Transcutaneous Bone Conduction Implants Research Articles

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.

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.

Staged implantation of active transcutaneous bone conduction hearing devices (BCHD) after explantation of older generation bone anchored hearing aids (BAHAs): Surgical outcomes and approach to management

PurposeTo evaluate outcomes following explantation of percutaneous or transcutaneous bone conduction implants (pBCIs or tBCIs) and subsequent implantation of transcutaneous active bone conduction hearing devices (BCHDs); to provide guidance regarding staging of surgery and adjunctive procedures. Materials and methodsRetrospective chart review of eight adult subjects (ten ears) with pBCIs or tBCIs who underwent explantation of their device and subsequent implantation with a BCHD [MED-EL BONEBRIDGE™ (n = 7, 70 %) or Cochlear™ Osia® (n = 3, 30 %)]. ResultsReasons for pBCI or tBCI explantation were pain (60 %, 6/10), infection (60 %, 6/10), skin overgrowth (50 %, 5/10), and inability to obtain new processors (20 %, 2/10). Median time between pBCI or tBCI removal and BCHD staged implant was 4.7 (IQR 2.2–8.1) months. Two subjects developed complications following BCHD implantation. One had a persistent wound overlying the osseointegrated screw after removal of the pBCI abutment, requiring removal and temporalis rotational flap. Staged Osia® implantation was performed, but ultimately wound dehiscence developed over the device. The second subject experienced an infection after BONEBRIDGE™ implantation (32 days after pBCI explant), necessitating washout and treatment with intravenous antibiotics. There was subsequent device failure. ConclusionThe transition from a pBCI or tBCI to a novel transcutaneous device is nuanced. Staged pBCI or tBCI explantation and novel BCHD implantation with sufficient time for wound healing is vital. Adjunctive procedures to augment soft tissue in cases of prior attenuation may be required to avoid complications with larger internal devices.

Early Results With the New Active Bone-Conduction Hearing Implant: A Systematic Review and Meta-Analysis.

The bone conduction implant (BCI) 602 is a new transcutaneous BCI with smaller dimensions. However, limited patient numbers restrict the statistical power and generalizability of the current studies. The present systematic review and meta-analysis summarize early audiological and medical outcomes of adult and pediatric patients implanted with the BCI 602 due to mixed or conductive hearing loss. Following the Preferred Reporting items for Systematic Reviews and Meta-analyses guidelines, 108 studies were reviewed, and 6 (5.6%) were included in the meta-analysis. The data on study and patient characteristics, surgical outcomes, and audiological test results were extracted from each article. Meta-analysis employed the fixed-effect and random-effects models to analyze the mean differences (MDs) between pre- and postoperative performances. In total, 116 patients were evaluated, including 64 (55%) adult and 52 (45%) pediatric patients. No intraoperative adverse events were reported, while postoperative complications were reported in 2(3.1%) adult and 2 (3.8%) pediatric patients. Studies consistently showed significant improvements in audiological outcomes, quality of life, and sound localization in the aided condition. In the meta-analysis, we observed a significant difference in the unaided compared to the aided condition in sound field thresholds (n = 112; MD, -27.05 dB; P < 0.01), signal-to-noise ratio (n = 96; MD, -6.35 dB; P < 0.01), and word recognition scores (n = 96; MD, 68.89%; P < 0.01). The implantation of the BCI 602 was associated with minimal surgical complications and excellent audiological outcomes for both the pediatric and the adult cohort. Therefore, our analysis indicates a high level of safety and reliability. Further research should focus on direct comparisons with other BCIs and long-term functional outcomes.

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.

Magnetic Resonance Imaging Artifact Associated With Transcutaneous Bone Conduction Implants: Cholesteatoma and Vestibular Schwannoma Surveillance.

To evaluate the magnetic resonance (MR) image artifact and image distortion associated with the two transcutaneous bone conduction implants currently available in the United States. Cadaveric study. Two cadaveric head specimens (1 male, 1 female) were unilaterally implanted according to manufacturer guidelines and underwent MR imaging (General Electric and Siemens 1.5 T scanners) under the following device conditions: (1) no device, (2) Cochlear Osia with magnet and headwrap, (3) Cochlear Osia without magnet, and (4) MED-EL Bonebridge with magnet. Maximum metal mitigation techniques were employed in all conditions, and identical sequences were obtained. Blinded image scoring (diagnostic vs nondiagnostic image) was performed by experienced neuroradiologists according to anatomical subsites. All device conditions produced artifact and image distortion. The Osia with magnet produced diagnostic T1- and T2-weighted images of the ipsilateral temporal bone, however, non-echo planar imaging diffusion-weighted imaging (DWI) was nondiagnostic. The Osia without magnet scanned on the Siemens MR imaging demonstrated the least amount of artifact and was the only condition that allowed for diagnostic imaging of the ipsilateral temporal bone on DWI. The Bonebridge produced a large area of artifact and distortion with the involvement of the ipsilateral and contralateral temporal bones. In summary, of the three device conditions (Osia with magnet, Osia without magnet, and Bonebridge), Osia without magnet offered the least amount of artifact and distortion and was the only condition in which diagnostic DWI was available for the middle ear and mastoid regions on the Siemens MR imaging scanner.

Percutaneous Bone-Anchored Hearing Implant Surgery: Do Syndromic Children Have More Adverse Perioperative Outcomes?

To evaluate and compare perioperative outcomes of percutaneous bone-anchored hearing implant (BAHI) surgery in syndromic and nonsyndromic pediatric patients. Retrospective cohort study. McGill University Health Centre in Montreal, Quebec, Canada. Forty-one pediatric patients (22 syndromic, 19 nonsyndromic) who underwent percutaneous BAHI surgery between March 2008 and April 2021. Percutaneous BAHI surgery. Patient demographics (age at surgery, gender, implant laterality), operative information (American Society of Anesthesia [ASA] score, anesthesia type, surgical technique, implant/abutment characteristics), and postoperative outcomes (implant stability, soft tissue integrity, surgical revisions, implant failure). The most frequent syndromes among implanted patients were Treacher Collins (27.3%), Goldenhar (13.6%), Trisomy 21 (13.6%), and Nager (9.1%). Syndromic patients were more frequently given higher ASA scores: 2 ( p = 0.003) and 3 ( p = 0.014). All cases of implant extrusion were in syndromic patients: two posttraumatic and two failures to osseointegrate. Nine (40.9%) syndromic patients experienced a Holgers Grade 4 skin reaction at one of their postoperative follow-up visits as compared to 0% of nonsyndromic patients ( p < 0.001). Implant stability was similar between cohorts at all postoperative time-points, except for significantly greater nonsyndromic implant stability quotient scores at 16 weeks ( p = 0.027) and 31+ weeks ( p = 0.016). Percutaneous BAHI surgery is a successful rehabilitation option in syndromic patients. However, it presents a relatively higher incidence of implant extrusion and severe postoperative skin reactions as compared to nonsyndromic patients. In light of these findings, syndromic patients may be great candidates for novel transcutaneous bone conduction implants.

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.

Bone Anchored Hearing Aid: A Narrative Review

Bone Anchored Hearing Aid (BAHA) is a small vibrator that can be reversibly attached to a Titanium (Ti) screw and implanted behind the ear. It uses the bone conduction channel to activate the cochleae by converting sound into the vibration of the screw. The two main indications are conductive hearing loss and unilateral deafness when using traditional hearing aids is not possible, as a rehabilitative or mixed hearing loss with a moderate perceptual component. For patients with canal atresia, Single-sided Deafness (SSD), and chronically discharged ears despite treatment, the BAHA implant is an option. Combination hearing loss is a crucial indicator for implanted hearing implants. Various options are accessible based on the bone conduction threshold. Patients with modest sensorineural impairment usually benefit from transcutaneous Bone Conduction Implants (BCI), while those with intermediate hearing loss may also benefit from percutaneous BCI devices. For combined, active middle ear implants are advised for hearing deficits with moderate and severe cochlear hearing loss. For individuals who need middle ear surgery or who are incompatible with other options for therapy, implants are a helpful and successful addition. Skin-drive Bone Conduction Devices (BCDs) are BCDs that vibrate the bone via the skin can also be separated into passive subcutaneous devices and traditional devices that are coupled, for instance, with soft bands with implanted magnets. BCDs that directly stimulate the bone, percutaneous devices, and dynamic transcutaneous devices are examples of direct-drive devices. The latter kind of apparatus uses embedded transducers to stimulate bone effectively via healthy skin. The BAHA, also known as the percutaneous direct-drive device (BCD), now rules the market. More direct-drive and skin-drive transcutaneous solutions are now being studied, partly due to problems with the transdermal implant and partly for aesthetic reasons.

COMPARISON OF ADHESIVE AND PASSIVE TRANSCUTANEOUS BONE CONDUCTION SYSTEMS IN ATRETIC CHILDREN

IntroductionIn 2017, the first adhesive bone conduction device (aBCD) was introduced. Since then, clinical studies have extensively compared adhesive bone conduction devices to conventional bone conduction systems on softbands. The aim of this study is to evaluate the audiological and subjective outcomes of patients suffering from conductive hearing loss (CHL) who used an aBCD for a trial period, comparing outcomes with their existing passive transcutaneous bone conduction implants (ptBCI), which was either the Sophono Alpha or the BAHA Attract.Material and methodsThis prospective study included 14 congenital aural atresia patients between 7 and 16 years old. Participants had been ptBCI users for at least 2 years and had bone conduction thresholds ≤ 25 dB HL. The aBCD trial was for 1 week. Average pure tone thresholds (PTA4) and word recognition scores (WRS) with disyllabic words at 65 dB SPL in quiet and in noise were measured for each device. Subjective outcomes were recorded using the aBCD mini questionnaire and the SSQ questionnaire for hearing satisfaction, which were filled in by parents.ResultsWe analyzed 16 ears. The mean sound field PTA4 was 52 dB HL unaided, 27 dB HL ptBCI-aided and 29 dB HL aBCD-aided. Mean WRS in quiet was 96% with ptBCI and 95% with BCD. In noise (+5 dB SNR) the mean WRS was 70% with ptBCI and 77% with aBCD. A questionnaire revealed easy handling and good acceptance of the aBCD.ConclusionsIn this group of patients, comparable audiological and subjective satisfaction results were achieved with a non-implantable adhesive bone conduction device. Despite differences in handling, the adhesive BCD presents itself as an alternative to transcutaneous bone conduction implants.

