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Examination of objective as well as subjective outcomes with a new transcutaneous bone-anchored hearing aid device. The study was designed as a prospective multicenter consecutive case-series study involving tertiary referral centers at two Danish University Hospitals. A total of 23 patients were implanted. Three were lost to follow-up. Patients had single-sided deafness, conductive or mixed hearing loss. Intervention: Rehabilitative. Aided and unaided sound field hearing was evaluated objectively using (1) pure warble tone thresholds, (2) pure-tone average (PTA4), (3) speech discrimination score (SDS) in quiet, and (4) speech reception threshold 50% at 70 dB SPL noise level (SRT50%). Subjective benefit was evaluated by three validated questionnaires: (1) the IOI-HA, (2) the SSQ-12, and (3) a questionnaire evaluating both the frequency and the duration of hearing aid usage. The mean aided PTA4 was lowered by 14.7 dB. SDS was increased by 37.5% at 50 dB SPL, SRT50% in noise improved 1.4 dB. Aided thresholds improved insignificantly at frequencies above 2 kHz. 52.9% of the patients used their device every day, and 76.5% used the device at least 5 days a week. Mean IOI-HA score was 3.4, corresponding to a good benefit. In SSQ-12, “quality of hearing” scored especially high. Patients with a conductive and/or mixed hearing loss benefitted the most. This device demonstrates a significant subjective hearing benefit 8 month post surgery. In patients with conductive and/or mixed hearing losses, patient satisfaction and frequency of use were high. Objective gain measures showed less promising results especially in patients with single-sided deafness (SSD) compared to other bone conduction devices.

This study investigated sound localization abilities in patients with bilateral conductive and/or mixed hearing loss (BCHL) when listening with either one or two middle ear implants (MEIs). Sound localization was measured by asking patients to point as quickly and accurately as possible with a head-mounted LED in the perceived sound direction. Loudspeakers, positioned around the listener within a range of +73°/−73° in the horizontal plane, were not visible to the patients. Broadband (500 Hz–20 kHz) noise bursts (150 ms), roved over a 20-dB range in 10 dB steps was presented. MEIs stimulate the ipsilateral cochlea only and therefore the localization response was not affected by crosstalk. Sound localization was better with bilateral MEIs compared with the unilateral left and unilateral right conditions. Good sound localization performance was found in the bilaterally aided hearing condition in four patients. In two patients, localization abilities equaled normal hearing performance. Interestingly, in the unaided condition, when both devices were turned off, subjects could still localize the stimuli presented at the highest sound level. Comparison with data of patients implanted bilaterally with bone-conduction devices, demonstrated that localization abilities with MEIs were superior. The measurements demonstrate that patients with BCHL, using remnant binaural cues in the unaided condition, are able to process binaural cues when listening with bilateral MEIs. We conclude that implantation with two MEIs, each stimulating only the ipsilateral cochlea, without crosstalk to the contralateral cochlea, can result in good sound localization abilities, and that this topic needs further investigation.

Active middle ear implants (AMEIs) such as the Vibrant Soundbridge (VSB) offer an effective treatment option for patients with mixed or conductive hearing loss and large air–bone gaps, where conventional hearing rehabilitation often fails. However, postoperative outcomes—particularly speech intelligibility at 65 dB SPL in free-field (WRS 65dB )—show high interindividual variability. This study aimed to develop a predictive model for WRS 65dB based on four clinically relevant parameters: postoperative bone conduction thresholds (BC PTA4 ), unaided preoperative maximum speech intelligibility (WRS max ), Vibrogram threshold (VIB PTA4 ), and age. Data from 20 patients were analyzed. Spearman’s correlation revealed significant associations between WRS 65dB and postoperative BC PTA4 , preoperative WRS max , and age. Using a seven-step approach supported by GPT-4o, we developed a sigmoid-transformed linear regression model. The final model included BC PTA4 , WRS max , and age and achieved an R² of 0.51, r  = 0.71, RMSE = 6.18, and MAE = 4.67. Model performance was assessed by means of residual and outlier analysis. This model provides a transparent and clinically applicable tool for preoperative outcome estimation in VSB candidates. Further validation in larger, multicenter cohorts is needed to confirm its generalizability.

