Clinical Trials in the USA / NCT04506853
Active, not recruiting
Not applicable
Single-Sided Deafness and Asymmetric Hearing Loss
NCT04506853 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Hearing Loss, UnilateralHearing Loss, Sensorineural
Investigational drug(s) / intervention(s)
MED-EL Cochlear Implant System
MED-EL Cochlear Implant System: Cochlear implant and audio processor
Study summary
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
Inclusion Criteria:
* 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
* Word recognition in the ear to be implanted of 5% or less on CNC word score in quiet
* Previous experience with an appropriately-fit Contralateral Routing of Signal (CROS) hearing aid, BI-Contralateral Routing of Signal (CROS) hearing aid, bone conduction, or traditional hearing aid, as deemed appropriate by investigator
* Fluent in English
Exclusion Criteria:
* 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)
* External or middle ear infection
* Suspected developmental or cognitive concern
* Other medical contraindication for surgery or anesthesia
Primary outcome measure(s)
- 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 — 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.
Trial sites (5)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Iowa | Iowa City | Iowa | |
| New York Eye and Ear Infirmary | New York | New York | |
| University of North Carolina | Chapel Hill | North Carolina | |
| Virginia Mason Medical Center | Seattle | Washington | |
| Sunnybrook Health Sciences Center | Toronto | Ontario |
More Med-El Corporation trials in the USA
Impact of Anatomy-Based Cochlear Implant Programming on Early Performance
Enrolling by invitation
Expanded Indications in the Pediatric BONEBRIDGE Population
Active, not recruiting
Other trials for the same condition
Impact of Anatomy-Based Cochlear Implant Programming on Early Performance
Enrolling by invitation
Investigation to Evaluate the Safety and Effectiveness of Cochlear Implantation in Children and Adults With Unilateral Hearing Loss/Single-sided Deafness
Active, not recruiting
Safety and Effectiveness of Cochlear Implantation in an Expanded Adult Population
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04506853 on ClinicalTrials.gov ↗ ← All trials in the USA