Active Transcutaneous Bone Conduction Implant Research Articles

Sound Localization in Active Transcutaneous Bone Conduction Implant Users with Single-Sided Deafness.

Evaluate sound localization accuracy of subjects with single-sided deafness (SSD) with active transcutaneous bone conduction implants (atBCIs). Prospective case-control study. Tertiary referral center. Ten SSD patients (with ATBCIS) and 10 controls. Localization was assessed in a semianechoic chamber using a 24-speaker array. Stimuli included broadband noise (BBN) and narrowband noise (NBN). Perceived stimulus angle was recorded and compared with presented location. Statistical analyses were performed using ANOVA and Wilcoxon rank sum tests. The primary outcome measures were as follows: 1) mean angular error (MAE) error (°) and regression slope and 2) subjective benefit assessment (Speech Spatial Qualities questionnaire). Subjects with SSD demonstrated worse localization by MAE and regression slope compared with controls for both broadband noise (p < 0.0001) and narrowband noise at 500 Hz and 1000 kHz (p < 0.0001). There was no statistically significant difference (p = 0.1090) in slope between all groups at 4000 Hz. There was no significant difference in slope or MAE aided compared with unaided. Localization ability varied widely within the SSD cohort, with some individuals showing some ability in the unaided condition, best at 4000 Hz. Although SSQ confirmed particular difficulty in the spatial hearing domain, all domains improved with device use. Localization ability for individuals with SSD falls into a somewhat bimodal distribution. Some have fair localization, particularly at high frequencies, that is preserved but not improved with the atBCI. Others have minimal to no localization ability at any frequency, with no apparent device benefit.

Tinnitus reduction after active bone-conduction implantation in patients with single-sided deafness: a prospective multicenter study.

Single-sided deafness (SSD) presents significant challenges for patients, including compromised sound localization, reduced speech recognition, and often, tinnitus. These issues are typically addressed using interventions such as cochlear implantation (CI) and bone conduction implant (BCI). However, evidence regarding the efficacy of BCI in reducing tinnitus in SSD patients remains limited. This study explored the ability of a novel active transcutaneous BCI (Bonebridge BCI602) to alleviate tinnitus in SSD patients. Prospective cohort multicenter study. Tertiary referral hospitals. A prospective multicenter study of 30 SSD patients was conducted. The patients were divided into two groups: those with (n = 19) and without (n = 11) tinnitus. Audiometric assessments, subjective questionnaires including the Abbreviated Profile of Hearing Aid Benefit (APHAB) and the Bern Benefit in Single-Sided Deafness (BBSS), and tinnitus evaluations with the Tinnitus Handicap Inventory (THI) and tinnitogram were conducted before and after BCI surgery. THI scores after surgery were significantly reduced in SSD patients with tinnitus. Subjective satisfaction improved in both the tinnitus and non-tinnitus groups; however, the former group exhibited a significantly greater improvement in the APHAB questionnaire score. According to tinnitograms, the loudness of tinnitus decreased, particularly in patients with ipsilateral tinnitus. Patients with residual hearing had greater reductions in their THI scores. However, three patients without residual hearing had a relative worsening of tinnitus after surgery. The Bonebridge BCI602 effectively reduced tinnitus in SSD patients, particularly in those with residual hearing. Subjective satisfaction improved in both the tinnitus and non-tinnitus groups. These findings demonstrate the therapeutic potential of BCI for managing SSD and associated tinnitus.

Active Bone Conduction Implant and Adhesive Bone Conduction Device: A Comparison of Audiological Performance and Subjective Satisfaction.

Introduction Atresia of the external auditory canal affects 1 in every 10 thousand to 20 thousand live births, with a much higher prevalence in Latin America, at 5 to 21 out of every 10 thousand newborns. The treatment involves esthetic and functional aspects. Regarding the functional treatment, there are surgical and nonsurgical alternatives like spectacle frames and rigid and softband systems. Active transcutaneous bone conduction implants (BCIs) achieve good sound transmission and directly stimulate the bone. Objective To assess the audiological performance and subjective satisfaction of children implanted with an active transcutaneous BCI for more than one year and to compare the outcomes with a nonsurgical adhesive bone conduction device (aBCD) in the same users. Methods The present is a prospective, multicentric study. The audiological performance was evaluated at 1, 6, and 12 months postactivation, and after a 1-month trial with the nonsurgical device. Results Ten patients completed all tests. The 4-frequency pure-tone average (4PTA) in the unaided condition was of 65 dB HL, which improved significantly to 20 dB HL after using the BCI for 12 months. The speech recognition in quiet in the unaided condition was of 33% on average, which improved significantly, to 99% with the BCI, and to 91% with the aBCD. Conclusion The aBCD demonstrated sufficient hearing improvement and subjective satisfaction; thus, it is a good solution for hearing rehabilitation if surgery is not desired or not possible. If surgery is an option, the BCI is the superior device in terms of hearing outcomes, particularly background noise and subjective satisfaction.

Experience With the New Active Transcutaneous Bone-Conduction Implant With Smaller Dimensions.

Recently, the Bonebridge 602 implant was introduced. Its smaller dimensions facilitate implantation even in surgically demanding cases. However, in extreme anatomical conditions, implant lifts are still required. We intended to report on the medical and audiological outcomes of all patients implanted with the implant with a secondary focus on the safety, efficacy, and feasibility of the use of 1-mmlifts. Retrospective cohort study. Tertiary academic center. We retrospectively analyzed all patients implanted with the Bonebridge 602. Patient demographics and surgically-specific data were collected from the medical charts. Furthermore, audiological results were assessed. Outcomes were compared between implantations with versus without lifts. Twenty-one devices were implanted during the study period. Satisfactory audiological results were observed, while no intra- or postoperative adverse events occurred. The majority of patients were daily users at the end of the observation period (n = 20/21, 95.2%), and one patient (n = 1/21, 4.8%) was a nonuser after 6 months of use because of subjective dissatisfaction. Due to anatomical considerations, 1-mm lifts were used in 4 implantations (19.0%). The application of lifts did not result in prolonged surgical times, complications, or shorter time of use, nor did it negatively affect audiometric results. Implantations with the new and smaller Bonebridge were associated with gratifying medical and audiological outcomes. Still, in extreme anatomical conditions, 1-mm lifts are necessary. Nonetheless, surgical placement with the help of lifts seems safe, effective, and feasible, and is a viable option in cases with challenging anatomies due to previous surgeries or anomalies.

EE83 Cost-Effectiveness Analysis of an Active Transcutaneous Bone Conduction Implant for Patients With Conductive or Mixed Hearing Loss or Single-Sided Deafness in Turkey

Bone conduction implants (BCIs) transmit sound directly to the inner ear via bone conduction. The aim of this study is to compare the cost effectiveness of an active transcutaneous BCI to a passive transcutaneous BCI as well as percutaneous BCIs for people with conductive or mixed hearing loss or single-sided deafness in Turkey.

Clinical Experience of Using Active Transcutaneous Bone Conduction Implants (Bonebridge) in Children Under 5 Years Old.

Clinical Experience of Using Active Transcutaneous Bone Conduction Implants (Bonebridge) in Children Under 5 Years Old.

Simultaneous Bilateral Bone Bridge Implantation in a Two-Year-Old Child with Atresia of the External Auditory canal: A Case Report

Introduction: Active transcutaneous bone conduction implants are indicated for mild to moderate conductive or mixed hearing loss (intact inner ear and auditory nerve) for subjects 5 years or older. The aim of the here presented study was to share our results with the Bonebridge in a child aged 2 years at time of surgery. Especially the new generation of the implant being half of the size, a re-evaluation of the given indication for children 5 years or older is highly recommended.

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.

Early Outcomes of a New Active Transcutaneous Bone Conduction Implant in Pediatric Patients.

To describe the early surgical and audiometric outcomes in pediatric patients implanted with a new active transcutaneous bone conduction implant system. Retrospective case review. Tertiary pediatric hospital. Pediatric patients (18 or younger) with conductive or mixed hearing loss that completed postoperative aided testing following implantation with the Cochlear Osia system from December 2019 to December 2020. Rehabilitative. Preoperative air conduction (AC), preoperative bone conduction (BC), and postoperative aided thresholds were compared. Pure-tone averages (PTA), air-bone gap (ABG), and functional gain were calculated. Surgical complications and patient satisfaction were summarized from the chart review. Sixteen patients (20 implants) met the inclusion criteria. The average age at the time of implantation was 12.9 ± 2.4 years. The preoperative AC and BC thresholds were 64.4 dB (±11.9 dB) and 7.9 dB (±4.90 dB), respectively, with an average ABG of 56.5 dB (±12.8 dB). The average postoperative aided threshold was 21.2 dB (± 4.25 dB) with a mean functional gain of 43.1 dB (±10.2 dB). One patient developed seroma postoperatively, which was treated conservatively. No other complications were reported over a mean follow-up time of 7.1 ± 4 months. For 13 patients with previous passive bone conduction implants or devices, the Osia system was universally favored. The new active transcutaneous bone conduction system showed favorable early clinical and audiometric outcomes. Repeated processor connectivity issues represent a potential area for future device development. This is the largest pediatric case series to date.Level of Evidence: Level 4-Retrospective Review.

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

Objective:To evaluate the audiological and subjective benefit from hearing rehabilitation with an active bone conduction implant in subjects with single-sided sensorineural deafness (SSD).Study Design:Prospective, multicenter, single-subject repeated measures.Setting:Tertiary referral center, five clinics in Germany and Switzerland.Patients:Seventeen subjects aged 18 years and older with severe to profound unilateral sensorineural hearing loss and contralateral normal hearing were followed up for 24 months.Intervention:Active bone conduction implant.Main Outcome Measures:Speech understanding in noise was assessed in three situations: with signal from front, deaf, or normal hearing side (with noise from front in all set-ups). Subjective benefit was evaluated using the Speech, Spatial, and Qualities of Hearing (SSQ-B) and Bern Benefit in Single-Sided Deafness (BBSS) questionnaire.Results:When the signal was coming from the deaf side the mean improvement of the speech reception threshold in noise ranged from 1.5 up to 2.2 dB with the device and was statistically and clinically significant at all tested timepoints. No significant difference between the aided and unaided situation was found when signal and noise were coming from the front. With the signal from the normal hearing side no clinically significant difference, that is, greater than 1 dB between the aided and unaided situation was found. The SSQ-B and BBSS questionnaire showed an overall improvement with no significant difference between time points.Conclusions:The study demonstrates long-term efficacy and benefit of the device in adults with SSD. Patients reported substantial and persistent subjective benefit from the active bone conduction implant.

Surgical Experience and Early Audiological Outcomes With New Active Transcutaneous Bone Conduction Implant.

Our objective was to report the very first surgical experiences, audiologic benefits, and satisfaction with the new active transcutaneous bone conduction implant, generation 602 (BCI602), in patients with mixed/conductive hearing loss (M/CHL) and single-sided deafness. A retrospective chart review from patients who underwent BCI602 surgery was performed. Twelve subjects were implanted (mean age 33.17 ± 21.67 yrs). Mean surgery time was 29.89 ± 8.59 minutes, with the longest being a difficult passive-BCI explantation due to excessive osseointegration. No surgical nor post-surgical complications occurred. No pre-operative surgical planning for device placement was necessary, no BCI-lifts were used and complete transmastoid implantation was possible. The mean functional gain in the M/CHL cohort significantly increased after 3 months (ρ < .0001). The mean word recognition score (%) in quiet for the M/CHL group significantly improved at activation and 3 months post-surgery (ρ = .0002; ρ < .0001). At the 3 months follow-up the subjects reported high satisfaction with the device accompanied with a mean wearing time of 10.13 hours per day (range 18-6 h/d) resulting in a reported battery change of every 8.29 ± 0.49 days. These early results of the new BCI602 showed significantly improved audiological performance, no limitations during surgery (youngest subject 2 yrs at surgery), no prior surgical planning necessary, accompanied by high patient satisfaction and increased wearing time. Based on these results, the BCI602 can be highly recommended and especially for difficult anatomical and surgical cases and the given indication for children older than 5 years should probably be revaluated.Level of Evidence: Level 4.

Active Transcutaneous Bone Conduction Implant: Audiometric Outcomes Following a Novel Middle Fossa Approach With Self-Drilling Screws.

To present surgical and audiometric outcomes of patients implanted with an active transcutaneous bone conduction implant following the novel middle fossa surgical approach with self-drilling screws. Retrospective review. Tertiary care center. Thirty-seven adults with either conductive or mixed hearing loss that met indications for an active transcutaneous bone conduction implant were consecutively implanted from April, 2013 to May, 2018. Unilateral middle fossa implantation of an active transcutaneous bone conduction implant. Patient charts were reviewed for surgical outcomes and complications over the 6-year period. Preoperative air conduction, preoperative bone conduction, and 3-month postoperative aided thresholds were recorded. Speech perception was assessed using CNC words and AzBio sentences. Pure-tone averages (PTAs; measured at 0.5, 1.0, 2.0 and 3.0 kHz), air-bone gap, and functional gain were calculated. Mean air conduction and bone conduction PTAs (±standard deviation) of the implanted ear were 66.8 dB (±14.9 dB) and 21.9 dB (±14.0 dB), respectively. Mean aided PTA was 26.5 dB (± 8.5 dB). The average functional gain was 40.3 dB (±19.0 dB). Favorable speech perception outcomes were observed. No complications or instances of revision surgery were reported, with a mean follow-up time of 32 months (range, 9-71 mo). This is the first paper to describe outcomes of patients implanted with an active transcutaneous bone conduction implant via the middle fossa with self-drilling screws. Favorable surgical outcomes were observed with a follow-up of up to 6 years.

The effect of an active transcutaneous bone conduction device on spatial release from masking

Objective: The aim was to quantify the effect of the experimental active transcutaneous Bone Conduction Implant (BCI) on spatial release from masking (SRM) in subjects with bilateral or unilateral conductive and mixed hearing loss.Design: Measurements were performed in a sound booth with five loudspeakers at 0°, +/−30° and +/−150° azimuth. Target speech was presented frontally, and interfering speech from either the front (co-located) or surrounding (separated) loudspeakers. SRM was calculated as the difference between the separated and the co-located speech recognition threshold (SRT).Study Sample: Twelve patients (aged 22–76 years) unilaterally implanted with the BCI were included.Results: A positive SRM, reflecting a benefit of spatially separating interferers from target speech, existed for all subjects in unaided condition, and for nine subjects (75%) in aided condition. Aided SRM was lower compared to unaided in nine of the subjects. There was no difference in SRM between patients with bilateral and unilateral hearing loss. In aided situation, SRT improved only for patients with bilateral hearing loss.Conclusions: The BCI fitted unilaterally in patients with bilateral or unilateral conductive/mixed hearing loss seems to reduce SRM. However, data indicates that SRT is improved or maintained for patients with bilateral and unilateral hearing loss, respectively.

