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

Skarżyński

Eur Arch Otorhinolaryngol

et al. 2022

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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.

Section: Discussionmentioning

confidence: 99%

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

Skarżyński

Eur Arch Otorhinolaryngol

et al. 2022

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“…Indications recommended by Med-El are: conductive or mixed mild-to-moderate hearing loss; pure tone average (PTA) BC threshold (measured at 0.5, 1, 2, 3, and 4 kHz) ≥ 45 dB HL (Figure 1);profound sensorineural hearing loss in one ear and normal hearing in the opposite ear; and air conduction hearing thresholds in the hearing ear or sensorineural hearing loss in one ear and normal hearing in the opposite ear; and air conduction dual medical history has to be assessed to check for the following: active infection; cholesteatoma; revision tympanoplasty; ear canal stenosis or chronically draining ears where conventional hearing aids are not suitable; and otosclerosis or tympanosclerosis that cannot be rectified to a sufficient extent by surgery. When there is an issue with treatment after cholesteatoma, it is still possible to apply a BCI, but before hand it is necessary to obliterate the cavity with bioactive glass [19,20]. On the other hand, favorable indications include wearing conventional hearing aids; congenital malformations in which the ear canals are absent; sudden deafness or other reasons that cause severe to profound sensorineural hearing loss on one side; anatomy that allows appropriate placement of the Bonebridge implant as determined by a CT scan; absence of retrocochlear and central auditory disorders; and psychological and emotional stability with realistic expectations of the benefits and limitations of an implant [21].…”

Section: Bonebridgedescriptionmentioning

confidence: 99%

“…When there is an issue with treatment after cholesteatoma, it is still possible to apply a BCI, but before hand it is necessary to obliterate the cavity with bioactive glass [19,20]. On the other hand, favorable indications include wearing conventional hearing aids; congenital malformations in which the ear canals are absent; sudden deafness or other reasons that cause severe to profound sensorineural hearing loss on one side; anatomy that allows appropriate placement of the Bonebridge implant as determined by a CT scan; absence of retrocochlear and central auditory disorders; and psychological and emotional stability with realistic expectations of the benefits and limitations of an implant [21].…”

Section: The New Bonebridgebci 602mentioning

confidence: 99%

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

Skarżyńśki

et al. 2021

JCM

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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.

“…All procedures were performed in the years 2019 to 2020 under general anesthesia according to the schemes described in previous publications [ 23 , 27 ], by one otosurgeon with many years of experience. The prospective study was approved by the Bioethical Committee of the Institute of Physiology and Pathology of Hearing, Warsaw, Poland (nr KB/17/2016).…”

Section: Methodsmentioning

confidence: 99%

“…In this paper, we propose a combination of two surgical techniques that will enable the use of the Bonebridge BCI 602 implant in a wider group of patients [ 23 , 24 ].…”

Section: Introductionmentioning

confidence: 99%

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

Skarżyńska

et al. 2021

Life

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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.