Introduction:
Bone conduction devices (BCDs) have transformed auditory rehabilitation for patients with conductive, mixed hearing loss, or single-sided deafness (SSD). Traditional percutaneous BCDs required an abutment through the skin, often associated with skin complications in up to 22% of cases. The Osia System, a transcutaneous active implant, eliminates this need, improving patient outcomes. Evaluating its safety profile is essential to optimize clinical management and understand its impact on patient quality of life.

Objective:
To review all medical or device-related adverse events (MDRAEs) associated with the Osia System.

Methods:
In Colombia, Cochlear maintains a national database of MDRAEs. A retrospective review was conducted for reports between June 2020 and September 2024. Events were classified as either patient-related or device-related. Patient-related events were analyzed using TISA criteria; device malfunctions (DMs) were stratified by type.

Results:
Among 1,198 implants, 28 patient-related adverse events (2.3%) were reported. Eleven were TISA 1 (pain, local discomfort, MRI-related issues), seven were TISA 2 (hematomas, granulomas, infections), and ten were TISA 3 (including four explants due to pain, trauma, infection, or Vistafix complications). Additionally, six device extrusions and one magnet-related pressure event were documented. Another 28 events (2.3%) were device-related: 14 processor malfunctions, seven connection failures, one screw fracture, and six magnet or safety line issues.

Conclusion:
The Osia System shows a low overall adverse event rate (4.6%), supporting its safety and reliability. Its design offers clinical benefits and reduced complication rates compared to percutaneous systems, reinforcing its role as a safe and effective solution in bone conduction hearing rehabilitation.

Background:
Patients with a history of canal wall down (CWD) mastoidectomy often present with unstable mastoid cavities, lifestyle limitations, and limited hearing rehabilitation options. Active transcutaneous bone conduction implants offer promising outcomes, but device placement can be complicated by altered anatomy and chronic infection risk. This study evaluates the safety and efficacy of simultaneous subtotal petrousectomy with external auditory canal (EAC) oversew and active transcutaneous bone conduction implantation.

Methods:
A retrospective case series was conducted on patients with prior CWD mastoidectomies who underwent subtotal petrousectomy with EAC oversew and active transcutaneous bone conduction device placement. All procedures were performed by a single neurotologic surgeon. Outcome measures included intraoperative feasibility, postoperative complications, audiologic performance, and patient-reported satisfaction.

Results:
All cases were successfully completed without intraoperative complications. Subtotal petrousectomy created a stable, closed field for device implantation, and no postoperative infections, flap complications, or device failures were observed during follow-up. Audiologic outcomes showed improvement in aided thresholds and speech recognition. All patients reported high satisfaction, citing reduced need for cavity care, improved hearing, and favorable cosmetic results.

Conclusion:
Simultaneous subtotal petrousectomy with EAC oversew allows safe placement of active transcutaneous bone conduction implants in patients with CWD mastoid cavities. This technique mitigates chronic infection risk and facilitates successful long-term rehabilitation. These findings support broader use of this approach in complex otologic cases with compromised anatomy.

Background: The Cochlear™ Osia® 2 is an active transcutaneous implant designed to treat various types of hearing loss. Due to its size, implantation requires adequate surgical experience, as the need for an extended flap and bone work can present challenges in certain cases. Our previous study demonstrated that the Osia system can achieve good vibroacoustic performance even without fixation to the skull using the BI300 titanium implant.
Methods: In the present study, we evaluated the audiological performance of patients previously implanted with a non-fixed Osia system. Unaided pure-tone thresholds and suprathreshold testing were conducted using the Osia sound processor on the non-fixed system. These results were compared with previously recorded postoperative outcomes. Additionally, ultrasound imaging was performed to assess peri-implant capsule thickness and monitor potential implant migration.
Results: Our results indicate that omitting fixation does not significantly impair the performance of the Osia 2 system, even 12–24 months postoperatively. Clinical findings suggest that the non-fixed Osia 2 system outperformed the Baha 5 on Softband in both pure-tone and suprathreshold tests, with stable outcomes over time.
Conclusion: Based on these findings, the use of a subperiosteal pocket technique for implantation without BI300 fixation appears to be a viable surgical alternative. This approach has demonstrated promising results in improving hearing outcomes while minimizing surgery-related complications.