MRI Metal Artifact Reduction Sequence for Auditory Implants: First Results with a Transcutaneous Bone Conduction Implant

Objective: Magnetic resonance imaging (MRI) is often limited in patients with auditory implants because of the presence of metallic components and magnets. The aim of this study was to evaluate the clinical usefulness of a customized MRI sequence for metal artifact suppression for patients with implants in the temporal bone region, specifically patients with a transcutaneous bone conduction implant. Methods: Two whole head specimens were unilaterally implanted with a transcutaneous bone conduction implant. MRI examinations with and without a primarily self-build sequence (SEMAC-VAT WARP) for metal artifact suppression were performed. The diagnostic usefulness of the acquired MRI scans was rated independently by two neuroradiologists. The sequence was also used to acquire postimplantation follow-up MRI in a patient with a transcutaneous bone conduction implant. Results: The customized SEMAC-VAT WARP sequence significantly improved the diagnostic usefulness of the postimplantation MRIs. The image acquisition time was 12 min and 20 s for the T1-weighted and 12 min and 12 s for the T2-weighted MRI. There was good agreement between the two blinded raters (Cohen’s κ = 0.61, p < 0.001). Conclusion: The sequence for metal artifact reduction optimized in Bern enables MRI at 1.5 T in patients with active transcutaneous bone conduction implants without sacrificing diagnostic imaging quality. Particularly on the implanted side, imaging of intracranial and supra- and infratentorial brain pathologies is clinically more valuable than standard diagnostic MRI without any artifact reduction sequences.

The First Active Transcutaneous Bone Conduction Implant in Romania-Case Report of Permanent Conductive Hearing Loss Due to Cleft Palate

The First Active Transcutaneous Bone Conduction Implant in Romania-Case Report of Permanent Conductive Hearing Loss Due to Cleft Palate

Retrospective Analysis of Hearing-Impaired Adult Patients Treated With an Active Transcutaneous Bone Conduction Implant.

To determine the therapeutic success and safety of an active transcutaneous bone conduction implant (tBCI) in adult patients with conductive or mixed hearing loss. Retrospective case review. Five university hospitals in Frankfurt, Hannover, Dresden, Würzburg, and Vienna. Data were analyzed from 61 patients (31 women, 30 men) with a mean age of 50 years (min. 26, max. 80). Forty patients had mixed, and 21 conductive hearing loss. Typical etiologies were history of otitis media (n = 20) and cholesteatoma (n = 17). Implantation of the active tBCI. Data were analyzed for the following time points: up to 6 months postoperatively ("short-term"), 6 to 37 months postoperatively ("long-term"), and the last available measurement per patient ("most recent"). Pure-tone audiometry (air and bone conduction, AC and BC) and sound field thresholds with warble tones (WT), word recognition scores with Freiburger monosyllables (WRS), as well as speech reception thresholds (SRT) using the Oldenburg sentence test (OLSA) in quiet (SRT) and in noise (signal-to-noise ratio, SNR) were collected. No significant changes in air- and bone-conduction thresholds were observed after implantation. A mean WRS improvement of 54% using the active tBCI was shown at the short-term assessment, i.e., a mean score of 79% compared with 25% in the unaided condition. Results remained stable, with a mean score of 75% at the long-term assessment. SRT in noise improved by 3.6 dB SNR in the implanted ear at the short-term assessment. Overall six adverse events and four serious adverse events were reported, resulting in a rate of 9.84 and 6.56%, respectively. The tBCI clearly improves speech intelligibility in patients with conductive or mixed hearing loss, showing stable results up to 1 year post-implantation.

Active Transcutaneous Bone Conduction Implant: Middle Fossa Placement Technique in Children With Bilateral Microtia and External Auditory Canal Atresia.

