Long-Term Outcomes of a Percutaneous Wide-Diameter Bone-Anchored Hearing Implant: A Clinical Evaluation of More than 800 Implants.

OBJECTIVE: This study evaluates the clinical outcomes of 807 percutaneous wide-diameter bone-anchored hearing implants (BAHIs) in 701 patients. In addition, it compares patient groups and examines bone conduction device (BCD) usage. STUDY DESIGN: Retrospective cohort study. Mean follow-up period of 3.8 years. SETTING: Tertiary referral center. PATIENTS: All patients implanted with a percutaneous wide-diameter BAHI until December 2020 were included. Patients were divided into age groups, "loading-time" groups, and, if applicable, specific subgroups thought to be at risk for complications postsurgery, e.g., intellectual disability and comorbidities. MAIN OUTCOME MEASURES: Soft tissue reaction, implant survival, revision surgery, and BCD usage. RESULTS: In 9.1% of the 5,188 observations of 807 implants, an adverse soft tissue reaction was reported according to the Holgers' scale. Significantly more (adverse) soft tissue reactions were observed in children and intellectually disabled (ID) patients (p < 0.05). Comorbidity subgroups showed no significant differences in soft tissue reactions. Implant loss percentage, including explantations, was 6.2%. Implant survival was significantly worse in patients with ID (14.1%; p = 0.021). Pediatric age, early loading, or comorbidities did not significantly influence implant survival. At least 592 implants (73.4%) were used for bone conduction hearing, of which 65.4% were used daily. CONCLUSION: Both children and ID patients are more prone to (adverse) soft tissue reactions, ID patients only have a higher risk of implant loss. The rate of implant loss in children seemed to be reduced compared to previous studies and thus more comparable to adults since using wide-diameter implants.

Audiologic Outcomes After Vestibulotomy in Patients With Congenital Absence of the Oval Window.

OBJECTIVE: To examine the clinical features and surgical outcomes in patients with congenital absence of the oval window (CAOW), and to investigate the potential factors that affect audiologic results. STUDY DESIGN: A retrospective chart review. SETTING: A tertiary academic center. PATIENTS AND INTERVENTION: A total of 17 ears among 16 patients were confirmed to have CAOW. Among them, 13 ears underwent vestibulotomy for hearing reconstruction. Clinical parameters associated with the hearing outcomes were analyzed. MAIN OUTCOME MEASURES: A mean air-bone gap (ABG) after 6-month and long-term follow-up was compared with preoperative measurements. RESULTS: Intraoperative findings showed that anomalies of the malleus or incus were observed in 11 ears (64.7%), stapes anomalies were present in all ears (100%), and facial nerve anomalies were present in 10 ears (58.8%). Because of unfavorable facial nerve anomalies, hearing reconstruction was aborted in four cases (23.5%). In the hearing reconstruction group, the mean ABG at 6 months postoperation was significantly reduced after compared with the preoperative value (44.0 ± 8.4 dB versus 58.8 ± 9.1 dB, p = 0.006). After dividing ears into a success subgroup (ABG ≤ 30 dB, seven ears) and non-success subgroup (ABG > 30 dB, six ears), the use of a drill during vestibulotomy was significantly related to a poor hearing outcome (100% versus 16.7%, p = 0.015). The long-term follow-up result (mean, 60 mo) revealed no deterioration compared with the 6-month postoperative result. Five ears (29.4%) underwent revision surgery, and three of them showed ABG improvements. No serious complications were reported. CONCLUSION: Vestibulotomy is an effective and safe option for hearing restoration in patients with CAOW, particularly when the use of a drill is not required. The long-term audiologic outcome is also reliable.

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.

Otic Capsule Demineralization and Hearing Outcome of Stapes Surgery for Osteogenesis Imperfecta in Comparison With Otosclerosis.

