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 @ 9:41 PM
Ignite Modification Date:
2025-12-24 @ 9:41 PM
NCT ID:
NCT06039332
Eligibility Criteria:
Inclusion Criteria:
* 18 years of age or older
* Unilateral and/or bilateral conductive or mixed hearing loss (CHL/MHL) in indication range.
* Implanted with a BCI602 device.
* Willingness and ability to use the hearing system and to perform all tests required for the study
* Signed, and dated informed consent before the start of any study specific procedure
* Native speaker
Exclusion Criteria:
* Profound unilateral sensorineural hearing loss, often termed Single sided deafness (SSD)
* Retrocochlear, or central auditory disorders
* Any physical, psychological, or emotional disorder that would interfere with the ability to perform on test and rehabilitation procedures
* Subjects who do not meet one or more of the above mentioned inclusion criteria are excluded from the study.
* Fluctuating hearing loss.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06039332
Study Brief:
Protocol Section:
NCT06039332