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:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-24 @ 7:36 PM
NCT ID:
NCT05923203
Eligibility Criteria:
Inclusion Criteria:
1. Children aged 5 to 17 years of age with either normal hearing (n=40) or at least 1 cochlear implant (CI) and binaural low-frequency acoustic hearing (n=40); adults aged 18+ years with either normal hearing (n=40) or at least 1 CI and binaural low-frequency acoustic hearing (n=40).
2. Experimental participants must have at least one CI and bilateral mild to severe sensorineural hearing loss For CI participants, audiometric thresholds in the non-CI ear must be consistent with at least a mild sensorineural hearing loss; that is, the investigators will not be enrolling participants with single-sided deafness (SSD) For CI participants, unaided audiometric thresholds must be less than or equal to 80 dB HL for 125 and 250 Hz, in both ears.
3. Nonverbal cognitive abilities within the typical range for all participants; adult participants must also pass cognitive screening via Montreal Cognitive Assessment (MoCA or HI-MoCA).
4. No confounding diagnosis such as autism, auditory neuropathy, neurological disorder, or general cognitive impairment.
5. Willingness to use EAS technology in the implanted ear(s) to be verified via data logging from cochlear implant and hearing aid software.
Exclusion Criteria:
1. Nonverbal intelligence standard score \< 85 (for any participant).
2. MoCA or HI-MoCA score \< 26 for adult participants.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
5 Years
Study:
NCT05923203
Study Brief:
Protocol Section:
NCT05923203