OBJECTIVE: To assess the location/number of otic capsule demineralization and hearing outcomes of stapes surgery (SS) for osteogenesis imperfecta (OI) compared with otosclerosis (OS). PATIENTS: This study included 11 and 181 consecutive ears from 6 and 152 patients with OI and OS, respectively. INTERVENTIONS: Demineralization loci observed as hypodense area of the otic capsule were examined using high-resolution computed tomography. All patients underwent SS. MAIN OUTCOME MEASURES: Locations of the hypodense areas were classified into the anterior oval window, anterior internal auditory canal, and pericochlear area. The location/number of hypodense areas and preoperative/postoperative hearing parameters were correlated. Postoperative hearing outcome was evaluated 12 months after surgery. RESULTS: Hypodense area was more frequently observed in OI (9 of 11 ears [81.8%]) than in OS (96 of 181 ears [53.0%]), with significant differences. Multiple sites were involved in 81.8% OI and 18.8% OS patients, showing significant differences. Preoperative air conduction (AC), bone conduction, and air-bone gap (ABG) were 48.9 ± 17.8, 28.0 ± 11.3, and 20.7 ± 8.4 dB, respectively, in OI and 56.2 ± 13.5, 30.5 ± 9.9, and 26.4 ± 9.7 dB, respectively, in OS, demonstrating greater AC and ABG in OS than in OI. Postoperative AC (31.3 ± 20.5 dB), ABG (10.6 ± 10.0 dB), and closure of ABG (12.1 ± 4.7 dB), that is, preoperative ABG minus postoperative ABG of OI, were comparable to those of OS (AC, 30.9 ± 13.3 dB; ABG, 7.0 ± 7.4 dB; closure of ABG, 20.1 ± 11.6 dB). CONCLUSION: OI ears showed more severe demineralization of otic capsule than OS ears. However, favorable hearing outcomes could be obtained through SS for OI and OS ears.

Microdrill Versus Diode Laser in Endoscopic Stapedotomy: A Comparative Study.

BACKGROUND: Microdrill and diode laser are two different methods used in endoscopic stapedotomy for otosclerosis. These two methods have not been compared in endoscopic stapedotomy. AIMS/OBJECTIVES: To analyze the differences between microdrill and diode laser in endoscopic stapedotomy for otosclerosis. MATERIALS AND METHODS: This is a randomized clinical trial; patients with otosclerosis were randomly divided into microdrill group (group A: n = 69) and diode laser group (group B: n = 62). Differences between the two groups were then compared. RESULTS: The preoperative air-bone gap (ABG) was 25.40 ± 10.88 dBHL in group A and 24.84 ± 12.23 dBHL in group B, with no significant between-group difference ( p > 0.05). The postoperative ABG in group A was 13.27 ± 9.91 dBHL versus 11.79 ± 10.82 dBHL in group B, and there was no significant difference between the groups ( p > 0.05). The surgical time in group B (64 ± 31.23 minutes) was significantly longer than that in group A (48 ± 25.62 minutes) ( p = 0.02). There were no significant between-group differences in basic patient-related data, preoperative air conduction (AC), preoperative bone conduction (BC), postoperative AC, distribution of postoperative ABG, preoperative ABG at different frequencies, and postoperative ABG at different frequencies. There was also no significant between-group difference in the average bleeding volume or number of patients with postoperative dizziness. CONCLUSION AND SIGNIFICANCE: The postoperative improvement in hearing level in the two group was equivalent, but group A had the advantage of a shorter operation time. LEVEL OF EVIDENCE: 4.

Provision of bone conduction hearing implants in England in adults and children: a review of Hospital Episode Statistics data 2012-2021.

OBJECTIVE: Bone conduction hearing implants are a well-established method of hearing rehabilitation in children and adults. This study aimed to review any changes in provision in England. METHODS: The total number of bone conduction hearing implantations performed was analysed from 2012 to 2021 utilising Hospital Episode Statistics data for England. RESULTS: The total number of procedures has increased by 58 per cent. One-stage bone conduction hearing implantations in adults accounts for the largest proportion of this increase (93 per cent of the total). The number performed in children has remained stable and accounts for 73 per cent (n = 433) of all two-stage procedures. CONCLUSION: The data show that bone conduction hearing implant surgery is becoming increasingly popular, particularly in adults. This has correlated with the increase in availability, national recommendations and choice of devices.

