Background: MED-EL BONEBRIDGE is an active transcutaneous device FDA-approved in the United States for patients over 12 years old. The aim of this study is to evaluate single institution outcomes for children aged 4-10 years implanted with BONEBRIDGE.

Methods: After institutional review board approval, patients were prospectively recruited into a novel indication clinical trial for device implantation beginning January 2024. Two patients undergoing off-label surgery were included. Descriptive statistics are presented.

Results: 10 children (ages 4-10 years, 40% female) underwent BONEBRIDGE implantation (9 unilateral, 1 bilateral) for conductive hearing loss (pre-operative bone conduction pure tone average (PTA) mean 62.7, range 52.5-73.8). All implants partially compressed the dura. There were no intraoperative complications, and minimal pain control was required post-operatively. Follow up has ranged from 1-12 months, with 2 patients experiencing minor complications: skin erythema, device retention difficulty. One medically complex patient had intracranial hypertension unrelated to the device post-operatively. There have not been any severe complications or need for device removal. All patients have reported benefit from device use. Consonant-nucleus-consonant (CNC) scores improved, from a mean 15% (range 0-56%) pre-operatively to mean 69% (range 44-78%) at 3 and 6 months post-operatively. Several children required replacement of the Samba 2 processor due to damage.

Conclusion: Implantation with MED-EL BONEBRIDGE has been performed safely in children as young as 4 years old with good audiometric outcomes. There have been minor wound and device retention complications, but all children continue to use and benefit from implanted devices. Long-term multi-institutional data collection is ongoing.

Background: During many decades, congenital aural atresia (CAA) was treated by surgery atresiaplasty, technically very difficult and bad results (<20 dB of functional gain). Besides, complications were frequent as restenosis and facial palsy. In 1977 the first percutaneous bone conduction devices (BAHA) was done, to bypass the outer/middle ear stimulating directly the bone structure of inner ear. Unfortunately, the rate of complications was huge. In 2012 first transcutaneous device appeared, Bonebridge (BB). Nowadays active prostheses with intact skin are the best hearing solution, with lowest rate of complications.
Method: Multicenter international study to describe the most usual approach in CAA. There are 3 approaches according Zernotti and Gavilan, Mastoid Regular approach (MARA), Postero-inferior (PIA) -misnamed retrosigmoid- and Supratemporal line approach (STELLA) or middle-fossa. Additionally, is important at the moment of election the possibility of reconstructive surgeries to improve the pinna because usually is the desire of patients or relatives; therefore, chose the approach is very important decision.
Results 135 patients implanted with BB were included. 49 (36,3%) were placed in mastoid (MARA) while only 17 (12,5%) were localized in PIA. STELLA was used in 69 patients (51,1%), being the most popular. Multiple reasons are, screws go into compact bone, the surface is flat in parietal area and is good option to posterior plastic reconstruction of pinna.
Conclusion: active transcutaneous bone conduction implants are the best option for CAA with very low incidence of complications and excellent audiological performance. The election of approach is favorable to STELLA.

Background: Children using bone conduction (BC) technology undergo a unique transition from non-surgical devices to implanted solutions. This multi-center prospective clinical trial compared audiological performance of the active transcutaneous Osia System with a non-surgical softband BC solution in children.
Methods: Fifty children aged 5-11 (mean age = 7.4) with conductive/mixed hearing loss (N=37) or single-sided deafness (SSD) (N=13) were enrolled. Pre-operative audiological assessments using a Baha 5 Power on a softband were compared to Osia System results at 3–6 months post-activation. Measures included CNC words and BKB-SIN, soundfield thresholds and parental satisfaction. Safety outcomes were monitored through 12-months post-surgery. Separate subgroup analyses were performed for SSD and mixed /conductive hearing loss.
Results: Mean CNC word scores improved significantly from a preoperative aided condition of 65.5% (SD ± 18.1%) to 85.2% (SD ± 8.7%) at six months post-activation (p<0.001). BKB-SIN SNR-50 showed significant improvement from a mean aided preoperative condition of 6.7 dB (SD ± 4.5 dB) to 4.0 dB (SD ± 3.1 dB) at six months post-activation (p=0.05). Furthermore, average soundfield thresholds with the Osia System were significantly better than preoperative aided thresholds at 2000 Hz and 4000 Hz (p= 0.009), p<0.001). These gains were consistent across both SSD and mixed/conductive groups. Parental satisfaction with the Osia was high ((mean rating 9.2 (SD ± 0.8) out of 10). Surgical and postoperative complications were minor and resolved as expected.
Conclusion: The results suggest that the Osia System provides good hearing outcomes and high parental satisfaction compared to a non-surgical option.

Background:
The Osia 2 is an active transcutaneous bone anchored hearing aid, that comprises a piezo-electrical transducer, implanted subcutaneously behind the pinna. Research showed that this piezo-electrical transducer is capable of reaching peak output performances at higher frequencies (i.e., 6-8kHz). It is expected that patients will benefit from an improved audibility at higher frequencies, especially in speech recognition-in noise. The primary objective of this study is to compare the preoperative non-surgical B81 bone conductor or conventional hearing aids (if applicable) versus the post-operative aided (Osia 2) at 3 months post-fitting.

