Background:

Vibrant Soundbridge (VSB) is an active middle-ear implant, providing amplification for moderate to profound sensorineural and mixed hearing loss. After recent broadening of reimbursement regulations, VSB can now be considered an alternative regular treatment, next to Bone Conduction Devices (BCD), when conventional hearing aids cannot be worn.



Methods:

This study gives an overview of experiences with VSB in the two tertiary outpatient clinics and audiological centers, describing the clinical outcomes of a group of VSB patients (N=100). An additional comparison with the results of patients with a powerful BCD will also be given.

Results:

We hypothesize that the VSB provides favorable outcomes and good or better hearing performance for patients with bone conduction thresholds over 45 dB HL, even up to 55 dB HL. The comparison will show that, even though the included VSB-patients in general have a comparable or larger sensorineural hearing loss, their performance in speech intelligibility and functional gain is on average as good as as the results of the BCD-population.

Conclusion:

Future research should aim to broaden the application of VSB across a more diverse population to more accurately assess its impact on speech understanding, everyday auditory functioning, quality of life, and cost-effectiveness.

Background: Active middle ear implants (MEIs) have been used for hearing rehabilitation for over 20 years. They are indicated for individuals with mild to severe sensorineural hearing loss or mild to moderate conductive or mixed loss who are intolerant of conventional digital hearing aids. MEIs offer improved functional gain, particularly at mid to high frequencies and sound laterality, while bypassing the external auditory canal. Short- to medium-term outcomes have been reported, but data on longer-term (>20 years) benefit are scarce.

Methods: A retrospective review of medical and audiological outcomes in patients implanted with MEIs at University Hospitals Birmingham over 20 years ago was conducted. A literature review was also undertaken.

Results: Fourteen patients implanted between 1997 and 2001 were reviewed, with an average follow-up of 24 years. Short-term data (<3 months) for mean functional gain are presented. On average, devices were used for 12 years. Three patients continue to use their MEI; for two, ongoing functional gain data are presented. Reasons for non-use in the remaining 11 patients are detailed. In nine patients, hearing loss progressed into UK cochlear implant criteria.

Conclusion: Medium-term data suggest average MEI use of 6.7 years. Long-term outcome data beyond 20 years are scarce, and this is the first retrospective review of its kind, providing a valuable source for counselling patients on long-term expectations for these devices.

Background: Effective mechanical coupling between middle ear implants and the ossicles or round window is essential for optimal auditory stimulation. The VIBRANT SOUNDBRIDGE (MED-EL, Innsbruck, Austria), an active middle ear implant, can be coupled to the incus, stapes, or round window. This study investigates how different coupling strategies affect auditory transmission.
Methods: SOUNDBRIDGE implantation was performed in six ears from five fresh-frozen human cadaver heads. Three coupling sites were evaluated: the short process of the incus, stapes head, and round window. Cochlear activation was assessed by measuring pressure changes within the scala vestibuli and scala tympani using custom intracochlear acoustic receivers (ICARs). Additionally, 3D velocity measurements were performed via laser Doppler vibrometry at the implant surface, coupler, incus, and stapes.
Results: Differences in intracochlear pressure across coupling conditions were smaller than intersample variability, indicating no statistically significant effect of the coupling site on overall cochlear stimulation. However, stapes head coupling yielded the highest 3D stapes velocity, while round window coupling resulted in the lowest. Notably, the direction of stapes motion varied with the coupling strategy.
Conclusion: The choice of coupling site had no statistically significant effect on intracochlear pressure, suggesting that individual anatomical and surgical factors may outweigh the effect of the coupling method alone. Moreover, stapes velocity magnitude does not reliably predict cochlear activation, as it does not align with intracochlear pressure. In addition, the direction of motion appears critical, and while stapes motion drives cochlear stimulation for incus and stapes coupling, it is a secondary effect in round window coupling.

