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Introduction: Bone conduction implants have been indicated for patients with conductive hearing loss, mixed hearing loss, and even profound unilateral sensorineural hearing loss. With the introduction of Bonebridge®, new transcutaneous implant options emerged. The latest is Osia®, a direct-drive variant or active systems, where the implant directly generates and applies vibration to the bone. Materials and Methods: Retrospective study of two cohorts of patients treated with active bone conduction implants at a single center, one with the Bonebridge® device and the other with Osia®. Outcomes: Fourteen patients were included, seven in each group (n = 14). The Bonebridge® group showed an average hearing gain in tonal intelligibility thresholds of 32.43 ± 21.39 dB and a gain in the average intelligibility threshold (with 50% discrimination) of 26.29 ± 19.10 dB. In the Osia® group, there was a gain in average tonal thresholds of 41.49 ± 14.16 dB and 23.72 ± 6.98 dB in average intelligibility thresholds. Both devices contributed to improvements in patients' quality of life, as assessed with APHAB in all the variables studied in the test. Both devices offer rehabilitation for hearing loss as an alternative to hearing aids. The Osia® system shows statistically significant (p < 0.05) improvements in mid and high frequencies, but Bonebridge® slightly outperforms in speech understanding at 50%. Differences in average tonal thresholds and quality of life are not statistically significant. Conclusions: While auditory improvement is observed postimplantation, other aspects, such as intelligibility thresholds and quality of life, lack statistical significance. Given the limited experience with Osia® and the small sample size, the choice of the device should be personalized. Although the literature is inconsistent due to small sample sizes and variable approaches, some studies suggest potential advantages of the Osia® system, especially in speech comprehension in different environments and greater hearing gain compared to Bonebridge®. [ABSTRACT FROM AUTHOR]

Introduction: Bone conduction implants have been indicated for patients with conductive hearing loss, mixed hearing loss, and even profound unilateral sensorineural hearing loss. With the introduction of Bonebridge®, new transcutaneous implant options emerged. The latest is Osia®, a direct-drive variant or active systems, where the implant directly generates and applies vibration to the bone. Materials and Methods: Retrospective study of two cohorts of patients treated with active bone conduction implants at a single center, one with the Bonebridge® device and the other with Osia®. Outcomes: Fourteen patients were included, seven in each group (n = 14). The Bonebridge® group showed an average hearing gain in tonal intelligibility thresholds of 32.43 ± 21.39 dB and a gain in the average intelligibility threshold (with 50% discrimination) of 26.29 ± 19.10 dB. In the Osia® group, there was a gain in average tonal thresholds of 41.49 ± 14.16 dB and 23.72 ± 6.98 dB in average intelligibility thresholds. Both devices contributed to improvements in patients' quality of life, as assessed with APHAB in all the variables studied in the test. Both devices offer rehabilitation for hearing loss as an alternative to hearing aids. The Osia® system shows statistically significant (p < 0.05) improvements in mid and high frequencies, but Bonebridge® slightly outperforms in speech understanding at 50%. Differences in average tonal thresholds and quality of life are not statistically significant. Conclusions: While auditory improvement is observed postimplantation, other aspects, such as intelligibility thresholds and quality of life, lack statistical significance. Given the limited experience with Osia® and the small sample size, the choice of the device should be personalized. Although the literature is inconsistent due to small sample sizes and variable approaches, some studies suggest potential advantages of the Osia® system, especially in speech comprehension in different environments and greater hearing gain compared to Bonebridge®. [ABSTRACT FROM AUTHOR]

Objective: The bone conduction implant (BCI) 602 is a new transcutaneous BCI with smaller dimensions. However, limited patient numbers restrict the statistical power and generalizability of the current studies. The present systematic review and meta‐analysis summarize early audiological and medical outcomes of adult and pediatric patients implanted with the BCI 602 due to mixed or conductive hearing loss. Data Source: Following the Preferred Reporting items for Systematic Reviews and Meta‐analyses guidelines, 108 studies were reviewed, and 6 (5.6%) were included in the meta‐analysis. Review Method: The data on study and patient characteristics, surgical outcomes, and audiological test results were extracted from each article. Meta‐analysis employed the fixed‐effect and random‐effects models to analyze the mean differences (MDs) between pre‐ and postoperative performances. Results: In total, 116 patients were evaluated, including 64 (55%) adult and 52 (45%) pediatric patients. No intraoperative adverse events were reported, while postoperative complications were reported in 2 (3.1%) adult and 2 (3.8%) pediatric patients. Studies consistently showed significant improvements in audiological outcomes, quality of life, and sound localization in the aided condition. In the meta‐analysis, we observed a significant difference in the unaided compared to the aided condition in sound field thresholds (n = 112; MD, −27.05 dB; P < 0.01), signal‐to‐noise ratio (n = 96; MD, −6.35 dB; P < 0.01), and word recognition scores (n = 96; MD, 68.89%; P < 0.01). Conclusion: The implantation of the BCI 602 was associated with minimal surgical complications and excellent audiological outcomes for both the pediatric and the adult cohort. Therefore, our analysis indicates a high level of safety and reliability. Further research should focus on direct comparisons with other BCIs and long‐term functional outcomes. [ABSTRACT FROM AUTHOR]

Purpose: To identify audiological and demographic variables that predict speech recognition abilities in patients with bilateral microtia who underwent Bonebridge (BB) implantation. Methods: Fifty patients with bilateral microtia and bilateral conductive hearing loss (CHL) who underwent BB implantation were included. Demographic data, preoperative hearing aid use experience, and audiological outcomes (including pure-tone hearing threshold, sound field hearing threshold [SFHT], and speech recognition ability) for each participant were obtained. The Chinese-Mandarin Speech Test Materials were used to test speech recognition ability. The word recognition score (WRS) of disyllabic words at 65 dB SPL signals was measured before and after BB implantation in quiet and noisy conditions. Results: The mean preoperative WRS under quiet and noisy conditions was 10.44 ± 12.73% and 5.90 ± 8.76%, which was significantly improved to 86.38 ± 9.03% and 80.70 ± 11.34%, respectively, following BB fitting. Multiple linear regression analysis revealed that lower preoperative SFHT suggested higher preoperative WRS under both quiet and noisy conditions. Higher age at implantation predicted higher preoperative WRS under quiet conditions. Furthermore, patients with more preoperative hearing aid experience and lower postoperative SFHT were more likely to have higher postoperative WRS under both quiet and noisy testing conditions. Conclusions: This study represents the first attempt to identify predictors of preoperative and postoperative speech recognition abilities in patients with bilateral microtia with BB implantation. These findings emphasize that early hearing intervention before implantation surgery, combined with appropriate postoperative fitting, contributes to optimal benefits in terms of postoperative speech recognition ability. [ABSTRACT FROM AUTHOR]

Objective: To investigate the safety and efficacy of a novel active transcutaneous bone conduction implant (BCI) device for patients with single‐sided deafness (SSD). Study Design: Prospective cohort study. Setting: Tertiary referral hospitals. Methods: This prospective multicenter study was conducted at 15 institutions nationwide. Thirty adult (aged ≥19 years) SSD patients were recruited. They underwent implantation of an active transcutaneous BCI device (Bonebridge BCI602). Objective outcomes included aided pure‐tone thresholds, aided speech discrimination scores (SDSs), and the Hearing in Noise Test (HINT) and sound localization test results. The Bern Benefit in Single‐Sided Deafness (BBSS) questionnaire, the Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire, and the Tinnitus Handicap Inventory (THI) were used to measure subjective benefits. Results: The mean aided pure‐tone threshold was 34.2 (11.3), mean (SD), dB HL at 500 to 4000 Hz. The mean total BBSS score was 27.5 (13.8). All APHAB questionnaire domain scores showed significant improvements: ease of communication, 33.6 (23.2) versus 22.6 (21.3), P =.025; reverberation, 44.8 (16.6) versus 32.8 (15.9), P =.002; background noise, 55.5 (23.6) versus 35.2 (18.1), P <.001; and aversiveness, 36.7 (22.8) versus 25.8 (21.4), P =.028. Moreover, the THI scores were significantly reduced [47.4 (30.1) versus 31.1 (27.0), P =.003]. Congenital SSD was a significant factor of subjective benefit (−11.643; 95% confidence interval: −21.946 to −1.340). Conclusion: The BCI602 active transcutaneous BCI device can provide functional hearing gain without any adverse effects and is a feasible option for acquired SSD patients with long‐term deafness. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the magnetic resonance (MR) image artifact and image distortion associated with the two transcutaneous bone conduction implants currently available in the United States. Study Design: Cadaveric study. Methods: Two cadaveric head specimens (1 male, 1 female) were unilaterally implanted according to manufacturer guidelines and underwent MR imaging (General Electric and Siemens 1.5 T scanners) under the following device conditions: (1) no device, (2) Cochlear Osia with magnet and headwrap, (3) Cochlear Osia without magnet, and (4) MED‐EL Bonebridge with magnet. Maximum metal mitigation techniques were employed in all conditions, and identical sequences were obtained. Blinded image scoring (diagnostic vs nondiagnostic image) was performed by experienced neuroradiologists according to anatomical subsites. Results: All device conditions produced artifact and image distortion. The Osia with magnet produced diagnostic T1‐ and T2‐weighted images of the ipsilateral temporal bone, however, non‐echo planar imaging diffusion‐weighted imaging (DWI) was nondiagnostic. The Osia without magnet scanned on the Siemens MR imaging demonstrated the least amount of artifact and was the only condition that allowed for diagnostic imaging of the ipsilateral temporal bone on DWI. The Bonebridge produced a large area of artifact and distortion with the involvement of the ipsilateral and contralateral temporal bones. Conclusion: In summary, of the three device conditions (Osia with magnet, Osia without magnet, and Bonebridge), Osia without magnet offered the least amount of artifact and distortion and was the only condition in which diagnostic DWI was available for the middle ear and mastoid regions on the Siemens MR imaging scanner. [ABSTRACT FROM AUTHOR]

