Iowa/Nucleus 10/10 mm and Nucleus Freedom Cochlear Implants Implanted Bilaterally in Children Ages 12-24 Months
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Pre-school Language Test
Study Overview
Brief Summary
The purpose of this study is to evaluate whether the Iowa/Nucleus 10/10 mm in one ear, in conjunction with a Nucleus Freedom implant in the other ear can provide useful binaural hearing in pediatric subjects who have bilateral severe to profound hearing loss and meet the criteria for cochlear implantation. The Iowa/Nucleus 10/10 mm cochlear implant has a short, 10 mm electrode array that it is inserted only into the more basal region of the cochlea. Unlike a conventional cochlear implant, the Iowa/Nucleus 10/10 mm 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. The Iowa/Nucleus 10/10 mm will be implanted in the contralateral ear from the Nucleus Freedom electrode array as a means of providing bilateral stimulation of auditory pathways while preserving the middle and apical regions of the scala media.
Detailed Description
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 population s. 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 severe-to-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.
Participants will receive one standard Nucleus Freedom electrode array and an Iowa/Nucleus 10/ 10 mm electrode array on the contralateral side. Half will be implanted with the 10 mm electrode array on their right side and half will be implanted with the 10 mm electrode array on their left side. We will alternate every other subject between the right and left ears. Postoperatively, Iowa/Nucleus 10110 mm electrode alone, standard Freedom electrode alone, and bilateral listening (i.e., Iowa/Nucleus 10/ 10 mm and standard electrodes together) 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 different cochlear implant devices while possibly preserving the scala media, organ of Corti, and supporting cells for future advances in the ear receiving the Iowa/Nucleus 10/ 10 mm electrode device. In addition, we will attempt to compare these results with age-matched unilaterally implanted children tested on the same speech perception and speech/language measures. In addition, if possible, we will attempt to compare speech perception and speech/language measures on age-matched children with bilateral standard long electrode arrays in both ears. The following defines the various modes referenced throughout the course of this text:
Iowa/Nucleus 10/10 mm Electrode Array: The Iowa/Nucleus 10/ 10 mm electrode array was designed to reduce the incidence of intracochlear injury and developed by the Iowa Cochlear Implant Team and Cochlear Americas. This array was designed to preserve the scala media, organ of Corti and supporting cells of the implanted ear for future advances in molecular and/or genetic treatments of the inner ear. This investigational device is very
similar to the Nucleus Hybrid-6 (formerly known as CI24RE Hybrid), the subject ofIDE No. 0990155. See ATTACHMENT 1 for a letter from the Sponsor ofIDE No. 0990155 authorizing the FDA to review the information in IDE No. 0990155 for purposes of the current IDE application. Like the Hybrid-6, the Iowa/Nucleus 10/ 10 mm cochlear implant is 0.2 mm x 0.4 mm in diameter and has a short, 10 mm electrode array that it is inserted only into the more basal region of the cochlea. In comparison to the Hybrid-6, the Iowa/Nucleus 10/ 10 mm cochlear implant has a total of 10 contacts, or 4 more than the 6 contacts/channels present on the Hybrid-6. The contacts are spaced closer together and occupy approximately 6 mm of the apical segment of the 10 mm array.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 12 Months to 24 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Twelve to twenty-four months of age at the time of implantation.
- •Audiometric thresholds for frequencies 250 to 8000 Hz in the severe-to-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.
- •Multiple visits may be necessary preoperatively and/or postoperatively for data collection due to age and attention.
- •Minimum of three month hearing aid trial.
- •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.
- •Must be in a habilitation/educational program with an emphasis on spoken language development.
Exclusion Criteria
- •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.
Arms & Interventions
A
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.
Intervention: Iowa/Nucleus 10/10 mm and Freedom Cochlear Implantation (Device)
Outcomes
Primary Outcomes
Pre-school Language Test
Time Frame: 48 months
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.
Secondary Outcomes
- Phonemically Balanced-Kindergarten Test (PB-K)-Bilateral(56 months)
Investigators
Bruce J Gantz
Department Head --Department of Otolaryngology
University of Iowa