Single-Sided Deafness and Asymmetric Hearing Loss
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5+
SponsorMed-El Corporation
About this trial
The purpose of the study is to evaluate the long-term safety and effectiveness of cochlear implantation of the approved population in adults and children with single-sided deafness and asymmetric hearing loss.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Five years of age or older at the time of implantation
Unilateral profound hearing loss, as defined by a pure-tone average (500, 1000, 2000, and 4000 Hz) of 90 dB or greater in the ear to be implanted
Sensorineural hearing loss in the ear to be implanted, as defined by an air-bone gap less than or equal to 10 dB at two or more frequencies out of 500, 1000, 2000, and 4000 Hz and a diagnosed pathology of the outer or middle ear
Normal hearing or mild to moderate hearing loss in the non-implanted ear, as defined by a pure-tone average (500, 1000, 2000, and 4000 Hz) of 55 dB or less
Disqualifiers
Duration of profound hearing loss of 10 years or more
Absence of cochlear development or non-functionality of cochlear nerve
Other retrocochlear hearing loss
Evidence of severe cochlear malformation (i.e., common cavity or ossification)
Trial design
Design model
Single group
Treatments tested in this trial
MED-EL Cochlear Implant System
DeviceCochlear implant and audio processor
Treatment groups
65 Participants
are divided into 1 treatment groupGroup A: Study ProcedureOther 1 intervention
Trial outcomes
Primary outcomes
1
Long-term performance of the Cochlear Implant System will be assessed through speech perception testing in noise completed through three years (36 months) post implantation
The primary effectiveness endpoint will be change on speech in noise when speech is presented to the front and noise is presented to the acoustic hearing (contralateral) ear. The pre-operative, best-aided score will be compared to the 12-month and 36-month CI score for AzBio sentences in noise(range of score 0-100, higher score is better). Improvement is defined as greater than or equal to 10 percentage points.
Time frame
Three years (36 months) post implantationSecondary outcomes
1
Long term performance of the Cochlear Implant System will be summarized through speech perception testing in noise completed through three years (36 months) post implantation
Speech in noise in two spatial conditions will demonstrate similar performance from the pre-operative, best-aided score to the CI score at 12 and 36 months post-activation. AzBio sentence in noise score will be summarized for two conditions: speech and noise presented from the front as well as speech presented to the front and noise presented to the CI ear.(Range of score 0-100, higher score is better)
Time frame
Three years (36 months) post implantation2
Long term performance of the Cochlear Implant System will be assessed through speech perception testing in quiet completed through three (36 months) post implantation
Speech perception in quiet will be summarized for the CI ear as well as the contralateral ear at the pre-operative, 12-month, and 36-month intervals. The CI ear is expected to demonstrate improvement (greater than or equal to 10 percentage point change), while the contralateral ear is expected to demonstrate no change. (Range of score 0-100, higher score is better)
Time frame
Three years (36 months) post implantation3
Long term subjective benefit of the Cochlear Implant System will be assessed through three years (36 months) post implantation
Subjective data will be collected via the Speech, Spatial, and Qualities of Hearing Scale (SSQ). Responses will be summarized from the pre-operative, 12-month, and 36-month intervals.(Range of score 0-10, lower score is better)
Time frame
Three years (36 months) post implantation4
Long term safety will be evaluated for all study subjects through three (36 months) years post implantation
Safety will be assessed by collecting and reporting device-related adverse events occurring throughout the study. This will be summarized and reported as the number and proportion of subjects experiencing an adverse device event.
Time frame
Three years (36 months) post implantationSponsors and contacts
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Source ClinicalTrials.gov