Spatial Release From Masking With Bilateral Bone Conduction Stimulation at Mastoid for Normal Hearing Subjects.

This study investigates the effect of spatial release from masking (SRM) in bilateral bone conduction (BC) stimulation at the mastoid. Nine adults with normal hearing were tested to determine SRM based on speech recognition thresholds (SRTs) in simulated spatial configurations ranging from 0 to 180 degrees. These configurations were based on nonindividualized head-related transfer functions. The participants were subjected to sound stimulation through either air conduction (AC) via headphones or BC. The results indicated that both the angular separation between the target and the masker, and the modality of sound stimulation, significantly influenced speech recognition performance. As the angular separation between the target and the masker increased up to 150°, both BC and AC SRTs decreased, indicating improved performance. However, performance slightly deteriorated when the angular separation exceeded 150°. For spatial separations less than 75°, BC stimulation provided greater spatial benefits than AC, although this difference was not statistically significant. For separations greater than 75°, AC stimulation offered significantly more spatial benefits than BC. When speech and noise originated from the same side of the head, the "better ear effect" did not significantly contribute to SRM. However, when speech and noise were located on opposite sides of the head, this effect became dominant in SRM.

Evaluation of the Baha SoundArc in children.

OBJECTIVE: The Baha SoundArc coupling system has been developed as a non-surgical coupling of a Baha sound processor to the skull allowing the transfer of vibrational energy to the cochlear partition via bone conduction pathways. Today, there are several alternatives to this non-surgical approach as the Baha headband/test band, or the Baha Softband, or adhesive patches. Each of these current options have benefits and liabilities. The aim of the study was to evaluate pediatric experience and performance when using two non-surgical options, the Baha SoundArc compared to the Baha Softband. METHODS: Twenty-five children with unilateral mixed or conductive hearing loss aged 5-12 years of age evaluated the use of the Baha SoundArc compared to their existing Baha Softband in a one month take home trial. Participants had a minimum of 3 months experience using the control, Baha Softband. Participants were assessed at baseline and one month following fit of the Baha SoundArc. Measures included an experience and use patient reported outcome, speech perception testing in quiet using Phonetically Balanced Kindergarten (PBK) words, and sound field audiometry. RESULTS: Mean aided soundfield thresholds across the frequency range were 27.6 dB HL for Softband and 26.0 dB HL for SoundArc, which were not significantly different (P = >.05). Mean word recognition score was 80.8% when aided with the Softband device and 85.1% with the SoundArc, which was also not significantly different (P = >.05). Most children favored the aesthetics and usability of the SoundArc over Softband, but comfort ratings were largely similar for both devices. CONCLUSIONS: Bone conduction sound processors mounted on a SoundArc or a Softband resulted in comparable improvements in aided thresholds and speech understanding in children suffering from conductive or mixed hearing loss. Both wearing modalities can be considered equivalent in terms of audiological outcomes, although both patients and clinicians preferred the usability and aesthetics of the SoundArc. The SoundArc provides an alternative wearing option for patients that may otherwise be discouraged by the aesthetics and usability of the Softband device. GOV IDENTIFIER: NCT03333577.

Outcomes and device use in children with bone-conduction hearing devices in South Africa.