Conductive nanofiber mats can be used in a broad variety of applications, such as electromagnetic shielding, sensors, multifunctional textile surfaces, organic photovoltaics, or biomedicine. While nanofibers or nanofiber from pure or blended polymers can in many cases unambiguously be prepared by electrospinning, creating conductive nanofibers is often more challenging. Integration of conductive nano-fillers often needs a calcination step to evaporate the non-conductive polymer matrix which is necessary for the electrospinning process, while conductive polymers have often relatively low molecular weights and are hard to dissolve in common solvents, both factors impeding spinning them solely and making a spinning agent necessary. On the other hand, conductive coatings may disturb the desired porous structure and possibly cause problems with biocompatibility or other necessary properties of the original nanofiber mats. Here we give an overview of the most recent developments in the growing field of conductive electrospun nanofiber mats, based on electrospinning blends of spinning agents with conductive polymers or nanoparticles, alternatively applying conductive coatings, and the possible applications of such conductive electrospun nanofiber mats.

Purpose The primary objective of the retrospective study was to collect speech intelligibility data on children and adolescents implanted with the vibrating ossicular prosthesis (VORP) 503. Methods This was a retrospective, multicentre study on 55 children and adolescents from 6 German clinics aged between 5 and 17 years suffering from mixed or conductive hearing loss implanted with a VORP 503. Pre- and postoperative bone-conduction pure tone thresholds were measured at 0.5, 1, 2 and 4 kHz, and word recognition scores in the unaided and VORP 503-aided conditions using monosyllabic speech intelligibility tests measured at 65-dB sound pressure level (SPL) were determined. Results Mean pre- and postoperative bone-conduction thresholds remained unchanged, showing the preservation of inner ear hearing. Speech intelligibility assessed in quiet at 65-dB SPL improved on average from 24.5% (SD ± 25.4) unaided to 86.4% (SD ± 13.4) aided. The average improvement of 61.9% (SD ± 25.3) was clinically and statistically significant. A total of three complications were found in the medical records of 55 subjects. The responsible investigators judged these events as procedure related. Conclusion The treatment of children suffering from conductive or mixed hearing loss with the VORP 503 implant demonstrates excellent aided benefit in terms of speech understanding and only minor complications.

To evaluate the long-term benefits in hearing-related quality of life, patient satisfaction and wearing time of patients rehabilitated with an active transcutaneous bone-conduction device. Adverse events and audiological outcomes are reported as secondary outcomes. This retrospective, mono-centric cohort analysis involves 16 adults with conductive or mixed hearing loss with a mean device experience of 51.25 months. Patient-reported outcome measures were assessed using the short version of the Speech, Spatial and Qualities of Hearing Scale (SSQ12-B) and the German version of the Audio Processor Satisfaction Questionnaire (APSQ). Audiological outcomes as well as incidence of adverse events were obtained from patients´ charts. The hearing-related quality of life improved significantly within all subscales of the SSQ12-B scoring a mean overall of 2.95 points. Patient satisfaction measured with the APSQ scored 8.8 points on average. Wearing times differed considerably and patients with lower levels of education seemed to use their device longer compared to patients with academic education. Eight minor adverse events were documented, all of which resolved during follow-up. The mean gain in word recognition score at the last follow-up measured at 65 dB was 75.9%, while speech reception threshold was lowered by 35.1 dB. Even after several years, patients report significant benefits in hearing-related quality of life and device satisfaction. In combination with a low rate of minor adverse events and significantly improved audiological outcomes, the device is considered as a comfortable and effective option in hearing rehabilitation.

Purpose Aim of the study was to evaluate the surgical, clinical and audiological outcome of 32 implantations of the Bonebridge, a semi-implantable transcutaneous active bone conduction implant. Methods In a retrospective cohort study, we analyzed data for 32 implantations in 31 patients (one bilateral case; seven age < 16 years) with conductive or mixed hearing loss, malformations, after multiple ear surgery, or with single-sided deafness as contralateral routing of signal (CROS). Results Four implantations were done as CROS. Five cases were simultaneously planned with ear prosthesis anchors, and 23 implantations (72%) were planned through three-dimensional (3D) “virtual surgery.” In all 3D-planned cases, the implant could be placed as expected. For implant-related complications, rates were 12.5% for minor and 3.1% for major complications. Implantation significantly improved mean sound field thresholds from a preoperative 60 dB HL (SD 12) to 33 dB HL (SD 6) at 3 postoperative months and 34 dB HL (SD 6) at > 11 postoperative months ( p  < 0.0001). Word recognition score in quiet at 65 dB SPL improved from 11% (SD 20) preoperatively to 74% (SD 19) at 3 months and 83% (SD 15) at > 11 months ( p  < 0.0001). The speech reception threshold in noise improved from − 1.01 dB unaided to − 2.69 dB best-aided ( p  = 0.0018). Conclusion We found a clinically relevant audiological benefit with Bonebridge. To overcome anatomical challenges, we recommend preoperative 3D planning in small and hypoplastic mastoids, children, ear malformation, and simultaneous implantation of ear prosthesis anchors and after multiple ear surgery.

