Single-Sided Deafness in the Medicare Population
- Conditions
- Hearing Loss, Unilateral
- Interventions
- Device: MED-EL Cochlear Implant System
- Registration Number
- NCT05250414
- Lead Sponsor
- Med-El Corporation
- Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of cochlear implantation in adults 65 years of age and older.
- Detailed Description
The study will be conducted as a single-subject, repeated measures, multi center study at 3 sites. Fifteen subjects will be enrolled in this study. Three centers in the United States and Canada will recruit subjects into this study. Study subjects will be followed for 12 months post-implantation of the device.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 15
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Study Procedure MED-EL Cochlear Implant System -
- Primary Outcome Measures
Name Time Method Performance of the Cochlear Implant System will be assessed through speech perception testing in noise completed through one year (12 months) post implantation. One year (12 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 6-month and 12-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.
- Secondary Outcome Measures
Name Time Method Performance of the Cochlear Implant System will be summarized through speech perception testing in noise completed through one year (12 months) post implantation. One year (12 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 6- and 12-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)
Performance of the Cochlear Implant System will be assessed through speech perception testing in quiet completed through one year (12 months ) post implantation. One year (12 months) post implantation Speech perception in quiet will be summarized for the CI ear as well as the contralateral ear at the pre-operative, 6-month, and 12-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)
Safety will be evaluated for all study subjects through one year (12 months) post implantation. One year (12 months) 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.
Subjective benefit of the Cochlear Implant System will be assessed through one year (12 months) post implantation. One year (12 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, 6-month, and 12-month intervals. (Range of score 0-10, lower score is better)
Trial Locations
- Locations (3)
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada