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

Abstract

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.

Outcomes After Transcutaneous Bone-Conduction Implantation in Adults and Children

“…The reduced thickness of the BCI 602 floating mass transducer has been suggested to reduce complications and surgical time. Cywka et al (3) reported a slightly shorter operation time for BCI 602 (mean, 28.3 ± 9.4 min; n = 42) compared with BCI 601 implantations (mean, 35.6 ± 8.1 min; n = 10). In our cohort, average surgical duration of BCI 602 implantation (94 ± 42 min) was shorter than BCI 601 implantation (109 ± 39 min), although significance was not reached ( p > 0.05).…”

“…This allows for less drilling depth while providing the same power output, reducing the risk of exposing or compressing the regional dura or sigmoid sinus. The external audio processor is the same for both devices (3).…”

Consensus report on bone conduction devices and middle ear implants in conductive and mixed hearing loss

“…Literatura krajowa i zagraniczna uwzględniająca wyniki audiologiczne oraz subiektywne wrażenia użytkowników potwierdza skuteczność wszczepialnych urządzeń wykorzystujących kostne przewodnictwo dźwięku u pacjentów z przewodzeniowym i mieszanym ubytkiem słuchu [2][3][4][5].…”

Multicentric study on surgical information and early safety and performance results with the Bonebridge BCI 602: an active transcutaneous bone conduction hearing implant

“…Fewer surgical steps also simplify and shorten the surgical procedure. The dimensions of the BCI 602 (MRI-conditional at 1.5 T) and its predecessor, the BCI 601, were described in a monocentric study by Cywka et al [ 8 ] (see also Fig. 1 a + b).…”