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 @ 12:40 PM
Ignite Modification Date:
2025-12-24 @ 12:40 PM
NCT ID:
NCT00594061
Eligibility Criteria:
Inclusion Criteria:
* Twelve to twenty-four months of age at the time of implantation.
* Audiometric thresholds for frequencies 250 to 8000 Hz in the severe-to-profound hearing range bilaterally. The type of hearing loss must be categorized as sensorineural in nature.
* English spoken as a primary language (mono-lingual English speaking family, where English is the primary language).
* Willingness to comply with all study requirements.
* Multiple visits may be necessary preoperatively and/or postoperatively for data collection due to age and attention.
* Minimum of three month hearing aid trial.
* Patent cochlea and normal cochlear anatomy as shown by a CT Scan. It is standard clinical practice to perform a CT Scan on any patient pursuing cochlear implantation.
* Must be in a habilitation/educational program with an emphasis on spoken language development.
Exclusion Criteria:
* Medical or psychological conditions that contraindicate undergoing surgery.
* Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array.
* Developmental disabilities or other conditions that would prevent or restrict participation in the audiological evaluations and clinical trial.
* Hearing loss of neural or central origin.
* Unrealistic expectations on the part of the candidate and/or candidate's family,regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices.
* Unwillingness or inability of the candidate to comply with all investigational requirements.
* Active middle ear infection.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Months
Maximum Age:
24 Months
Study:
NCT00594061
Study Brief:
Protocol Section:
NCT00594061