Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
Eligibility Criteria
- 1. Cochlear implant candidate in one or two ears per current FDA indications
- 2. Sufficient residual hearing to support use of electrocochleography, as determined by the investigator
- 3. Cochlear implantation using the Advanced Bionics SlimJ electrode array
- 4. 18 years of age or older at the time of enrollment
- 5. Willingness to participate in and comply with all requirements of the protocol
- 4. History of temporal bone fracture that involves the cochlea/internal auditory canal.
- 5. Retrocochlear etiology (e.g. diagnosis of auditory neuropathy, cochlear nerve deficiency, or lesions of the acoustic nerve or central auditory pathway).
- 6. Active middle-ear infection or tympanic membrane perforation in the presence of active middle ear disease.
- 7. Planned or current participation in a clinical study of an investigational device or drug that may impact data collection or outcomes related to this investigation.
- 8. Additional medical concerns that would prevent participation in evaluations as determined by the investigator.
- 9. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the procedure and investigational device.
- 10. Vulnerable subject, as per FDA regulations 21 CFR Parts 50 and 56
Ages Eligible for Study
12 Years to
Sexes Eligible for Study
ALL
Accepts Healthy Volunteers
No