The aim of this study is to present the middle fossa technique (MFT) as an alternative for patients who cannot undergo traditional surgery for active transcutaneous bone conduction implants (ATBCI) due to their altered anatomy or desire for future aesthetic reconstruction. A case series descriptive study was designed. The MFT was developed. Preoperative and postoperative information from 24 patients with external auditory canal atresia (EACA) and implanted with ATBCI was reviewed. A total of 24 children with bilateral EACA received implants in the middle cranial fossa. Their average age was 12. Of these patients, eight had an associated congenital disorder: Goldenhar Syndrome, Treacher Collins Syndrome or the Pierre Robin Sequence. The average follow-up was at 17 months (ranging from between 2- and 36 mo) and there were no major complications. Four patients showed skin erythema at the processor site after turn on, which was solved by lowering the magnet strength. One patient had a scalp hematoma that required puncture drainage. The hearing thresholds went down on average from 66.5 to 25.2 dB 1 month after turn on. Speech recognition improved respectively from 29.4% without and 78.9% with a bone conduction hearing aid to 96.4%. MFT placement of the ATBCI was proven to be safe and effective and a viable option for treating pediatric patients with EACA who cannot receive implants at the sinodural angle or in the retrosigmoidal position because of their altered anatomy and/or desire for future aesthetic reconstruction.

The Bonebridge Bone Conduction Hearing Implant: indication criteria, surgery and a systematic review of the literature.

Hearing aids and implants employing bone conduction (BC) stimulation have a long tradition in the treatment of conductive or mixed hearing loss, with their indications being extended in the 2000s to include single-sided deafness (SSD). Existing percutaneous bone conduction implants (BCI) provide significant audiological gain but are associated with a high rate of complications. This has led to the development of passive transcutaneous BCIs; however, audiological benefit may be compromised. An active transcutaneous BCI, the Bonebridge, was recently introduced and first implanted in 2011 as part of a clinical trial. To introduce and assess the safety and effectiveness of the Bonebridge for individuals with conductive or mixed hearing loss, and SSD. Systematic review. The Cochrane Library, PubMed and OVIDSP (MEDLINE) and EMBASE were searched to identify papers on the Bonebridge published as of June 2014. No exclusion criteria were set on publication language, study design or reported outcomes. The literature found was supplemented by presentations from relevant conferences. Study selection, data extraction and study quality assessment were carried out by a single reviewer with any uncertainties resolved with consulting a second reviewer. Studies were synthesised narratively and results were tabulated. A total of 29 studies, 17 published and 12 presentations, were identified. The highest quality evidence was from three single-arm trials. In those assessing the safety of implantation, 6 of 117 patients experienced a minor adverse event with superficial revision surgery being required in one case. Studies demonstrated improved hearing thresholds and speech recognition with the Bonebridge when compared to no aiding in adults and children with either type of hearing loss. This was reflected in high device satisfaction rates. Data collected in the second year of device use further suggest the benefit to remain constant. The transcutaneous BCI system Bonebridge provides a valuable and stable audiological benefit to patients suffering from conductive or mixed hearing loss and SSD. With its active transcutaneous design, the Bonebridge offers a lower complication rate to percutaneous systems and higher and more reliable hearing gain compared to other transcutaneous or percutaneous systems. Moreover, the fast activation of the implant system enables the recipient of the system to benefit in a short time frame postoperatively from the intervention.

Outcomes after Bonebridge Implantation: Audiological Benefits and Health Related Quality of Life

Objective: Bone conduction implants (BCI) are medical devices for conductive and mixed hearing losses as well as for single side sensorineural deafness (SSD). All direct-drive BCI transmit vibrations directly to the skull bone and can be divided into percutaneous and active transcutaneous devices. Method: We report a case series of 10 patients, suffered from mixed or conductive hearing loss, submitted to Bonebridge implantation. Audiological evaluation was conducted at six months to observe the functional impact of this device. Patients were asked to answer the Glasgow Benefit Inventory (GBI), a retrospective questionnaire, to measure the effect of the surgical intervention on the health-related quality of life. Results: The functional gain was found to range from 25 dB to 40 dB. Speech perception in noise improves in all patients and no post-operative complications were observed. GBI questionnaire has reflected high device satisfaction rate. Conclusion: Active transcutaneous BCI represent an effective and safety solution for people that cannot have adequate benefit from conventional hearing aids, to restore good audiological performance and life satisfaction.