Methods:
Fourteen adult patients with conductive or mixed hearing loss and a bone conduction threshold of 45dB or lower, who are found to be eligible candidates for treatment with a transcutaneous bone anchored hearing aid were included. At baseline (pre-operatively) unaided and aided with the B81 bone conductor and if applicable conventional hearing aids, hearing thresholds, speech recognition scores in quiet and in noise, and free field thresholds are measured. Daily usage and IOI-HA and (m)AIADH patient-reported outcomes are measured.

Results:
The trial is currently ongoing, and follow-up will be completed on short notice, certainly before the Osseo meeting .

Conclusion:
Expected results are improved aided (with Osia 2) audibility at high frequencies, also in conductive and mixed hearing loss cases. Furthermore, better audibility at high frequencies (6-8kHz) is expected to enhance speech recognition in noise.

Background:
A new active transcutaneous bone-anchored hearing implant system under evaluation for safety and performance in an ongoing clinical investigation received regulatory clearance in 2024. This abstracts' objective is to focus on performance outcomes from 16 Dutch individuals with conductive/mixed hearing losses (CHL/MHL) or single sided deafness (SSD), 24 months after implant installation.
Methods: The study includes follow-up at 3, 6, 12, and 24 months after implantation. Performance outcome variables include variables related to surgery (e.g. type of anaesthesia, and surgery time), audiology (e.g., sound field thresholds and speech intelligibility in quiet), and patient perceived benefits and quality of life (International Outcome Inventory Hearing Aids (IOI-HA)).
Results: The cohort represents an adult sub-group with a mean age of 48 (range 33-72) years; 75% CHL (n=12), 19% MHL (n=3), and 6% SSD (n=1) on the implanted side. Average surgery duration was 62 min (range 45 - 85 min). In one case, surgery was done with local anaesthesia only. The mean aided threshold i.e., 23.4 (SD 4.1) dB, measured after treatment was lower compared to the unaided situation; 46.4 (SD 8.1) dB. This resulted in a functional gain PTA4 of 25.2 dB (SD 7.7). Speech recognition in quiet was improved from 46.2% (SD 33.5) unaided, to 97.9% (SD 3.3) aided. After implant installation, the studied population showed an improved QoL, that is, a IOI-HA total score of 3.3 (SD 0.6)
Conclusion: There are significant improvements in hearing outcomes, patient benefits, and quality of life after implantation, and 24-months follow-up in patients with CHL, MHL and SSD

Background: A new active transcutaneous bone-anchored hearing implant system, under clinical evaluation for safety and performance, received regulatory clearance in 2024. This abstract presents surgical outcomes from 51 individuals with conductive/mixed hearing losses (CHL/MHL) or single-sided deafness (SSD) six months post-implantation.
Methods: Follow-ups were at 3, 6, 12, and 24 months post-implantation. Surgical outcomes included pre-operative planning, skin thickness, anaesthesia type, incision techniques, surgery duration, soft-tissue complications, and adverse events.
Results: The cohort (mean age 50, range 24-77 years) included 51% CHL, 25% MHL, and 24% SSD. Pre-operative imaging was not used in 55% of cases. No surgeries were aborted due to insufficient bone thickness or unexpected anatomy. Skin thickness varied between 4-9 mm (median/mean 6 mm). Common incision types were C-type (49%) and Lazy S (26%). Surgery duration averaged 58 minutes (range 23-85), mostly under general anesthesia; two surgeries used local anesthesia with sedation. All surgical wounds healed within two weeks, with one mild skin infection (2%). At the 6-month follow-up, 55 adverse events were reported, mainly related to the surgical procedure and immediate post-operative phase. No serious adverse events related to the procedure or device were reported.
Conclusion: The study demonstrated successful implantation without pre-operative imaging in most cases, with no surgeries aborted due to insufficient bone thickness or unexpected anatomy. All surgical wounds healed within two weeks, with minimal complications. These findings support the safety and efficiency of the surgical procedure for the new active transcutaneous bone-anchored hearing implant.

The paediatric hearing implant team offer all clinically available percutaneous and transcutaneous bone conduction implants (BCI). The team has seen a shift in device choice with families and children opting for transcutaneous BCI's if clinically appropriate. Transcutaneous BCI’s are increasingly utilized in paediatric populations with conductive or mixed hearing loss, as well as unaidable unilateral hearing loss (UUHL). The Sentio system from Oticon Medical is currently approved for use in children aged 12 years and older. A clinical trial is underway to evaluate implantation feasibility, audiological outcomes, and patient-reported outcomes in a younger paediatric population aged 3–11 years, (Clinicaltrials.gov identifier: NCT06976086)
Method:
This is a prospective, multicenter, single-arm clinical investigation of the Sentio system in children. The study evaluates multiple endpoints, including patient satisfaction, quality of life, and listening fatigue following implantation. Assessment tools include the Vanderbilt Fatigue Scale for Paediatrics (VFS-Peds), the Glasgow Children’s Benefit Inventory (GCBI), and additional instruments for measuring user satisfaction and device usability.
Results:
Preliminary findings from two children with UUHL, aged 4 and 9 years, will be presented. These early results highlight the importance of integrating patient-reported outcome measures in paediatric audiological care. Practical experiences with the fitting process of the Sentio 1 Mini sound processor, including magnet strength selection and device retention in younger children, will also be discussed.
Conclusions:
Initial conclusions suggest that the Sentio 1 Mini sound processor is straightforward to fit and user-friendly for paediatric patients. Patient-reported outcomes indicate positive experiences, and the available range of magnet strengths appears suitable for this age group.