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

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.

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

“…The BCI 602 can be effectively applied in patients after a radical cavity operation or even after mastoid obliteration [ 26 , 27 ]. It can be applied more effectively and there is a better chance of long-term results [ 28 ].…”

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

“…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].…”

“…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].…”

Performance with a new bone conduction implant audio processor in patients with single-sided deafness

“…One option available is the BONEBRIDGE system (MED-EL, Innsbruck, Austria), an active transcutaneous bone conduction implant [7]. It is indicated for the treatment of patients with SSD as well as conductive or mixed hearing loss [8][9][10][11][12]. Its latest audio processor, the SAMBA 2 BB (AP2), offers more frequency and compression bands than its predecessor, the SAMBA BB (AP1).…”