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

Study Overview
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Brief Summary
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The Bonebridge system using the BCI 601 is marketed since 2012. Previous prospective, multi-center, non-randomized studies on the BCI 601 Bonebridge performed in adult and paediatric populations have shown a significant improvement in terms of aided sound field (SF) thresholds, word recognition scores (WRS), speech reception thresholds (SRT) and subjective device satisfaction. Safety was established by stable residual hearing and low complication rates. The Bonebridge, implanted in over 600 clinics worldwide, is the world's first active transcutaneous bone conduction implant (BCI) system. This study now focuses on the further developed BCI 602 (marketed since 2019) that has the same indication criteria and performance characteristics. The aim of this post-market clinical follow-up (PMCF) study is to provide clinical data for the long-term performance and safety when implanted with the Bonebridge BCI 602 .

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

Conditions
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Hearing Loss, Hearing Loss, Conductive, Hearing Loss, Mixed, Hearing Loss, Unilateral, Hearing Loss, Bilateral, Hearing Loss, Sensorineural

Intervention / Treatment
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* Device: Bone Conduction Implant


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CHL & MHL (18 years and older)<br>CHL= conductive hearing loss, MHL= mixed hearing loss | Device: Bone Conduction Implant<br>* Bonebridge system BCI 602<br>|
| CHL & MHL (5 to 17 years)<br> | Device: Bone Conduction Implant<br>* Bonebridge system BCI 602<br>|
| SSD (5 years and older)<br>SSD= single sided deafness | Device: Bone Conduction Implant<br>* Bonebridge system BCI 602<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sound Field audiometry | Investigate if the PTA4 sound field thresholds (SF) improve with the BCI 602 (aided) at 12 months post-operative compared to the unaided test situation. (PTA4 = average of audiometric test frequencies 0.5, 1.0, 2.0, 4.0 kHz) | 12 months post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Word Recognition Score (CHL/MHL) | Investigate if speech intelligibility improves with the BCI 602 (aided) at 12 months post-operative compared to the unaided test situation in the following speech intelligibility test. Word Recognition Score (WRS): S0°, WRS correct @ 65 dB SPL Signal Monosyllabic (MS) word lists are presented from the front (0°) at 65 dB SPL (45 dB HL) and the percent correct score [%] (0 % to 100 %) is recorded. (SPL= Sound Pressure Level; Score: 0% to 100% words understood ) | 12 months post-operative | 
| Speech Reception Threshold in quiet (CHL/MHL) | Investigate if speech intelligibility improves with the BCI 602 (aided) in CHL/MHL at 12 months post-operative compared to the unaided test situation in the following speech intelligibility test. Speech Reception Threshold in quiet (SRT) : S0°, SRT for 50% correct | 12 months post-operative | 
| Speech Reception Threshold in noise (CHL/MHL) | Investigate if speech intelligibility improves with the BCI 602 (aided) in CHL/MHL at 12 months post-operative compared to the unaided test situation in the following speech intelligibility test. Speech Reception Threshold in noise (SNR): S0° N0°, SNR for 50% correct @ 65 dB SPL Noise | 12 months post-operative | 
| Speech Reception Threshold in noise (SSD) Sssd Nnh | Investigate if speech intelligibility improves with the BCI 602 (aided) in SSD at 12 months post-operative compared to the unaided test situation in the following speech intelligibility tests. Sssd Nnh, SNR for 50% correct @ 65 dB SPL Noise (S= Signal; N= Noise; ssd = single sided deaf ear; nh = normal hearing ear) | 12 months post-operative | 
| Speech Reception Threshold in noise (SSD) S0° Nnh | Investigate if speech intelligibility improves with the BCI 602 (aided) in SSD at 12 months post-operative compared to the unaided test situation in the following speech intelligibility tests. S0° Nnh, SNR for 50% correct @ 65 dB SPL Noise | 12 months post-operative | 
| Residual hearing | Investigate whether residual hearing by means of bone conduction (BC) PTA4 thresholds of subjects implanted with the BCI 602 remains stable 12 months post-operative compared to the pre operative test situation. | 12 months post-operative | 
| Adverse Events | Monitor the long-term safety of subjects implanted with the BCI 602 by collecting and reviewing adverse events (AEs). | 12 months post-operative | 
| Surgical Questionnaires | Monitor the long-term safety of subjects implanted with the BCI 602 by administering a surgical evaluation questionnaire to the surgeon. | 12 months post-operative | 
| Speech Spatial Qualities questionnaire | Investigate the Quality of Life with the SSQ questionnaire of subjects implanted with the BCI 602 12 months post-operative. (SSQ = Speech Spatial Qualities) | 12 months post-operative | 
| Assessment Quality of Life questionnaire | Investigate the Quality of Life with the AQoL questionnaire of subjects implanted with the BCI 602 12 months post-operative. (AQoL= Assessment Quality of Life) | 12 months post-operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bonebridge system, BCI 601, BCI 602, bone conduction, bone conduction implant