Trial Outcomes & Findings for Iowa/Nucleus 10/10 mm and Nucleus Freedom Feasibility Study (NCT NCT00594061)

Last Updated: 2018-05-23

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

9 participants

Primary outcome timeframe

48 months

Results posted on

2018-05-23

Participant Flow

Participant milestones

Participant milestones
Measure	Iowa/Nucleus 10/10 mm and Freedom Cochlear Implantation There is no arm to this study--(each participant serves as his 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. 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.
Overall Study STARTED	9
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Iowa/Nucleus 10/10 mm and Nucleus Freedom Feasibility Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Iowa/Nucleus 10/10 mm and Freedom Cochlear Implantation n=9 Participants 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. 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.
Age, Categorical <=18 years	9 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment United States	9 Participants n=5 Participants
Infant-Toddler Meaningful Auditory Integration Scale (IT-MAIS)	2.6 units on a scale STANDARD_DEVIATION 5.5 • n=5 Participants
MacArthur Communicative Developmental Inventories (CDI)	10.4 months STANDARD_DEVIATION 2.19 • n=5 Participants
Minnesota Child Development Inventory	11.3 months STANDARD_DEVIATION 2.6 • n=5 Participants
Preschool Language Scale-3	74.2 units on a scale STANDARD_DEVIATION 8.1 • n=5 Participants

PRIMARY outcome

Timeframe: 48 months

Outcome measures

Outcome measures
Measure	Iowa/Nucleus 10/10 mm and Freedom Cochlear Implantation n=8 Participants There is no arm to this study--(each participant serves as his 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. 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	82.4 units on a scale Standard Deviation 22.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Iowa/Nucleus 10/10 mm and Freedom Cochlear Implantation n=8 Participants There is no arm to this study--(each participant serves as his 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. 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.
Phonemically Balanced-Kindergarten Test (PB-K)-Bilateral bilateral	85.7 percentage of words correct Standard Error 3.31
Phonemically Balanced-Kindergarten Test (PB-K)-Bilateral short electrode	55.6 percentage of words correct Standard Error 7.9
Phonemically Balanced-Kindergarten Test (PB-K)-Bilateral long electrode	85.9 percentage of words correct Standard Error 2.33

Adverse Events

Iowa/Nucleus 10/10 mm and Freedom Cochlear Implantation

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Iowa/Nucleus 10/10 mm and Freedom Cochlear Implantation n=9 participants at risk 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. 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.
Ear and labyrinth disorders Failed device	11.1% 1/9 • Following surgical implantation of the device and longitudinally at 4, 8, 12, 18, and 24 months, and annually thereafter through five years of age.
Ear and labyrinth disorders Failed Device	11.1% 1/9 • Following surgical implantation of the device and longitudinally at 4, 8, 12, 18, and 24 months, and annually thereafter through five years of age.

Other adverse events

Adverse event data not reported

Additional Information

Bruce Gantz

University of Iowa

Phone: 319-353-8776

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place