Background: The BONEBRIDGE® (Med-El GmbH) is a bone-conduction device comprising an external audio processor and an internal Bone Conduction-Floating Mass Transducer (BC-FMT) surgically anchored to the temporal bone. Due to the implant's size, its placement may be challenging in certain anatomies, necessitating thorough surgical planning. Manual planning methods are laborious, time-intensive, and prone to errors. This study aimed to develop and validate an automated algorithm for determining skull thickness, aiding in the surgical planning of the BONEBRIDGE and other devices requiring similar bone thickness estimations. Materials and methods: Twelve cadaveric temporal bones underwent clinical computed tomography (CT). A custom Python algorithm was developed to automatically segment bone from soft tissue, generate 3D models, and perform ray-tracing to estimate bone thickness. Two thickness colormaps were generated for each sample: the cortical thickness to the first air cell and the total thickness down to the dura. The algorithm was validated against expert manual measurements to achieve consensus interpretation. Results: The algorithm estimated bone-to-air thicknesses (mean = 4.7 mm, 95% Confidence Interval [CI] of 4.3–5.0 mm) that closely matched the expert measurements (mean = 4.7 mm, CI of 4.4–5.0 mm), with a mean absolute difference (MAD) of 0.3 mm. Similarly, the algorithm's estimations to the dura (6.0 mm, CI of 5.4–6.5 mm) were comparable to the expert markings (5.9 mm, CI of 5.4–6.5 mm), with a MAD of 0.3 mm. Conclusions: The first automated algorithm to calculate skull thickness to both the air cells and dura in the temporal bone was developed. Colormaps were optimized to aid with the surgical planning of BONEBRIDGE implantation, however the tool can be generalized to aid in the surgical planning of any bone thickness application. The tool was published as a freely available extension to the open-source 3D Slicer software program (www.slicer.org).

Purpose: The SAMBA 2 BB audio processor for the BONEBRIDGE bone conduction implant features a new automatic listening environment detection to focus on target speech and to reduce interfering speech and background noises. The aim of this study was to evaluate the audiological benefit of the SAMBA 2 BB (AP2) and to compare it with its predecessor SAMBA BB (AP1). Methods: Prospective within-subject comparison study. We compared the aided sound field hearing thresholds, speech understanding in quiet (Freiburg monosyllables), and speech understanding in noise (Oldenburg sentence test) with the AP1 and AP2. Each audio processor was worn for 2 weeks before assessment and seven users with single-sided sensorineural deafness (SSD) participated in the study. For speech understanding in noise, two complex noise scenarios with multiple noise sources including single talker interfering speech were used. The first scenario included speech presented from the front (S0NMIX), while in the second scenario speech was presented from the side of the implanted ear (SIPSINMIX). In addition, subjective evaluation using the SSQ12, APSQ, and the BBSS questionnaires was performed. Results: We found improved speech understanding in quiet with the AP2 compared to the AP1 aided condition (on average + 17%, p = 0.007). In both noise scenarios, the AP2 lead to improved speech reception thresholds by 1.2 dB (S0NMIX, p = 0.032) and 2.1 dB (SIPSINMIX, p = 0.048) compared to the AP1. The questionnaires revealed no statistically significant differences, except an improved APSQ usability score with the AP2. Conclusion: Clinicians can expect that patients with SSD will benefit from the SAMBA 2 BB by improved speech understanding in both quiet and in complex noise scenarios, when compared to the older SAMBA BB. [ABSTRACT FROM AUTHOR]

Abstract Objectives The young population requires early rehabilitation of their hearing loss for normal cognitive, auditive hence social development. All of which, in turn, may have an impact on quality of life (QoL). This study aims to evaluate QoL between two different bone conduction (BC) hearing devices: a noninvasive adhesive hearing aid (Adhear [ADH]) vs. an active transcutaneous implant (Bonebridge [BB]). Methods This study composed of 12 BB and 15 ADH users. Pure tone as well as speech in noise and quiet measurements were evaluated and compared to the Assessment in QoL questionnaire (AQoL‐6d). Results Freefield results showed significant improvements for both devices compared to the unaided condition (p

Purpose: In children and adolescents, preoperative planning for a semi-implantable bone conduction device (SIBCD) is crucial. The geometric changes of the new version of a common SIBCD should enable a higher rate of successful implantation due to its flatter actuator. Thus, this radioanatomic study compared the rate of successful implantation of both device versions at the traditional mastoidal localization and two alternative sites, retrosigmoidal, and parietal, and investigated parameters helping to estimate the feasibility. Methods: A retrospective analysis of 136 CT scans of 0 to 20-year-old patients, evaluation of demographic parameters, radioanatomy, and assessment of head diameter was conducted. The feasibility was investigated for certain age groups at three implantation sites. Prediction of feasible implantation by means of different parameters was calculated. Results: A significant higher implantation rate was observed with the new device for all three sites and age groups. The age group of 6–8 years (n = 19) had most striking differences with a 58.1% rate of successful implantation with the new device without spacer (80% with spacer) at the mastoidal localization, whereas none with the old implant. Head diameter was identified as the most predictive parameter regarding all implantation sites (mastoidal: p = 0.030; retrosigmoidal: p = 0.006; parietal: p < 0.0001), age for the mastoidal (p < 0.0001) and retrosigmoidal (p < 0.0001), and gender for the parietal site (p = 0.001). Conclusion: The geometric changes of the actuator lead to a higher rate of successful implantation in all age-groups and all three localizations with reducing the requirement for spacers. Parameters age and head diameter might aid in estimating the rate of successful implantation in young patients and may be a novel tool to assist in the decision-making process for a SIBCD. [ABSTRACT FROM AUTHOR]

Auditory implants are classified into bone conduction (BAHA and Bonebridge; BB) and active middle ear implants (Vibrant Soundbridge; VSB) that stimulate cochlear hair cells, and cochlear implants (CIs) that stimulate neural structures. CIs should be performed as early as possible, and bilateral CIs have become popular because sound localization and speech recognition can be improved. CI is also considered a desirable treatment option for patients with single-sided deafness. VSB provides a safe and effective option for patients with conductive or mixed hearing loss and moderate to severe sensorineural hearing loss (SNHL); however, it use in patients with conductive or mixed hearing loss have only been approved in Japan. BAHA and BB implants have been approved by national insurance in Japan as bone conduction implants for patients with conductive or mixed hearing loss. Two fully implantable devices (Cochlear Carina and Envoy Esteem) are provided for patients with SNHL. [ABSTRACT FROM AUTHOR]

Purpose: To examine the subjective and objective audiological benefits of the Osia system compared to devices commonly implanted prior to the introduction of this system. Methods: Osia recipients with either conductive hearing loss (CHL/MHL) (n = 9) or single-sided deafness (SSD) (n = 8) who underwent surgery from February 2021 to March 2022 were prospectively recruited. The audiological outcomes and usage rate of Osia implantees were compared with those of retrospectively recruited patients implanted with other devices (n = 50). The subjective satisfaction of the Osia implantees was also evaluated through questionnaires. Results: All users of the Osia system were classified as regular users. In the CHL/MHL group, the effective gain of the Osia system (11.1 ± 14.9 dB) surpassed that of the Baha and Bonebridge (− 2.7 ± 12.6 dB) at 2 kHz (p = 0.01, Mann–Whitney U test). Among the devices, the Osia system tended to tolerate the worst bone conduction thresholds, up to the level of 61 dB. In the SSD group, the functional gain of Osia at 4 kHz (37.5 ± 3.1 dB) was higher than that of the Baha and Bonebridge group (26.9 ± 3.0 dB) (p = 0.05, Mann–Whitney U test). Conclusion: The Osia system yielded larger audiological gain than the Baha Attract and Bonebridge devices, especially at high frequencies, leading to substantially higher compliance. The Osia system tended to have the strongest tolerance to aggravated bone conduction thresholds among the available transcutaneous bone conduction hearing implants. Therefore, the Osia system could potentially be a good option for CHL/MHL patients with bone conduction thresholds of 50 dB HL or more, as well as patients with SSD. [ABSTRACT FROM AUTHOR]

