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 @ 4:31 PM
Ignite Modification Date:
2025-12-24 @ 4:31 PM
NCT ID:
NCT04207866
Eligibility Criteria:
Inclusion Criteria:
* Newly implanted subjects who might need additional auditory training supports (e.g. long-term deafened, limited communication partners etc.)
* Post-lingual onset of hearing loss
* No cognitive deficits
* English must be their native language
* Willingness to use teleconferencing methods to obtain AT services and residing \>1 hr away by car from the hospital
* Willingness to attend these appointments with a communication partner wherever possible
Exclusion Criteria:
* Onset of hearing loss prior to two years of age (prelingual hearing loss)
* Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array, as confirmed by medical examination and imaging including MRI
* Hearing loss of retro-cochlear or central origin
* Additional handicaps that would prevent participation in evaluations
* Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic device
* Active middle ear infection
* Unwillingness or inability of the candidate to comply with all investigational requirements
* History of radiation
* Patient concerns regarding their own technological skills and ability to use teleconferencing methods
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04207866
Study Brief:
Protocol Section:
NCT04207866