BACKGROUND:  Bone-conduction hearing devices (BCHD) can provide hearing solutions in settings where middle ear pathology is rife. OBJECTIVES:  Describe functional hearing outcomes and device use of children fitted with BCHD. METHOD:  Retrospective review of 79 children fitted with BCHD between January 2017 and May 2022. Outcomes included device use and subjective reports measured with the Parents' Evaluation of Aural/Oral Performance of Children (PEACH) and the Teachers' Evaluation of Aural/Oral Performance of Children (TEACH). Analysis of variance established association between mean data logging and type and degree of hearing loss. Thematic analyses were done for qualitative outcomes. RESULTS:  Average usage was 7.0 h/day (5.4 SD; range 0.1-24). PEACH ratings indicated 93.3% of children wore their BCHD 'always' or 'often', with 80% displaying Typical auditory performance at 1-month follow-up. TEACH ratings indicated 84.2% of children wore their BCHD 'always' or 'often', with 78.9% showing typical auditory behaviour. Increased usage was noted for conductive, mixed, moderate and severe hearing losses. There was a mean delay of 17.2 months (23.4 SD; range 0-90) between age of diagnosis and fitting. Thematic analyses identified two main themes: advantages and barriers to BCDH use. CONCLUSION:  Average device use fell short of the internationally recommended 10 h/day. Higher BCHD use was associated with higher functional listening performance scores. Long waiting times for medical or surgical intervention for conductive hearing losses can delay BCHD fitting.Contribution: Limited information is available to examine outcomes in children fitted with BCHD.

The effect of local dexamethasone on stapedotomy surgery outcomes in patients with otosclerosis.

BACKGROUND: Some studies have shown a positive effect of systemic corticosteroid on hearing results after stapedotomy, but its side effects can limit its routine administration. AIM: The aim of this study was to investigate the effect of local dexamethasone on the results of stapedotomy surgery. MATERIAL AND METHODS: Fifty two patients undergone stapedotomy surgery for otosclerosis involved. In the case group after stapedotomy we fulfilled the middle ear with dexamethasone and then the placement of the prosthesis was done. In the control group after stapedotomy we did not use dexamethasone in the middle ear. RESULTS: Gender, age, nausea, vomiting, postoperative vertigo and nystagmus did not significantly differ between the groups. A significant difference was observed in tinnitus rate between two groups. In the case group ABG decrease was higher and bone conduction thresholds improved at frequencies of 1000, 2000, and 4000 three months after surgery. CONCLUSION: Since local dexamethasone had a positive effect on the results of stapedotomy surgery, it can be used instead of systemic corticosteroids to reduce the side effects and increasing surgery's success rate. SIGNIFICANCE: If local dexamethasone had a positive influence on the results of stapedotomy surgery, it can be used instead of systemic corticosteroids to reduce the side effects and increasing surgery's success rate.

Comparison of Quality of Life Outcomes for Percutaneous Versus Transcutaneous Implantable Hearing Devices: A Systematic Review and Meta-analysis.

OBJECTIVE: To compare quality of life (QOL) outcomes of percutaneous and transcutaneous bone conduction devices (pBCD and tBCD, respectively). DATABASES REVIEWED: Pubmed, Scopus, CINAHL. METHODS: A systematic review was performed searching for English language articles from inception to March 15, 2023. Studies reporting QOL outcomes measured using a validated tool following implantation of either pBCDs or tBCDs were considered for inclusion. QOL outcomes included scores for Glasgow Benefit Inventory, Glasgow Children's Benefit Inventory, Abbreviated Profile of Hearing Aid Benefit, and the Speech, Spatial, and Qualities of Hearing Scale. A meta-analysis of continuous measures was performed. RESULTS: A total of 52 articles with 1,469 patients were included. Six hundred eighty-nine patients were implanted with pBCDs, and the remaining 780 were implanted with tBCDs. Average Glasgow Benefit Inventory scores for the tBCD group (33.0, 95% confidence interval [22.7-43.3]) were significantly higher than the pBCD group (30.9 [25.2-36.6]) (Δ2.1 [1.4-2.8], p < 0.0001). Mean Glasgow Children's Benefit Inventory scores (Δ3.9 [2.0-5.8], p = 0.0001) and mean gain in Abbreviated Profile of Hearing Aid Benefit scores (Δ5.6 [4.8-6.4], p < 0.0001) were significantly higher among patients implanted with tBCDs than those implanted with pBCDs. Patients implanted with tBCDs also had significantly higher gains on the Speech (Δ1.1 [0.9-1.3], p < 0.0001), Spatial (Δ0.8 [0.7-0.9], p < 0.0001), and Qualities of Hearing (Δ1.2 [1.1-1.3], p < 0.0001) portions of the Speech, Spatial, and Qualities of Hearing Scale than those implanted with pBCDs. CONCLUSIONS: Patients implanted with transcutaneous devices had better QOL outcomes than those implanted with percutaneous devices.

