Binaural hearing in monaural conductive or mixed hearing loss fitted with unilateral Bonebridge.

Objective: To determine the benefits of binaural hearing rehabilitation in patients with monaural conductive or mixed hearing loss treated with a unilateral bone conduction implant (BCI). Methods: This monocentric study includes 7 patients with monaural conductive or mixed hearing loss who underwent surgical implantation of a unilateral BCI (Bonebridge, Med-El). An ITA Matrix test was performed by each patient included in the study - without and with the BCI and in three different settings - to determine the summation effect, squelch effect and head shadow effect. Subjective hearing benefits were assessed using the Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire. Results: The difference in signal to noise ratio of patients without and with BCI was 0.79 dB in the summation setting (p < 0.05), 4.62 dB in the head shadow setting (p < 0.05) and 1.53 dB (p = 0.063) in the squelch setting. The APHAB questionnaire revealed a subjective discomfort in the presence of unexpected sounds in patients using a unilateral BCI (aversiveness score) compared to the same environmental situations without BCI, with a mean discomfort score of 69.00% (SD ± 21.24%) with monaural BCI versus 25.67% (SD ± 16.70%) without BCI (difference: -43.33%, p < 0.05). In terms of global score, patients wearing a unilateral Bonebridge implant did not show any significant differences compared to those without hearing aid (difference: -4.00%, p = 0.310). Conclusions: Our study shows that the use of a unilateral BCI in patients affected by monaural conductive or mixed hearing loss can improve speech perception under noise conditions due to the summation effect and to the decrease of the head shadow effect. However, since monaural BCIs might lead to discomfort under noise conditions in some subjects, a pre-operative assessment of the possible individual benefit of a monaural BCI should be carried out in patients affected by unilateral conductive or mixed hearing loss in order to investigate the possible additional effect of the fitting of hearing aids.

Clinical Outcomes of an Active, Transcutaneous, Bone Conduction Hearing Device: A Retrospective Study.

OBJECTIVE: The purpose of this study was to review patient demographics, indications, intraoperative findings, complications/adverse events, and audiological outcomes related to the implantation of the Osia 2 device. STUDY DESIGN: Retrospective case series. SETTING: Single tertiary institutional experience. METHODS: Patients who had undergone Osia 2 implantation by the senior author were identified from 2019 to present. Information was extracted from patient charts concerning patient demographics, indications for implantation, surgical findings, audiological outcomes, and adverse events. RESULTS: Sixty patients and 67 implants were included. The median age was 51 years (R: 11-92). Fifty-five percent of patients had mixed hearing loss (HL), 30% had single-sided deafness, and 15% had conductive HL. The mean operative time was 53.9 minutes. Only 4.5% of patients required bone polishing, and 3.0% required tissue thinning. The mean pure-tone averages 4 gain from unaided conditions was 41.2 dB. Mean gain at 6 and 8 kHz from unaided conditions was 35.42 and 40.67 dB, respectively. Mean improvement in speech recognition threshold and word recognition score was significant in noise and quiet conditions. The all-cause adverse event/complication rate in our series was 10.4%. The most common complications were infections (4.5%) and poorly controlled postoperative pain (3.0%). Hematomas occurred in 1.5% of patients. Reoperation was required in 4 patients; explant in 1. CONCLUSION: Use of the Osia 2 device in our series has resulted in good hearing outcomes, particularly in terms of high frequency gain. Complication rates were low. To our knowledge, this is the largest study to date reporting on Osia 2 outcomes.

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

OBJECTIVE: 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. DATA SOURCE: 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. REVIEW METHOD: 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. RESULTS: 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). CONCLUSION: 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.

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

OBJECTIVE: 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. STUDY DESIGN: Cadaveric study. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Clinical performance, safety, and patient-reported outcomes of an active osseointegrated bone-conduction hearing implant system at 24-month follow-up.

PURPOSE: To investigate 2-year post-operative hearing performance, safety, and patient-reported outcomes of hearing-impaired adults treated with the Osia® 2 System, an active osseointegrated bone-conduction hearing implant that uses piezoelectric technology. METHODS: A prospective, multicenter, open-label, single-arm, within-subject clinical study conducted at three tertiary referral clinical centers located in Melbourne, Sydney and Hong Kong. Twenty adult recipients of the Osia 2 System were enrolled and followed up between 12 and 24 months post-implantation: 17 with mixed or conductive hearing loss and 3 with single-sided sensorineural deafness. Safety data, audiological thresholds, speech recognition thresholds in noise, and patient-reported outcomes were collected and evaluated. In addition, pre-and 6-month post-implantation data were collected retrospectively for this recipient cohort enrolled into the earlier study (ClinicalTrials.gov NCT04041700). RESULTS: Between 6- and 24-month follow-up, there was no statistically significant change in free-field hearing thresholds or speech reception thresholds in noise (p = > 0.05), indicating that aided improvements were maintained up to 24 months of follow-up. Furthermore, improvements in health-related quality of life and daily hearing ability, as well as clinical and subjective measures of hearing benefit remained stable over the 24-month period. No serious adverse events were reported during extended follow-up. CONCLUSIONS: These study results provide further evidence to support the longer term clinical safety, hearing performance, and patient-related benefits of the Osia 2 System in patients with either a conductive hearing loss, mixed hearing loss, or single-sided sensorineural deafness. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04754477. First posted: February 15, 2021.

Efficacy of the Bonebridge BCI602 for Adult Patients with Single-sided Deafness: A Prospective Multicenter Study.

OBJECTIVE: To investigate the safety and efficacy of a novel active transcutaneous bone conduction implant (BCI) device for patients with single-sided deafness (SSD). STUDY DESIGN: Prospective cohort study. SETTING: Tertiary referral hospitals. METHODS: This prospective multicenter study was conducted at 15 institutions nationwide. Thirty adult (aged ≥19 years) SSD patients were recruited. They underwent implantation of an active transcutaneous BCI device (Bonebridge BCI602). Objective outcomes included aided pure-tone thresholds, aided speech discrimination scores (SDSs), and the Hearing in Noise Test (HINT) and sound localization test results. The Bern Benefit in Single-Sided Deafness (BBSS) questionnaire, the Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire, and the Tinnitus Handicap Inventory (THI) were used to measure subjective benefits. RESULTS: The mean aided pure-tone threshold was 34.2 (11.3), mean (SD), dB HL at 500 to 4000 Hz. The mean total BBSS score was 27.5 (13.8). All APHAB questionnaire domain scores showed significant improvements: ease of communication, 33.6 (23.2) versus 22.6 (21.3), P = .025; reverberation, 44.8 (16.6) versus 32.8 (15.9), P = .002; background noise, 55.5 (23.6) versus 35.2 (18.1), P < .001; and aversiveness, 36.7 (22.8) versus 25.8 (21.4), P = .028. Moreover, the THI scores were significantly reduced [47.4 (30.1) versus 31.1 (27.0), P = .003]. Congenital SSD was a significant factor of subjective benefit (-11.643; 95% confidence interval: -21.946 to -1.340). CONCLUSION: The BCI602 active transcutaneous BCI device can provide functional hearing gain without any adverse effects and is a feasible option for acquired SSD patients with long-term deafness.

Decision making in bone conduction and active middle ear implants - hearing outcomes and experiences over a 10-year period.

