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 @ 2:53 AM
Ignite Modification Date:
2025-12-25 @ 2:53 AM
NCT ID:
NCT04427033
Eligibility Criteria:
Inclusion Criteria:
* Geographically and physically able to return to the investigational site for scheduled evaluations and follow-up appointments
* Fluent in the language used in the investigational site and used for evaluation
* Signed and dated informed consent before the start of any study-specific procedure and collection of any retrospective data.
* Subjects meet the indication criteria according to the instructions for use (IFU):
* Subject 5 years of age and older
* The physician must fully assess the potential risks and benefits for the patient and his/her realistic expectations with the device prior to the decision to implant the BCI 602. The physician must exercise medical judgement and consider the patient's complete medical history.
* Bonebridge candidates suffer from either
* • conductive or mixed hearing loss as indicated by audiometric testing with bone conduction thresholds better than or equal to 45 dB HL at 0.5, 1.0, 2.0 and 3.0 kHz.
* • single-sided sensorineural deafness, that is severe-to-profound sensorineural hearing loss in one ear while the other ear has normal hearing (air conduction (AC) should be better than or equal to 20 dB HL measured at 0.5, 1.0, 2.0 and 3.0 kHz).
Exclusion Criteria:
* A subject whose hearing loss has demonstrated an improving and decreasing fluctuation over a two-year period of \>15 dB HL in either direction
* Severe, chronic, non-revisable diseases or disorders (vestibular disorder, cancer etc.)
* A subject with any psychological (anxiety, depression, hallucinations etc.), emotional (schizophrenia, mania, melancholia etc.) or from that originating physical disorder that would interfere with the ability to perform on test procedures
* Simultaneous participation in another clinical trial (on device or on drug) which would interfere with the results of the study.
* Any active ear infection
* Subjects who meet any of the contraindications in the IFU:
* Evidence that hearing loss is of retrocochlear or central origin (ipsilateral CHL /MHL; contralateral SSD)
* Skin or scalp conditions that may preclude attachment of the Audio Processor (AP) or that may interfere with the use of the AP
* Skull size or abnormality would preclude appropriate placement of the BCI 602 implant
* Intolerant to the materials in the BCI 602 implant.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Study:
NCT04427033
Study Brief:
Protocol Section:
NCT04427033