Modification of skin incision for Baha Attract System Implantations.

<b><br>Introduction:</b> In an era of wide accessibility to various systems for hearing impairment prosthetics, there exists a broad spectrum of surgical techniques facilitating system implantation.</br> <b><br>Aim:</b> The aim of the study is to present the technique of vertical incision in the implantation of the Baha Attract magnetic system as an alternative incision, maintaining a compromise between optimizing the surgical procedure and preserving the functionality and quality of life of the patient.</br> <b><br>Materials and methods:</b> The vertical incision technique is presented based on 5 patients treated between December 2022 and March 2023 diagnosed with conductive or mixed hearing loss.</br> <b><br>Results:</b> There were no adverse consequences or complications resulting from the performed surgical incision. All patients experienced uncomplicated healing. Patients are using sound processor magnets ranging from 4-5 in strength and Baha 6 Max sound processors weighing 11.5 g.</br> <b><br>Conclusions:</b> The vertical incision technique serves as an alternative to the C-shaped perimeter incision, allowing for the optimization and standardization of the surgical procedure, resulting in a smooth scar formation and maintaining good audiological and aesthetic outcomes.</br>.

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.

Efficacy of vibrant sound bridge in congenital aural atresia: an updated systematic review.

PURPOSE: The indications of Vibrant Soundbridge (VSB) have been expanded to include patients with conductive and mixed hearing loss due to congenital aural atresia (CAA). However, the current evidence supporting the auditory outcomes of VSB is based mainly on case reports and retrospective chart reviews. Therefore, the present systematic review aims to summarize and critically appraise the current evidence regarding the safety and effectiveness of VSB in children and adult patients with CAA. METHODS: A systematic literature search retrieved studies that evaluated the outcomes of unilateral or bilateral implantation of VSB in patients with CAA. The bibliographic search was conducted in PubMed, Scopus, EBSCO, and Cochrane Central Register of Controlled Trials (CENTRAL) databases from January 2000 to December 2022. RESULTS: Twenty-seven studies were included in the present systematic review. Overall, the speech perception after VSB was good, with a mean word recognition score (WRS) score ranging from 60 to 96.7%. The mean postoperative speech recognition threshold (SRT) after implantation ranged from 20.8 to 50 dB. The effective gain was reported in 15 studies, ranging from 31.3 to 45.5 dB. In terms of user satisfaction with VSB, the included studies showed significant improvements in the patient-reported outcomes, such as the Speech Spatial and Qualities of Hearing scale and Glasgow Hearing Aid Benefit Profile. The VSB implantation was generally safe with low incidence of postoperative complications. CONCLUSION: VSB provides significant benefits to individuals with hearing loss owing to CAA, with very good subjective outcomes and a low risk of complications.

Middle Ear Tophi: A Case Series of Two Unusual Lesions and a Report of Facial Weakness and Review of the Literature.

OBJECTIVE: Tophaceous lesions of the middle ear from calcium pyrophosphate deposition disease (CPPD, or pseudogout) and gout are infrequently reported. Recognizing its characteristic findings will allow clinicians to accurately narrow the differential diagnosis of bony-appearing middle ear lesions and improve management. PATIENTS: Two consecutive cases of tophaceous middle ear lesions presenting to a tertiary care center between January 2021 and December 2021. Neither with previous rheumatologic history. INTERVENTIONS: Surgical excision of tophaceous middle ear lesions. MAIN OUTCOME MEASURE: Improvements in facial weakness and conductive hearing loss. RESULTS: The first case was a 66-year-old gentleman with progressive conductive loss, ipsilateral progressive facial weakness over years, and an opaque, irregular-appearing tympanic membrane anterior to the malleus found to have CPPD on surgical pathology, with immediate postoperative improvement of facial function. The second was a 75-year-old gentleman with progressive conductive loss and similar appearing tympanic membrane as case 1, previously diagnosed with tympanosclerosis, found to have gout on surgical pathology. In both cases, the CT showed a heterogenous, bony-appearing lesion in the middle ear, and both tophaceous lesions were a of gritty, chalky consistency intraoperatively. CONCLUSION: Tophaceous lesions of the middle ear are rare but have similar findings. Notably, the tympanic membrane can appear opaque and irregular, and the CT demonstrates a radiopaque, heterogeneous appearance. Facial weakness is an unusual finding. Specimens of suspected tophi must be sent to pathology without formalin for accurate diagnosis.

