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Bonebridge active transcutaneous bone conduction hearing implant: Results in the pediatric population
Laura Cavallé Garrido1, Carlos de Paula Vernetta1, Abel Guzmán Calvete2
1Otorhinolaryngology Service, La Fe University and Polytechnic Hospital of Valencia, Spain; Departamento de Cirugía. Universidad de Valencia, Spain.
Insights
The Bonebridge BCI 602 implant is safe and effective for children with hearing loss. This active transcutaneous bone conduction device significantly improves speech understanding and hearing capabilities in pediatric patients.
Area of Science:
- Otolaryngology
- Biomedical Engineering
- Pediatric Audiology
Background:
- Conductive/mixed hearing loss (CHL/MHL) and single-sided deafness (SSD) significantly impact pediatric communication and quality of life.
- Active transcutaneous bone conduction implants offer a potential solution for hearing rehabilitation in pediatric populations.
Purpose of the Study:
- To evaluate the safety and performance of the Bonebridge BCI 602 active transcutaneous bone conduction implant in pediatric patients.
- To collect prospective and retrospective data on audiological outcomes and quality of life.
Main Methods:
- Prospective and retrospective data collection from 22 pediatric patients (aged 4-17) receiving the Bonebridge BCI 602.
- Audiological assessments (pure-tone average, word recognition score, speech-in-noise) at multiple postoperative intervals.
- Quality of life evaluation using validated questionnaires (SSQ12/P, KID KINDL, APSQ) and a custom postoperative questionnaire.
Main Results:
- Significant functional gain (31.9 dB HL) in the CHL/MHL group and improved speech recognition in noise (24.6% to 74.9%).
- High word recognition scores (83%) achieved at 3 months post-op in the CHL/MHL group.
- No major complications reported; minor issues resolved. Stable audiological thresholds confirmed safety.
Conclusions:
- The Bonebridge BCI 602 demonstrates safety and effectiveness in the pediatric population.
- The implant provides substantial audiological benefits and is well-tolerated by children.
- This technology represents a viable option for hearing rehabilitation in pediatric CHL/MHL and SSD.
Purpose:
This study provides prospective and retrospective data on safety and performance results with the Bonebridge BCI 602 (MED-EL) active transcutaneous bone conduction implant in children.
Methods:
Audiological data were collected at 3 intervals (preoperative, initial activation and 3 months postoperative). Quality of life was assessed with the Speech, Spatial, and Qualities of Hearing (SSQ12/P), KID KINDL and Audio Processor Satisfaction Questionnaire (APSQ) as well as a postoperative questionnaire specifically designed for this study.
Results:
22 pediatric patients (20 conductive/mixed hearing loss (CHL/MHL) and 2 single-sided deafness (SSD)) aged 4-17 received a BCI 602. Three-month post-op pure-tone average (PTA4) functional gain (FG) was 31.9 dB HL for the CHL/MHL group and 11.3 dB HL in the SSD patients. CHL/MHL patients had a mean word recognition score (WRS) improvement of 80.6 ± 23.9 % at initial activation and 83 ± 20.3 % at 3 months post-op. Speech recognition in noise at +5 dB SNR in the CHL/MHL group improved from 24.6 ± 28.3 % unaided to 74.9 ± 26 % aided at 3 months post-op. The mean post-op total scores were 5.5 ± 1.8 on the SSQ12/P and 8.87 ± 0.93 on the APSQ questionnaires. No major complications were noted on the postoperative questionnaire; minor complications were resolved by the end of the study. Stable bone and air conduction thresholds confirmed device safety.
Conclusion:
The Bonebridge BCI 602 is safe and effective for use in the pediatric population.