Active middle ear implants such as the Vibrant Soundbridge (VSB) represent effective treatment options for patients with conductive or mixed hearing loss when conventional hearing aids are insufficient. Nevertheless, postoperative speech intelligibility varies considerably, even among patients with comparable audiometric profiles. This first part of a two-part prospective observational study aimed to analyze outcomes and identify clinically accessible predictors of postoperative speech intelligibility. Twenty adults who underwent unilateral VSB implantation were included. Audiological assessments comprised postoperative bone conduction (BC), Vibrogram (VIB), free-field thresholds, maximum unaided speech intelligibility (WRS max ), and aided speech intelligibility at 65 dB SPL (WRS 65dB ). Additional parameters included coupling efficiency, effective gain, dynamic range, loudness scaling, and patient-reported outcomes (PROMs; IOI-HA, SSQ12). Key predictors of WRS 65dB were identified using Spearman correlation analysis (ρ). The mean postoperative WRS 65dB was 81.5% (SD = 9.0%). The strongest correlations were observed with age (ρ = − 0.63) and two surrogate parameters of cochlear reserve - WRS max (ρ = 0.56) and postoperative BC PTA4 (ρ = − 0.52). PROMs confirmed high subjective benefit and displayed correlations with audiological outcomes. Age, WRS max and postoperative BC PTA4 will serve as the basis for the AI-based prediction model presented in part II. The correlation of PROMs with audiological outcomes highlights the importance of integrating objective and subjective measures in hearing rehabilitation.

Purpose To present the surgical outcomes and one-year audiological and quality of life results of implantation of the Osia ®  2 active piezoelectric bone conduction implant. Methods Twenty adults with mixed and conductive hearing loss were implanted with the Osia ® 2 system and followed up for at least one year. The surgical course, healing, and soft tissue condition were assessed. Audiometric tests included pure tone audiometry, speech audiometry and direct bone conduction measurements. Participants completed the APHAB and SSQ questionnaires. Results All surgeries were successful. No soft tissue problems were observed. Pure tone audiometry showed a mean functional gain of 47.4 ± 5.6 dB HL ( p  = 0.000089). The Polish Monosyllabic Word Test showed mean improvements for silent, medium and loud speech of 59.5 ± 1.8%, 46.5 ± 32.3% and 13.3 ± 20.9% in quiet and 38.5 ± 24.4%, 62.0 ± 9.1%, and 36.5 ± 34.4% in noise (all p  < 0.05). The Polish Matrix Test indicated a mean SNR improvement of 8.78 ± 2.31 dB SPL ( p  = 0.000155). BC in situ measurements were significantly better post-implantation compared to preoperative levels with Baha ®  6 Max on the Softband. APHAB scores showed significant improvements in global, ease of communication, background noise and reverberation scores (all p  < 0.001). SSQ scores improved significantly in speech, spatial and quality subscales (all p  < 0.000001). Conclusion The Osia ®  2 implantation is an effective treatment for patients with mixed and conductive hearing loss. The surgery is relatively easy and safe, with no significant postoperative or magnet pressure-related complications. Osia ®  2 significantly improves speech understanding in noise and reduces communication problems.

This study aimed to characterize effects of bilateral bone conduction devices (BCD) including the Cochlear™ Osia ® (Osia) and the Cochlear™ percutaneous Baha ® Connect System (Baha) on localization of stationary and moving sound in children and adolescents with bilateral atresia. Participants were 11 listeners with BCDs [ M Age (SD) = 14.7(3.5) years] and 11 age-matched controls [ M Age (SD) = 14.9(1.9) years]. Outcomes were word recognition in quiet and noise, spatial release from masking (SRM) [spondee-word recognition thresholds in noise at co-located/0° or separated (90° left/right) positions], self-reported hearing using the Speech, Spatial and Qualities of Hearing Scale (SSQ), and localization of stationary and moving sound with tracking of real-time unrestricted head movements. BCD users had reduced speech perception accuracy in noise during unilateral listening ( p < .001) and higher speech recognition thresholds than controls ( p = .001). BCD users had higher errors than controls during stationary ( p < .001) and moving ( p < .001) sound localization consistent with self-reported spatial hearing challenges. BCD users had significantly reduced errors during bilateral use compared to unilateral use for stationary ( p < .01) but not always for moving (right unilateral: p < .01; left unilateral: p = .46) sound localization. BCD users spent less time moving their heads in the correct direction compared to controls for stationary and moving sound localization ( p < .01). Results indicate that children and adolescents with BCDs demonstrate improved localization of stationary but not moving sound-sources, with bilateral device use compared to unilateral use. This finding provides evidence for some access to binaural cues and mitigation of head shadow despite transcranial attenuation, but ineffective use of head movements.