Trial Outcomes & Findings for Iowa Cochlear Implant Clinical Research Center Hybrid L24 and Standard Cochlear Implants in Profoundly Deaf Infants (NCT NCT03156465)

Last Updated: 2025-01-08

Results Overview

Parent questionnaire that consists of ten questions regarding a young infant or toddler's auditory behavior, e.g. "Does the child spontaneously respond to his/her name in quiet with auditory cues?" Each question is scored on a five point scale: 0=never, 1=rarely, 2=occasionally, 3=frequently, and 4=always. The aim of this tool is to assess the benefit of the child's personal amplification device(s). This questionnaire is generally used during the cochlear implant work-up to assess hearing aid benefit. It is also used post-cochlear implantation to chart the progress the child is making with his/her cochlear implant when other formalized speech perception tests are not appropriate.

Recruitment status

COMPLETED

Study phase

Target enrollment

11 participants

Primary outcome timeframe

Preoperative through 24 months

Results posted on

2025-01-08

Participant Flow

Participant milestones

Participant milestones
Measure	Hybrid L24 and Standard CI Fifteen infants will receive one Nucleus L24 array and a FDA approved standard-length array on contralateral ears. Hybrid L24: Fifteen infants will receive one Nucleus L24 array and a FDA approved standard-length array on contralateral ears.
Overall Study STARTED	11
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Hybrid L24 and Standard CI Fifteen infants will receive one Nucleus L24 array and a FDA approved standard-length array on contralateral ears. Hybrid L24: Fifteen infants will receive one Nucleus L24 array and a FDA approved standard-length array on contralateral ears.
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Iowa Cochlear Implant Clinical Research Center Hybrid L24 and Standard Cochlear Implants in Profoundly Deaf Infants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hybrid L24 and Standard CI n=11 Participants Fifteen infants will receive one Nucleus L24 array and a FDA approved standard-length array on contralateral ears. Hybrid L24: Fifteen infants will receive one Nucleus L24 array and a FDA approved standard-length array on contralateral ears.
Age, Categorical <=18 years	11 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	7 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Preoperative through 24 months

Population: some children did not complete the visit

Outcome measures

Outcome measures
Measure	Hybrid L24 and Standard CI n=9 Participants Fifteen infants will receive one Nucleus L24 array and a FDA approved standard-length array on contralateral ears. Hybrid L24: Fifteen infants will receive one Nucleus L24 array and a FDA approved standard-length array on contralateral ears.
The Infant-Toddler Meaningful Auditory Integration Scale (IT-MAIS) Preoperative	0 percentage out of 40 Standard Error 0
The Infant-Toddler Meaningful Auditory Integration Scale (IT-MAIS) 3 months postoperative	53 percentage out of 40 Standard Error .07
The Infant-Toddler Meaningful Auditory Integration Scale (IT-MAIS) 6 months postoperative	64 percentage out of 40 Standard Error .07
The Infant-Toddler Meaningful Auditory Integration Scale (IT-MAIS) 12 months postoperative	75 percentage out of 40 Standard Error .03
The Infant-Toddler Meaningful Auditory Integration Scale (IT-MAIS) 24 months postoperative	83 percentage out of 40 Standard Error .05

PRIMARY outcome

Timeframe: 48 months

Population: one child did not complete this test. Average age that the children reached a ceiling effect occurred at 30 months (SE: 3.19)

Speech perception test that requires the identification of a spondee or monosyllable from a set of four spondees (i.e., French fry, airplane, hotdog, popcorn) or monosyllables (i.e., ball, book, bird, boat), respectively presented in quiet. The CID test will be scored as total number of words correct. It will be administered in both the unilateral and bilateral listening conditions at 70 dB C. This test is given post-operatively until the child scores a ceiling effect which is considered 90% or better in all test conditions.

Outcome measures

Outcome measures
Measure	Hybrid L24 and Standard CI n=8 Participants Fifteen infants will receive one Nucleus L24 array and a FDA approved standard-length array on contralateral ears. Hybrid L24: Fifteen infants will receive one Nucleus L24 array and a FDA approved standard-length array on contralateral ears.
The Early Speech Perception Four Choice Spondee and Monosyllable Left Ear	98 percentage of words correct Standard Error .73
The Early Speech Perception Four Choice Spondee and Monosyllable Right Ear	98 percentage of words correct Standard Error 1.71
The Early Speech Perception Four Choice Spondee and Monosyllable Bilateral	97 percentage of words correct Standard Error 2.11

PRIMARY outcome

Timeframe: 60 months

Population: one child withdrew before testing was completed. Average age of testing was 61 mos. (SE: 2.65)

The PB-K test has multiple 50-word lists. The test will be scored as total number of words correct as well as phonemically. It will be administered in both the unilateral and bilateral listening conditions at 70 dB C. Test is administered age-appropriately through study completion.

Outcome measures

Outcome measures
Measure	Hybrid L24 and Standard CI n=8 Participants Fifteen infants will receive one Nucleus L24 array and a FDA approved standard-length array on contralateral ears. Hybrid L24: Fifteen infants will receive one Nucleus L24 array and a FDA approved standard-length array on contralateral ears.
Phonetically Balanced-Kindergarten Right Ear	80 percentage of words correct Standard Error 3.5
Phonetically Balanced-Kindergarten Left Ear	78 percentage of words correct Standard Error 4.5
Phonetically Balanced-Kindergarten Bilateral	81 percentage of words correct Standard Error 5.6

Adverse Events

Hybrid L24 and Standard CI

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Camille Dunn

University of Iowa

Phone: 319-353-8776

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place