Implants, CochlearNCT03156465
Iowa Cochlear Implant Clinical Research Center Hybrid L24 and Standard Cochlear Implants in Profoundly Deaf Infants
A study testing Hybrid L24 in people with Implants, Cochlear and Child, run by University of Iowa at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 24 months
- Conditions the study is for
- Implants, Cochlear, Child, Hearing Loss, Bilateral
- What is being tested?
- Hybrid L24
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Sep 2011to 3 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Iowa
Iowa City, Iowa, 52241
University of Iowa
Iowa City, Iowa, 52242
About this study
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.
Read the 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.
- Conditions
- Implants, Cochlear, Child, Hearing Loss, Bilateral
- Being tested
- Hybrid L24
- Medical subject headings
- Hearing Loss, Bilateral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid L24Device
Fifteen infants will receive one Nucleus L24 array and a FDA approved standard-length array on contralateral ears.
| Study group | Role | What they receive |
|---|---|---|
| Hybrid L24 and Standard CI | Experimental | Fifteen infants will receive one Nucleus L24 array and a FDA approved standard-length array on contralateral ears. Receives: Device: Hybrid L24 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start15 Sep 2011
- Primary completion3 Nov 2022
- Study completion3 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Implants, CochlearStudies of the same condition, open and under way.
- More trials run by University of IowaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- repeated-measure, single-subject experiment
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruce J Gantz, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03156465
- Sponsor's protocol ID
- 201109746
- Status last verified
- Jan 2025
- First submitted
- 14 Apr 2017
- Last updated
- 8 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iowa Cochlear Implant Clinical Research Center Hybrid L24 and Standard Cochlear Implants in Profoundly Deaf Infants
- ClinicalTrials.gov ID
- NCT03156465
- Acronym / sponsor ID
- 201109746
- Conditions
- Implants, Cochlear, Child, Hearing Loss, Bilateral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- 15 Sep 2011 (actual)
- Primary completion
- 3 Nov 2022 (actual)
- Study completion
- 3 Nov 2022 (actual)
- First posted
- 17 May 2017 (actual)
- Results
- Posted 8 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- repeated-measure, single-subject experiment
| Arm | Type | Receives |
|---|---|---|
| Hybrid L24 and Standard CI | Experimental | Device: Hybrid L24Fifteen infants will receive one Nucleus L24 array and a FDA approved standard-length array on contralateral ears. |
Who may qualify
- Ages
- 12 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hybrid L24Fifteen infants will receive one Nucleus L24 array and a FDA approved standard-length array on contralateral ears. | Device | Hybrid L24 and Standard CI |
Primary outcome
The Infant-Toddler Meaningful Auditory Integration Scale (IT-MAIS)
Time frame: Preoperative through 24 months
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.
The Early Speech Perception Four Choice Spondee and Monosyllable
Time frame: 48 months
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.
Phonetically Balanced-Kindergarten
Time frame: 60 months
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce J Gantz, MD principal investigator
University of Iowa
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid L24 in people with Implants, Cochlear and Child, run by University of Iowa at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Infant-Toddler Meaningful Auditory Integration Scale (IT-MAIS) (time frame: Preoperative through 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2025.