Background: Congenital bilateral microtia presents both aesthetic and functional challenges, with conductive hearing loss being a common complication. Bone conduction hearing devices (BCHDs) offer a promising solution for auditory rehabilitation. However, the optimal strategy for integrating BCHD implantation with auricular reconstruction remains underexplored, especially in pediatric populations with underdeveloped mastoid structures.
Methods: This retrospective study included 41 pediatric patients (aged 8–16 years) with bilateral microtia who underwent simultaneous auricle reconstruction and BCHD implantation between January 2018 and January 2024. Patients were divided into three groups based on the device used: Baha Attract (n=13), Sophono (n=18), and Bone Bridge (n=10). Audiometric assessments (free-field pure tone thresholds and speech recognition thresholds) and postoperative complications were analyzed.
Results: Significant auditory improvement was observed across all groups post-implantation. Mean free-field hearing thresholds improved from 57.6 ± 7.42 dB SPL to 22.19 ± 6.40 dB SPL (p<0.001), and speech recognition thresholds improved from 69.42 ± 4.21 dB to 39.16 ± 6.78 dB (p<0.001). No statistically significant differences in hearing gain were noted among the three device groups. Reported complications were mostly mild and resolved with conservative treatment, including transient skin erythema, pressure discomfort, and hematoma. No adverse events compromised the safety or appearance of the reconstructed auricle.
Conclusion: Simultaneous BCHD implantation and auricular reconstruction is a safe and effective approach for bilateral microtia patients. All three devices demonstrated satisfactory auditory outcomes. Device selection should consider anatomical constraints and potential soft tissue complications, particularly in patients with limited mastoid space.

Background
This study investigated the safety of utilizing further posterior placement than recommended by the manufacturer of a bone conduction implant and compared its auditory performance to that of implants placed in the recommended location.

Method
This is a prospective cohort study included children (aged ≤ 18 years) who received the Osia System implantation between January 2022 and May 2024. We recorded demographics, comorbidities, radiological imaging findings, operative details, pre- and postoperative audiological testing (audiometric measurements, speech discrimination, and sound localization), surgical outcomes, and complications. We compared the outcomes of placing the BI300 at 5.5 cm and 7 cm from the external auditory canal.

Results
This study included 23 children (29 implants) with a median implantation age of 7 years (range 3–17 years). Six patients underwent simultaneous bilateral implantation, and none of the patients experienced serious complications. Group 1 (5.5 cm) had 12 implants, and Group 2 (7 cm) had 17 implants. There was no difference in median pure-tone average postoperatively, 21.67 dB HL for group 1 and 20.83 dB HL for group 2 (p = 0.66). Speech discrimination was comparable between the groups (92% and 95%, respectively). Sound localization improved significantly in both groups (Group 1: from 26% to 90% and Group 2: from 30% to 85%), without any statistically significant difference between the groups.

Conclusion
Placing the BI300 at 7 cm posterior to the external auditory canal yielded an auditory performance similar to the manufacturer’s recommendation of 5.5 cm. Postero-inferior incision approach, can be an option for children prior to auricular reconstruction.

Background
According to the anatomical landmarks of the lateral aspect of the skull, there are three types of approaches, mastoid (over the mastoid cell complex), middle fossa (situated above supratemporal line) and retrosigmoid (placed behind the sigmoid sinus). Even though these terms are accurate, they seem to have neurosurgical implication. Therefore Zernotti and Gavilan proposed more suitable names: MARA (MAstoid Regular Approach), PIA (Postero-Inferior Approach) and STELLA (Supra TemporaL Line Approach).
Methods
Based on 100 bone conduction implants surgery performed, pearls and pitfalls were described according to the approach elected.
In MARA, the main tip is to get enough anatomical space. The use of OTOPLAN seems suitable. The screw needs to be fitted in solid cortical bone, and not in the air mastoid cells, meaning one screw should be over the bone of temporal line, the other over thick cortical surface. In the PIA, care must be taken with the emissary vein. Drilling must be performed 5 cm posterior to the external auditory canal, near the asterion. Finally in STELLA, duramater is necessary exposed and knowledge of the middle meningeal artery and Labbe’s vein position is needed.
Results:
In the series of one hundred patients only three had complications, partial necrosis of skin, seroma and neuralgic pain. These complications were not attributed to the prosthesis
Conclusion:
Planning surgery is crucial step, the 3 approaches have precise indications. Anatomic knowledge of the zone is essential, and the knowledge of pearls and pitfalls help us to avoid complications reaching better audiological results.