The effect of piston diameter in primary stapes surgery on surgical success.

PURPOSE: To evaluate the effect of piston diameter in patients undergoing primary stapes surgery on audiometric results and postoperative complications. METHODS: A retrospective single-center cohort study was performed. Adult patients who underwent primary stapes surgery between January 2013 and April 2022 and received a 0.4-mm-diameter piston or a 0.6-mm-diameter piston were included. The primary and secondary outcomes were pre- and postoperative pure-tone audiometry, pre- and postoperative speech audiometry, postoperative complications, intraoperative anatomical difficulties, and the need for revision stapes surgery. The pure-tone audiometry included air conduction, bone conduction, and air-bone gap averaged over 0.5, 1, 2 and 3 kHz. RESULTS: In total, 280 otosclerosis patients who underwent 321 primary stapes surgeries were included. The audiometric outcomes were significantly better in the 0.6 mm group compared to the 0.4 mm group in terms of gain in air conduction (median = 24 and 20 dB, respectively), postoperative air-bone gap (median = 7.5 and 9.4 dB, respectively), gain in air-bone gap (median = 20.0 and 18.1 dB, respectively), air-bone gap closure to 10 dB or less (75% and 59%, respectively) and 100% speech reception (median = 75 and 80 dB, respectively). We found no statistically significant difference in postoperative dizziness, postoperative complications and the need for revision stapes surgery between the 0.4 and 0.6 mm group. The incidence of anatomical difficulties was higher in the 0.4 mm group. CONCLUSION: The use of a 0.6-mm-diameter piston during stapes surgery seems to provide better audiometric results compared to a 0.4-mm-diameter piston, and should be the preferred piston size in otosclerosis surgery. We found no statistically significant difference in postoperative complications between the 0.4- and 0.6-mm-diameter piston. Based on the results, we recommend always using a 0.6-mm-diameter piston during primary stapes surgery unless anatomical difficulties do not allow it.

Complications and audiological results of percutaneous bone-anchored hearing devices.

OBJECTIVE: To describe the post-operative complications and audiological results related to percutaneous bone-anchored hearing devices. METHODS: A retrospective review was conducted of 44 patients with bilateral conductive or mixed hearing loss who were implanted with unilateral Baha Connect or Ponto devices. A generalised linear model for repeated measurements was used. RESULTS: Twenty patients were Baha Connect users, and 24 were implanted with Ponto devices. Twenty-seven patients experienced complications. No fewer complications were found in the group of patients using longer abutments. When we compared the frequency of complications between Ponto and Baha Connect users, there was no statistically significant difference (p = 0.90). Free-field hearing thresholds were statistically significantly improved when we compared pre- and post-operative results (p < 0.001). Average speech perception also improved (p < 0.001). CONCLUSION: Despite percutaneous bone-anchored hearing devices having a high rate of complications, they provide significant audiological benefits.

Minimally Invasive OSIA Bone Conduction Hearing Implant (MOSIA) in Children: How I do it?

The MOSIA is a novel minimally invasive endoscopic-assisted technique that has been shown to reduce postoperative morbidity and improve aesthetics. This is the first series to include children under the age of 12, as the FDA in the United States only approved OSIA for children 12 and older. Laryngoscope, 134:1901-1906, 2024.

Post-implantation clinical cost analysis between transcutaneous and percutaneous bone conduction devices.

