An interventional study of MED-EL Cochlear Implant System in Hearing Loss, Unilateral and Hearing Loss, Sensorineural, sponsored by Med-El Corporation. Active, not recruiting at 5 sites in 2 countries. Open to participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Med-El Corporation · Not applicable, Interventional, and Treatment
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.
The study will be conducted as a single-subject, repeated measures, multi center study at 6 sites. Sixty-five subjects will be enrolled in this study. Six centers across the United States and Canada will recruit subjects into this study. Study subjects will be followed for a minimum of 3 years post-implantation of the device.
51 studies on the registry are indexed under Hearing Loss, Unilateral; 7 are open to participants now.
This study's planned enrollment of 65 is above the median of 35 across 35 interventional studies indexed under Hearing Loss, Unilateral.
Browse Hearing Loss, Unilateral studies →Med-El Corporation is the lead sponsor of 16 studies on the registry; 1 is open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 7 (70%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: MED-EL Cochlear Implant System
Cochlear implant and audio processor
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 implantation
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 implantation
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 implantation
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 implantation
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 implantation
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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