Pediatric morphometric study to guide the optimized implantation of the Osia® 2 implant system

Abstract

Purpose Continuous technological advances result in the availability of new bone conduction hearing implants, of which their suitability for pediatric patients is of major concern. The CochlearTMOsia® 2 is a new active osseointegrated steady-state implant system that uses digital piezoelectric stimulation to treat hearing loss. The implant in the United States was approved for patients aged 12 years and above, whereas the CE mark is independent of age, the only requirement is body weight of at least 7 kg. Therefore, further clinical studies are required to assess device characteristics in younger patients. The aim of our study was to perform a morphometric study among 5–12-year-old children, and to develop a surgical protocol for Osia 2 system implantation based on these findings. Methods We examined retrospectively cranial CT scans of 5–12-year-old patients from our clinical database. We measured the bone and soft-tissue thickness in the region of interest, and the position of the sigmoid sinus. 3D printed temporal bones were also used for planning. Results Soft-tissue thickness varied between 3.2 ± 0.5 mm and 3.6 ± 0.6 mm and bone thickness varied between 3.5 ± 1.1 mm and 4.7 ± 0.3 mm. The sigmoid sinus was located 1.3 ± 0.2 cm posterior to the ear canal, and the anterior distance was 4.8 ± 0.9 to 7.1 ± 1.1 mm. Conclusions Our morphometric studies showed that patients aged 5–12 have different anatomical dimensions compared to adults, but that implantation of the Osia 2 system is feasible in these patients using an altered implant positioning recommended by our data. The Cochlear™ Osia® 2 is, therefore, an option for hearing rehabilitation in younger pediatrics.

Provision of bone conduction hearing implants in England in adults and children: a review of Hospital Episode Statistics data 2012–2021

“…This correlates with the increase in availability, national recommendations and choice of devices. 1,3,5,7,8,10,11,[15][16][17][18][19][20][21]24 Competing interests. None declared…”

“…11 However, patient age at implantation is highly debated in the literature. 10,11,13,15,17 Kruyt and colleagues’ systematic review, published in 2020, suggests there is no higher rate of implant loss in children undergoing single-stage surgery. 13 In fact, it went on to suggest that the complication rate is lower in single-stage surgery compared to two-stage surgery, although specific age groups were not reviewed and the groups were too heterogeneous for formal conclusions to be made.…”

“…Two-stage procedures are more common in younger children aged under 5 years, and one-stage procedures are more common in children aged over 10 years. 10,11,15,17 These data are expected, as the clinical commissioning policy of NHS England 2013 recommends that implant surgery be performed in two stages in children aged up to 10 years. 11 However, patient age at implantation is highly debated in the literature.…”

“…It is used in those individuals with congenital or acquired absence of the ear canal, or those with pathology preventing effective sound conduction. [1][2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18] Bone conduction hearing implants consist of two parts: a processor device that converts sound to a digital signal, and a mount or attachment connecting this device to the overlying skin or directly to the temporal bone. The processor comprises a microphone, amplifier, digital processor and transducer.…”

Early Results With the New Active Bone‐Conduction Hearing Implant: A Systematic Review and Meta‐Analysis

“…Additionally, these can compare the BCI 602 to other transcutaneous implants for this group of patients. 40,41 The optimized geometry of the BCI 602 should facilitate implantation in patients with challenging anatomical conditions or with a cortical bone thickness from 4.5 mm. 10,13 Nevertheless, dura was exposed in certain cases.…”