Aim: This European multicentric study aimed to prove safety and performance of the Bonebridge BCI 602 in children and adults suffering from either conductive hearing loss (CHL), mixed hearing loss (MHL), or single-sided sensorineural deafness (SSD). Methods: 33 patients (13 adults and 10 children with either CHL or MHL and 10 patients with SSD) in three study groups were included. Patients were their own controls (single-subject repeated measures), comparing the unaided or pre-operative to the 3-month post-operative outcomes. Performance was evaluated by sound field thresholds (SF), word recognition scores (WRS) and/or speech reception thresholds in quiet (SRT) and in noise (SNR). Safety was demonstrated with a device-specific surgical questionnaire, adverse event reporting and stable pure-tone measurements. Results: The Bonebridge BCI 602 significantly improved SF thresholds (+ 25.5 dB CHL/MHL/SSD), speech intelligibility in WRS (+ 68.0% CHL/MHL) and SRT in quiet (− 16.5 dB C/MHL) and in noise (− 3.51 dB SNR SSD). Air conduction (AC) and bone conduction (BC) thresholds remained stable over time. All adverse events were resolved, with none unanticipated. Mean audio processor wearing times in hours [h] per day for the CHL/MHL group were ~ 13 h for adults, ~ 11 h for paediatrics and ~ 6 h for the SSD group. The average surgical length was 57 min for the CHL/MHL group and 42 min for the SSD group. The versatility of the BCI 602 (reduced drilling depth and ability to bend the transition for optimal placement) allows for treatment of normal, pre-operated and malformed anatomies. All audiological endpoints were reached. Conclusions: The Bonebridge BCI 602 significantly improved hearing thresholds and speech understanding. Since implant placement follows the patient's anatomy instead of the shape of the device and the duration of surgery is shorter than with its predecessor, implantation is easier with the BCI 602. Performance and safety were proven for adults and children as well as for the CHL/MHL and SSD indications 3 months post-operatively. [ABSTRACT FROM AUTHOR]

Purpose: The aim of this study was to analyze the hearing outcomes and quality of life in a series of 52 patients affected by conductive or mixed hearing loss and treated with Bonebridge®. Methods: 52 of 71 patients implanted with Bonebridge® between October 2012 and January 2022, were included in the study. We compared the air conduction thresholds at the frequencies 500, 1000, 2000, 3000, 4000 Hz, the SRT50% and the World Recognition Score at an intensity of 50 dB with and without the implant. The Abbreviated Profile of Hearing Aid Benefit (APHAB) was employed to assess the quality of life of patients. Results: The liminal tone audiometry (free field) pure tone average for air conduction after 6 months with the implant was 35.12 dB, obtaining a mean gain of 31.83 dB. With Bonebridge®, the mean SRT was 34.17 dB, whereas before the surgery no patient achieved 50% of correct answers at a sound intensity of 50 dB. The world recognition score at 50 dB changed from 11% without the implant to 85% with it. We observed one case of implant failure and one case of implant exposure. The APHAB questionnaire showed an improvement after implantation in practically all the subscales. Conclusions: The hearing outcomes and the subjective benefits reported by patients obtained in our study are similar to those published in the literature. Bonebridge® represents an excellent method for the rehabilitation of patients with conductive and mixed hearing loss, showing a low rate of complications. [ABSTRACT FROM AUTHOR]

Objectives: The young population requires early rehabilitation of their hearing loss for normal cognitive, auditive hence social development. All of which, in turn, may have an impact on quality of life (QoL). This study aims to evaluate QoL between two different bone conduction (BC) hearing devices: a noninvasive adhesive hearing aid (Adhear [ADH]) vs. an active transcutaneous implant (Bonebridge [BB]). Methods: This study composed of 12 BB and 15 ADH users. Pure tone as well as speech in noise and quiet measurements were evaluated and compared to the Assessment in QoL questionnaire (AQoL‐6d). Results: Freefield results showed significant improvements for both devices compared to the unaided condition (p <.0001). Emphasis needs to be drawn on the different unaided level of conductive hearing loss as well as the indication range for both evaluated device groups: the ADH subjects exhibited a mean BC value of 9.50 ± 7.96 dB HL (the indication range up to 25 dB) and the BB subjects a mean of 23.33 ± 25.66 dB HL (the indication range up to 45 dB). Speech perception in quiet and in noise was significantly improved (p <.05; p <.001, respectively). QoL was significantly improved for both treatments (p <.05) but was not different among the devices, and the values were similar to their normal hearing, age, and sex‐matched control group. High correlations were found between QoL utility scores and improved PTA4 in the aided condition (r2 =.8839 and.7810 for BB and ADH, respectively). Conclusion: Our results show that both devices offer significant beneficial audiological rehabilitations with significantly increased QoL. However, the underlying condition and the unaided degree of hearing loss, hence the required higher stimulation must be the deciding factor when opting for a hearing device, and this should be independent of age. Level of evidence: 2c. [ABSTRACT FROM AUTHOR]

Purpose: Transcutaneous active bone conduction hearing aids represent an alternative approach to middle ear surgery and conventional hearing aids for patients with conductive or mixed hearing loss. The aim of this study was to determine quality of life, subjective hearing experience and patients' satisfaction after implantation of a bone conduction hearing aid. Methods: This monocentric and retrospective study included twelve adult patients who received a bone conduction hearing aid (Bonebridge, MedEL) consisting of an extracorporeal audio processor and a bone conduction implant (BCI) between 2013 and 2017. On average 40 months after implantation, the patients were asked to answer three questionnaires regarding quality of life (AqoL-8D), self-reported auditory disability (SSQ-12-B) and user's satisfaction (APSQ) after implantation of the Bonebridge (BB). A descriptive statistical analysis of the questionnaires followed. Results: 12 patients aged 26–85 years (sex: m = 7, w = 5) were recruited. The quality of life of all patients after implantation of the BB (AqoL 8D) averaged an overall utility score of 0.76 (SD ± 0.17). The mean for 'speech hearing' in the SSQ-12-B was + 2.43 (SD ± 2.03), + 1.94 (SD ± 1.48) for 'spatial hearing' and + 2.28 (SD ± 2.32) for 'qualities of hearing'. 11 out of 12 patients reported an improvement in their overall hearing. The APSQ score for the subsection 'wearing comfort' was 3.50 (SD ± 0.87), 'social life' attained a mean of 4.17 (SD ± 1.06). The 'device inconveniences' reached 4.02 (SD ± 0.71) and 'usability' of the device was measured at 4.23 (SD ± 1.06). The average wearing time of the audio processor in the cohort was 11 h per day, with 8 of 12 patients reporting the maximum length of 12 h per day. Conclusion: BB implantation results in a gain in the perceived quality of life (AqoL 8D). The SSQ-12-B shows an improvement in subjective hearing. According to the APSQ, it can be assumed that the BB audio processor, although in an extracorporeal position, is rated as a useful instrument with positive impact on social life. The majority stated that they had subjectively benefited from BB implantation and that there were no significant physical or sensory limitations after implantation. [ABSTRACT FROM AUTHOR]

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Purpose: The use of magnetic resonance imaging (MRI) is often limited in patients with auditory implants because of the presence of metallic components and magnets. The aim of this study was to evaluate the clinical usefulness of a customized MRI sequence for metal artifact suppression in patients with BONEBRIDGETM BCI 602 implants (MED-EL, Innsbruck, Austria), the successor of the BCI 601 model. Methods: Using our in-house developed and customized metal artifact reduction sequence (SEMAC-VAT WARP), MRI artifacts were evaluated qualitatively and quantitatively. MRI sequences were performed with and without artifact reduction on two whole head specimens with and without the BCI 602 implant. In addition, the influence of two different implantation sites (mastoid versus retrosigmoid) and head orientation on artifact presence was investigated. Results: Artifact volume was reduced by more than the 50%. Results were comparable with those obtained with the BCI 601, showing no significant differences in the dimensions of artifacts caused by the implant. Conclusion: SEMAC-VAT WARP was once more proved to be efficient at reducing metal artifacts on MR images. The dimensions of artifacts associated with the BCI 602 are not smaller than those caused by the BCI 601. [ABSTRACT FROM AUTHOR]

