Clinical Utility of Residual Hearing in the Cochlear Implant Ear
Ohio State University
Summary
The current study is a randomized multi-center clinical trial that investigates the role an intraoperative hearing monitoring system (electrocochleography) has on helping to save residual hearing in patients undergoing cochlear implantation (CI).
Description
The clinical importance of residual acoustic hearing in CI remains unclear. It is estimated that only five percent of adult candidates undergo CI. A major barrier is the loss of residual hearing associated with surgery, meaning most patients lose any or all residual hearing as a result of the CI surgery, especially since the majority of today's candidates do not suffer from complete deafness. Hence, many candidates are faced with the decision to relinquish their remaining acoustic hearing in exchange for electric hearing via the CI, as CI surgery often results in complete loss of any residual…
Eligibility
- Age range
- 18–79 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Provision of signed and dated informed consent form. 2. Adults, males and females, ages 18 -79 who have a bilateral sensorineural hearing loss with postlingual onset. 3. Minimum of 30 days experience with appropriately fit binaural amplification (standardized National Acoustic Laboratories (NAL) fitting method) verified with real ear measurements within 5 dB SPL of targets. 4. Limited benefit from conventional amplification in the best aided condition as defined by test scores of: 1. The ear to implanted: Consonant-nucleus-consonant (CNC) words ≤ 60% or AzBio senten…
Interventions
- DeviceElectrocochleography
The use of ECochG monitoring will be employed. This will be conducted intraoperatively during the entire portion of the CI electrode insertion component. For the purposes of this clinical trial, the stimulus will consist of a 500 Hz tone burst presented at \~105-110 dB SPL. This was chosen due to the time and resource limitations in the operating room. Hence, the surgical team can only utilize a very limited dataset for intraoperative decision making and previous studies have demonstrated that 500 Hz stimulation offers the most robust, reliable, and useful ECochG signal during electrode insertions.
Locations (5)
- Mayo ClinicRochester, Minnesota
- Washington University in St. LouisSt Louis, Missouri
- University of North Carolina, Chapel HillChapel Hill, North Carolina
- Ohio State University Eye and Ear InstituteColumbus, Ohio
- Medical College of WisconsinMilwaukee, Wisconsin