INTRODUCTION: Bone conduction devices (BCD) are effective for hearing rehabilitation in patients with conductive and mixed hearing loss or single-sided deafness. Transcutaneous bone conduction devices (tBCD) seem to lead to fewer soft tissue complications than percutaneous BCDs (pBCD) but have other drawbacks such as MRI incompatibility and higher costs. Previous cost analyses have shown a cost advantage of tBCDs. The purpose of this study is to compare long-term post-implantations costs between percutaneous and transcutaneous BCDs. MATERIALS AND METHODS: Retrospective data from 77 patients implanted in a tertiary referral centre with a pBCD (n = 34), tBCD (n = 43; passive (tpasBCD; n = 34) and active (tactBCD; n = 9) and a reference group who underwent cochlear implantation (CI; n = 34), were included in a clinical cost analysis. Post-implantation costs were determined as the sum of consultation (medical and audiological) and additional (all post-operative care) costs. Median (cumulative) costs per device incurred for the different cohorts were compared at 1, 3 and 5 years after implantation. RESULTS: After 5 years, the total post-implantation costs of the pBCD vs tpasBCD were not significantly different (€1550.7 [IQR 1174.6-2797.4] vs €2266.9 [IQR 1314.1-3535.3], p = 0.185), nor was there a significant difference between pBCD vs tactBCD (€1550.7 [1174.6-2797.4] vs €1428.8 [1277.3-1760.4], p = 0.550). Additional post-implantation costs were significantly highest in the tpasBCD cohort at all moments of follow-up. CONCLUSION: Total costs related to post-operative rehabilitation and treatments are comparable between percutaneous and transcutaneous BCDs up to 5 years after implantation. Complications related to passive transcutaneous bone conduction devices appeared significantly more expensive after implantation due to more frequent explantations.

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.

A Novel Method to Determine the Maximum Output of Individual Patients for an Active Transcutaneous Bone Conduction Implant Using Clinical Routine Data.

OBJECTIVES: The maximum output provided by a bone conduction (BC) device is one of the main factors that determines the success when treating patients with conductive or mixed hearing loss. Different approaches such as sound pressure measurements using a probe microphone in the external auditory canal or a surface microphone on the forehead have been previously introduced to determine the maximum output of active transcutaneous BC devices that are not directly accessible after implantation. Here, we introduce a method to determine the maximum output hearing level (MOHL) of a transcutaneous active BC device using patients' audiometric data. DESIGN: We determined the maximum output in terms of hearing level MOHL (dB HL) of the Bonebridge using the audiometric and direct BC threshold of the patient together with corresponding force levels at hearing threshold and the maximum force output of the device. Seventy-one patients implanted with the Bonebridge between 2011 and 2020 (average age 45 ± 19 years ranging from 5 to 84 years) were included in this study. The analyses of MOHLs were performed by (1) dividing patients into two groups with better or worse average audiometric BC threshold (0.5, 1, 2, 4 kHz), on the ipsilateral side or (2) by separating the MOHLs based on better or worse frequency-by-frequency specific audiometric BC thresholds on the ipsilateral (implanted) side. RESULTS: When using a frequency-by-frequency analysis obtained average ipsilateral MOHLs were in the range between 51 and 73 dB HL for frequencies from 0.5 to 6 kHz in the group with better audiometric BC threshold on the ipsilateral ears. The average contralateral MOHLs in the group with better contralateral hearing were in the range from 43 to 67 dB HL. The variability of the data was approximately 6 to 11 dB (SDs) across measured frequencies (0.5 to 6 kHz). The average MOHLs were 4 to 8 dB higher across frequencies in the group with better audiometric BC threshold on the ipsilateral ears than in the group with better audiometric BC threshold on the contralateral ears. The differences between groups were significant across measured frequencies ( t test; p < 0.05). CONCLUSIONS: Our proposed method demonstrates that the individual frequency-specific MOHL on the ipsilateral and contralateral side of individual patients with a transcutaneous BC device can be determined mainly using direct and audiometric BC threshold data of the patients from clinical routine. The average MOHL of the implant was found 4 to 8 dB higher on the ipsilateral (implanted) side than on the contralateral side.

