Clinical Trial: Hybrid Cochlear Implants in Severe to Profound Adults, Children, and Adolescents

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: Iowa Cochlear Implant Clinical Research Center Hybrid Cochlear Implants in Severe to Profound Adults, Children, and Adolescents

Brief Summary: The purpose of this study is to determine if adults and children with residual low-pitch hearing in the severe hearing loss range can develop improved speech perception by combining their residual acoustic hearing with electrical stimulation through a short cochlear implant. The low-pitches would be amplified with a hearing aid and the high-pitch sounds would be stimulated electrically.

Detailed Summary:

The purpose of this study is to determine if individuals with residual low-frequency hearing in the severe range can develop improved speech perception by combining their residual acoustic hearing with electrical processing through a cochlear implant designed to stimulate the high-frequency basal and middle turn of the cochlea while preserving useful low-frequency acoustic hearing. To accomplish this, we propose to implant individuals with severe hearing with a Cochlear® Nucleus™ Hybrid L24 Implant or a Cochlear® Nucleus™ Hybrid S12 in the poorer ear. We believe these devices will do less damage to the Organ of Corti structures, than longer, more invasive standard cochlear implant electrodes.

Two different populations will be studied under this IDE.

Population 1: 15 Adults who have a severe sensorineural hearing loss with a pure-tone average (PTA) between 60-90 decibels (dB) hearing level (HL) between 125-1500 Hz and profound loss at higher frequencies will be implanted with the Cochlear® Nucleus™ Hybrid L24 Implant. The potential subject will present with Consonant-Nucleus-Consonant (CNC) monosyllabic word scores between 0-35% in the ear to be implanted and up to 60% understanding in the contralateral ear in the best-aided condition.

Population 2: 30 Children (ages 5-12 years) and adolescents (ages 13-15 years) who have a sensorineural hearing loss with a pure-tone average (PTA) between 60-90 dB HL between 125-1500 Hz and profound loss at higher frequencies will be implanted with the Cochlear® Nucleus™ Hybrid L24 Implant or the Cochlear® Nucleus™ Hybrid S12 Implant. Those that have hearing thresholds between 60-90 dB HL at 1500 Hz would be implanted with the less invasive shorter 10 mm Hybrid S12 in attempt to better p
Sponsor: Bruce J Gantz

Current Primary Outcome: change in CNC word perception [ Time Frame: pre-op, 3, 6, 12, 24 months in the adults and pre-op, 4, 8, 12, 24, 36, 48, and 60 months post-implantation for children ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Change in Complex-Tone Pitch Discrimination (CTPD) [ Time Frame: pre-op, 3, 6, 12, 24 months in the adults and pre-op, 4, 8, 12, 24, 36, 48, and 60 months post-implantation for children ]
  This test assesses the participants' ability to discriminate direction of pitch change as a function of interval size (fundamental frequency range, 131-1048 Hz). This adaptive test results in a threshold (across all frequencies) at which the participant is able to achieve 75% accuracy. This is a brief test (5-10 minutes) that can be repeatedly administered in multiple conditions accurately. Testing will be attempted using appropriately fit hearing aids in the ear to be implanted at 70 dB (A).
• change in Localization [ Time Frame: Preoperatively and at 6 and 24 months post op in adults and pre op and 12 and 24 mos in children ]

  Pre-operatively, testing will be conducted in the ear to be implanted and bilaterally with appropriately fit hearing aids. Post-operatively, tests will be attempted in the following conditions (unless otherwise noted):

  • Bimodal stimulation

  • Combined stimulation

    16 different everyday sounds will be randomly played from one of 8 loudspeakers ranging from -55 degrees to +55 degrees azimuth. Sounds are played at 60 dB(A). 96 presentations are scored.

• Change in Real World Melody Recognition [ Time Frame: Adults: pre operatively and at 3, 6, 12, and 24 months postoperatively ]

  Test conditions

  • Pre-operatively in the ear to be implanted
  • Hybrid stimulation This test examines the influence of speech and pitch perception in the recognition of excerpts from "real-world" melodies.
• change in Modified Melodies Test: Nudge 2 [ Time Frame: Adults: pre operatively and at 3, 6, 12, and 24 months postoperatively ]

  Test conditions

  • Pre-operatively in the ear to be implanted
  • Hybrid stimulation
  • Cochlear Implan (CI) Only

  This test assesses the ability of participants to detect pitch errors in two familiar melodies: Old MacDonald and Twinkle Twinkle when specific notes are modified/nudged by 2 semitones. Testing will be attempted at 70 dB(A).

• Change in Iowa Test Appraisal of Sound Quality [ Time Frame: Adults: pre operatively and at 3, 6, 12, and 24 months postoperatively ]

  Test conditions

  • Pre-operatively in the ear to be implanted
  • Combined stimulation

  This test evaluates participants' appraisal of timbre and sound quality of music instruments and real-world music with and without lyrics. Using 4 bipolar adjective scales, participants describe the sound quality of the each excerpt and also rank their preference for the sound. Testing will be attempted at 70 dB(A).

• Peabody Picture Vocabulary Development Scale (PPVT) [ Time Frame: preop and 12, 24, 36, 48, and 60 months following implantation in children ]
  The PPVT 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. It is appropriate for children and adults from 2 years, 6 months to 90 years, 11 months of age.
• Goldman Fristoe Test of Articulation (GFTA-2) [ Time Frame: preop and 12, 24, 36, 48, and 60 months following implantation in children ]
  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
• change in Woodcock Reading Mastery Test (WRMT-R) [ Time Frame: preop and 12, 24, 36, 48, and 60 months following implantation in children ]
  These tests are standardized from kindergarten through high school. The Word Identification and Word Attack subtests from the WRMT-R will be used to assess children's word recognition abilities. These subtests measure accuracy of sight word recognition and phonetic decoding of pronounceable non-words. Reading comprehension abilities will be assessed by the
  
  

  Original Secondary Outcome: Same as current
  
  Information By: University of Iowa
  

  Dates:
  Date Received: July 6, 2012
  Date Started: July 2011
  Date Completion: July 2020
  Last Updated: April 13, 2017
  Last Verified: April 2017
  

  

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