The BONEBRIDGE is a partially implantable, transcutaneous bone conduction device that can be used to treat conductive or mixed mild-to-moderate hearing loss in patients who do not attain sufficient improvement from conventional hearing aids. The following case report describes sequential bilateral BONEBRIDGE implantation in a 25-year-old patient with achondroplasia and bilateral mixed-hearing loss with a significant sensorineural component in the setting of chronic suppurative otitis media. Although the patient did not meet the approved BONEBRIDGE criteria, implantation was successful with improvements in audiological outcomes and self-reported quality of life. There were no reported complications at 5-years post-implantation. [ABSTRACT FROM AUTHOR]

Background: To investigate the characteristics of mismatch negativity (MMN) in terms of latency and amplitude in children with bilateral congenital microtia using a Bone conduction implant (Bonebridge), and to explore the relationship between cortical level auditory discrimination, speech perception, and psychosocial well-being., Methods: This descriptive, observational, cross-sectional study compared three groups: eight children with bilateral congenital microtia and Bonebridge implants (bilateral group), eight children with unilateral congenital microtia and no hearing aids (unilateral group), and eight children with normal hearing (NH group). Participants underwent MMN evaluation using a classic oddball paradigm with a pure tone burst stimulus, featuring a 1000 Hz standard stimulus and a 1200 Hz deviant stimulus, presented in a sound field at 65 dBHL. Additionally, speech perception tests, the Meaningful Use of Speech Scale (MUSS), and psychosocial status questionnaires, including the Social Anxiety Scale for Children (SASC) and the Children's Loneliness Scale (CLS), were administered to all subjects., Results: The bilateral group's average MMN latency was 241.23 ± 29.47 ms, and the unilateral group's was 209.96 ± 54.32 ms, both significantly longer than the NH group's 146.05 ± 15.73 ms (p < 0.0001, F=3.509, 95 % CI 68.09 to 122.3 and p = 0.0097, F=11.92, 95 % CI 18.07 to 109.8, respectively). However, no significant difference was found in MMN latency between the bilateral and unilateral groups (p = 0.202, F=3.397, 95 % CI -18.84 to 81.36). The unilateral group scored significantly higher on the MUSS (38.63 ± 1.41 vs. 30.75 ± 3.80, p = 0.0001, F=7.276, 95 % CI -11.16 to -4.590), had lower CLS scores (47.13 ± 8.13 vs. 58.25 ± 8.39, p = 0.024, F=1.065, 95 % CI 1.652 to 20.60), and lower SASC scores (4.13 ± 2.09 vs. 6.50 ± 2.25, p = 0.062, F=1.204, 95 % CI -0.138 to 4.89) compared to the bilateral group. MMN latency in the bilateral group correlated with SASC scores., Conclusion: The MMN latency in congenital microtia patients may serve as an indicator of central auditory discrimination capabilities. In children with bilateral congenital microtia and Bonebridge implants, MMN latency can reflect social anxiety conditions to a certain degree., (Copyright © 2024. Published by Elsevier B.V.)

Introduction Bone conduction implants, responsible for transmitting sound from an external processor to the inner ear, can be divided into active and passive, depending on the vibratory stimulus location. The use of transcutaneous device has increased, given its aesthetic appeal, the complications and limitations of percutaneous devices, and patient's treatment adherence, focusing mainly on efficacy. However, various complications are associated with the use of transcutaneous prosthesis, which can often be serious. Objective To approach the literature on complications involving transcutaneous bone-anchored prostheses through a systematic review of articles published in the past 10 years (2011-2021). Data Synthesis TheMEDLINE, EMBASE, Scopus, and Cochrane Library databases were searched. All articles written in English reporting on currently available transcutaneous prosthesis implantation and its complications were selected. Studies on both children and adults were included. The data on complications were extracted, and complications were classified as minor or major and associated to each device used. Thirty-seven articles were included in the study, of which 14 were prospective cohort studies, 22 were retrospective case series, and 1was a case report. Most studies (18) included both adults and children. Moreover, 901 implantations were performed, of which 552 implanted Baha Attract (Cochlear Ltd., Sydney, Australia), 244 implanted BoneBridge (MED-EL, Innsbruck, Austria), and 105 implanted Sophono (Sophono Inc., Boulder, CO, USA]). Furthermore, 192 adverse events were reported (total complication rate, 21.3%), with 161 minor complications (84.3%) and 31 major complications (16.1%). Conclusion Transcutaneous prosthesis is an audiological alternative with fewer complications than percutaneous prosthesis. However, its indication should be judicious because complications are common, and although most complications are minor, serious infections requiring explantation may develop. [ABSTRACT FROM AUTHOR]

The functional hearing outcome with hearing implants does not always properly reflect the subjective benefit in everyday listening situations. In this study, the functional hearing gain and the impact on the subjective hearing ability and quality of life were assessed in patients with a Bonebridge. A chart review was performed on 45 patients with a Bonebridge who were provided with questionnaires regarding the hearing quality and health-related quality of life during their last clinical visit. The questionnaires consisted of the Speech, Spatial and Qualities (SSQ) and the Health Utility Index Mark 3 (HUI3). Eleven patients had to be excluded due to missing data. A total of 34 patients (37 ears) were included in the study. Aided hearing thresholds were significantly lower compared with the unaided condition, with a mean functional gain of 26.87 dB for patients with mixed/conductive hearing loss (MHL/CHL). Although patients with single-sided deafness (SSD) scored slightly lower on the SSQ compared with patients with MHL/CHL, all included patients reported improved subjective hearing quality with the BB compared with the hearing situation before implantation. No correlation was found between the functional hearing gain and the subdomains of the SSQ. SSD patients scored the HUI3 subdomain "hearing" slightly lower compared with MHL/CHL patients. Although not significant, a relationship was found between the functional gain and the "hearing" subdomain. No correlation was found for the other subdomains of the HUI3. Audiological measurements showed significantly improved hearing thresholds with the Bonebridge. Most importantly, the subjective benefit achieved in everyday listening situations was superior compared with the previous hearing condition. The lack of correlation between subjective questionnaire results and the functional hearing gain shows the importance of assessing both audiological and subjective hearing quality parameters in clinical routine. [ABSTRACT FROM AUTHOR]

Purpose: (1) To assess the effectiveness and safety of a bone-conduction implant, the Bonebridge BCI 602, in adults with conductive or mixed hearing loss. (2) To investigate whether the Bonebridge BCI 602 is at least as effective as the Bonebridge BCI 601 in such patients. Methods: The study group included 42 adults who had either conductive or mixed hearing loss. All patients underwent Bonebridge BCI 602 implant surgery. Before and after implantation, pure-tone audiometry, speech recognition tests (in quiet and noise), and free-field audiometry were performed. Word recognition scores were evaluated using the Polish Monosyllabic Word Test. Speech reception thresholds in noise were assessed using the Polish Sentence Matrix Test. Subjective assessment of benefits was done using the APHAB (Abbreviated Profile of Hearing Aid Benefit) questionnaire. Results: The APHAB questionnaire showed that difficulties in hearing decreased after BCI 602 implantation. Both word recognition in quiet and speech reception threshold in noise were significantly better after BCI 602 implantation and remained stable for at least 12 months. A significant advantage of the device is a reduced time for surgery while maintaining safety. In this study, the mean time for BCI 602 implantation was 28.3 min ± 9.4. Conclusions: The second-generation Bonebridge BCI 602 implant is an effective hearing rehabilitation device for patients with conductive or mixed hearing loss. Patient satisfaction and audiological results confirm its efficacy and safety. Its new shape and dimensions allow it to be used in patients previously excluded due to insufficient or difficult anatomical conditions. The new BCI 602 implant is as effective as its predecessor, the BCI 601. [ABSTRACT FROM AUTHOR]