Background:
The transition from passive BAHA® systems (Connect/Attract) to the active Osia® implant ,Patients using passive bone conduction hearing systems, such as BAHA Connect or Attract, often encounter limitations including discomfort, skin complications, or suboptimal hearing performance. The newer Osia® active transcutaneous system offers a promising alternative. In clinical practice, there is growing interest in converting eligible patients to Osia, yet evidence remains fragmented.
Objective:
To review the current literature on clinical outcomes of patients who transitioned from BAHA systems to Osia implants, with a focus on hearing performance, patient satisfaction, and surgical considerations.including audiological results,
Methods:
A scoping review was conducted including case reports, series, and observational studies that documented BAHA-to-Osia conversions. Data were extracted regarding patient profiles, reasons for transition, surgical approach, hearing outcomes, and any complications.
Results:
The review identified over 70 reported conversions, with consistent findings across studies. Osia implantation resulted in improved hearing thresholds, especially at high frequencies, and better speech understanding in noise. Patients also reported higher comfort and reduced skin-related issues compared to BAHA systems. Most conversions were driven by chronic skin irritation (in BAHA Connect users) or discomfort from magnet pressure (in BAHA Attract users). Surgical procedures were typically straightforward, with low complication rates and favorable cosmetic results.
Conclusion:
Current evidence supports the Osia system as a reliable upgrade for selected BAHA users. It offers both audiological and quality-of-life improvements, with a safe surgical profile. Further prospective studies are needed to validate long-term outcomes in diverse patient populations.

Background:
The Vibrant Soundbridge, manufactured by MED EL, is a middle ear implant that provides a direct-drive approach to hearing for individuals with moderate to severe hearing loss who don't benefit from conventional hearing aids. It converts sound signals into mechanical vibrations that stimulate the middle ear, offering more natural sound perception than hearing aids. Surgical insertion involves a postaural incision, cortical mastoidectomy, positioning of the implant body under a pericranial flap, and careful placement of the vibrating mass transducer onto the ossicular chain or round window. This surgery has traditionally been carried out under general anaesthesia.

Methods:
Utilising surgical and anaesthetic experience from our cochlear implant programme, where an increasing proportion of patients choose local anaesthetic surgery, two patients have now been successfully and uneventfully implanted with Vibrant Soundbridge implants using local anaesthesia and dexmedetomidine sedation.

Results:
Two cases will be presented, along with techniques for successful implantation which include surgical approach, operating room setup, anaesthetic perspective, and patient communication and consent. Patient experience and satisfaction will be presented, along with plans for responsible future service development, including routinely offering local anaesthesia with sedation, to improve accessibility to hearing implantation for patients who are not suitable for general anaesthesia, and for patients who prefer not to have general anaesthesia.

Conclusion:
Middle ear implant surgery can be safely carried out under local anaesthesia and sedation, with excellent patient satisfaction and positive patient experience. Keys to success include motivated and well-prepared patients, surgical expertise in local anaesthetic auditory implantation, and anaesthetic experience in sedation techniques.

Purpose: The VSB is an established active-middle-ear-implant for patients with moderate-to-profound hearing-loss. This surgery is referred to as "Vibroplasty". Sufficient transfer of the VSB's floating-mass-transducers (FMT) energy to the inner ear is a crucial factor influencing the coupling-quality (CQ). However, assessing CQ is hamper by two issues: the method of CQ-assessment itself and the method of FMT-fixation during Vibroplasty.

Methods: This prospective study explored the influence of intraoperative auditory-brainstem-response (+ ABR) measurements and various fixation methods on postoperative CQ after Vibroplasty as compared to matched-patients after Vibroplasty without intraoperative ABR (-ABR). Propensity-score-matching was performed based on preoperative bone-conduction-pure-tone-average-3 (BC-PTA3) at 1-, 2- and 4 kHz. Primary outcome parameters were postoperative CQ-PTA3, intraoperative ABR threshold for various fixation methods and postoperative BC-PTA3.

Results: A total of 28 patients were included, of which 14 were + ABR. Preoperative BC-PTA3, sex, age, and number of previous surgeries did not differ significantly between groups (all p > 0.301). Mean postoperative CQ-PTA3 was significantly better for + ABR (1.8 vs. 12.3 dB-HL; p = 0.006). Mean intraoperative ABR threshold was superior for cartilage-counter-bearing and cartilage-housing compared to additional fixation with injectable-platelet-rich- fibrin (53 vs. 56 & 57 dB-HL, respectively; p = 0.04; η2 = 0.33). Mean postoperative BC-PTA3 did not significantly differ between patients (41.4 vs. 41.8 dB-HL; p = 0.77). A total of 7% of the patients required intraoperative readjustment of the FMT based on unsatisfactory intraoperative ABR threshold.

Conclusion: Intraoperative ABR measurement resulted in significantly better postoperative CQ. Cartilage-counter-bearing & cartilage-housing were observed to have superior CQ.