OBJECTIVES: To review the decision-making paradigm in the recommendations of BCI and aMEI overlapping candidacy for patients with conductive or mixed HL, and to determine if there are differences in hearing and quality of life outcomes between these implantable hearing devices. METHODS: Retrospective data from patients receiving BCI or aMEI in the past decade were analysed. Patients were grouped into: 1. BCI candidates, 2. BCI or aMEI candidates, and 3. aMEI candidates. We compared outcomes and examined the impact of BC threshold, age at implantation, and duration of hearing loss on candidacy. RESULTS: 89 participants were included: 30 BCI, 37 aMEI, and 22 BCI or aMEI candidates. All groups performed similarly in aided sound field threshold testing. BCI group had lower speech scores in quiet compared to 'BCI or aMEI.' No significant differences were found in APHAB global scores. BC threshold, duration of hearing loss, and age at implantation had no significant effects. DISCUSSION: Outcomes were generally similar across groups, except for higher effective gain in the aMEI group. CONCLUSION: Our proposed patient pathway and decision-making approach facilitate candidate selection for aMEI and BCI, aiming to optimise outcomes.

Influence of Bone Conduction Hearing Device Implantation on Health-Related Quality of Life for Patients with and without Tinnitus.

(1) Background: Tinnitus, often related to hearing loss, is an addressable public health concern affecting health-related quality of life (HRQoL). This study aimed to explore the influence of bone conduction hearing aid (BCHA) implantation on HRQoL and hearing disability in patients with hearing loss suffering from tinnitus. (2) Methods: Data were collected from an international hearing implant registry. Health Utilities Index Mark 3 (HUI-3), Spatial and Qualities of Hearing- 49 Questionnaire (SSQ) and self-reported tinnitus burden data for adult patients implanted with a BCHA (n = 42) who provided baseline as well as follow-up data 1-year post-implantation were extracted from the registry. Wilcoxon signed rank tests and paired samples t-tests were used to analyse outcomes data. (3) Results: Patients, with or without tinnitus, demonstrated clinically important mean improvements in HUI-3 multi-attribute utility scores, HUI-3 hearing attribute and SSQ scores. Hearing loss patients with tinnitus presented with a lower HRQoL than patients without tinnitus. (4) Conclusions: These findings demonstrate the importance of hearing rehabilitation in improving the quality of life and hearing disability of patients with or without tinnitus and in providing tinnitus relief in some patients with hearing loss and tinnitus.

Comparison of Active Bone Conduction Hearing Implant Systems in Unilateral and Bilateral Conductive or Mixed Hearing Loss.

BACKGROUND: To assess and compare binaural benefits and subjective satisfaction of active bone conduction implant (BCI) in patients with bilateral conductive or mixed hearing loss fitted with bilateral BCI and patients with monaural conductive hearing loss fitted with monaural BCI. METHODS: ITA Matrix test was performed both on patients affected by bilateral conductive or mixed hearing loss fitted with monaural bone conduction hearing implant (Bonebridge, Med-El) before and after implantation of contralateral bone conduction hearing implant and on patients with monaural conductive or mixed hearing loss before and after implantation of monaural BCI. The Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire was administered to both groups of subjects and the results were compared with each other. RESULTS: Patients of group 1 reported a difference of 4.66 dB in the summation setting compared to 0.79 dB of group 2 (p < 0.05). In the squelch setting, group 1 showed a difference of 2.42 dB compared to 1.53 dB of group 2 (p = 0.85). In the head shadow setting, patients of group 1 reported a difference of 7.5 dB, compared to 4.61 dB of group 2 (p = 0.34). As for the APHAB questionnaire, group 1 reported a mean global score difference of 11.10% while group 2 showed a difference of -4.00%. CONCLUSIONS: Bilateral BCI in patients affected by bilateral conductive or mixed hearing loss might show more advantages in terms of sound localisation, speech perception in noise and subjective satisfaction if compared to unilateral BCI fitting in patients affected by unilateral conductive hearing impairment. This may be explained by the different individual transcranial attenuation of each subject, which might lead to different outcomes in terms of binaural hearing achievement. On the other hand, patients with unilateral conductive or mixed hearing loss fitted with monaural BCI achieved good results in terms of binaural hearing and for this reason, there is no absolute contraindication to implantation in those patients.