Bone conduction implants (BCI) represent an innovative solution for individuals with conductive, mixed hearing loss, and SSD, where traditional hearing aids may not be effective. Access to various devices requires knowledge of their indications, criteria, capabilities, and limitations. The Osia, Bonebridge, and Sentio implants differ in design, mechanisms of action, and fitting range and require specific anatomical conditions. The aim of the study was to compare the effectiveness of three bone conduction implants.
The study involved 24 patients with conductive or mixed hearing loss who underwent implantation with Osia (n=8), Bonebridge (n=8), and Sentio (n=8). All patients were evaluated for quality of life and hearing levels in different acoustic conditions. Assessments were conducted before implantation and one-month post-activation. Audiological tests and the Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire were used to evaluate hearing quality.
One month post-activation, we measured aided free-field thresholds across frequencies 500, 1000, 2000, and 4000 Hz. Speech discrimination in free-field conditions improved: Osia improved from 1.7% to 94%, Sentio from 5.5% to 94.5%, and Bonebridge from 3.3% to 91.5%. Matrix test results indicated improvements in speech-in-noise perception. APHAB questionnaire results demonstrated notable reductions in perceived hearing difficulties. However, a decline was observed in the Aversiveness (AV) subscale for OSIA users.
Bonebridge, Sentio, and Osia are effective rehabilitation devices for children and adults with various hearing loss. The choice of the appropriate BCI system depends on hearing test results, age, anatomical conditions, and individual needs. All implant systems provided significant improvements in hearing thresholds, speech discrimination, and speech-in-noise perception.

Background: Bone-conduction implants are a well established and promising treatment option for conductive, mixed hearing losses and single-sided deafness. The Osia® System is an active osseointegrated implant utilising a piezoelectric transducer. We present our experience from 125 consecutive implantations. The key learnings from surgical and audiological perspective are shared.

Methods: Data was collected prospectively on 125 consecutive adult Osia® implantations during a three-year period. The clinical outcomes were reviewed retrospectively. Two audiologists performed the assessments and activations and the surgeries were undertaken by 3 surgeons.

Results: 125 Osia® devices were implanted in 94 patients during the three-year period (bilateral implantation in 31 (24.8%)). The mean age of recipients was 54.2 years (range 21yrs – 79yrs). The mean duration of surgery was 41min (range 25min to 70min). The indications were mixed hearing loss in 94 (75%), conductive in 17 (13.6%) and single sided deafness in 14 (11.2%) The most commonly used incision was the Sheffield ‘S’ incision (72%). Bone polishing was undertaken in 38 (30%). Twelve (9.6%) experienced minor complications (pain and numbness), none of which were device-related. The average gain in conductive and mixed loss was 42dB. Three devices (2.4%) were explanted due to wound breakdown from patient related factors.

Conclusion: The active transcutaneous piezoelectric Osia® System is a significant advancement in the auditory implantation portfolio. It is a safe, stable device with sustained predictable output along with high patient usage and satisfaction. There were no device failures and low patient related complications.

Background:
The Bonebridge system is an active transcutaneous bone conduction implant indicated for patients with conductive or mixed hearing loss. The middle fossa approach offers a viable alternative for patients with unfavorable mastoid anatomy. This study reports on a 11-year institutional experience using the middle fossa technique, comparing audiologic and surgical outcomes between the first-generation (BCI 601) and second-generation (BCI 602) Bonebridge implants.
Methods:
A retrospective review was conducted of 62 patients who underwent unilateral Bonebridge implantation via the middle fossa approach between April 2013 and June 2024. Audiometric data included preoperative air conduction (AC) and bone conduction (BC) pure-tone averages (PTAs) at 0.5-3.0 kHz, postoperative aided thresholds, functional gain (FG), and speech perception scores (CNC words, AzBio sentences) at 3 months. Surgical outcomes and complications were also recorded.
Results:
Fifty-nine patients met inclusion criteria (mean age: 45.4 years; 36 conductive, 23 mixed hearing loss). The BCI 601 group (n=44) had mean AC and BC PTAs of 64.3±14.7 dB and 24.4±12.4 dB; the BCI 602 group (n=15) had 65.0±20.1 dB and 26.6±20.8 dB. Mean functional gain was 38.8±16.1 dB across the cohort, with no significant difference between groups (601: 38.4±15.0 dB; 602: 39.9±19.7 dB; p=0.79). Speech perception improved in both groups postoperatively. No intraoperative complications or revision surgeries were reported.
Conclusion:
The middle fossa approach for Bonebridge implantation demonstrates favorable audiologic benefit and an excellent safety profile. Outcomes were equivalent across BCI 601 and BCI 602 models, supporting the ongoing use of this technique for appropriately selected patients.