Bone cement repair of malleus handle fractures: Intraoperative video and case report of two patients.

Isolated malleus fractures are a rare occurrence with few reported cases in the literature. Symptoms include sudden otalgia, hearing loss, tinnitus and aural fullness. Work-up and diagnosis are based on a combination of thorough anamnesis and careful otoscopic evaluation or high-resolution computer tomography. We present two cases of isolated malleus handle fractures who were diagnosed based on a combination of pneumatic otoscopy and tympanometry. Both fractures were surgically repaired using hydroxyapatite bone cement as showcased in the supplemental video material. Post-operative audiometry showed improvement in the pure-tone-average of both patients as well as normalisation of tympanometry. Isolated malleus fracture should be suspected in cases of sudden hearing loss and tinnitus following digital manipulation of the outer ear canal together with a conductive hearing loss with a mostly high-frequent air-bone-gap and hypercompliant tympanometry with hypermobility of the tympanic membrane on pneumatic insufflation. Surgical repair of the fracture using bone cement has good hearing outcomes and leads to improvement in auditory symptoms.

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.

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.

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.

Long term results of glass ionomer ossiculoplasty.

OBJECTIVE: To analyze and compare the early and late post-operative results of glass ionomer bone cement (GIBC) used in ossiculoplasty. METHODS: The pre-operative, early post-operative (3 months) and late post-operative (> 2 years) audiometric findings, namely the pure-tone average (PTA), bone conduction threshold (BCT) and air-bone gap (ABG) of 40 patients who underwent GIBC ossiculoplasty for different etiologies were analyzed. Early and late results were compared. Also, the patients were grouped in terms of prognostic factors and applied ossiculoplasty techniques, and the results were compared between the groups. RESULTS: There were statistically significant improvements in the pure-tone average and air-bone gap of the patients in the early post-operative period (PTA from 59.60 ± 15.95 to 40.37 ± 17.83 and ABG from 37.12 ± 11.18 to 19.78 ± 10.41, p < 0.001 for both). There were no statistically significant changes in any of the audiometric parameters in the late post-operative period (PTA from 40.37 ± 17.83 to 39.79 ± 17.91, ABG from 19.78 ± 10.41 to 19.32 ± 9.60, BCT from 17.99 ± 12.71 to 18.31 ± 13.99, p > 0.05 for all). Presence of tympanosclerosis was found to be the only prognostic factor to affect the outcome. CONCLUSION: GIBC is a safe and reliable material for ossiculoplasty, which maintains its ability to conduct sound in the long-term follow-up.

Long-term results and quality of life after vibrant soundbridge implantation (VSBs) in children and adults with aural atresia.

PURPOSE: The aim of this study was to evaluate the long-term effectiveness and acceptance of the active middle ear implant system Vibrant Soundbridge (VSB®, MED-EL, Austria) in patients with aural atresia or aplasia (children and adults). METHODS: Data from 51 patients (mean age 13.9 ± 11.3 years), 42 (79.2%) children and adolescents, and 11 (20.8%) adults) who received a VSB implant between 2009 and 2019 at the Department of Otolaryngology at LMU Clinic Großhadern, Munich were included in the study. Pure-tone audiometry, speech recognition in a quiet environment and in a noisy environment were performed preoperatively, during the first fitting of the audio processor, after 1-3 years, after 3-5 years, and after 5 years (if possible). The follow-up period ranged from 11 to 157 months with a mean of 58.6 months (4.8 years). Furthermore, the benefit of the VSB was evaluated by self-assessment questionnaires (Speech, Spatial, and Qualities of Hearing Scale, respectively, for parents). RESULTS: Significant improvements were observed in hearing and speech comprehension immediately after the initial fitting of the VSB system (mean hearing gain 38.4 ± 9.4 dB HL) and at follow-up intervals (1-3, 3-5 and after 5 years) for children and adults (p < 0.01). The values remained stable over the long-term, indicating a sustained functional gain from the VSB (mean hearing gain 38.9 ± 9.2 dB HL). The results of the self-assessments affirm the positive influence on hearing and speech comprehension with the VSB. With the VSB, there was an improvement of 41.3 ± 13.7% in the Freiburg monosyllable test. CONCLUSION: These results (a stable hearing gain over the long term, a good tolerance of the implant and an improvement in quality of life) affirm the recommendation for using the active middle ear implant VSB as early as permitted for aural atresia and aplasia patients. This study represents the audiometric results with the (to date) largest collective of aural atresia patients and with a long follow-up period.