Performance of an active transcutaneous bone conduction implant, the Osia system, in high frequencies and hearing in noise in users converted from a Baha attract system: a prospective study.

PURPOSE: Hearing rehabilitation through middle ear surgery can be challenging, particularly for patients with chronic otitis media, but new hearing devices offer opportunity to reach this goal. The aim was to compare hearing outcomes and quality of life in patients who were converted from a Baha Attract system to the Osia system. METHODS: Prospective observational study, in which each subject acted as their own control. Six patients who were converted from a Baha Attract to an Osia system performed audiometric and quality of life assessments with different sound processor at fitting, 3, 6 and 12 months. The speech performance in noise with the Osia system at 12 months, expressed as dB SNR, was compared to the baseline condition (Baha 5). RESULTS: The PTA4 hearing thresholds improved from 42.6 ± 11 with Baha 5 Power to 34.8 ± 13.3 with Baha 5 SuperPower and to 25.4 ± 3.5 with the Osia at 12 months, leading to a significant functional gain of 17.2 ± 10.9 dB vs Baha 5 (p < 0.02). Speech understanding in both quiet and noise was clinically improved reaching a mean SNR of less than 1 dB at 12 months with the Osia system. Quality of life outcomes improved by more than 20% at 12-month follow-up. CONCLUSION: Aided hearing thresholds and speech understanding in noise improved when patients were converted from the Baha Attract system to the Osia system. The aided hearing threshold was maintained up to 8 kHz (26 dB) with the Osia system.

Minimally invasive surgery as a new clinical standard for bone anchored hearing implants-real-world data from 10 years of follow-up and 228 surgeries.

Purpose: To explore the clinical practice development of different surgical techniques when installing bone-anchored hearing implants and their associated trends in outcomes. Design: Retrospective study of 228 bone-anchored hearing implants in 200 patients, performed over a 10-year period between 2012 and 2022 in a referral hospital. Method: Real-world data of demography, etiology, surgical setup, complications, and audiological outcomes were collected. Eligibility criteria from clinical practice were applied. Results: The minimally invasive technique is associated with shorter surgery duration, 20 vs. 44 min as compared to a linear incision technique. The minimally invasive technique was also associated with a lower occurrence of complications when compared to linear incision techniques (intraoperative; 1.8% vs. 4.9%, postoperative; 49% vs. 66%). Most differences were seen in complications relating to skin and wound healing. Conclusion: Adoption of a minimally invasive surgical technique for the installations of bone-anchored hearing implants can reduce surgical complexity without compromising safety aspects or clinical benefits.

Improvement in quality of life comparing noninvasive versus invasive hearing rehabilitation in children.

Objectives: The young population requires early rehabilitation of their hearing loss for normal cognitive, auditive hence social development. All of which, in turn, may have an impact on quality of life (QoL). This study aims to evaluate QoL between two different bone conduction (BC) hearing devices: a noninvasive adhesive hearing aid (Adhear [ADH]) vs. an active transcutaneous implant (Bonebridge [BB]). Methods: This study composed of 12 BB and 15 ADH users. Pure tone as well as speech in noise and quiet measurements were evaluated and compared to the Assessment in QoL questionnaire (AQoL-6d). Results: Freefield results showed significant improvements for both devices compared to the unaided condition (p < .0001). Emphasis needs to be drawn on the different unaided level of conductive hearing loss as well as the indication range for both evaluated device groups: the ADH subjects exhibited a mean BC value of 9.50 ± 7.96 dB HL (the indication range up to 25 dB) and the BB subjects a mean of 23.33 ± 25.66 dB HL (the indication range up to 45 dB). Speech perception in quiet and in noise was significantly improved (p < .05; p < .001, respectively). QoL was significantly improved for both treatments (p < .05) but was not different among the devices, and the values were similar to their normal hearing, age, and sex-matched control group. High correlations were found between QoL utility scores and improved PTA4 in the aided condition (r 2 = .8839 and .7810 for BB and ADH, respectively). Conclusion: Our results show that both devices offer significant beneficial audiological rehabilitations with significantly increased QoL. However, the underlying condition and the unaided degree of hearing loss, hence the required higher stimulation must be the deciding factor when opting for a hearing device, and this should be independent of age. Level of evidence: 2c.

