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 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT07213505
Eligibility Criteria:
Inclusion Criteria:
* Minimum age of eighteen (18) years at time of enrolment
* Experienced MED-EL cochlear implant (CI) user (≥ 6 months) for the ear to be tested
* User of a MED-EL Audio Processor (i.e. a SONNET, SONNET 2, SONNET 3, or RONDO 3 ≥ 3months)
* Post-lingual onset of severe to profound sensory-neural hearing loss on the ear to be tested
* A minimum of 40% speech recognition in the Freiburg Monosyllables Test in quiet at 65 dB sound pressure level (SPL) for the ear to be tested (at the last time tested in clinical routine)
* Signed and dated Informed Consent Form (ICF) before the start of any study-specific procedure.
Exclusion Criteria:
* Lack of compliance with any inclusion criteria
* CI user with contralateral hearing equal to or better than 30 dB (pure-tone average over the following frequencies: 250, 500, 1000, and 2000 Hz)
* Implanted with C40X, or C40C on the ear to be tested
* Implanted with an auditory brainstem implant (ABI) or Split electrode array
* Known allergic reactions to components of the investigational medical device
* Anything that, in the opinion of the Investigator, would
* place the subject at increased risk
* preclude the subject's full compliance with or completion of the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07213505
Study Brief:
Protocol Section:
NCT07213505