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 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 12:39 AM
NCT ID:
NCT01736267
Eligibility Criteria:
Inclusion Criteria:
* 18 years of age or older
* English as the primary language
* Medically and psychologically suitable
* Willing to receive/have received meningitis / pneumococcal vaccinations
* Able to comply with study requirements, including travel to the investigational site
* Cochlear or retrocochlear anomaly/pathology that interferes with transmission of auditory information from the cochleae to the brainstem, resulting in severe to profound bilateral deafness (thresholds of 90 dB or worse in both ears on pure tone audiometry ranging from 250 to 2,000 Hz and speech recognition scores ≤ 30% in both ears). All subjects will undergo bone conduction audiometry and tympanometry to confirm sensorineural hearing loss and rule out potential middle ear disorders.
* Conditions that cannot be otherwise treated, with conventional hearing aids or cochlear implants. If CI were previously used, subjects will have had a failed response, defined as ≤ 30% speech recognition and patient perception of inadequate benefit to continue using the device.
* Expected subjects include those with these diagnoses:
* Bilaterally severe/completely ossified cochleae
* Bilateral cochlear malformations leading to poor CI outcomes
* Bilateral temporal bone fractures, where the VIIIth cranial nerves have been disrupted
* Bilateral cochlear nerve agenesis
* Not a CI candidate based on above listed pathology, intolerable adverse effects with CI (e.g. stimulation of the facial nerve), or Evoked Auditory Potential testing predictive of a poor response
Exclusion Criteria:
* Anomalies/pathology involving the brainstem or cortex
* Retrocochlear pathology due to NF2 or other types of cranial nerve or brainstem neoplasm
* Co-existing medical conditions that require irradiation of the brainstem or auditory cortex
* Medical or psychological conditions that serve as contraindication to surgery
* Additional handicaps that would prevent or limit participation in evaluations
* Unrealistic patient or family expectations regarding the benefits, risks, and limitations inherent to the procedure and the prosthetic device
* Pregnant women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01736267
Study Brief:
Protocol Section:
NCT01736267