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 @ 3:46 AM
Ignite Modification Date:
2025-12-25 @ 3:46 AM
NCT ID:
NCT02984202
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥18 and ≤75 years
2. Diagnosis of NF2 (i.e., Neurofibromatosis Type 2)
3. Bilateral deafness without a functional auditory nerve or insufficient residual hearing while being ineligible for cochlear implant
4. Eligible for brainstem or midbrain surgery for a standard clinical procedure, including to remove a tumor, replace or reposition an existing ABI, or implant a new ABI
5. No or minimal benefit from a previously implanted auditory brainstem implant (ABI) (i.e. patient has requested an alternative hearing option due to insufficient benefit on a daily basis); or poor performance expected with an ABI due to a high risk of array movement associated with removal of a large tumor or anatomical abnormalities/damage (e.g., associated with altered development, tumor compression, radiation therapy, surgical intervention, or other treatments)
6. No further lesions of the auditory pathway from the inferior colliculus (IC) to the auditory cortex
7. Post-linguistic onset of contralateral severe-to-profound neural hearing loss
8. Women with childbearing potential: willingness to use a reliable contraceptive method (e.g. copper intrauterine devices or hormonal methods) after consulting their gynecologists
9. Written informed consent
Exclusion Criteria:
1. Medical, neurological, or psychological conditions that would contra-indicate undergoing surgery, e.g. acute cardiac infarction, history of stroke, dementia
2. Additional handicaps that would prevent participation in evaluations
3. Pregnant and breast feeding woman, prisoners, or anyone in custody
4. Known allergies to one of the components of the implant
5. Other active devices with potential interference with brain implants, such as transcranial magnetic stimulators
6. Additionally, in the event of other serious diseases (e.g. progressive carcinoma or chronic renal failure) the investigators will decide on a case-by-case basis whether to enroll the patient in the trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02984202
Study Brief:
Protocol Section:
NCT02984202