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.

Systematic Review and Meta-Analysis of a New Active Transcutaneous Bone Conduction Implant.

OBJECTIVE: This review aims to quantify the pooled functional gain (FG) in different types of hearing loss with the transcutaneous hearing device, Osia (Cochlear, Sydney, Australia) in comparison with the unaided state. Secondary outcomes are patient-reported outcomes measures (PROMs) and complication rates. DATA SOURCES: Medline, Embase, SCOPUS, Cochrane CENTRAL, PROSPERO and Cochrane Library. REVIEW METHODS: Systematic review and meta-analysis of indexed search terms relating to "Osia," "Osseointegration," "Cochlear Implant," and "Bone-Anchored Prosthesis" was performed from database inception to September 20, 2022. RESULTS: Of the 168 studies identified, 14 studies with 15 patient cohorts (n = 314) met inclusion criteria for meta-analysis. Pooled overall mean FG for all types of hearing loss was 35.0 dB sound pressure level (SPL) (95% confidence interval [CI] 29.12-40.97) compared against unaided hearing. Pooled FG for conductive/mixed hearing loss was 37.7 dB SPL (95% CI 26.1-49.3). Pooled single-sided deafness (SSD) FG could not be calculated due to the small patient cohort for whom SSD data was reported. There is a trend toward improvements in speech receptiveness threshold, signal to noise ratio, and some PROMs compared with baseline hearing. Early complication rates demonstrate risks similar to other transcutaneous implants, with a low predicted explantation (0.11%, 95% CI 0.00%-1.90%) and wound infection rate (1.92% [95% CI 0.00%-6.17%]). No articles directly comparing transcutaneous devices were identified. CONCLUSION: The Osia devices demonstrate clear audiologic benefits and a good safety profile for the included patient population. Our study results indicate that frequency-specific gain, PROMs, and the audiological benefit in single-sided deafness may be areas for future prospective research. Laryngoscope, 134:1531-1539, 2024.

Role of early hearing aid experience in speech recognition in patients with bilateral congenital microtia following Bonebridge implantation: a retrospective cohort study.

PURPOSE: To identify audiological and demographic variables that predict speech recognition abilities in patients with bilateral microtia who underwent Bonebridge (BB) implantation. METHODS: Fifty patients with bilateral microtia and bilateral conductive hearing loss (CHL) who underwent BB implantation were included. Demographic data, preoperative hearing aid use experience, and audiological outcomes (including pure-tone hearing threshold, sound field hearing threshold [SFHT], and speech recognition ability) for each participant were obtained. The Chinese-Mandarin Speech Test Materials were used to test speech recognition ability. The word recognition score (WRS) of disyllabic words at 65 dB SPL signals was measured before and after BB implantation in quiet and noisy conditions. RESULTS: The mean preoperative WRS under quiet and noisy conditions was 10.44 ± 12.73% and 5.90 ± 8.76%, which was significantly improved to 86.38 ± 9.03% and 80.70 ± 11.34%, respectively, following BB fitting. Multiple linear regression analysis revealed that lower preoperative SFHT suggested higher preoperative WRS under both quiet and noisy conditions. Higher age at implantation predicted higher preoperative WRS under quiet conditions. Furthermore, patients with more preoperative hearing aid experience and lower postoperative SFHT were more likely to have higher postoperative WRS under both quiet and noisy testing conditions. CONCLUSIONS: This study represents the first attempt to identify predictors of preoperative and postoperative speech recognition abilities in patients with bilateral microtia with BB implantation. These findings emphasize that early hearing intervention before implantation surgery, combined with appropriate postoperative fitting, contributes to optimal benefits in terms of postoperative speech recognition ability.