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

The purpose of this feasibility study is to evaluate whether implantation of one Nucleus L24 electrode array and one FDA approved standard-length device in the contralateral ear can provide useful binaural hearing in pediatric subjects who have bilateral severe to profound hearing loss, meeting the criteria for cochlear implantation. Unlike a conventional cochlear implant, the Nucleus L24 is expected to preserve the regions of the cochlear partition that are apical to the electrode, thus leaving them available for possible future advances in the field of otolaryngology and hearing devices, such as mammalian hair cell regeneration techniques or improved implantable hearing devices. Whether or not this group of children will be able to take advantage of future hair cell regeneration strategies is yet to be determined and will have to wait for future development. At this time there are no accurate imaging strategies available to identify preservation of the scala media. Ultra thin micro CT scanning is in development, however the level of radiation delivery to the subject is too great to be considered for clinical use. When imaging strategies become available to determine cellular structure of the inner ear, they will be applied to this group of subjects. The Nucleus L24 array stimulates the basal turn of the cochlea, in an attempt to preserve the middle and apical regions of the scala media.

Study Overview

• Status: Completed
• Conditions: Child; Hearing Loss, Bilateral; Implants, Cochlear
• Intervention / Treatment: Device: Hybrid L24

Detailed Description

The purpose of this feasibility study is to evaluate whether a Nucleus L24 and a FDA approved standard-length device in the contralateral ear can provide useful binaural hearing in pediatric subjects who have bilateral profound hearing loss, meeting the criteria for cochlear implantation. Unlike a conventional cochlear implant, the Nucleus L24 is designed to preserve the regions of the cochlear partition that are apical to the electrode, thus leaving them available for possible future advances in the field of otolaryngology and hearing devices, such as mammalian hair cell regeneration techniques or improved implantable hearing devices. The Nucleus L24 (16 mm) array stimulates the basal turn of the cochlea, in an attempt to preserve the middle and apical regions of the scala media.

The study will be conducted as a repeated-measure, single-subject experiment. A single-subject research design (in which each participant serves as his or her own control) is appropriate because it accommodates the heterogeneity that characterizes hearing-impaired populations. 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.

Preoperatively, candidates will be assessed with their current amplification to evaluate their appropriateness for entrance into the study. The candidates' audiometric configuration must meet the above inclusion criteria. That is, the candidate must have a profound sensorineural hearing loss from 250 to 8000 Hz. Prior to testing, the appropriateness of the hearing aid fitting will be assessed and adjustments made if necessary. In cases where amplification has not been used for more than one year, new hearing aids will be fit, worn for a minimum three-month trial and the participants re-evaluated to confirm continuance with the study.

Fifteen infants will receive one Nucleus L24 array and a FDA approved standard-length array on contralateral ears. The investigator will alternate every other subject between the right and left ears as to which ear gets the Nucleus L24. Postoperatively, the right ear only, left ear only, and the bilateral listening modes will be compared with repeated testing through five years of age of the child. These comparisons will help to evaluate the effects of bilateral stimulation using a shorter electrode cochlear implant to possibly preserve the scala media, organ of Corti, and supporting cells for future medical interventions and a standard length implant on the contralateral ear. In addition, the investigator will attempt to compare speech perception and speech/language measure results with age-matched children implanted with standard-length bilateral devices.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa
    • Iowa City, Iowa, United States, 52241
      • University of Iowa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 8 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Twelve to twenty-four months of age at the time of implantation.
2. Audiometric thresholds for frequencies 250 to 8000 Hz in the profound hearing range bilaterally. The type of hearing loss must be categorized as sensorineural in nature.
3. English spoken as a primary language (mono-lingual English speaking family, where English is the primary language).
4. Willingness to comply with all study requirements.
5. Minimum of three-month hearing aid trial with appropriately fit hearing aids.
6. Patent cochlea and normal cochlear anatomy as shown by a CT scan. It is standard clinical practice to perform a CT scan on any patient pursuing cochlear implantation.

