Implantation of two generations of Bonebridge after mastoid obliteration with bioactive glass S53P4.

PURPOSE: After radical surgery for chronic cholesteatoma (CWD mastoidectomy), patients have the option to have the posterior wall of their external auditory canal surgically reconstructed with S53P4 bioactive glass. The procedure eliminates some of the restrictions related to having a postoperative cavity and extends the options for a hearing prosthesis. If classic reconstruction is not possible and a hearing aid is not used, we suggest use of a Bonebridge implant. METHODS: This study describes, over 18 months of follow-up, 16 patients after a two-stage surgical procedure: obliteration of the mastoid cavity with bioactive glass followed by Bonebridge implantation. There were 7 patients who received the first generation implant (BCI 601) and 9 who used the second (BCI 602). Before and after implantation, pure tone audiometry, sound field thresholds, and free-field audiometry were performed. 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: During the observation period, no serious complications were found. The study demonstrated the safety and validity of the procedures and confirmed the safety of using S53P4 bioactive glass in otosurgery (antibacterial effect, nonrecurrence of cholesteatoma, and no effect on the inner ear). The audiological benefits expected from using the Bonebridge implant processor were also confirmed. CONCLUSION: It is concluded that, after reconstructing the posterior wall of the external auditory canal with bioactive glass, two-stage implantation of a Bonebridge implant in a typical site is a safe solution for patients who have difficult anatomical conditions following their CWD mastoidectomy.

Evaluation of the Bonebridge BCI 602 active bone conductive implant in adults: efficacy and stability of audiological, surgical, and functional outcomes.

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.

The Bonebridge BCI 602 Active Transcutaneous Bone Conduction Implant in Children: Objective and Subjective Benefits.

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.

Effectiveness of Bone Conduction Hearing Aids in Young Children with Congenital Aural Atresia and Microtia.

BACKGROUND The aim of this study was to assess the effectiveness of bone conduction hearing aids in children under 2 years old who have congenital microtia and atresia. MATERIAL AND METHODS This prospective study involved 42 children under 2 years old with congenital microtia and atresia who were divided into 2 groups: 21 with unilateral defect and 21 with bilateral defect. All children were provided with bone conduction hearing aids on a softband. Air and bone auditory thresholds were assessed by auditory brainstem responses (ABRs). The LittlEARS questionnaire was used to evaluate auditory development at baseline and after 6 months of hearing aids use. Behavioral observation audiometry (BOA) was used to assess auditory thresholds and compare aided and unaided hearing. RESULTS After 6 months of hearing aid use, the total score of the LittlEARS questionnaire in children with unilateral defect was 24±5.60, while children with bilateral defect achieved a result of 26.29±6.17. Hearing thresholds in both groups with bone conduction hearing aids improved significantly and approached the normal level. CONCLUSIONS Our results confirm that bone conduction hearing aids provide an effective method of auditory rehabilitation for children with conductive and mixed hearing loss caused by microtia and atresia. Using bone conduction hearing aids in such children is crucial for proper hearing, speech, and language development.

Implantation of the Vibrant Soundbridge in a Case of Bilateral Malformation of the Middle and External Ear.

BACKGROUND Here we present a case of Vibrant Soundbridge implantation in a 13-year-old girl with bilateral aural atresia of the external ear canal. In this instance, we attached the device's floating mass transducer (FMT) to a mobilizable complex of the incus and malleus, which functionally connected to the short process of the incus. CASE REPORT The article presents a case study of a patient with a congenital defect of the middle and external ear and conductive hearing loss, who was referred for middle ear implantation. Tonal audiometry revealed bilateral moderate to severe hearing loss with a 30 to 50 dB air-bone gap. After making a sufficiently wide antromastoidectomy, it became apparent that implantation of the MedEl Bonebridge hearing aid was not possible because of an overhanging dura. The short process of the incus was then visualized and, by drilling the bone laterally and anteriorly, the incus and malleus were found to have formed a conglomerate, firmly fused to the anterior wall of a rather small tympanic cavity. By removing the bony adhesion, mobility of the ossicular chain was restored. The MedEl Vibrant Soundbridge could then be implanted by attaching its FMT to the incus-like conglomerate. CONCLUSIONS Restoration of ossicular chain mobility was achieved, and the patient's hearing was improved by implanting the Vibrant Soundbridge hearing aid. Speech audiometry 1 month later showed improved hearing. Implantation of the Vibrant Soundbridge following ossiculoplasty may be a feasible solution in cases of bilateral congenital defect of the middle and external ear.

Implantation of the Bonebridge BCI 602 after Mastoid Obliteration with S53P4 Bioactive Glass: A Safe Method of Treating Difficult Anatomical Conditions-Preliminary Results.

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.

Mastoid Obliteration with S53P4 Bioactive Glass Can Make Bonebridge Implantation Feasible: A Case Report.

BACKGROUND Obliteration of the mastoid cavity with S53P4 bioactive glass is becoming a popular method of treatment, allowing most of the problems with the postoperative cavity to be eliminated. In the case of a hearing aid, reconstruction of the posterior wall of the auditory canal is an extremely beneficial procedure and, in the case of the Bonebridge implant, is necessary. After reconstruction, the FMT transducer is covered by bone and bioactive glass and has no contact with the postoperative cavity. The aim of this article is to present a case report. CASE REPORT A 41-year-old male patient with a history of bilateral otitis media with cholesteatoma since childhood had undergone many ear operations since 2001, including radical modified operations and postoperative revisions. There had been ossiculoplasty using own materials and a Kurz TORP prosthesis which gave a short-term hearing improvement for 3 months. The patient underwent tests for implantable devices, which showed a potential significant improvement in hearing and understanding speech. The patient met the audiological criteria qualifying him for the use of an implantable bone conduction device. However, a CT scan of the temporal bone showed that the Bonebridge implant could not be implanted due to insufficient mastoid volume. In order to safely implant the Bonebridge device, it was necessary to first rebuild the posterior wall of the left ear canal. The absolute condition was no inflammation of the ear or leaks for several months. CONCLUSIONS The two-stage surgical procedure as described in this case report can allow the Bonebridge implant to be used in a wider group of patients with previous anatomical limitations.

A Comparative Study of a Novel Adhesive Bone Conduction Device and Conventional Treatment Options for Conductive Hearing Loss.

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.

The Bonebridge in Adults with Mixed and Conductive Hearing Loss: Audiological and Quality of Life Outcomes.

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.

Preservation of Hearing Following Cochlear Implantation Using Different Steroid Therapy Regimens: A Prospective Clinical Study.

BACKGROUND A prospective clinical study was conducted to assess different regimens of steroid therapy and preservation of hearing following cochlear implantation. MATERIAL AND METHODS Study 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. RESULTS There 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. CONCLUSIONS Prolonged steroid therapy using combined oral and IV steroids stabilized hearing thresholds and preserved hearing in adult patients following cochlear implantation.