Isolated Fracture of the Malleus: An Overlooked Cause of Conductive Hearing Loss?

OBJECTIVE: To report the largest case series of isolated malleus fractures with systematic review to characterize the disease's presentation and natural history, and provide suggestions for management. DATA SOURCES: PubMed, Embase, Cochrane Library. REVIEW METHODS: Retrospective cohort study was performed on 12 patients with isolated malleus fractures. History, physical exam, pre- and post-treatment audiograms, and imaging were obtained. Systematic review of the literature was performed. RESULTS: Including the cases herein, 58 isolated malleus fractures were identified, the majority of which were published in the 21st century. Mean time to presentation after injury was 34.4 months. Most common etiology was external auditory canal (EAC) manipulation. Physical exam and imaging did not identify any abnormality at presentation in 16% and 21% of cases, respectively. The majority of fractures involved the manubrium. Air-bone gap (ABG) at initial presentation ranged from 16 to 26 dB, and was greater at higher frequencies. Thirty-six cases underwent surgery. ABG improvement was greater at all frequencies for those who underwent surgery. Final ABG was significantly less than initial ABG at nearly every frequency for those who underwent surgery (p < 0.05), while not at any frequency for those who were observed. CONCLUSIONS: Isolated malleus fractures may occur more often than historical data suggests, and are perhaps underdiagnosed. Abrupt removal of a finger from the EAC with pain and hearing loss is nearly pathognomonic. Conductive hearing loss with ABG greater at higher frequencies is most often observed. Observation is unlikely to produce spontaneous improvements in hearing, while surgery demonstrates reliable decreases in ABG. Laryngoscope, 134:1032-1041, 2024.

Retrospective observational study analysing the trends in ventilation tube insertion in children in Scotland between 2001 and 2018.

OBJECTIVES: Otitis media with effusion (OME) is common, affecting up to 90% of children. Around 25% will have a persistent effusion with conductive hearing loss which can impact their development. Ventilation tubes (VTs) can improve their hearing in the short term. This study aims to analyse the trends in VT insertion rates across Scotland. DESIGN: Retrospective observational study. SETTING: All mainland Scottish health boards. PARTICIPANTS: All children aged 0-16 who underwent a VT insertion procedure from 2001 to 2018 were included. MAIN OUTCOME MEASURES: Data were provided by the Scottish Public Health Observatory, using Scottish Morbidity Records. Mid-year population estimates were obtained from the National Records Office of Scotland. Socioeconomic deprivation was estimated based on area of residence using the Scottish Index of Multiple Deprivation. VT insertion rates were calculated and trends analysed. RESULTS: A total of 35 878 VT procedures were performed in total with a mean rate of 2.02 per 1000 children per year. The highest insertion rates were observed in children aged 4-6. VT insertion rates reduced during the study period (R = -0.729, p = .001). Variability in VT insertion rates between health boards reduced. There was a significant association between socioeconomic deprivation and VT insertion rate, with the most deprived children having the highest rate (p < .001). CONCLUSIONS: VT insertion rates and the variability between Scottish health boards have reduced over the past two decades, suggesting a more equitable system. Our data intimates that the decision to perform VT insertion is based upon disease prevalence rather than clinician preference.

Balloon dilation improves both the hearing level and the quality of life in patients suffering from obstructive Eustachian tube dysfunction.

PURPOSE: Chronic obstructive Eustachian tube dysfunction (OETD) can lead to tympanic membrane (TM) retraction and middle ear effusion (MEE) which can cause conductive hearing impairment, which among other ear symptoms can lower the quality of life (QoL). In this prospective study we assess hearing results and subjective changes in QoL following balloon Eustachian tuboplasty (BET) in treatment of OETD. METHODS: Totally 25 ears with TM retraction and 18 ears with MEE due to chronic OETD underwent BET as the sole intervention. Outcomes including otoscopy, ability to perform the Valsalva maneuver, tympanometry, audiometry, Eustachian tube inflammation scale and the Glasgow Benefit Inventory questionnaire (GBI) were obtained on all patients preoperatively and 6 months postoperatively. RESULTS: Hearing thresholds improved statistically significantly (p < 0.05) with means of 3 dB in the TM retraction group and 9 dB in the MEE group. Total GBI results indicated a positive influence on patients' QoL. Valsalva success rate was 80% in patients with TM retraction and 67% in patients with MEE. Tympanometry results improved in 50% of TM retraction patients and in 33% of MEE patients. CONCLUSIONS: Here we demonstrated that the BET has a positive impact on patients' conductive hearing loss and QoL in patients with TM retraction or MEE. Results were better in TM retraction group than in MEE group.