A Novel Representation of Audiological and Subjective Findings for Acoustical, Bone Conduction and Direct Drive Hearing Solutions.

BACKGROUND: The benefit of hearing rehabilitation is often measured using audiological tests or subjective questionnaires/interviews. It is important to consider both aspects in order to evaluate the overall benefits. Currently, there is no standardized method for reporting combined audiological and patient reported subjective outcome measures in clinical practice. Therefore, this study focuses on showing the patient's audiological, as well as subjective outcomes in one graph using data from an existing study. METHOD: The present paper illustrated a graph presenting data on four quadrants with audiological and subjective findings. These quadrants represented speech comprehension in quiet (unaided vs. aided) as WRS% at 65 dB SPL, speech recognition in noise (unaided vs. aided) as SRT dB SNR, sound field threshold (unaided vs. aided) as PTA4 in dB HL, wearing time and patient satisfaction questionnaire results. RESULTS: As an example, the HEARRING graph in this paper represented audiological and subjective datasets on a single patient level or a cohort of patients for an active bone conduction hearing implant solution. The graph offered the option to follow the user's performance in time. CONCLUSION: The HEARRING graph allowed representation of a combination of audiological measures with patient reported outcomes in one single graph, indicating the overall benefit of the intervention. In addition, the correlation and consistency between some results (e.g., aided threshold and aided WRS) can be better visualized. Those users who lacked performance benefits on one or more parameters and called for further insight could be visually identified.

Surgical and audiological outcomes with a new transcutaneous bone conduction device with reduced transducer thickness in children.

PURPOSE: Due to smaller bone thickness, young children with conductive or mixed hearing loss or single-sided deafness were previously most commonly treated with a percutaneous osseointegrated bone-anchored hearing aid (BAHA) or an active middle-ear implant. While the BAHA increases the risk of implant infections, skin infection, overgrowth of the screw or involvement of the implant in head trauma, middle-ear implant surgery involves manipulation of the ossicles with possible risk of surgical trauma. These complications can be omitted with transcutaneous bone conduction implant systems like the MED-EL Bonebridge system. The purpose of this study was to analyze whether the second generation of the Bonebridge (BCI 602) that features a decreased implant thickness with a reduced surgical drilling depth can be implanted safely in young children with good postoperative hearing performance. METHODS: In this study, 14 patients under 12 years were implanted with the second generation of the Bonebridge. Preoperative workup comprised a CT scan, an MRI scan, pure tone audiometry, or alternatively a BERA (bone conduction, air conduction). Since children under 12 years often have a lower bone thickness, the CT was performed to determine the suitability of the temporal bone for optimal implant placement using the Otoplan software. RESULTS: All patients (including three under the age of five) were successfully implanted and showed a good postoperative hearing performance. CONCLUSION: With adequate preoperative workup, this device can be safely implanted in children and even children under 5 years of age and allows for an extension of indication criteria toward younger children.

