Sponsor study identifier
interventional
20
1 country
2
Study Start
July 2011
Actual (reported)Primary Completion
September 8, 2018
Actual (reported)Study Completion
September 8, 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 8, 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2011
Actual (reported)July 6, 2012
Actual (reported)November 4, 2013
Actual (reported)September 8, 2018
Actual (reported)September 8, 2018
Actual (reported)June 8, 2022
Actual (reported)Change in CNC Word Perception
Pre-operatively, speech perception testing will be conducted using the ear implanted and bilaterally with appropriately fit hearing aids. Post-operatively, speech perception testing will be attempted in the following conditions (unless otherwise noted): Combined stimulation (cochlear implant and any hearing aids worn on the implanted or non-implanted ears) Testing will be in quiet at 60 dB(A). The CNC word perception test consists of multiple lists of 50 3-syllable words (consonant-nucleus-consonant) that are presented through a loudspeaker using an open set format. Percent correct is calculated by the number of words identified by the subject out of the 50 words presented.
pre-op, 3, 6, 12, 24 months in the adults and pre-op, 3, 6, 12, 24, 36, 48, and 60 months post-implantation for children
Change in Localization
Preoperatively and at 6 and 24 months post op in adults and pre op and 12 and 24 mos in children
AzBio +5 Noise
Adults pre-op, 3, 6, 12, 24 months post op
Population 1: 15 Adults who have a severe sensorineural hearing loss with a pure-tone average (PTA) between 60-90 dB HL between 125-1500 Hz and profound loss at higher frequencies. Intervention: These patients will receive a Hybrid L24 cochlear implant.
Children (ages 5-12 years) and adolescents (ages 13-15 years) who have a sensorineural hearing loss with a pure-tone average (PTA) between 70-90 dB HL between 125-1500 Hz, a hearing threshold \>90 dB HL at 1500 Hz and profound loss at higher frequencies. Intervention: These patients will receive a Hybrid L24 cochlear implant.
The Nucleus Hybrid L24 cochlear implant incorporates an electrode array designed to preserve residual hearing. This has been accomplished by employing a thin, straight, intracochlear electrode array attached to a Nucleus cochlear implant receiver/stimulator. The Nucleus Hybrid L24 array has 22 electrodes spread over 16 mm and an anticipated insertion depth of 16 mm. It is slim, with its dimensions ranging from 0.35 x 0.25 mm (at the tip) to 0.55 x 0.4 mm, and designed to minimize lateral wall forces with a stiffened basal section to prevent buckling. The resultant insertion angle is about 280-300° in the scala tympani for the Hybrid L24, as confirmed in temporal bone trials at the Medical University Hannover and the University of Melbourne.
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
University of Iowa
Iowa City, Iowa, 52242, United States
Bruce Gantz, MD
University of Iowa
20 participants (actual enrollment reported by the registry).
First Submitted
July 6, 2012
First Posted
November 4, 2013
Study Start
July 2011
Actual (reported)Children (ages 5-12 years) and adolescents (ages 13-15 years) who have a sensorineural hearing loss with a pure-tone average (PTA) between 70-90 dB HL between 125-1500 Hz, a hearing threshold hearing threshold between 70-90 dB HL at 1500 Hz and profound loss at higher frequencies. Intervention: These patients will receive a Hybrid S12 cochlear implant.
The Nucleus Hybrid S12 cochlear implant incorporates an electrode array designed to stimulate the high-frequency, basal region of the cochlea while maintaining useful acoustic hearing in the low-frequency, apical region. This has been accomplished by employing a short, thin, straight intracochlear electrode array attached to a Nucleus cochlear implant receiver/stimulator. The electrode array incorporates a collar to prevent over-insertion, or further migration, into the cochlea beyond the point where the basal turn curves into the ascending segment. Thus, the electrode array is placed within the straight segment of the basal turn of the scala tympani via a cochleostomy.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
September 8, 2018
Actual (reported)Study Completion
September 8, 2018
Actual (reported)Last Updated
June 8, 2022
Results First Posted
June 8, 2022
Record last verified: 2022-05
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: