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 @ 3:58 PM
Ignite Modification Date:
2025-12-24 @ 3:58 PM
NCT ID:
NCT02259192
Eligibility Criteria:
Inclusion Criteria:
* Is an adult (18 years of age or older)
* English as the primary language
* Able to undergo general anesthesia, as determined by physical examination and written report from the physician
* Receives pneumovax vaccine within 2 weeks of surgery and provides documentation to the principal investigator
* Profoundly/severely deaf in one ear ("implant ear"), as defined by:
* 3-frequency pure-tone average≥70 dB Hearing Loss
* Bone conduction thresholds consistent with air conduction thresholds (i.e., no conductive component to the hearing loss)
* HINT sentence recognition score ≤40% correct, 60 dBA presentation level
* Post-lingual onset of hearing loss, i.e., after age 6 years of age
* Hearing loss occurred \<10 years prior, as obtained by history
* Normal hearing in one ear ("non-implant ear"), as defined by:
* 3-frequency PTA ≤25 dB HL
* No tested frequency air conduction threshold \>35 dB HL
* Bone conduction thresholds consistent with air conduction thresholds
* Word recognition score ≥80% correct, 60 dBA presentation level
* HINT sentence recognition score ≥ 80%, 60 dBA presentation level
* Provides informed consent
* Willing and able to follow the study protocol
Exclusion Criteria:
* Retrocochlear pathology resulting from Neurofibromatosis 2, or other types of cranial nerve/brainstem tumors
* Co-existing medical conditions that require radiotherapy of the brainstem and/or auditory cortex
* Any medical contraindication precluding safe administration of general anesthesia, e.g.,
* Cardiopulmonary disease
* Renal disease
* Otologic conditions which contraindicate surgery
* Active middle ear infection
* Tympanic membrane perforation
* Anatomic abnormalities detected on CT preventing appropriate placement of the stimulator housing in the bone of the skull or placement of the electrode array in the cochlea (e.g., ossification)
* Psychological conditions contraindicating surgery
* Skin or scalp conditions that may preclude attachment of the coil or that may interfere with the use of the coil
* Chronic pain in or around the head
* Current or previous use of an active hearing implant (e.g., bone-anchored hearing aids, cochlear implant, etc.)
* Developmental delays or organic brain dysfunction
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02259192
Study Brief:
Protocol Section:
NCT02259192