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Background: Although it is a recognized phenomenon, there is little published in the literature on the discontinuation of auditory implant use. Aim: To evaluate the incidence of device non-use of transcutaneous auditory implants. Patients and Methods: This is a retrospective study of all living individuals (children and adults) implanted at the La Paz Hospital (Madrid, Spain) between 1992–2015, with a follow-up examination endpoint of December 2022. 356 device recipients were included: 316 with cochlear implants (CI), 22 with middle-ear implants (Vibrant Soundbridge, VSB), and 18 with bone conduction implants (Bonebridge, BB). Results: Nine CI recipients (2.8%) were identified as non-users (mean follow-up 15.1 ± 5.4 years). The reasons for non-use were implant failure and reimplantation rejection, lack of benefit, non-attendance of rehabilitation sessions, loss of the audio processor, and cognitive and linguistic difficulties. None of them experienced any surgical complications. Six VSB recipients (27.3%) were device non-users (mean follow-up 11.4 ± 2.1 years). All of them experienced device failure or surgical complications. To date, none of the BB recipients is a non-user (mean follow-up 8.6 ± 1.1 years). Conclusion: The rates of non-use of transcutaneous auditory implants vary widely between different types of implants. Given the small proportion of non-users, information on what are the predictive factors could not be determined. The reasons for non-use should be carefully documented and used to guide careful patient selection to reduce the risk of non-use in future candidates.

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.

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 (S 0 N MIX ), while in the second scenario speech was presented from the side of the implanted ear (S IPSI N MIX ). 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 (S 0 N MIX , p  = 0.032) and 2.1 dB (S IPSI N MIX , 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.

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.

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.

Objective To determine whether exposure to monopolar electrosurgery during subsequent surgeries following Bonebridge implantation has negative impact on the implant. Study Design Retrospective study. Setting Tertiary medical center. Methods Fifty‐six patients who received Bonebridge implantation between December 2014 and June 2024 were reviewed. Twelve patients with exposure to monopolar electrosurgery during subsequent operation were included. Bonebridge‐aided sound field thresholds, as well as subjective outcomes based on patient experience were analyzed to determine if there are any adverse effects on the implant after monopolar electrosurgery exposure. Results The mean age at receiving Bonebridge implantation and subsequent operation were 15.1 ± 6.8 (range, 7.7‐29.9) years and 16.5 ± 6.5 (range, 10.2‐30.1) years, respectively. Each of the included patients experienced one episode of monopolar electrosurgery exposure after Bonebridge implantation. All monopolar electrosurgery exposures were in the head‐and‐neck region, but none of them involved the ipsilateral temporoparietal area. The mean pre‐monopolar electrosurgery and post‐monopolar electrosurgery Bonebridge aided sound field thresholds pure tone average were 31.8 ± 3.3 decibel hearing level and 29.5 ± 3.9 decibel hearing level, respectively (Wilcoxon signed‐rank test, P = .203). No adverse events associated with implant malfunction occurred after monopolar electrosurgery exposure. Conclusion No adverse events or hearing impairment were observed in this series of Bonebridge‐implanted patients who underwent operations involving monopolar electrosurgery. Notably, the exposures were of relatively brief duration and limited to areas outside the ipsilateral temporoparietal region. Further multicenter, prospective studies with larger cohorts and comprehensive adverse event analysis are warranted to better corroborate these findings.

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.

Purpose Single-sided deafness (SSD) presents significant challenges for patients, including compromised sound localization, reduced speech recognition, and often, tinnitus. These issues are typically addressed using interventions such as cochlear implantation (CI) and bone conduction implant (BCI). However, evidence regarding the efficacy of BCI in reducing tinnitus in SSD patients remains limited. This study explored the ability of a novel active transcutaneous BCI (Bonebridge BCI602) to alleviate tinnitus in SSD patients. Study design Prospective cohort multicenter study. Setting Tertiary referral hospitals. Methods A prospective multicenter study of 30 SSD patients was conducted. The patients were divided into two groups: those with ( n  = 19) and without ( n  = 11) tinnitus. Audiometric assessments, subjective questionnaires including the Abbreviated Profile of Hearing Aid Benefit (APHAB) and the Bern Benefit in Single-Sided Deafness (BBSS), and tinnitus evaluations with the Tinnitus Handicap Inventory (THI) and tinnitogram were conducted before and after BCI surgery. Results THI scores after surgery were significantly reduced in SSD patients with tinnitus. Subjective satisfaction improved in both the tinnitus and non-tinnitus groups; however, the former group exhibited a significantly greater improvement in the APHAB questionnaire score. According to tinnitograms, the loudness of tinnitus decreased, particularly in patients with ipsilateral tinnitus. Patients with residual hearing had greater reductions in their THI scores. However, three patients without residual hearing had a relative worsening of tinnitus after surgery. Conclusion The Bonebridge BCI602 effectively reduced tinnitus in SSD patients, particularly in those with residual hearing. Subjective satisfaction improved in both the tinnitus and non-tinnitus groups. These findings demonstrate the therapeutic potential of BCI for managing SSD and associated tinnitus.

Bone-conduction implants are a standard therapeutic option for patients with conductive, unilateral, or mixed hearing loss who either do not tolerate conventional hearing aids or can benefit from surgery. The aim of this study was to evaluate long-term medical and technical outcomes, and audiological results with the Bonebridge transcutaneous bone-conduction implant. This retrospective study included all patients implanted with a bone-conduction hearing implant at a tertiary medical referral center between March 2012 and October 2018. Medical and technical outcomes included the mean length of implant usage, medical and technical complications (skin and wound infection, lack of benefit, technical failure), explantations and revisions, coupling approaches, implant failure rate, implant survival and the implant loss for added follow-up years. Auditory results were measured by functional hearing gain and the Freiburger monosyllabic test at 65 dB sound pressure level. Sixty-four patients were included in the study; five of these were implanted bilaterally (69 devices). Five unilaterally implanted patients were lost to follow-up. The mean follow-up was 27.1 months (range: 0.2 months–6.3 years). The mean implant usage was 25.9 months (range: 0.2 months–6.3 years). Fifty-seven implants (89.1%) were in use at the end of the follow-up period. Complications occurred in six ears (9.4%). Five implants (7.8%) were explanted without reimplantation. Device failure occurred in one implant (1.6%), which was possibly caused by recurrent head trauma. The rate of implant loss due to technical device failure (damage to device) was 1 per 72 follow-up years. The mean improvement on the Freiburger monosyllabic test (52.1%, p = 0.0001), and in functional hearing gain across frequencies (26.5 dB, p = 0.0001) was significant. This single-center follow-up reveals the medical and technical reliability of a transcutaneous bone-conduction implant for hearing rehabilitation because complication and revision rates were low. The majority of patients still used the device at the end of the observation period. Implantation resulted in favorable hearing outcomes in comparison to that of unaided conditions. Cautious patient selection mainly regarding co-morbidities, the history of chronic otologic diseases and proper surgical technique seems to be crucial in reducing complications.

This study aimed to investigate the benefit of Bonebridge devices in patients with single-sided deafness. 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). 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. 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.