Objective
The Bonebridge® (MED-EL, Innsbruck, Austria) is a partially implantable active transcutaneous Bone Conduction hearing Implant (BCI) approved in Europe for adults and children since 2012 (MED-EL, Innsbruck, Austria). The 2nd generation of the Bonebridge the BCI 602 was launched in 2019. The purpose of this post-market clinical follow-up (PMCF) study is to confirm long-term safety and performance and user device satisfaction of the BCI 602.
Patients and methods
Here we present preliminary 12 Months follow up data of 15 children with a mean age of 7 years (range 5 to 12 years) suffering from CHL (N=12) or MHL (N=3) . Patients were their own controls (single-subject repeated measures), comparing the unaided or pre-operative to the 12-month post-operative outcomes. Performance was evaluated by sound field thresholds (SF), word recognition scores (WRS) and/or speech reception thresholds in quiet (SRT) and in noise (SNR). Safety was demonstrated with a device-specific surgical questionnaire, adverse event reporting and stable pure-tone measurements. Study endpoints were stable BC PTA4 thresholds (≤ 10 dB) and improvements of ≥ 10 dB in PTA4 Functional Gain (FG), ≥ 15% in WRS, ≥ 15 dB SPL in SRT in quiet and ≥ 1.0 dB SNR in SRT in noise. The Speech Spatial Qualities questionaire for Parents (SSQ-P) was used to evaluate hearing satisfaction with the Bonebridge post-operatively.
Results 12-months post operative
Safety
The average surgery duration was 54 min. The BCI 602 (reduced drilling depth and ability to bend the transition for optimal placement) allows treatment of children with pre-operated and malformed anatomies. Air conduction (AC) and bone conduction (BC) thresholds remained stable. Only one adverse events was reported until 12 months post operative.
Performance
The Bonebridge BCI 602 significantly improved SF thresholds (+ 28.94 dB), speech intelligibility in WRS (+ 64.34% ) and SRT in quiet (− 20.77 dB ) and in noise (− 6.93 dB SNR). All audiological endpoints were reached.
Satisfaction
Mean audio processor wearing times were ~ 10.6 hours per day. The SSQ-P shows improvements of 1.6, 2.8, 1.0 and 1.7 respectively for speech understanding, spatial hearing, listening qualities and total hearing.
Conclusion
12 months after treatment the new BCI 602 in children
• allows for more placement options due to a new geometry that may be advantageous for use  in children
acknowledging thin bones, malformations, or pre-operated ears
• is safe with one AE and stable hearing thresholds
• improves hearing thresholds and speech understanding
• improves subjective listening ability and listening experience

## Objective
The Bonebridge® (MED-EL, Innsbruck, Austria) is a partially implantable active transcutaneous Bone Conduction hearing Implant (BCI) approved in Europe for adults and children since 2012 (MED-EL, Innsbruck, Austria). The 2nd generation of the Bonebridge the BCI 602 was launched in 2019. The purpose of this post-market clinical follow-up (PMCF) study is to confirm long-term safety and performance and user device satisfaction of the BCI 602.
## Patients and methods
Here we present preliminary 12 Months follow up data of 15 children with a mean age of 7 years (range 5 to 12 years) suffering from CHL (N=12) or MHL (N=3) . Patients were their own controls (single-subject repeated measures), comparing the unaided or pre-operative to the 12-month post-operative outcomes. Performance was evaluated by sound field thresholds (SF), word recognition scores (WRS) and/or speech reception thresholds in quiet (SRT) and in noise (SNR). Safety was demonstrated with a device-specific surgical questionnaire, adverse event reporting and stable pure-tone measurements. Study endpoints were stable BC PTA4 thresholds (≤ 10 dB) and improvements of ≥ 10 dB in PTA4 Functional Gain (FG), ≥ 15% in WRS, ≥ 15 dB SPL in SRT in quiet and ≥ 1.0 dB SNR in SRT in noise. The Speech Spatial Qualities questionaire for Parents (SSQ-P) was used to evaluate hearing satisfaction with the Bonebridge post-operatively.
## Results 12-months post operative
### Safety
The average surgery duration was 54 min. The BCI 602 (reduced drilling depth and ability to bend the transition for optimal placement) allows treatment of children with pre-operated and malformed anatomies. Air conduction (AC) and bone conduction (BC) thresholds remained stable. Only one adverse events was reported until 12 months post operative.
### Performance
The Bonebridge BCI 602 significantly improved SF thresholds (+ 28.94 dB), speech intelligibility in WRS (+ 64.34% ) and SRT in quiet (− 20.77 dB ) and in noise (− 6.93 dB SNR). All audiological endpoints were reached.
### Satisfaction
Mean audio processor wearing times were ~ 10.6 hours per day. The SSQ-P shows improvements of 1.6, 2.8, 1.0 and 1.7 respectively for speech understanding, spatial hearing, listening qualities and total hearing.
## Conclusion
### 12 months after treatment the new BCI 602 in children
• allows for more placement options due to a new geometry that may be advantageous for use  in children
acknowledging thin bones, malformations, or pre-operated ears
• is safe with one AE and stable hearing thresholds
• improves hearing thresholds and speech understanding
• improves subjective listening ability and listening experience

Surgical information and 12 months safety and performance results with the Bonebridge BCI 602 in the pediatric population.

It is with great pleasure and enthusiasm, that on behalf of the Cochlear Implant centers of the Radboud UMC in Nijmegen and Erasmus MC Sophia Children’s Hospital in Rotterdam to invite you to attend the 16th European Symposium on Pediatric Cochlear Implantation to Rotterdam, the Netherlands in 2023.

Yours sincerely, on behalf of the CI Centers at Radboud UMC and Erasmus MC,