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.

Endoscopic ossiculoplasty in traumatic conductive hearing loss with intact tympanic membrane: a five-year experience.

BACKGROUND: Exploratory tympanotomy in cases of traumatic ossicular disruption with intact tympanic membrane is crucial for both diagnostic and therapeutic purposes. Performing this procedure using the endoscope is gaining popularity. Hence, this study aimed to demonstrate varieties of ossicular pathology and their management in our institution. METHODS: A retrospective evaluation was conducted of 136 ears in patients with traumatic ossicular disruption with an intact tympanic membrane, who underwent endoscopic exploratory tympanotomy. A proposed algorithm was followed, to incorporate different traumatic ossicular possibilities. Assessment of hearing outcomes and surgical complications was performed six months post-operatively. RESULTS: Incudostapedial dislocation was the most commonly encountered type of traumatic ossicular disruption (35.3 per cent). Air conduction threshold improved significantly following endoscopic ossiculoplasty, from 50.9 ± 6.35 dB pre-operatively to 22.35 ± 3.27 dB post-operatively, with successful air-bone gap closure. CONCLUSION: Endoscopic ear surgery is effective in the diagnosis and management of challenging cases of post-traumatic ossicular disruption with an intact tympanic membrane.

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.

Prediction of postoperative speech comprehension with the transcutaneous partially implantable bone conduction hearing system Osia®.

BACKGROUND: The active transcutaneous, partially implantable osseointegrated bone conduction system Cochlear™ Osia® (Cochlear, Sydney, Australia) has been approved for use in German-speaking countries since April 2021. The Osia is indicated for patients either having conductive (CHL) or mixed hearing loss (MHL) with an average bone conduction (BC) hearing loss of 55 dB HL or less, or having single-sided deafness (SSD). OBJECTIVES: The aim of this retrospective study was to investigate the prediction of postoperative speech recognition with Osia® and to evaluate the speech recognition of patients with MHL and in particular an aided dynamic range of less than 30 dB with Osia®. MATERIALS AND METHODS: Between 2017 and 2022, 29 adult patients were fitted with the Osia®, 10 patients (11 ears) with CHL and 19 patients (25 ears) with MHL. MHL was subdivided into two groups: MHL­I with four-frequency pure-tone average in BC (BC-4PTA) ≥ 20 dB HL and < 40 dB HL (n = 15 patients; 20 ears) vs. MHL-II with BC-4PTA ≥ 40 dB HL (n = 4 patients; 5 ears). All patients tested a bone conduction hearing device on a softband preoperatively. Speech intelligibility in quiet was assessed preoperatively using the Freiburg monosyllabic test in unaided condition, with the trial BCHD preoperatively and with Osia® postoperatively with Osia®. The maximum word recognition score (mWRS) unaided and the word recognition score (WRS) with the test system at 65 dB SPL were correlated with the postoperative WRS with Osia® at 65 dB SPL. RESULTS: Preoperative prediction of postoperative outcome with Osia® was better using the mWRS than by the WRS at 65 dB SPL with the test device on the softband. Postoperative WRS was most predictive for patients with CHL and less predictable for patients with mixed hearing loss with BC-4PTA ≥ 40 dB HL. For the test device on a softband, the achievable outcome tended to a minimum, with the mWRS tending to predict the realistically achievable outcome. CONCLUSION: Osia® can be used for the treatment of CHL and MHL within the indication limits. The average preoperative bone conduction hearing threshold also provides an approximate estimate of the postoperative WRS with Osia®, for which the most accurate prediction is obtained using the preoperative mWRS. Prediction accuracy decreases from a BC-4PTA of ≥ 40 dB HL.

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.