The BCI 602 BONEBRIDGE Post-Market Clinical Follow-up Study

Ki vehet részt

• 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)

Ki nem vehet részt

• Simultaneous participation in another clinical trial (on device or on drug) which would interfere with the results of the study
• 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
• 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
• A subject whose hearing loss has demonstrated an improving and decreasing fluctuation over a two-year period of >15 dB HL in either direction