Background:
Adults and children with sensorineural, conductive or mixed hearing loss who cannot wear a hearing aid can be treated with an active middle ear implant (AMEI) like the Vibrant Soundbridge (VSB; MED-EL, Austria). A critical process is the optimal placement of the actuator of the AMEI. Various couplers have been developed that can be placed at different locations in the middle ear. Regardless of the coupler used, the coupling efficiency is crucial for the patient's postoperative hearing outcome. The aim of this study was to investigate the effectiveness of the different coupling methods with a measurement system based on auditory brainstem responses (ABR).
Methods:
This study includes data from 124 patients receiving a VSB using six different types of couplers. Preoperatively, the bone conduction thresholds were measured according to standard routine. Intraoperative ABR were recorded using a broadband stimulus and thresholds were estimated by identifying wave V of the AEP. Postoperatively, in-situ measurements of the patients' vibrogram thresholds were performed.
Results:
ABR thresholds were successfully determined in all patients. A good correlation between preoperative bone conduction and intraoperative ABR threshold confirms the reliability of the measurements. There was also a good correlation between the preoperative bone conduction thresholds and the postoperative vibrogram thresholds. No significant differences between the couplers could be detected.
Conclusion:
Intraoperative measurements can be used to assess coupling efficiency and in case of poor performance, the FMT placement can be optimized on site. In addition, this already provides a good prediction for the postoperative hearing results.

Background
Active middle ear implants, such as the Vibrant Soundbridge (VSB), offer effective hearing for patients with complex middle ear pathology unsuitable for conventional hearing aids. However, optimizing implant coupling in cases with prior ossicular dysfunction, especially following stapes mobilization, remains challenging. Objective, intraoperative assessment tools for coupling quality are needed to predict and enhance postoperative outcomes. This case report presents a novel approach utilizing intraoperative auditory brainstem response (ABR) and Coupling Quality Index (CQI) to guide round window (RW) placement of a VSB in a patient with severe mixed hearing loss and persistent tinnitus after stapes footplate mobilization.
Methods
A 63-year-old female with right-sided, severe mixed hearing loss and refractory tinnitus underwent RW VSB implantation following stapes mobilization. Intraoperative ABR and CQI measurements were used to assess and optimize coupling efficiency. Pre- and postoperative audiological outcomes were analyzed.
Results
Intraoperative ABR thresholds improved from 80 dB nHL to 75 dB nHL after stapes mobilization, with a final CQI of 21.5 dB indicating “good coupling.” Twenty days postoperatively, the patient achieved a functional hearing gain of 42.5 dB, effective gain of -10dB, stable bone conduction thresholds. The patient also reported a marked reduction in tinnitus.

Conclusion
Round window VSB placement following stapes mobilization, guided by intraoperative ABR and CQI, can achieve substantial hearing improvement and stable cochlear function in patients with complex middle ear pathology.

Abstract

Methods This is a prospective study conducted at a tertiary center. The medical records were retrieved for all patients who
underwent VSB implantation and had an intraoperative objective assessment for the coupling efficiency. AcoustiAP was used to evaluate the intraoperative ABR thresholds, which were assessed directly after the floating mass transducer (FMT) placement using acoustic CE-Chirp signals. The Vibrogram was used for the postoperative audiological evaluation. A new coupling quality index was calculated based on the intraoperative ABR thresholds.
Results Ten patients were eligible for the present study. The ABR thresholds for good coupling ranged from 35 to 60
dBnHL. The loose coupling thresholds ranged considerably from 40 to 100 dBnHL. Overall, the median intraoperative ABR
threshold at good coupling was 42.5 (40–60) dBnHL and 60 (40–100) dBnHL at loose coupling. The analysis showed that
there was a significant change in the coupling quality index at the good and loose coupling points (24.3 ± 14 vs 38.8 ± 18.2,
respectively, p < 0.001). At a cut-off value of 22.6 dB, the coupling quality index had a sensitivity of 70% and specificity of 90% for discriminating good and loose coupling.
Conclusion This study provides evidence for the utility of intraoperative ABR measurements in predicting the coupling efficiency in patients with VSB. Our results showed that the coupling quality index had an acceptable accuracy in discriminating between good and poor coupling, which can help clinicians optimize the fitting process for individuals and may ultimately lead to improved patient outcomes.