Clinical and functional results after implantation of the bonebridge, a semi-implantable, active transcutaneous bone conduction device, in children and adults

Abstract Purpose Aim of the study was to evaluate the surgical, clinical and audiological outcome of 32 implantations of the Bonebridge, a semi-implantable transcutaneous active bone conduction implant. Methods In a retrospective cohort study, we analyzed data for 32 implantations in 31 patients (one bilateral case; seven age < 16 years) with conductive or mixed hearing loss, malformations, after multiple ear surgery, or with single-sided deafness as contralateral routing of signal (CROS). Results Four implantations were done as CROS. Five cases were simultaneously planned with ear prosthesis anchors, and 23 implantations (72%) were planned through three-dimensional (3D) “virtual surgery.” In all 3D-planned cases, the implant could be placed as expected. For implant-related complications, rates were 12.5% for minor and 3.1% for major complications. Implantation significantly improved mean sound field thresholds from a preoperative 60 dB HL (SD 12) to 33 dB HL (SD 6) at 3 postoperative months and 34 dB HL (SD 6) at > 11 postoperative months (p < 0.0001). Word recognition score in quiet at 65 dB SPL improved from 11% (SD 20) preoperatively to 74% (SD 19) at 3 months and 83% (SD 15) at > 11 months (p < 0.0001). The speech reception threshold in noise improved from − 1.01 dB unaided to − 2.69 dB best-aided (p = 0.0018). Conclusion We found a clinically relevant audiological benefit with Bonebridge. To overcome anatomical challenges, we recommend preoperative 3D planning in small and hypoplastic mastoids, children, ear malformation, and simultaneous implantation of ear prosthesis anchors and after multiple ear surgery.

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Functional Results and Subjective Benefit of a Transcutaneous Bone Conduction Device in Patients With Single-Sided Deafness

Otology & Neurotology ◽

10.1097/mao.0000000000000791 ◽

2015 ◽

Vol 36 (7) ◽

pp. 1151-1156 ◽

Cited By ~ 27

Author(s):

Roman D. Laske ◽

Christof Röösli ◽

Flurin Pfiffner ◽

Dorothe Veraguth ◽

Alex M. Huber

Keyword(s):

Bone Conduction ◽

Functional Results ◽

Single Sided Deafness ◽

Bone Conduction Device

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First experiences with bone conduction implant Sophono

Otorinolaryngologie a foniatrie ◽

10.48095/ccorl2021102 ◽

2021 ◽

Vol 70 (2) ◽

pp. 102-108

Author(s):

Lukáš Varga ◽

Branislava Bercíková ◽

Zuzana Kabátová ◽

Milan Profant

Keyword(s):

Hearing Loss ◽

Functional Outcomes ◽

Conductive Hearing Loss ◽

Bone Conduction ◽

Detailed Knowledge ◽

Advantages And Disadvantages ◽

Mixed Hearing Loss ◽

Bone Conduction Implant ◽

Single Sided Deafness ◽

Conductive Hearing

ntroduction: Bone conduction implants are currently used for rehabilitation of conductive and mixed hearing loss as well as for single sided deafness. A growing number of these implants available on the market increases requirements on detailed knowledge on their technical properties, and on their advantages and disadvantages in clinical practice. Sophono is one of the recent members in this implant group. The aim of the study is to summarize our first experiences with Sophono at our implantation center in Bratislava. Patients and methods: We present data of the first two adult patients who underwent Sophono implantation. Both suffered from bilateral conductive hearing loss of different etiology. We focused on their audiological functional outcomes, basic surgical aspects and subjective assessment by the patients. Results: In free field tone audiometry with the implant, both patients achieved improvement of hearing thresholds by 21.25 dB and 31.25 dB, respectively. In speech tests with and without noise, we also demonstrated a clear benefit of the implant, which was in a narrow relationship with the degrees of their hearing loss: speech discrimination scores in noise were 30% and 60% in patients 1 and 2, respectively. The surgical procedure in Sophono implantation is relatively simple and does not include any work on middle ear structures. Patient satisfaction with the implant does not always correspond to the measured functional outcomes. Conclusion: The Sophono implant represents a suitable option for rehabilitation of conductive and mixed hearing loss as well as single sided deafness in selected patients. The candidate selection is always based on comprehensive assessment in which the audiological results are an elementary criterion, but definitely not a single one. Keywords: Sophono – implantation – conductive hearing loss

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Faculty Opinions recommendation of Preliminary functional results and quality of life after implantation of a new bone conduction hearing device in patients with conductive and mixed hearing loss.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.718258625.793490893 ◽

2014 ◽

Author(s):

James Rainsbury

Keyword(s):

Quality Of Life ◽

Hearing Loss ◽

Bone Conduction ◽

Functional Results ◽

Mixed Hearing Loss ◽

Hearing Device ◽

Bone Conduction Hearing

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Outcomes after Application of Active Bone Conducting Implants

