CROS, BI-CROS, bone conduction, or traditional hearing aid, as deemed appropriate by investigator Fluent in English Exclusion Criteria: Duration of profound hearing loss of 10 years or more Sudden onset of hearing loss within six months of implantation Evidence of non-functional cochlear nerve or other retrocochlear hearing loss Evidence of severe cochlear malformation (i.e., common cavity or ossification) External or middle ear infection Suspected cognitive concern Other medical contraindication for surgery or anesthesia

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Study Procedure<br> | Device: MED-EL Cochlear Implant System<br>* Cochlear implant and audio processor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance of the Cochlear Implant System will be assessed through speech perception testing in noise completed through one year (12 months) post implantation. | The primary effectiveness endpoint will be change on speech in noise when speech is presented to the front and noise is presented to the acoustic hearing (contralateral) ear. The pre-operative, best aided score will be compared to the 6-month and 12-month CI score for AzBio sentences in noise (range of score 0-100, higher score is better). Improvement is defined as greater than or equal to 10 percentage points. | One year (12 months) post implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance of the Cochlear Implant System will be summarized through speech perception testing in noise completed through one year (12 months) post implantation. | Speech in noise in two spatial conditions will demonstrate similar performance from the pre-operative, best-aided score to the CI score at 6- and 12-months post activation. AzBio sentence in noise score will be summarized for two conditions: speech and noise presented from the front as well as speech presented to the front and noise presented to the CI ear. (Range of score 0-100, higher score is better) | One year (12 months) post implantation | 
| Performance of the Cochlear Implant System will be assessed through speech perception testing in quiet completed through one year (12 months ) post implantation. | Speech perception in quiet will be summarized for the CI ear as well as the contralateral ear at the pre-operative, 6-month, and 12-month intervals. The CI ear is expected to demonstrate improvement (greater than or equal to 10 percentage point change), while the contralateral ear is expected to demonstrate no change. (Range of score 0-100, higher score is better) | One year (12 months) post implantation | 
| Subjective benefit of the Cochlear Implant System will be assessed through one year (12 months) post implantation. | Subjective data will be collected via the Speech, Spatial, and Qualities of Hearing Scale (SSQ). Responses will be summarized from the pre-operative, 6-month, and 12-month intervals. (Range of score 0-10, lower score is better) | One year (12 months) post implantation | 
| Safety will be evaluated for all study subjects through one year (12 months) post implantation. | Safety will be assessed by collecting and reporting device-related adverse events occurring throughout the study. This will be summarized and reported as the number and proportion of subjects experiencing an adverse device event. | One year (12 months) post implantation |