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.

Subtemporalis Muscle Middle Cranial Fossa Bone-Island Craniotomy Technique for Placement of an Active Transcutaneous Bone-Conduction Implant.

Placement of an active transcutaneous bone-conduction implant (BCI) requires drilling of a precise bone bed to accommodate the device and allow for fixation points to make appropriate contact with bone, which can be difficult even when lifts are used. We describe a subtemporalis muscle middle cranial fossa bone-island craniotomy technique that simplifies the procedure and obviates the need for lifts in securing the device. Prospective case series. Tertiary academic medical center. Seventeen patients underwent surgery for placement of 18 transcutaneous BCIs, 14 for conductive or mixed hearing loss, and 4 for single-sided deafness. Surgical placement of a transcutaneous BCI with a bone-island craniotomy technique. Functional gain in air-conduction thresholds, aided air-bone gap, frequency of need for lifts, and minor and major complications. For the conductive or mixed hearing loss cohort, with the transcutaneous BCI in place, there was a highly statistically significant mean functional gain of 35.4 dB hearing level (HL) (range, 16.7-50.25 dB HL; standard deviation, 12.4 dB HL) compared with the unaided condition (p < 0.0001; 95% confidence interval, 36.6-51.6 dB HL). Lifts were not needed in any case. There was one minor complication requiring a second procedure in a patient who had previously received radiation and no major complications. There was no device loss or failure. A subtemporalis muscle middle cranial fossa bone-island craniotomy technique eliminates the need for lifts and is a safe and effective method for placement of a transcutaneous BCI.

Audiometric and Surgical Outcomes of a Novel Bone-Conduction Hearing Aid.

To report the audiometric and surgical outcomes of a series of patients having undergone implantation of a novel transcutaneous bone conduction implant (t-BCI). Retrospective case series. Single academic tertiary referral center. Adults (≥18 yr) implanted between December 1, 2019, and August 1, 2021, with audiometric data available before and after device implantation and a minimum of 4 weeks follow-up. Surgical t-BCI. Change in aided pure tone average (PTA) after implantation. Secondary outcomes include average operative time, and adverse events. Twenty-three patients underwent implantation of the t-BCI via either a conventional or minimally invasive surgical approach. The most common indication for implantation was unilateral conductive hearing loss with a history of chronic otitis media. The mean operative time was 59 minutes. The mean preimplantation unaided air conduction PTA was 65 dB, and mean postimplantation was 27.2 dB. The mean change in PTA was 37.8 dB, which was significant ( p < 0.0001). There were 30.4% of the patients that suffered from adverse events, the most common of which were pain (8.7%) and device-related complications (13%). One major adverse event occurred, involving magnet displacement that impaired device activation and required reoperation for replacement. Forming the largest series of patients implanted with this t-BCI in the published literature, our data demonstrate that implantation of the device is feasible via either a traditional or minimally invasive surgical approach, with good audiometric benefit and a favorable safety profile.

Transcutaneous Bone Conduction Implants in Patients With Single-Sided Deafness: Objective and Subjective Evaluation.

This study aimed to investigate the audiological outcomes and subjective benefits of transcutaneous bone conduction implants (BCIs) in patients with single-sided deafness (SSD). This retrospective study was conducted on 11 patients with SSD implantations between 2015 and 2018 at a tertiary center. Pure-tone audiometry, speech reception threshold (SRT), and speech-in-noise (SPIN) tests were performed. Preoperative and postoperative performances were compared. Subjective satisfaction level was assessed using validated questionnaires. A PubMed search was conducted to identify the relevant studies published to date. All patients demonstrated significant audiological improvements compared with their preoperative condition. The mean SRT improved significantly (p = 0.001) from 109dB to 23dB after implantation. The mean SPIN score improved significantly after implantation. The questionnaires showed an overall positive benefit of transcutaneous bone conduction devices (BCDs). A literature search revealed 21 articles, of which 14 reported the use of BCIs in patients with SSD. Our results agree with the published evidence showing the overall benefit of BCI in patients with SSD. Transcutaneous BCDs could be considered as an alternative treatment option for patients with SSD, it could show good audiological outcomes and high satisfaction levels. Further studies should be conducted on patients with SSD to determine the most appropriate hearing solutions.

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.