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| Name | Class |
|---|---|
| Med-El Corporation | INDUSTRY |
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The purpose of the study is to evaluate cochlear implant speech outcomes and subjective benefit for cochlear implant recipients with single-sided deafness using patient-specific, anatomy-based array selection versus standard of care with a fixed array size for all patients. Subjects will prospectively be assigned to receive an Anatomy-Based Electrode (FLEX26, FLEX28, or FLEXSOFT) or the Standard of Care Electrode array (FLEX28). Speech performance and subjective benefit will be evaluated between these two groups.
To determine the effectiveness of Anatomy-Based Electrode selection versus Standard of Care Electrode selection in SSD listeners a prospective, single-blinded study design will be used to evaluate the outcomes in these two groups by evaluating speech understanding in quiet, speech understanding in noise, subjective listening difficulty and sound quality, and datalogging.
Subjects will be randomly assigned to either group to receive an electrode based on their anatomy (ABE) or the Standard of Care electrode (SOCE). Five participants will be in each group, for a total of 10 participants.
All subjects will receive a MED-EL Cochlear Implant and will subsequently be fit with an audio processor approved by Health Canada. Post-operative evaluations will occur at one and six months post-activation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anatomy-Based Electrode Selection | Experimental | For individuals in the anatomy-based electrode (ABE) group, magnetic resolution imaging (MRI) or computed tomography (CT) scans will be evaluated by MED-EL Canada employees. Based on these results, an appropriate electrode array will be selected. |
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| Standard of Care Electrode Selection | Active Comparator | The comparison in this study will be to current standard of care, which is to select a single electrode length for most patients, in this case the FLEX28 electrode, which is 28 mm long. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anatomy-Based Electrode Array Selection | Other | Use of pre-operative imaging to select the appropriate length electrode vs standard of care |
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| Measure | Description | Time Frame |
|---|---|---|
| Speech perception in spatially separated noise | Change in percent correct on the AzBio sentences in noise, with speech presented to the front and noise to the better hearing ear | 6 months post activation |
| Measure | Description | Time Frame |
|---|---|---|
| Speech perception in noise | Change in percent correct on the AzBio sentences in noise, in two conditions. Condition 1 is with speech and noise both presented to the front. Condition 2 is with speech presented from the front and noise presented to the CI ear | 6 months post activation |
| Speech perception in quiet |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David P Morris, MD | Contact | 902-473-1986 | dp.morris@dal.ca |
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| Standard of Care Electrode Array Selection | Other | Use of standard of care electrode which is the FLEX 28 electrode |
|
Change in percent correct on the CNC words in quiet in implanted ear. |
| 6 months post activation |
| Speech Spatial and Qualities of Hearing Scale (SSQ) | Subjective questionnaire on speech perception and sound quality | 6 months post activation |
| Datalogging | Evaluate average daily device use | 6 months post activation |