Iowa/Nucleus 10/10 mm and Nucleus Freedom Feasibility Study

NCT00594061 | Completed Results DMC

• 1 other identifier: 200710716
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing Loss, Sensorineural; Hearing Loss, Bilateral

Outcome Measures

Primary Outcomes (1)

• Pre-school Language Test

  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.

  48 months

Secondary Outcomes (1)

• Phonemically Balanced-Kindergarten Test (PB-K)-Bilateral

  56 months

Study Arms (1)

A

EXPERIMENTAL

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.

Device: Iowa/Nucleus 10/10 mm and Freedom Cochlear Implantation

Interventions

Iowa/Nucleus 10/10 mm and Freedom Cochlear Implantation DEVICE

Participants will receive one standard Nucleus Freedom electrode array and an Iowa/Nucleus 10/10 mm electrode array on the contralateral side.

A

Eligibility Criteria

• Age: 12 Months - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• 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 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.

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

• Bruce J Gantz: lead

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural; 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: Bruce Gantz
• Organization: University of Iowa

bruce-gantz@uiowa.edu

319-353-8776

Study Officials

• Bruce J Gantz, MD

  University of Iowa Department of Otolaryngology Pediatric Cochlear Implant Program

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department Head --Department of Otolaryngology

Study Record Dates

• First Submitted: January 3, 2008
• First Posted: January 15, 2008
• Study Start: December 1, 2007
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: May 23, 2018
• Results First Posted: May 23, 2018

Record last verified: 2018-05

Locations

US (1)