Purpose: To review functional and subjective benefit after implantation of an active transcutaneous bone conduction device (BCD) in patients with congenital microtia with atresia or stenosis of the external auditory canal. Methods: Retrospective chart analysis and questionnaire on the subjective impression of hearing (Speech, Spatial and Qualities of Hearing Scale (SSQ-B) of patients treated between 2012 and 2015. ResultsResults: 18 patients (24 ears) with conductive or mixed hearing loss in unilateral (n = 10) or bilateral (n = 8) atresia were implanted with a BCD. No major complications occurred after implantation. Preoperative unaided air conduction pure tone average at 0.5, 1, 2 and 4 kHz (PTA 4) was 69.2 ± 11.7 dB, while postoperative aided PTA 4 was 33.4 ± 6.3 dB, resulting in a mean functional hearing gain of 35.9 +/- 15.6 dB. Preoperatively, the mean monosyllabic word recognition score was 22.9 % ± 22.3 %, which increased to 87.1 % +/- 15.1 % in the aided condition. The Oldenburger Sentence Test at S0N0 revealed a decrease in signal-to-noise-ratio from − 0.58 ± 4.40 dB in the unaided to − 5.67 ± 3.21 dB in the postoperative aided condition for all patients investigated. 15 of 18 patients had a subjective benefit showing a positive SSQ-B score (mean 1.7). Conclusion: The implantation of an active bone conduction device brings along subjective and functional benefit for patients with conductive or combined hearing loss. [ABSTRACT FROM AUTHOR]

Introduction Bone conduction implants, responsible for transmitting sound from an external processor to the inner ear, can be divided into active and passive, depending on the vibratory stimulus location. The use of transcutaneous device has increased, given its aesthetic appeal, the complications and limitations of percutaneous devices, and patient's treatment adherence, focusing mainly on efficacy. However, various complications are associated with the use of transcutaneous prosthesis, which can often be serious. Objective To approach the literature on complications involving transcutaneous bone-anchored prostheses through a systematic review of articles published in the past 10 years (2011–2021). Data Synthesis The MEDLINE, EMBASE, Scopus, and Cochrane Library databases were searched. All articles written in English reporting on currently available transcutaneous prosthesis implantation and its complications were selected. Studies on both children and adults were included. The data on complications were extracted, and complications were classified as minor or major and associated to each device used. Thirty-seven articles were included in the study, of which 14 were prospective cohort studies, 22 were retrospective case series, and 1 was a case report. Most studies (18) included both adults and children. Moreover, 901 implantations were performed, of which 552 implanted Baha Attract (Cochlear Ltd., Sydney, Australia), 244 implanted BoneBridge (MED-EL, Innsbruck, Austria), and 105 implanted Sophono (Sophono Inc., Boulder, CO, USA]). Furthermore, 192 adverse events were reported (total complication rate, 21.3%), with 161 minor complications (84.3%) and 31 major complications (16.1%). Conclusion Transcutaneous prosthesis is an audiological alternative with fewer complications than percutaneous prosthesis. However, its indication should be judicious because complications are common, and although most complications are minor, serious infections requiring explantation may develop.

The Bonebridge active transcutaneous bone conduction implant has been used as an effective treatment for hearing rehabilitation in children with aural atresia. It is currently indicated for children aged five and above. We present a case report of two children implanted with the Bonebridge under the age of five and followed up for more than five years. Both children have had good results and continue to wear their implant for approximately 12 hours per day. To our knowledge, this is the first report of long-term results in children implanted with the Bonebridge under the age of five.

Abstract Background Malformations of the temporal bone present different challenges to the implantation of a transcutaneous active bone conduction device, such as Bonebridge (Med-el, Innsbruck, Austria). This study aims to describe the benefits of high-resolution computed tomography (HRCT) in preoperative assessment and to analyze whether characteristics of the mastoid process, intraoperative compression of the dura or sigmoid sinus, and the use of the Lifts system, lead to differences in audiological performance after implantation. Methods We examined 110 cases of congenital microtia. The structure of the temporal bone was examined using HRCT and a 3D simulation software program. The mean anteroposterior mastoid bone thickness from the external auditory canal to the sigmoid sinus was measured (a measurement referred to as “AP”, hereafter). Sound field threshold (SFT), speech reception threshold (SRT) in noise, and word recognition score (WRS) in quiet, before and after implantation, were also measured. Independent variables were recorded in all patients: mastoid type (well pneumatized or poorly pneumatized), the presence of dural or sigmoid sinus compression, and the use of the Lifts system. Results We found that the mean AP in the non-compression group was 16.2 ± 2.3 mm and in the compression group, 13.1 ± 2.9 mm (p 0.05). Conclusions The AP dimension in the non-compression group was significantly larger than that in the compression group. This finding combined with the ROC curve analysis revealed the AP dimension was a high-accuracy predictor of potential surgical complications involving the dura and sigmoid sinus compression. Further analysis revealed that there was no interaction between the chosen variables: mastoid type, dural or sigmoid sinus compression, and the use of the Lifts system, and that all of these factors had no significant impact on hearing performance. Bonebridge was shown to produce effective and stable bone conduction and to improve patients’ hearing performance.

Abstract Background The BONEBRIDGE (MED-EL, Innsbruck, Austria) is a bone-conduction implant used in the treatment of conductive and mixed hearing loss. The BONEBRIDGE consists of an external audio processor and a bone-conduction floating mass transducer that is surgically implanted into the skull in either the transmastoid, retrosigmoid or middle fossa regions. The manufacturer includes self-tapping screws to secure the transducer; however, self-drilling screws have also been used with success. In cases where the skull is not thick enough to house the transducer, lifts are available in a variety of sizes to elevate the transducer away from the skull. The objective of the present study was to investigate the effects of screw type, lift thickness, and implant location on the sound transmission of the BONEBRIDGE. Method Six cadaveric temporal bones were embalmed and dried for use in this study. In each sample, a hole was drilled in each of the three implant locations to house the implant transducer. At the middle fossa, six pairs of screw holes were pre-drilled; four pairs to be used with self-tapping screws and lifts (1, 2, 3, and 4 mm thick lifts, respectively), one pair with self-tapping screws and no lifts, and one pair with self-drilling screws and no lifts. At the transmastoid and retrosigmoid locations, one pair of screw holes were pre-drilled in each for the use of the self-tapping screws. The vibration of transmitted sound to the cochlea was measured using a laser Doppler vibrometry technique. The measurements were performed on the cochlear promontory at eight discrete frequencies (0.5, 0.75, 1, 1.5, 2, 3, 4 and 6 kHz). Vibration velocity of the cochlear wall was measured in all samples. Measurements were analyzed using a single-factor ANOVA to investigate the effect of each modification. Results No significant differences were found related to either screw type, lift thickness, or implant location. Conclusions This is the first known study to evaluate the effect of screw type, lift thickness, and implant location on the sound transmission produced by the BONEBRIDGE bone-conduction implant. Further studies may benefit from analysis using fresh cadaveric samples or in-vivo measurements.

OBJECTIVE: This study used questionnaires to examine the patient-reported satisfaction with 2 hearing implant devices to determine the level of overall satisfaction with the devices, which, if any, factors predicted good or poor perceived outcomes, or whether there were any specific aspects of the devices where dissatisfaction was apparent. METHODS: A post-treatment questionnaire survey of 39 adult patients who had received a Vibrant Soundbridge (VSB) or Bonebridge (BB) hearing implant, with at least 3 months of follow-up, was conducted using the Glasgow Benefit Inventory (GBI) and Hearing Device Satisfaction Scale (HDSS). Satisfaction scores were compared to pre- and post-operative audiologic outcomes. The correlation between GBI and HDSS scores was also examined. RESULTS: A total of 28 of the 39 patients (72%) responded: 13 with a BB and 15 with a VSB at a mean of 13 months after implantation. The overall mean total GBI score was 30, with no significant differences across the groups. The responders generally reported that they were "satisfied" across most domains of the HDSS. In the study, 25 of the 28 responders were largely satisfied with their devices but 3 respondents were not. Two were known non-users, while one used the device but did not gain the benefit expected. It is instructive to note that all of these dissatisfied recipients were close to the manufacturer recommended limits for implantation of their respective devices at the time of surgery. Certain themes were identified within the patients' responses, indicating common aspects where satisfaction was poorer. CONCLUSION: This series of 28 implant recipients demonstrates high levels of satisfaction with implantable hearing devices across 2 different validated questionnaires. Implant teams could exercise caution and manage patient expectations if the patients are close to the recommended limits of a particular device. [ABSTRACT FROM AUTHOR]

Background Implant lifts were recently introduced to facilitate implantation of the Bonebridge and to reduce the risk of uncovering the sigmoid sinus and/or dura. Purpose The current study analyzed medical, technical, and audiological outcomes of implantation with the Bonebridge implant using lifts. Research Design This was a retrospective study on all consecutive patients implanted with a bone-conduction hearing implant at a tertiary medical referral center between March 2012 and October 2018. Outcome measures were complications, explantations, and revisions and the mean time of implant use. Audiological results were assessed as well. Outcomes were evaluated for devices implanted with BCI Lifts and compared with those implanted without lifts. Results In the study period, 13 out of a total of 54 implantations were conducted using one or two 1- to 4-mm BCI Lifts. During the follow-up period, two complications occurred and both in patients implanted without lifts (2/41; 4.9%). All patients in the lifts group were using the implant at the end of observation period. No statistically significant difference was observed in functional hearing gain or word-recognition improvement at 65 dB between two groups. Conclusions The use of BCI Lifts in Bonebridge implantations was not associated with adverse events during the observation period. The clinical follow-up revealed no complications in implantations requiring lifts. Furthermore, the functional hearing gain and the word-recognition improvement did not differ from those of devices implanted without lifts. Data indicate safety and efficacy for Bonebridge implantations using lifts. [ABSTRACT FROM AUTHOR]