Exclusion Criteria:

1. Medical or psychological conditions that contraindicate undergoing surgery.
2. Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array.
3. Developmental disabilities or other conditions that would prevent or restrict participation in the audiological evaluations and clinical trial.
4. Hearing loss of neural or central origin.
5. Unrealistic expectations on the part of the candidate and/or candidate's family, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices.
6. Unwillingness or inability of the candidate to comply with all investigational requirements.
7. Active middle ear infection.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hybrid L24 and Standard CI; Fifteen infants will receive one Nucleus L24 array and a FDA approved standard-length array on contralateral ears.	Device: Hybrid L24; Fifteen infants will receive one Nucleus L24 array and a FDA approved standard-length array on contralateral ears.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Infant-Toddler Meaningful Auditory Integration Scale (IT-MAIS)	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.	PreOperative
The Infant-Toddler Meaningful Auditory Integration Scale (IT-MAIS)	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.	Post-operative through 2 years
The Glendonald Auditory Screening Procedure Word Test (GASP)	Speech perception test that contains 12 single-syllable and multisyllable words. The child will be tested in the bilateral listening condition. This test is always administered in a live-voice mode. The child is asked to repeat the word presented by the clinician. The child is encouraged to use sign if his or her verbal approximations are not clear to the clinician. This test is the easiest open-set measure in this battery because it includes common vocabulary and the speaker is familiar. It can be administered to children as young as two years of age.	Post-operatively through study completion (child is 5 years of age) or until the child scores 90% or better in all test conditions
The Early Speech Perception Four Choice Spondee and Monosyllable	Speech perception tests 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.	Post-operatively through study completion (child is 5 years of age) or until the child scores 90% or better in all test conditions
The Multisyllabic Lexical Neighborhood Test	Open-set word recognition tests. The experimenter gives a list of 24 words and the participants are expected to repeat the word after each presentation. The MLNT consists of two parallel lists. The LNT and MLNT are based on the lexical characteristics of word frequency and neighborhood density, and include words found in the vocabularies of children age three to five. The child will be tested in the bilateral listening condition at 70 dB C.	Post-operatively through study completion at which time the child is 5 years of age.
Phonetically Balanced-Kindergarten	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	Post-operatively through study completion at which time the child is 5 years of age.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Preschool Language Scale-3 (PLS-3)	A standardized language test that is used to measure the language development of children with normal hearing aged 0 months to 83 months. The test evaluates "Expressive Communication" and "Auditory Comprehension" and is designed to evaluate skills in a variety of areas: vocal development, social communication, attention, semantics (content), structure (form), and integrative thinking skills.	Pre-Operative
The Preschool Language Scale-3 (PLS-3)	A standardized language test that is used to measure the language development of children with normal hearing aged 0 months to 83 months. The test evaluates "Expressive Communication" and "Auditory Comprehension" and is designed to evaluate skills in a variety of areas: vocal development, social communication, attention, semantics (content), structure (form), and integrative thinking skills.	Post-operatively through study completion at which time the child is 5 years of age.
Peabody Picture Vocabulary Development Scale (PPVT).	The PPVT (Dunn & Dunn, 1997) is a standardized, norm-referenced measure of receptive vocabulary skills. The test is a multiple-choice measure consisting of sets of four black and white line drawings. The examiner names one of the pictures and the test recipient is expected to indicate which picture has been labeled, either verbally or through pointing.	Post-operatively through study completion at which time the child is 5 years of age.
Goldman-Fristoe Test of Articulation-2	The GFTA-2 is a standardized, norm-based articulation measure that samples spontaneous sound production. Children are asked to respond to picture plates and verbal cues from the examiner with single words that test consonant accuracy in initial, medial, and final positions. This measure has norms based on the performance of normal-hearing children from age 2 years to 21 years.	Post-operatively through study completion at which time the child is 5 years of age.

Collaborators and Investigators

• Sponsor: Bruce J Gantz
• Investigators: Principal Investigator: Bruce J Gantz, MD, University of Iowa

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2011
• Primary Completion (Actual): November 3, 2022
• Study Completion (Actual): November 3, 2022

Study Registration Dates

• First Submitted: April 14, 2017
• First Submitted That Met QC Criteria: May 15, 2017
• First Posted (Actual): May 17, 2017

Study Record Updates

• Last Update Posted (Actual): November 4, 2022
• Last Update Submitted That Met QC Criteria: November 3, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Hearing Loss, Bilateral
• Other Study ID Numbers: 201109746

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes