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 @ 9:25 PM
Ignite Modification Date:
2025-12-24 @ 9:25 PM
NCT ID:
NCT04006132
Eligibility Criteria:
Inclusion Criteria:
* Adult BAHS users, minimum 18 years and maximum 75 years.
* Native English speakers.
* Patients that are already bilaterally implanted.
* Patients with a bilateral conductive or mixed conductive-sensorineural hearing loss.
* Experience with bilateral Ponto of at least 6 months.
* Patients that are using both their sound processors daily.
* PTA BC (at 0.5, 1, 2, 3 kHz) on both sides lower or equal to 65 dB HL.
* If the masked BC is available on the patient's journal, the average difference in masked BC (at 0.5, 1, 2, 4 kHz) between L and R ear should be lower than 15 dB.
* If the masked BC is not available on the patient's journal, the average difference in unmasked BC (at 0.5, 1, 2, 4 kHz) between L and R ear should be lower than 15 dB.
Exclusion Criteria:
* Not deemed suited by the principal investigator.
* If the physician assesses that the patient is not fit for trial participation at any stage.
* Audiogram at 1st visit shows too large masked BC thresholds (PTA BC - at 0.5, 1, 2, 3 kHz - on either side larger than 65 dB HL).
* Audiogram at 1st visit shows asymmetric masked BC thresholds (average difference in masked BC - at 0.5, 1, 2, 4 kHz - between L and R ear larger or equal to 15 dB).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04006132
Study Brief:
Protocol Section:
NCT04006132