Objectives: This study investigated the effect of an active transcutaneous bone conduction implant (BoneBridgeⓇ) in the management of tinnitus in patients with unilateral sensorineural hearing loss.Methods: From October 2016 to July 2018, 15 patients with unilateral tinnitus accompanied by ipsilateral sensorineural hearing loss received BoneBridgeⓇ implants. Pure-tone average, tinnitus handicap inventory (THI), and a visual analogue scale (VAS) for awareness, loudness, and annoyance were measured before and 6 months after surgery. We defined improvement as a reduction of more than 20% between preoperative and postoperative VAS and THI scores, and changes in the THI of over 7 points were also assessed.Results: Mean THI scores before surgery (72.8 ± 16.1) had significantly improved by 6 months postoperatively (50.9 ± 18.9) (p = 0.003). VAS scores for loudness and annoyance also statistically significantly improved (p = 0.011 and 0.002). The amount of functional hearing gain correlated with changes in VAS scores for annoyance. This correlation was stronger with the improvement of high frequency hearing.Conclusion: BoneBridgeⓇ is beneficial in patients with tinnitus accompanied by sensorineural hearing loss. This finding can help select patients who will benefit most from bone conduction implants. [ABSTRACT FROM AUTHOR]

Bonebridge (BB) is the first active implantation system for bone conduction that is placed fully under the skin. Experience suggests that BB is characterized by low incidence of postoperative complications. This case report presents a rare case of a 16-year-old girl with incidence of emphysema occurring over the implant 1 year after operation. We performed a computed tomography scan that showed pockets of gas above the floating mass transducer so we provided the revision surgery and sealed the artificial opening with fat from the earlobe and fibrin glue. Since that time, no air has collected in the retroauricular area and the implant has been fully functional. [ABSTRACT FROM AUTHOR]

Abstract Background Bone conduction implants can be used in the treatment of conductive or mixed hearing loss. The BONEBRIDGE bone conduction implant (BB-BCI) is an active, transcutaneous device. BB-BCI implantation can be performed through either the transmastoid or retrosigmoid approach with their respective limitations. Here, we present a third, novel approach for BB-BCI implantation. Objective Describe the detailed surgical technique of BB-BCI implantation through a middle fossa approach with self-drilling screws and present preliminary audiometric outcome data following this approach. Methods A single institution, retrospective chart review was completed for patients implanted with the BB-BCI via the middle fossa approach. Preoperative planning and modelling were performed using 3D Slicer. Audiological testing was performed pre- and post-operatively following standard audiometric techniques. Results Forty patients underwent BB-BCI implantation using the middle fossa approach. Modelling techniques allowed for implantation through the use of external landmarks, obviating the need for intraoperative image guidance. The surgical technique was refined over time through experience and adaptation. Mean follow-up was 29 months (range 3–71 months) with no surgical complications, favourable cosmesis, and expected audiometric outcomes. An average functional gain of 39.6 dB (± 14.7 SD) was found. Conclusion The middle fossa technique with self-drilling screws is a safe and effective option for BONEBRIDGE implantation. As a reference for other groups considering this approach, an annotated video has been included as a supplement to the study.

Background: The BONEBRIDGE® (Med-El GmbH) is a bone-conduction device comprising an external audio processor and an internal Bone Conduction-Floating Mass Transducer (BC-FMT) surgically anchored to the temporal bone. Due to the implant's size, its placement may be challenging in certain anatomies, necessitating thorough surgical planning. Manual planning methods are laborious, time-intensive, and prone to errors. This study aimed to develop and validate an automated algorithm for determining skull thickness, aiding in the surgical planning of the BONEBRIDGE and other devices requiring similar bone thickness estimations., Materials and Methods: Twelve cadaveric temporal bones underwent clinical computed tomography (CT). A custom Python algorithm was developed to automatically segment bone from soft tissue, generate 3D models, and perform ray-tracing to estimate bone thickness. Two thickness colormaps were generated for each sample: the cortical thickness to the first air cell and the total thickness down to the dura. The algorithm was validated against expert manual measurements to achieve consensus interpretation., Results: The algorithm estimated bone-to-air thicknesses (mean = 4.7 mm, 95% Confidence Interval [CI] of 4.3-5.0 mm) that closely matched the expert measurements (mean = 4.7 mm, CI of 4.4-5.0 mm), with a mean absolute difference (MAD) of 0.3 mm. Similarly, the algorithm's estimations to the dura (6.0 mm, CI of 5.4-6.5 mm) were comparable to the expert markings (5.9 mm, CI of 5.4-6.5 mm), with a MAD of 0.3 mm., Conclusions: The first automated algorithm to calculate skull thickness to both the air cells and dura in the temporal bone was developed. Colormaps were optimized to aid with the surgical planning of BONEBRIDGE implantation, however the tool can be generalized to aid in the surgical planning of any bone thickness application. The tool was published as a freely available extension to the open-source 3D Slicer software program (www.slicer.org)., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2024 The Authors. Published by Elsevier Ltd.)

Purpose: The present study aimed to evaluate and compare the outcome of different bone conduction hearing implants (BCHIs) in subjects with mixed hearing loss (MHL) and single-sided deafness (SSD) in terms of audiometric results and compliance. Methods: Twenty-one subjects with MHL and 18 subjects with SSD undergoing implantation of Baha connect, Baha attract, or Bonebridge were enrolled. Functional gain, effective gain, and usage rate of BCHIs were retrospectively reviewed. Results: As for MHL, the functional gain of three devices was not significantly different (p = 0.477), while the effective gain of Bonebridge was higher (− 8.8 [− 15.0, − 3.5] dB) than that of Baha connect (− 20.0 [− 26.3, − 11.3] dB, p = 0.037), especially at 0.5 kHz (p = 0.010) and 1 kHz (p = 0.014). In SSD subjects, the effective gain of Bonebridge was significantly higher than that of Baha attract (− 11.3 [− 15.0, − 7.5] vs − 21.3 [− 21.3, − 16.3] dB, p = 0.012), while the functional gain of Bonebridge and Baha attract was not different. The constant usage rate of BCHIs tends to be higher in MHL subjects [17/21 (82%)] than that in SSD subjects [10/18 (56%)]. In SSD subjects, the constant user group showed higher functional gain than the non-constant user group, with a significant difference at 3 kHz (35.0 [33.8, 45.0] vs 17.5 [10.0, 27.5] dB, p = 0.006). Conclusion: Bonebridge shows a higher effective gain than Baha connect in the MHL group and Baha attract in the SSD group. The usage rate of BCHIs is lower in SSD than that in MHL. In SSD subjects, the constant user group tended to show higher functional gain than the non-constant user group. Irrespective of the device type, the tendency of higher functional gain of BCHIs, especially at mid frequencies, may potentially lead to yield good compliance in SSD, mandating a meticulous fitting strategy ensuring a sufficient mid-frequency functional gain in SSD. [ABSTRACT FROM AUTHOR]

The Bonebridge implant can be a satisfactory solution for patients with conductive or mixed hearing loss (CHL or MHL), or with single-sided deafness (SSD). The aim of the study was to assess patients’ self-reported benefits with the Bonebridge and characterize the relationships between pre-implantation audiometric data, auditory functioning, and satisfaction after implantation. A focus was to see whether different types of hearing loss were associated with particular benefits. The study sample consisted of 81 patients. Procedures comprised pure tone audiometry before implantation, the Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire, and a structured interview asking about satisfaction. Statistically significant improvements after implantation were found in all groups (CHL, MHL, SSD) on the APHAB questionnaire. In the structured interview, patients with SSD were the least satisfied. No significant correlation was found between pre-operative air-bone gap and bone conduction thresholds or with APHAB score. Bonebridge implantation is beneficial to patients with CHL or MHL, or with SSD. Assessment of patients for Bonebridge implantation is complex, and audiometric data should be complemented by patient-reported outcomes to provide deeper insight into their individual needs and attitudes.