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

AIM: This European multicentric study aimed to prove safety and performance of the Bonebridge BCI 602 in children and adults suffering from either conductive hearing loss (CHL), mixed hearing loss (MHL), or single-sided sensorineural deafness (SSD). METHODS: 33 patients (13 adults and 10 children with either CHL or MHL and 10 patients with SSD) in three study groups were included. Patients were their own controls (single-subject repeated measures), comparing the unaided or pre-operative to the 3-month post-operative outcomes. Performance was evaluated by sound field thresholds (SF), word recognition scores (WRS) and/or speech reception thresholds in quiet (SRT) and in noise (SNR). Safety was demonstrated with a device-specific surgical questionnaire, adverse event reporting and stable pure-tone measurements. RESULTS: The Bonebridge BCI 602 significantly improved SF thresholds (+ 25.5 dB CHL/MHL/SSD), speech intelligibility in WRS (+ 68.0% CHL/MHL) and SRT in quiet (- 16.5 dB C/MHL) and in noise (- 3.51 dB SNR SSD). Air conduction (AC) and bone conduction (BC) thresholds remained stable over time. All adverse events were resolved, with none unanticipated. Mean audio processor wearing times in hours [h] per day for the CHL/MHL group were ~ 13 h for adults, ~ 11 h for paediatrics and ~ 6 h for the SSD group. The average surgical length was 57 min for the CHL/MHL group and 42 min for the SSD group. The versatility of the BCI 602 (reduced drilling depth and ability to bend the transition for optimal placement) allows for treatment of normal, pre-operated and malformed anatomies. All audiological endpoints were reached. CONCLUSIONS: The Bonebridge BCI 602 significantly improved hearing thresholds and speech understanding. Since implant placement follows the patient's anatomy instead of the shape of the device and the duration of surgery is shorter than with its predecessor, implantation is easier with the BCI 602. Performance and safety were proven for adults and children as well as for the CHL/MHL and SSD indications 3 months post-operatively.

Transcutaneous versus percutaneous bone-anchored hearing aids: A quality of life comparison.

PURPOSE: To determine whether patients have improved quality of life outcomes with percutaneous bone conduction implant (p-BCI) versus transcutaneous bone conduction implant (t-BCI). MATERIALS & METHODS: Retrospective chart review of patients who have undergone placement of a BCI in the Ascension St John Providence Health System from 2013 to 2018. Patient satisfaction of t-BCI and p-BCI was measured using a questionnaire that incorporated the Glasgow Benefit Inventory (GBI) and BAHA, aesthetic, hygiene & use (BAHU) survey. Key outcome variables were separated into 2 categories: (1) evaluation of wound healing and implant-associated complications, and (2) quality of life improvements. RESULTS: Comparative analysis of the 27 p-BCI patients and 10 t-BCI patients showed overall positive benefit with no statistically significant difference on quality of life improvement between the two groups. Total complication rates for p-BCI (48.1 %) vs t-BCI (10 %) was marginally significant (p = 0.056). Rate of revision for p-BCI versus t-BCI was 14.8 % vs 0 %, respectively. CONCLUSION: This study provides a much-needed comparative insight in patient's experience with these two devices. Understanding which device is preferable in the patient's view will offer helpful information for guiding proper implant selection.

Influence of Bone Conduction Hearing Implantation on Health-Related Quality of Life for Patients with Chronic Otitis Media.

BACKGROUND: Chronic otitis media is a major public health burden that can result in a disabling hearing loss. Bone conduction hearing implants are an accepted form of hearing rehabilitation in these patients, but evidence supporting their usage typically comes from studies investigating mixed indications. The objective of our study was to examine how these devices impact health-related quality of life and hearing-disability in adult patients suffering from chronic otitis media. METHODS: Health Utilities Index-mark III (n = 10) and Speech Spatial and Qualities of Hearing-49 data (n = 6) were extracted for adult patients with chronic otitis media from an international hearing implant registry. Data were compared at baseline and at 12-month post-implantation with a bone conduction hearing implant. RESULTS: Patients demonstrated a clinically relevant mean utility gain of 0.145 following implantation and clinically relevant mean improvement in global speech spatial and qualities of hearing score following implantation. CONCLUSIONS: Bone conduction implantation was found to improve hearing and health-related quality of life and reduce hearing disability in a small cohort of patients with chronic otitis media. These data highlight the importance of providing appropriate hearing rehabilitation for individuals with chronic otitis media.

