Safety and Efficacy of Remote Programming of Nucleus Cochlear Implants (TEL)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02644343|
Recruitment Status : Completed
First Posted : December 31, 2015
Last Update Posted : February 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Telemedicine||Device: Custom Sound||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Efficacy of Remote Programming of Nucleus Cochlear Implants|
|Study Start Date :||January 2016|
|Actual Primary Completion Date :||May 17, 2017|
|Actual Study Completion Date :||May 17, 2017|
Experimental: Remote Programming Group
Subjects will undergo remote programming of Nucleus cochlear implants via Custom Sound software using an online interactive meeting platform.
The intervention is the programming of the cochlear implant, the experimental aspect is the remote delivery method.
Device: Custom Sound
Custom Sound is the programming software used to program Nucleus cochlear implants.
- Speech Perception on monosyllabic word test, CNC Words [ Time Frame: 2-4 weeks post remote programming session ]Subjects will listen to and repeat monosyllabic words from the Consonant Nucleus Consonant word test (Peterson & Lehiste, 1962) to examine their speech perception abilities after each remote programming session.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02644343
|United States, Colorado|
|Rocky Mountain Ear Center|
|Englewood, Colorado, United States, 80113|
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48108|
|United States, North Carolina|
|University of North Carolina|
|Chapel Hill, North Carolina, United States, 27713|
|United States, Wisconsin|
|The Medical College of Wisconsin|
|Milwaukee, Wisconsin, United States, 53226|