Objective: This study aimed to investigate the benefit of Bonebridge devices in patients with single-sided deafness. Method: Five patients with single-sided deafness who were implanted with Bonebridge devices were recruited in a single-centre study. Participants' speech perception and horizontal sound localisation abilities were assessed at 6 and 12 months post-operatively. Speech intelligibility in noisy environments was measured in three different testing conditions (speech and noise presented from the front, speech and noise presented from the front and contralateral (normal ear) side separately, and speech presented from the ipsilateral (implanted Bonebridge) side and noise from the contralateral side). Sound localisation was evaluated in Bonebridge-aided and Bonebridge-unaided conditions at different stimuli levels (65, 70 and 75 dB SPL). Results: All participants showed a better capacity for speech intelligibility in quiet environments with the Bonebridge device. The speech recognition threshold with the Bonebridge device was significantly decreased at both short- and long-term follow up in the speech presented from the ipsilateral (implanted Bonebridge) side and noise from the contralateral side condition (p < 0.05). Additionally, participants maintained similar levels of sound localisation between the Bonebridge-aided and unaided conditions (p > 0.05). However, the accuracy of localisation showed some improvement at 70 dB SPL and 75 dB SPL post-operatively. Conclusion: The Bonebridge device provides the benefit of improved speech perception performance in patients with single-sided deafness. Sound localisation abilities were neither improved nor worsened with Bonebridge implantation at the follow-up assessments. [ABSTRACT FROM AUTHOR]

Background: The BONEBRIDGE (MED-EL, Innsbruck, Austria) is a bone-conduction implant used in the treatment of conductive and mixed hearing loss. The BONEBRIDGE consists of an external audio processor and a bone-conduction floating mass transducer that is surgically implanted into the skull in either the transmastoid, retrosigmoid or middle fossa regions. The manufacturer includes self-tapping screws to secure the transducer; however, self-drilling screws have also been used with success. In cases where the skull is not thick enough to house the transducer, lifts are available in a variety of sizes to elevate the transducer away from the skull. The objective of the present study was to investigate the effects of screw type, lift thickness, and implant location on the sound transmission of the BONEBRIDGE. Method: Six cadaveric temporal bones were embalmed and dried for use in this study. In each sample, a hole was drilled in each of the three implant locations to house the implant transducer. At the middle fossa, six pairs of screw holes were pre-drilled; four pairs to be used with self-tapping screws and lifts (1, 2, 3, and 4 mm thick lifts, respectively), one pair with self-tapping screws and no lifts, and one pair with self-drilling screws and no lifts. At the transmastoid and retrosigmoid locations, one pair of screw holes were pre-drilled in each for the use of the self-tapping screws. The vibration of transmitted sound to the cochlea was measured using a laser Doppler vibrometry technique. The measurements were performed on the cochlear promontory at eight discrete frequencies (0.5, 0.75, 1, 1.5, 2, 3, 4 and 6 kHz). Vibration velocity of the cochlear wall was measured in all samples. Measurements were analyzed using a single-factor ANOVA to investigate the effect of each modification. Results: No significant differences were found related to either screw type, lift thickness, or implant location. Conclusions: This is the first known study to evaluate the effect of screw type, lift thickness, and implant location on the sound transmission produced by the BONEBRIDGE bone-conduction implant. Further studies may benefit from analysis using fresh cadaveric samples or in-vivo measurements. [ABSTRACT FROM AUTHOR]

Background: Malformations of the temporal bone present different challenges to the implantation of a transcutaneous active bone conduction device, such as Bonebridge (Med-el, Innsbruck, Austria). This study aims to describe the benefits of high-resolution computed tomography (HRCT) in preoperative assessment and to analyze whether characteristics of the mastoid process, intraoperative compression of the dura or sigmoid sinus, and the use of the Lifts system, lead to differences in audiological performance after implantation. Methods: We examined 110 cases of congenital microtia. The structure of the temporal bone was examined using HRCT and a 3D simulation software program. The mean anteroposterior mastoid bone thickness from the external auditory canal to the sigmoid sinus was measured (a measurement referred to as "AP", hereafter). Sound field threshold (SFT), speech reception threshold (SRT) in noise, and word recognition score (WRS) in quiet, before and after implantation, were also measured. Independent variables were recorded in all patients: mastoid type (well pneumatized or poorly pneumatized), the presence of dural or sigmoid sinus compression, and the use of the Lifts system. Results: We found that the mean AP in the non-compression group was 16.2 ± 2.3 mm and in the compression group, 13.1 ± 2.9 mm (p < 0.001). We analyzed the hearing improvement of patients grouped by mastoid development, dural or sigmoid sinus compression, and use of the Lifts system, and found that these factors did not interact and that they had no influence on the hearing outcomes (p > 0.05). Conclusions: The AP dimension in the non-compression group was significantly larger than that in the compression group. This finding combined with the ROC curve analysis revealed the AP dimension was a high-accuracy predictor of potential surgical complications involving the dura and sigmoid sinus compression. Further analysis revealed that there was no interaction between the chosen variables: mastoid type, dural or sigmoid sinus compression, and the use of the Lifts system, and that all of these factors had no significant impact on hearing performance. Bonebridge was shown to produce effective and stable bone conduction and to improve patients' hearing performance. [ABSTRACT FROM AUTHOR]

Background: Bonebridge (BB) and bone conduction hearing aid (BCHA) are effective in patients with bilateral congenital microtia-atresia (CMA). Objectives: To investigate and compare the outcomes of these devices in a large sample size. Materials and methods: This single center prospective study involved 100 patients with bilateral CMA who were implanted with BBs and used BCHAs before implantation. Sound field threshold (SFT), speech reception thresholds (SRTs) and word recognition scores (WRSs) were compared between unaided, BCHA used and implanted patients. The Abbreviated Profile of Hearing Aid Benefit (APHAB) was used to evaluate subjective satisfaction. Results: Compared to unaided condition, the SFT, WRS and SRT of BCHA and BB were significantly improved. With BCHA or BB, the three subscale scores of the APHAB (ease of communication, background noise and reverberation) significantly reduced. However, the aversiveness subscale scored significantly higher than unaided condition. All outcomes were better in BB condition than BCHA. Conclusions: BB or BCHA use can be considered as effective methods to improve audiological outcomes and subjective satisfaction. Although not as good as BB, BCHA use is critical for improving hearing in the early period of language and auditory pathway development before the skull is suitable for BB implantation. [ABSTRACT FROM AUTHOR]

Background: Various amplification options are available for patients with congenital bilateral conductive hearing loss. Unilateral bone conduction hearing device (BCHD) is widely used for these patients, whereas benefits of bilateral BCHDs in certain subgroups of patients require further exploration. Objectives: To evaluate functional and directional hearing in patients with unilateral Bonebridge (MEDEL) and contralateral ADHEAR (MEDEL) devices. Materials and methods: This study included 32 patients (20 males, 12 females), of mean age 11.8 years (range 7–27 years). Hearing thresholds, speech perception and sound localization were tested three months after activation of the Bonebridge under three conditions: unaided, unilateral BHCD (Bonebridge) and bilateral BHCDs (Bonebridge plus contralateral ADHEAR). Patient acceptance of these devices in daily life was evaluated by questionnaire. Results: Compared with unaided, the mean hearing thresholds (0.5, 1, 2, and 4 kHz) and speech perception with unilateral BCHD and bilateral BCHDs were improved significantly (p <.05 each). Markers of directional hearing ability, including percentages of accurate responses, bias angles and RMS errors, were significantly better with bilateral BCHDs than unilateral BHCD (p <.05 each). Questionnaire revealed high patient satisfaction with both unilateral and bilateral devices. Conclusions: Functional hearing and sound localization abilities were better with bilateral BCHDs than unilateral BCHD. [ABSTRACT FROM AUTHOR]

Objective: To assess the performance of an active transcutaneous implantable-bone conduction device (TI-BCD), and to evaluate the benefit of device digital signal processing (DSP) features in challenging listening environments. Design: Participants were tested at 1- and 3-month post-activation of the TI-BCD. At each session, aided and unaided phoneme perception was assessed using the Ling-6 test. Speech reception thresholds (SRTs) and quality ratings of speech and music samples were collected in noisy and reverberant environments, with and without the DSP features. Self-assessment of the device performance was obtained using the Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire. Study sample: Six adults with conductive or mixed hearing loss. Results: Average SRTs were 2.9 and 12.3 dB in low and high reverberation environments, respectively, which improved to −1.7 and 8.7 dB, respectively with the DSP features. In addition, speech quality ratings improved by 23 points with the DSP features when averaged across all environmental conditions. Improvement scores on APHAB scales revealed a statistically significant aided benefit. Conclusions: Noise and reverberation significantly impacted speech recognition performance and perceived sound quality. DSP features (directional microphone processing and adaptive noise reduction) significantly enhanced subjects' performance in these challenging listening environments. [ABSTRACT FROM AUTHOR]

