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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01975571
Other study ID # 201106758
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 2011
Est. completion date September 8, 2018

Study information

Verified date May 2022
Source University of Iowa
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Device:
Cochlear® Nucleus™ Hybrid L24
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.
Cochlear® Nucleus™ Hybrid S12
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.

Locations

Country Name City State
United States University of Iowa Iowa City Iowa
United States University of Iowa Hospitals and Clinics Iowa City Iowa

Sponsors (1)

Lead Sponsor Collaborator
Bruce J Gantz

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary Change in Localization Pre-operatively and post-operative, testing will be conducted using bilaterally fitted devices (preoperatively) and a cochlear implant and bilateral hearing aids (if applicable) postoperatively (combined condition). Everyday sounds will be presented from one of eight loudspeakers at 60 dBA forming a 108- arc. The participant will face the center of the speaker array at a 1.4 m. 16 different sounds will be repeated 6 times and presented randomly from one of the loudspeakers. Localization performance was calculated by the average root-mean-square (RMS) error in degrees. Preoperatively and at 6 and 24 months post op in adults and pre op and 12 and 24 mos in children
Secondary AzBio +5 Noise Sentences in a +5 dB noise will be administered. Sentences will be tested at 60 dB(A) and noise at 55 dB(A) from the front. 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) The AzBio sentence perception test consists of multiple lists of 20 sentences that are presented in sound-field from a loudspeaker using an open set format. Percent correct is calculated by the number of words correctly identified by the subject out of the total number of words presented in the sentence lists. Adults pre-op, 3, 6, 12, 24 months post op
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