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.

Background: the Bonebridge hearing implant is an active transcutaneous bone conduction implant suitable for various types of hearing loss. It was first launched in 2012 as the BCI 601, with a newer internal part (BCI 602) released in 2019. With the new size and shape, the BCI 602 can be used in patients previously excluded due to insufficient anatomical conditions, especially in patients with congenital defects of the outer and middle ear. Objectives: the purpose of this study is to evaluate the objective and subjective benefits of the new Bonebridge BCI 602 in children who have hearing impairment due to conductive or mixed hearing loss. Safety and effectiveness of the device was assessed. Methods: the study group included 22 children aged 8–18 years (mean age 14.7 years) who had either conductive or mixed hearing loss. All patients were implanted unilaterally with the new Bonebridge BCI 602 implant. Pure tone audiometry, speech recognition tests (in quiet and noise), and free-field audiometry were performed before and after implantation. Word recognition scores were evaluated using the Demenko and Pruszewicz Polish Monosyllabic Word Test, and speech reception thresholds in noise were assessed using the Polish Sentence Matrix Test. The subjective assessment of benefits was carried outusing the APHAB (Abbreviated Profile of Hearing Aid Benefit) questionnaire. Results: after implantation of the Bonebridge BCI 602 all patients showed a statistically significant improvement in hearing and speech understanding. The mean word recognition score (WRS) changed from 12.1% before implantation to 87.3% after 6 months. Mean speech reception threshold (SRT) before implantation was +4.79 dB SNR and improved to −1.29 dB SNR after 6 months. All patients showed stable postoperative results. The APHAB questionnaire showed that difficulties in hearing decreased after implantation, with a statistically significant improvement in global score. Pre-operative scores (M = 35.7) were significantly worse than post-operative scores at 6 months (M = 25.7). Conclusions: the present study confirms that the Bonebridge BCI 602 is an innovative and effective solution, especially for patients with conductive and mixed hearing loss due to anatomical ear defects. The Bonebridge BCI 602 system provides valuable and stable audiological and surgical benefits. Subjective assessment also confirms the effectiveness of the BCI 602. The BCI 602 offers the same amplification as the BCI601, but with a smaller size. The smaller dimensions make it an effective treatment option for a wider group of patients, especially children with congenital defects of the outer and middle ear.

BackgroundA prospective clinical study was conducted to assess different regimens of steroid therapy and preservation of hearing following cochlear implantation.Material/MethodsStudy participants were ≥18 years-of-age, with a cochlear duct length ≥27.1 mm measured by computed tomography (CT), with hearing sound levels in the range of 10–120 decibels (dB) and sound frequencies of 125–250 hertz (Hz); sound levels of 35–120 dB and frequencies of 500–1,000 Hz; sound levels of 75–120 dB and frequencies of 2,000–8,000 Hz. Study exclusion criteria included diseases with contraindications for steroid therapy or medications that increased the effects of steroids. Patients had cochlear implantation and were divided into three treatment groups: intravenous (IV) steroid therapy (standard steroid therapy): combined oral and IV steroid therapy (prolonged steroid therapy); and a control group (cochlear implantation without steroid therapy). Hearing preservation was established by pure tone audiometry based on the pre-operative and postoperative average hearing thresholds according to the formula developed by the HEARRING Network.ResultsThere were 36 patients included in the study. In all cases, the cochlear implant electrode was inserted via the round window approach with a straight electrode length of 28 mm. Patients with combined oral and IV steroid therapy (prolonged steroid therapy) had better results when compared with patients with intravenous (IV) steroid therapy (standard steroid therapy) and the control group.ConclusionsProlonged steroid therapy using combined oral and IV steroids stabilized hearing thresholds and preserved hearing in adult patients following cochlear implantation.

No abstract

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.

Objective: To compare the audiological performance with the novel adhesive bone conduction hearing device (ADHEAR) to that with a passive bone conduction (BC) implant and to that with a bone conduction device (BCD) on a softband. Study Design: Prospective study in an acute setting, single-subject repeated measure in three situations: unaided, with conventional BCDs (passive implant or on softband), and with the ADHEAR. Setting: Tertiary referral center. Patients: Ten subjects with conductive hearing loss were evaluated with the ADHEAR. Five of these were users of a passive BC implant (Baha Attract with Baha4); five received a BCD (Baha4) on a softband for test purposes. Intervention: Use of non-invasive adhesive bone conduction system for the treatment of conductive hearing loss. Main Outcome Measures: Air and bone conduction thresholds, sound field thresholds, word recognition scores in quiet, and speech recognition thresholds in quiet and noise were assessed. Results: Users of the passive BC implant received comparable hearing benefit with the ADHEAR. The mean aided thresholds in sound field measurements and speech understanding in quiet and noise were similar, when subjects were evaluated either with the ADHEAR or the passive BC implant. The audiological outcomes for the non-implanted group were also comparable between the ADHEAR and the BCD on softband. Conclusions: Based on our initial data, the ADHEAR seems to be a suitable alternative for patients who need a hearing solution for conductive hearing loss but for medical reasons cannot or do not want to undergo surgery for a passive BC implant.

No abstract

This study presents the preliminary results of a new otosurgical method in patients after canal wall down (CWD) surgery; it involves the implantation of the Bonebridge BCI 602 implant after obliteration of the mastoid cavity with S53P4 bioactive glass. The study involved eight adult patients who had a history of chronic otitis media with cholesteatoma in one or both ears and who had had prior radical surgery. The mean follow-up period was 12 months, with routine follow-up visits according to the schedule. The analysis had two aspects: a surgical aspect in terms of healing, development of bacterial flora, the impact on the inner ear or labyrinth, recurrence of cholesteatoma, and possible postoperative complications (firstly, after obliteration of the mastoid cavity with S53P4 bioactive glass, then after implantation). The second was an audiological aspect which assessed audiometric results and the patient’s satisfaction based on questionnaires. During the follow-up period, we did not notice any serious postoperative complications. Studies demonstrated significantly improved hearing thresholds and speech recognition in quiet and noise using the Bonebridge BCI 602. Data collected after six months of use showed improved audiological thresholds and patient satisfaction. Based on the preliminary results, we believe that the proposed two-stage surgical method using bioactive glass S53P4 is a safe and effective way of implanting the Bonebridge BCI 602 in difficult anatomical conditions. This makes it possible to treat a larger group of patients with the device.