Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT02677220
Eligibility Criteria:
Inclusion Criteria:
* Meet current cochlear implant criteria at the implanting center
* 18 years or older with bilateral sensorineural hearing loss
* Limited benefit from appropriate binaural hearing aids
* Moderate to profound hearing loss in the low frequencies and profound hearing loss in the mid to high frequencies
* Preoperative unaided threshold between 40 and 65 dB HL, inclusively, at 250 Hertz (Hz) and 500 Hz in the ear to be implanted
* Fluent speaker in the language used to assess clinical performance
Exclusion Criteria:
* Evidence of hearing loss prior to age 5
* Sensorineural severe to profound hearing loss greater than 20 years at and above 2000Hz
* Simultaneous bilateral implantation prior to the study
* Medical or psychological conditions that contraindicate undergoing general anesthesia or surgery
* Cochlear anomaly that might prevent complete insertion of the electrode array
* Hearing impairment due to lesion or neuropathy of the acoustic nerve, VIII nerve, or central auditory pathway
* Active middle ear infection
* Tympanic membrane perforation
* Unrealistic expectations
* Unwillingness or inability co comply with all investigational requirements
* Patients with existing cerebral shunts or drains
* Recurrent episodes of bacterial meningitis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02677220
Study Brief:
Protocol Section:
NCT02677220