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:
NCT03052920
Eligibility Criteria:
Inclusion Criteria:
* 18 years of age or older
* English as the native language
* Have a desire for functional binaural hearing
* Have failed a previous hearing aid (HA) treatment for asymmetric hearing loss (BiCROS or poor ear HA) or willing to complete a trial if necessary
* Willingness to comply with all study requirements
* Ability to provide informed consent
* Poor ear (ear to be implanted):
* Pure-tone average (PTA) at .5, 1 and 2 kilohertz (kHz) \> 70 dB HL (hereafter referred to as severe to profound hearing loss - SPHL)
* Aided word recognition score (CNC Word Test) at 60 dB SPL ≤ 30%
* Duration of SPHL ≥ 6 months
* Onset of hearing loss ≥ 6 years of age
* Better ear:
* PTA at .5, 1, 2, 4 kHz of 40 to 70 dB HL
* Currently using a HA
* Aided word recognition score (CNC Word Test) at 60 dB SPL \> 40%
* Stable hearing for the previous 1-year period. "Stable" is defined as thresholds that have not changed by more than 10 dB at 2 or more octave interval audiometric frequencies
Exclusion Criteria:
* Medical condition that contraindicates surgery
* Actively using an implantable device in the ear to be implanted
* Known cochlear malformation or obstruction that would preclude full insertion of the electrode array in the ear to be implanted
* Hearing loss of neural or central origin
* Unrealistic expectations related to the benefits and limitations of cochlear implantation
* Unwillingness or inability to comply with all investigational requirements
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03052920
Study Brief:
Protocol Section:
NCT03052920