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Active transcutaneous Bone Conduction Implant: Benefit in children

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Abstract

Active transcutaneous Bone Conduction Implant: Benefit in children
Objectives: The latest generation of the Bonebridge, the BCI 602 is intended to treat individuals with either conductive or mixed hearing loss (C/MHL) or single sided deafness (SSD). Here we present preliminary data of conductive and mixed hearing loss in children implanted with Bonebridge, in a prospective multicentric study conducted in Spain. The main objective is to demonstrate the effectiveness and safety of the Bonebridge system in the pediatric population using free field tonal and verbal thresholds.
Methods: A total of 19 paediatric patients (≤17 years) were analysed. This group encompassed 12 female, 8 male, 13 right-side and 6 left-side implanted patients with an average age of 11 years. The pure tone average (PTA4= 0.5, 1, 2,4 kHz) air bone gap measured was greater than or equal to 15 dB. Patients were their own controls (single-subject repeated measures), comparing the unaided or pre-operative to the post-operative outcomes. Performance was evaluated by sound field thresholds (SF), word recognition scores (WRS) and/or speech reception thresholds in quiet (SRT). Safety was demonstrated by stable pure-tone measurements and adverse events reported.
Results: The Bonebridge improved SF thresholds (+25.3 dB), speech intelligibility in WRS (+72,3%), SRT in quiet (+28.9 dB), speech in noise with SNR0 (+16%) and for speech in noise with SNR5 (+45,9%). AC and BC thresholds remained stable over time.
So far, only 1 paediatric individual has been excluded from the study, as it was not within the audiological criteria to participate in it. We have 2 minor adverse events to report from 2 patients that did not perform the tests on the time frame permitted. 15 out of these 19 patients have already submitted the last tests (12-month tests), which corresponds to 78,9% of the population.
Conclusions: With now more than 10 years of experience with the Bonebridge system in its latest implant generation the BCI 602 significantly improves hearing thresholds and speech understanding in patients suffering from CHL/MHL.
Authors: Dr Raúl Mellidez Acosta, Dra Natalia Jaramillo Ángel, Dr Carlos de Paula Vernetta, Dra Laura Cavallé Garrido, Hospital Universitario y Politécnico La Fe de Valencia, Spain_;_ Dr Iñigo Ruiz de Erenchun Lasa, Dra Manuela del Carmen Zapata, Hospital Universitario de Navarra, Pamplona, Spain; Dr Pedro Sarría Echegaray, Dr Claudio Carnevale, Hospital Universitario Son Espases, Palma de Mallorca, Spain.

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