Audiology and Neurotology ◽

10.1159/000502052 ◽

2019 ◽

Vol 24 (4) ◽

pp. 197-205 ◽

Cited By ~ 3

Author(s):

Eleonor Koro ◽

Mimmi Werner

Keyword(s):

Hearing Aids ◽

Pure Tone ◽

Care Center ◽

Pure Tone Audiometry ◽

Sound Field ◽

Hearing Gain ◽

Mixed Hearing Loss ◽

Glasgow Benefit Inventory ◽

The Mean ◽

Single Sided Deafness

Background: A bone conducting implant is a treatment option for individuals with conductive or mixed hearing loss (CHL, MHL) who do not tolerate regular hearing aids, and for individuals with single-sided deafness (SSD). An active bone conducting implant (ABCI) was introduced in 2012 with indication in CHL, MHL, and SSD, and it is still the only ABCI available. With complete implantation of the active transducer and consequent intact skin, a decrease in infections, skin overgrowth, and implant losses, all common disadvantages with earlier passive bone conducting implants, could be expected. Our Ear, Nose and Throat Department, a secondary care center for otosurgery that covers a population of approximately 365,000 inhabitants, was approved to implant ABCIs in 2012. Objectives: Our aim was to conduct an evaluation of audiological and subjective outcomes after ABCIs. Method: A cohort study with retrospective and prospective data collection was performed.The first 20 consecutive patients operated with an ABCI were asked for informed consent. The main outcome measures werepure tone and speech audiometry and the Glasgow Benefit Inventory (GBI). Results: Seventeen patients accepted to participate and 15 were able to complete all parts. Six patients had CHL or MHL. In this group the pure tone audiometry tests are comparable with an average functional hearing gain of 29.8 dB HL. With bilateral hearing, the mean Word Recognition Score (WRS) in noise was 35.7% unaided and 62.7% aided. Ten patients had the indication SSD. With the hearing ear blocked, the pure tone average was >101 dB HL, compared to 29.3 dB HL in sound field aided. With bilateral hearing, the mean WRS in noise was 59.7% unaided and 72.8% aided. The mean of the total GBI score was 42.1 in the group with CHL or MHL and 20.6 in the group with SSD. Conclusions: The patients benefit from their implants in terms of quality of life, and there is a substantial hearing gain from the implant for patients with conductive or MHL. Patients with SSD benefit less from the implant than other diagnoses but the positive outcomes are comparable to other options for this group.

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Sound-localization performance of patients with single-sided deafness is not improved when listening with a bone-conduction device

Hearing Research ◽

10.1016/j.heares.2018.04.007 ◽

2019 ◽

Vol 372 ◽

pp. 62-68 ◽

Cited By ~ 13

Author(s):

Martijn J.H. Agterberg ◽

Ad F.M. Snik ◽

Rens M.G. Van de Goor ◽

Myrthe K.S. Hol ◽

A. John Van Opstal

Keyword(s):

Sound Localization ◽

Bone Conduction ◽

Localization Performance ◽

Single Sided Deafness ◽

Bone Conduction Device

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Long-term Subjective Benefit With a Bone Conduction Implant Sound Processor in 44 Patients With Single-Sided Deafness

Otology & Neurotology ◽

10.1097/mao.0000000000000297 ◽

2014 ◽

Vol 35 (6) ◽

pp. 1017-1025 ◽

Cited By ~ 21

Author(s):

Jolien Desmet ◽

Kristien Wouters ◽

Marc De Bodt ◽

Paul Van de Heyning

Keyword(s):

Bone Conduction ◽

Bone Conduction Implant ◽

Single Sided Deafness ◽

Sound Processor

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Multicenter Results with an Active Transcutaneous Bone Conduction Implant in Patients with Single-sided Deafness

Otology & Neurotology ◽

10.1097/mao.0000000000003418 ◽

2021 ◽

Vol Publish Ahead of Print ◽

Author(s):

Alexander M. Huber ◽

Bernd Strauchmann ◽

Marco D. Caversaccio ◽

Wilhelm Wimmer ◽

Thomas Linder ◽

...

Keyword(s):

Bone Conduction ◽

Bone Conduction Implant ◽

Single Sided Deafness

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

Journal of Clinical Medicine ◽

10.3390/jcm10245916 ◽

2021 ◽

Vol 10 (24) ◽

pp. 5916

Author(s):

Katarzyna B. Cywka ◽

Henryk Skarżyński ◽

Bartłomiej Król ◽

Piotr H. Skarżyński

Keyword(s):

Hearing Loss ◽

Word Recognition ◽

Middle Ear ◽

Bone Conduction ◽

Free Field ◽

Subjective Assessment ◽

Congenital Defects ◽

Mixed Hearing Loss ◽

Speech Reception ◽

Bone Conduction Implant

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.

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