Objective: Our objective was to evaluate the surgical restrictions, audiologic benefits and satisfaction from using an active transcutaneous bone conduction device (BCD), Bonebridge® (BB) in patients with mixed/conductive hearing loss (MCHL) or single-sided deafness (SSD). Design: A retrospective review from all patients who underwent BB surgery at the Pusan National University Hospital from 2015 to 2017 for SSD or MCHL was performed. Study sample: Twenty-two patients with SSD and five with MCHL had a BB implanted and analysed. Results: Complete transmastoid implantation of the device was possible for all patients with an intact canal wall (ICW), using lifts if necessary. The overall functional hearing gain (FHG) in SSD and MCHL was 31.4 and 37.6 dB, respectively. The mean percentage of speech recognition in a quiet was 81% (vs. 11% unaided) for MCHL group and 82% (vs. 29% unaided) for SSD group. Mean speech recognition scores in noise improved significantly under various signal-to-noise ratio (SNR) for both groups. Questionnaires showed overall improvement, and there was no significant difference between the two groups. Conclusions: The BB provides improved functional gain, and there were no limitations during surgery despite the large device. Both MCHL and SSD group had benefit and improved quality of life with BB. [ABSTRACT FROM AUTHOR]

Abstract The aim of this letter is to respond to a commentary on a published article on the middle fossa approach to BONEBRIDGE implantation with self-drilling screws published by the senior authors.

Introduction: Bone conduction implants have been indicated for patients with conductive hearing loss, mixed hearing loss, and even profound unilateral sensorineural hearing loss. With the introduction of Bonebridge®, new transcutaneous implant options emerged. The latest is Osia®, a direct-drive variant or active systems, where the implant directly generates and applies vibration to the bone., Materials and Methods: Retrospective study of two cohorts of patients treated with active bone conduction implants at a single center, one with the Bonebridge® device and the other with Osia®., Outcomes: Fourteen patients were included, seven in each group (n = 14). The Bonebridge® group showed an average hearing gain in tonal intelligibility thresholds of 32.43 ± 21.39 dB and a gain in the average intelligibility threshold (with 50% discrimination) of 26.29 ± 19.10 dB. In the Osia® group, there was a gain in average tonal thresholds of 41.49 ± 14.16 dB and 23.72 ± 6.98 dB in average intelligibility thresholds. Both devices contributed to improvements in patients' quality of life, as assessed with APHAB in all the variables studied in the test. Both devices offer rehabilitation for hearing loss as an alternative to hearing aids. The Osia® system shows statistically significant (p &lt; 0.05) improvements in mid and high frequencies, but Bonebridge® slightly outperforms in speech understanding at 50%. Differences in average tonal thresholds and quality of life are not statistically significant., Conclusions: While auditory improvement is observed postimplantation, other aspects, such as intelligibility thresholds and quality of life, lack statistical significance. Given the limited experience with Osia® and the small sample size, the choice of the device should be personalized. Although the literature is inconsistent due to small sample sizes and variable approaches, some studies suggest potential advantages of the Osia® system, especially in speech comprehension in different environments and greater hearing gain compared to Bonebridge®., (© 2024 S. Karger AG, Basel.)

Purpose: To evaluate the audiological effectiveness of Bonebridge implantation in patients with bilateral congenital malformation of the external and middle ear. Methods: Twenty-eight cases [17 boys and 11 girls; median age, 12 years (range 8–36 years)] had unilateral Bonebridge implantation. Audiological tests were performed preoperatively and postoperatively, and included the pure-tone audiometry test, speech discrimination score (SDS), and evaluation of the unaided and aided hearing thresholds in sound fields. For the group of patients aged > 12 years, Mandarin Speech Test Materials were used to determine the SDS. For the other cases, the Mandarin Lexical Neighborhood Test was used. The daily life efficacy was assessed using the Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire postoperatively. The t and t′ tests were used in the statistical analyses. Results: The hearing threshold with the Bonebridge improved by 25–35 dB HL, compared to that of the unaided condition. The SDS of patients aged > 12 years improved by about 50%; the SDS also improved by 10–20% in the three patients aged < 12 years. According to the APHAB, the mean Bonebridge scores of ease of communication, background noise, and reverberation decreased by 60.3 ± 15.7, 50.2 ± 11.1, and 59.4 ± 7.8, respectively, compared to the preoperative scores, and the Bonebridge score of aversiveness was higher (69.8 ± 10.8) than the unaided score. Conclusions: The audiological effectiveness of the Bonebridge was significant and noticeable in bilateral congenital malformation of the external and middle ear. The Bonebridge can be an alternative and effective solution for those patients to improve hearing. [ABSTRACT FROM AUTHOR]

Abstract Objectives The objective of this study is to evaluate the safety and efficacy of the transcutaneous Bone Conduction Implant, the Bonebridge, in patients with congenital aural atresia. Methods Audiometry, speech recognition test and free field audiometry were performed. Word recognition scores and speech perception was evaluated using Spanish phonetically-balanced disyllables word list. Results Fourteen subjects were implanted with the Bonebridge (seven bilateral placements). The study cohort comprised seven males and seven females aged from 3 to 17 years (mean age 9.76yrs). All patients accepted and benefited from the implanted Bonebridge system. The pre-operative PTA 4 was 66.4 dB (64.2–68.6, 95-%CI) and improved after activation to 19.2 dB (16.9–21.5, 95% CI), resulting in a mean functional gain of 47,2 dB. Regarding speech discrimination, the pre-operative outcomes of the disyllabic measurements were 34.3% and for monosyllables 27.4%. Following activation the speech discrimination improved to 98.6% and 97.9%, respectively. No infections or adverse device related effects occurred in patient group. Conclusion We have concluded that the Bonebridge implant is an innovative solution for patients with conductive or mixed hearing loss and unilateral loss suffering from congenital atresia. Different surgical techniques may be used for implant placement, based on the patient's anatomy. Studies show improved functional gain, better speech perception, and lower rates of percutaneous complications associated with this implant. [ABSTRACT FROM AUTHOR]

Abstract Introduction For children with conductive or mixed hearing loss, in whom use of conventional hearing aids is impossible or limited, use of bone conduction devices is recommended. The choice between the available types of devices depends mostly on the degree of hearing loss, age, and anatomical conditions. One device application in children older than 5 years is the Bonebridge implant. The aim of this study is to assess the benefits and safety of this device in children. Methods The material was a group of 11 older children and adolescents aged 10–17 years (mean = 14.7, SD = 2.45) with single-sided or bilateral conductive or mixed hearing loss, implanted unilaterally with the Bonebridge system at the World Hearing Center in Kajetany near Warsaw between 2014 and 2016. Benefits of the Bonebridge were assessed with warble tone audiometry and word audiometry in free field, as well as an APHAB (Abbreviated Profile of Hearing Aid Benefit) questionnaire before and after implantation. Results Hearing tests showed a statistically significant improvement in hearing sensitivity and speech discrimination. Results of the questionnaire confirm the benefits of Bonebridge implantation to the older children in terms of their auditory performance under various acoustic conditions. Conclusions At a one-year follow up the Bonebridge system was found to be a safe, efficient, and effective tool for compensating for conductive or mixed hearing loss in older children and adolescents. For good anatomical conditions the Bonebridge implant provides a safe alternative to other popular bone conduction systems. [ABSTRACT FROM AUTHOR]

Background: Considering that hearing loss has a significant impact on social functioning, everyday activity and a person's emotional state, one of the most important goals of hearing rehabilitation with bone conduction devices is improvement in a patient's quality of life.Objectives: To measure self-assessed quality of life in patients implanted with the Bonebridge, a bone conduction device.Method: Prospective, observational, longitudinal study with one treatment group. Twenty-one patients with mixed or conductive hearing loss were included, and each individual served as its own control. The Abbreviated Profile of Hearing Aid Benefit (APHAB) was used to measure patient-reported quality of life before intervention and at 3 and 6 months after activation of the device. At the same time frames, pure-tone audiometry and speech understanding in quiet and in noise were tested.Results: Hearing-specific quality of life increased significantly after intervention and remained stable up to 6 months. Both word recognition in quiet and speech reception threshold in noise were significantly better after 6 months compared to before surgery. Outcomes of aided speech understanding were independent of initial bone conduction thresholds and equally high (word recognition score >75%) across the device's indication range.Conclusions: The Bonebridge provides not only significant audiological benefit in both speech understanding in quiet and in noise, but also increases self-perceived quality of life in patients suffering from mixed and conductive hearing loss. Together with a very low rate and minor nature of adverse events, it is the state-of-the-art solution for hearing rehabilitation in patients with mixed or conductive hearing loss up to a bone conduction threshold of 45 dB HL. [ABSTRACT FROM AUTHOR]