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

NCT03156465 | Completed Results FDA Device

• 1 other identifier: 201109746
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Implants, Cochlear; Child; Hearing Loss, Bilateral

Outcome Measures

Primary Outcomes (3)

• 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 through 24 months

• The Early Speech Perception Four Choice Spondee and Monosyllable

  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.

  48 months

• 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. Test is administered age-appropriately through study completion.

  60 months

Study Arms (1)

Hybrid L24 and Standard CI

EXPERIMENTAL

Fifteen infants will receive one Nucleus L24 array and a FDA approved standard-length array on contralateral ears.

Device: Hybrid L24

Interventions

Hybrid L24 DEVICE

Fifteen infants will receive one Nucleus L24 array and a FDA approved standard-length array on contralateral ears.

Hybrid L24 and Standard CI

Eligibility Criteria

• Age: 12 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Twelve to twenty-four months of age at the time of implantation.
• 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.
• English spoken as a primary language (mono-lingual English speaking family, where English is the primary language).
• Willingness to comply with all study requirements.
• Minimum of three-month hearing aid trial with appropriately fit hearing aids.
• 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.

You may not qualify if:

• Medical or psychological conditions that contraindicate undergoing surgery.
• Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array.
• Developmental disabilities or other conditions that would prevent or restrict participation in the audiological evaluations and clinical trial.
• Hearing loss of neural or central origin.
• 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.
• Unwillingness or inability of the candidate to comply with all investigational requirements.
• Active middle ear infection.

Sponsors & Collaborators

• University of Iowa: lead

Study Sites (2)

University of Iowa

Iowa City, Iowa, 52241, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Hearing Loss, Bilateral

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Camille Dunn
• Organization: University of Iowa

camille-dunn@uiowa.edu

319-353-8776

Study Officials

• Bruce J Gantz, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: repeated-measure, single-subject experiment

Study Record Dates

• First Submitted: April 14, 2017
• First Posted: May 17, 2017
• Study Start: September 15, 2011
• Primary Completion: November 3, 2022
• Study Completion: November 3, 2022
• Last Updated: January 8, 2025
• Results First Posted: January 8, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)