Cochlear implantation for older adults with single-sided deafness
Cochlear Implantation in the Single-Sided Deafness in the Medicare Population
NA · Med-El Corporation · NCT05250414
This study is testing if cochlear implants can help older adults with hearing loss in one ear hear better and improve their quality of life.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Med-El Corporation (industry) |
| Locations | 3 sites (Iowa City, Iowa and 2 other locations) |
| Trial ID | NCT05250414 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of cochlear implantation in adults aged 65 and older who have unilateral profound hearing loss. It is a multi-center, single-subject, repeated measures study involving three sites in the United States and Canada. A total of fifteen subjects will be enrolled and followed for 12 months after receiving the MED-EL Cochlear Implant System. The study aims to assess improvements in hearing and quality of life for participants post-implantation.
Who should consider this trial
Good fit: Ideal candidates are adults aged 65 and older with unilateral profound hearing loss and normal hearing in the non-implanted ear.
Not a fit: Patients with a duration of profound hearing loss of 10 years or more or sudden onset hearing loss within six months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve hearing and communication abilities for older adults with single-sided deafness.
How similar studies have performed: Other studies have shown positive outcomes with cochlear implantation in similar populations, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 65 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 * Normal or near-normal hearing in the non-implanted ear, as defined by a pure-tone average (500, 1000, 2000, and 4000 Hz) of 30 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 CROS, BI-CROS, 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 * Sudden onset of hearing loss within six months of implantation * Evidence of non-functional cochlear nerve or other retrocochlear hearing loss * Evidence of severe cochlear malformation (i.e., common cavity or ossification) * External or middle ear infection * Suspected cognitive concern * Other medical contraindication for surgery or anesthesia
Where this trial is running
Iowa City, Iowa and 2 other locations
- University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States (RECRUITING)
- University of North Carolina — Chapel Hill, North Carolina, United States (RECRUITING)
- Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hearing Loss, Unilateral