Complications of Transcutaneous Protheses - A Systematic Review of Publications Over the Past 10 Years

Abstract Introduction Bone conduction implants, responsible for transmitting sound from an external processor to the inner ear, can be divided into active and passive, depending on the vibratory stimulus location. The use of transcutaneous device has increased, given its aesthetic appeal, the complications and limitations of percutaneous devices, and patient's treatment adherence, focusing mainly on efficacy. However, various complications are associated with the use of transcutaneous prosthesis, which can often be serious. Objective To approach the literature on complications involving transcutaneous bone-anchored prostheses through a systematic review of articles published in the past 10 years (2011-2021). Data Synthesis The MEDLINE, EMBASE, Scopus, and Cochrane Library databases were searched. All articles written in English reporting on currently available transcutaneous prosthesis implantation and its complications were selected. Studies on both children and adults were included. The data on complications were extracted, and complications were classified as minor or major and associated to each device used. Thirty-seven articles were included in the study, of which 14 were prospective cohort studies, 22 were retrospective case series, and 1 was a case report. Most studies (18) included both adults and children. Moreover, 901 implantations were performed, of which 552 implanted Baha Attract (Cochlear Ltd., Sydney, Australia), 244 implanted BoneBridge (MED-EL, Innsbruck, Austria), and 105 implanted Sophono (Sophono Inc., Boulder, CO, USA]). Furthermore, 192 adverse events were reported (total complication rate, 21.3%), with 161 minor complications (84.3%) and 31 major complications (16.1%). Conclusion Transcutaneous prosthesis is an audiological alternative with fewer complications than percutaneous prosthesis. However, its indication should be judicious because complications are common, and although most complications are minor, serious infections requiring explantation may develop.

Complications of Transcutaneous Protheses - A Systematic Review of Publications Over the Past 10 Years.

Introduction Bone conduction implants, responsible for transmitting sound from an external processor to the inner ear, can be divided into active and passive, depending on the vibratory stimulus location. The use of transcutaneous device has increased, given its aesthetic appeal, the complications and limitations of percutaneous devices, and patient's treatment adherence, focusing mainly on efficacy. However, various complications are associated with the use of transcutaneous prosthesis, which can often be serious. Objective To approach the literature on complications involving transcutaneous bone-anchored prostheses through a systematic review of articles published in the past 10 years (2011-2021). Data Synthesis The MEDLINE, EMBASE, Scopus, and Cochrane Library databases were searched. All articles written in English reporting on currently available transcutaneous prosthesis implantation and its complications were selected. Studies on both children and adults were included. The data on complications were extracted, and complications were classified as minor or major and associated to each device used. Thirty-seven articles were included in the study, of which 14 were prospective cohort studies, 22 were retrospective case series, and 1 was a case report. Most studies (18) included both adults and children. Moreover, 901 implantations were performed, of which 552 implanted Baha Attract (Cochlear Ltd., Sydney, Australia), 244 implanted BoneBridge (MED-EL, Innsbruck, Austria), and 105 implanted Sophono (Sophono Inc., Boulder, CO, USA]). Furthermore, 192 adverse events were reported (total complication rate, 21.3%), with 161 minor complications (84.3%) and 31 major complications (16.1%). Conclusion Transcutaneous prosthesis is an audiological alternative with fewer complications than percutaneous prosthesis. However, its indication should be judicious because complications are common, and although most complications are minor, serious infections requiring explantation may develop.

Achondroplasia and severe sensorineural hearing loss: The role of active bone conduction implants.

The BONEBRIDGE is a partially implantable, transcutaneous bone conduction device that can be used to treat conductive or mixed mild-to-moderate hearing loss in patients who do not attain sufficient improvement from conventional hearing aids. The following case report describes sequential bilateral BONEBRIDGE implantation in a 25-year-old patient with achondroplasia and bilateral mixed-hearing loss with a significant sensorineural component in the setting of chronic suppurative otitis media. Although the patient did not meet the approved BONEBRIDGE criteria, implantation was successful with improvements in audiological outcomes and self-reported quality of life. There were no reported complications at 5-years post-implantation.