Iowa/Nucleus 10/10 mm and Nucleus Freedom Feasibility Study
|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: NCT00594061|
Recruitment Status : Completed
First Posted : January 15, 2008
Results First Posted : May 23, 2018
Last Update Posted : May 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hearing Loss, Sensorineural Hearing Loss, Bilateral||Device: Iowa/Nucleus 10/10 mm and Freedom Cochlear Implantation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Iowa/Nucleus 10/10 mm and Nucleus Freedom Cochlear Implants Implanted Bilaterally in Children Ages 12-24 Months|
|Study Start Date :||December 2007|
|Actual Primary Completion Date :||September 2016|
|Actual Study Completion Date :||September 2016|
There is no arm to this study--(each participant serves ashis or her own control). Blinding or masking procedures are not included in the design, as it is not possible to conceal the presence or absence of a cochlear implant from device recipients and/or clinical investigators.
Device: Iowa/Nucleus 10/10 mm and Freedom Cochlear Implantation
Participants will receive one standard Nucleus Freedom electrode array and an Iowa/Nucleus 10/10 mm electrode array on the contralateral side.
- Pre-school Language Test [ Time Frame: 48 months ]Assesses global language skills using toys and pictures. This test assess auditory comprehension and expressive communication and a total language score is calculated. The reported score was assessed at 48 months post-implantation. The total language standard score ranges from 50-150. A higher total score indicates better performance. A raw score for total language is calculated and converted into a standard score.
- Phonemically Balanced-Kindergarten Test (PB-K)-Bilateral [ Time Frame: 56 months ]PB-K Test was constructed to be an open-set test of word understanding for children. It is scored as a percentage of words correct. The test was measured using the Iowa/Nucleus 10/10 mm and Nucleus Freedom together, the Iowa/Nucleus 10/10 mm only, and the Nucleus Freedom electrode only conditions. The higher the score, the better the word understanding. The post-operative time point for this score was reported on average at 56 months post-implantation.
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): NCT00594061
|United States, Iowa|
|University of Iowa Hospitals and Clinics|
|Iowa City, Iowa, United States, 52242|
|Principal Investigator:||Bruce J Gantz, MD||University of Iowa Department of Otolaryngology Pediatric Cochlear Implant Program|