Bone Conduction Implants: Comparative of Audiometric Results and Quality-of-Life Bonebridge® versus Osia®.

INTRODUCTION: Bone conduction implants have been indicated for patients with conductive hearing loss, mixed hearing loss, and even profound unilateral sensorineural hearing loss. With the introduction of Bonebridge®, new transcutaneous implant options emerged. The latest is Osia®, a direct-drive variant or active systems, where the implant directly generates and applies vibration to the bone. MATERIALS AND METHODS: Retrospective study of two cohorts of patients treated with active bone conduction implants at a single center, one with the Bonebridge® device and the other with Osia®. OUTCOMES: Fourteen patients were included, seven in each group (n = 14). The Bonebridge® group showed an average hearing gain in tonal intelligibility thresholds of 32.43 ± 21.39 dB and a gain in the average intelligibility threshold (with 50% discrimination) of 26.29 ± 19.10 dB. In the Osia® group, there was a gain in average tonal thresholds of 41.49 ± 14.16 dB and 23.72 ± 6.98 dB in average intelligibility thresholds. Both devices contributed to improvements in patients' quality of life, as assessed with APHAB in all the variables studied in the test. Both devices offer rehabilitation for hearing loss as an alternative to hearing aids. The Osia® system shows statistically significant (p < 0.05) improvements in mid and high frequencies, but Bonebridge® slightly outperforms in speech understanding at 50%. Differences in average tonal thresholds and quality of life are not statistically significant. CONCLUSIONS: While auditory improvement is observed postimplantation, other aspects, such as intelligibility thresholds and quality of life, lack statistical significance. Given the limited experience with Osia® and the small sample size, the choice of the device should be personalized. Although the literature is inconsistent due to small sample sizes and variable approaches, some studies suggest potential advantages of the Osia® system, especially in speech comprehension in different environments and greater hearing gain compared to Bonebridge®.

A Large-Scale Study of the Relationship Between Degree and Type of Hearing Loss and Recognition of Speech in Quiet and Noise.

OBJECTIVES: Understanding speech in noise (SIN) is the dominant complaint of individuals with hearing loss. For decades, the default test of speech perception in routine audiologic assessment has been monosyllabic word recognition in quiet (WRQ), which does not directly address patient concerns, leading some to advocate that measures of SIN should be integrated into routine practice. However, very little is known with regard to how SIN abilities are affected by different types of hearing loss. Here, we examine performance on clinical measures of WRQ and SIN in a large patient base consisting of a variety of hearing loss types, including conductive (CHL), mixed (MHL), and sensorineural (SNHL) losses. DESIGN: In a retrospective study, we examined data from 5593 patients (51% female) who underwent audiometric assessment at the Stanford Ear Institute. All individuals completed pure-tone audiometry, and speech perception testing of monaural WRQ, and monaural QuickSIN. Patient ages ranged from 18 to 104 years (average = 57). The average age in years for the different classifications of hearing loss was 51.1 (NH), 48.5 (CHL), 64.2 (MHL), and 68.5 (SNHL), respectively. Generalized linear mixed-effect models and quartile regression were used to determine the relationship between hearing loss type and severity for the different speech-recognition outcome measures. RESULTS: Patients with CHL had similar performance to patients with normal hearing on both WRQ and QuickSIN, regardless of the hearing loss severity. In patients with MHL or SNHL, WRQ scores remained largely excellent with increasing hearing loss until the loss was moderately severe or worse. In contrast, QuickSIN signal to noise ratio (SNR) losses showed an orderly systematic decrease as the degree of hearing loss became more severe. This effect scaled with the data, with threshold-QuickSIN relationships absent for CHL, and becoming increasingly stronger for MHL and strongest in patients with SNHL. However, the variability in these data suggests that only 57% of the variance in WRQ scores, and 50% of the variance in QuickSIN SNR losses, could be accounted for by the audiometric thresholds. Patients who would not be differentiated by WRQ scores are shown to be potentially differentiable by SIN scores. CONCLUSIONS: In this data set, conductive hearing loss had little effect on WRQ scores or QuickSIN SNR losses. However, for patients with MHL or SNHL, speech perception abilities decreased as the severity of the hearing loss increased. In these data, QuickSIN SNR losses showed deficits in performance with degrees of hearing loss that yielded largely excellent WRQ scores. However, the considerable variability in the data suggests that even after classifying patients according to their type of hearing loss, hearing thresholds only account for a portion of the variance in speech perception abilities, particularly in noise. These results are consistent with the idea that variables such as cochlear health and aging add explanatory power over audibility alone.

The influence of intraoperative auditory brainstem responses on vibroplasty coupling-quality and analysis of the impact of different fixation steps on the coupling.

PURPOSE: The Vibrant Soundbridge (VSB) is an established active-middle-ear-implant for patients with moderate-to-profound hearing-loss. This surgery is referred to as "Vibroplasty". Sufficient transfer of the VSB's floating-mass-transducers (FMT) energy to the inner ear is a crucial factor influencing the coupling-quality (CQ). However, assessing CQ is hamper by two issues: the method of CQ-assessment itself and the method of FMT-fixation during Vibroplasty. METHODS: This prospective study explored the influence of intraoperative auditory-brainstem-response (+ ABR) measurements and various fixation methods on postoperative CQ after Vibroplasty as compared to matched-patients after Vibroplasty without intraoperative ABR (-ABR). Propensity-score-matching was performed based on preoperative bone-conduction-pure-tone-average-3 (BC-PTA3) at 1-, 2- and 4 kHz. Primary outcome parameters were postoperative CQ-PTA3, intraoperative ABR threshold for various fixation methods and postoperative BC-PTA3. RESULTS: A total of 28 patients were included, of which 14 were + ABR. Preoperative BC-PTA3, sex, age, and number of previous surgeries did not differ significantly between groups (all p > 0.301). Mean postoperative CQ-PTA3 was significantly better for + ABR (1.8 vs. 12.3 dB-HL; p = 0.006). Mean intraoperative ABR threshold was superior for cartilage-counter-bearing and cartilage-housing compared to additional fixation with injectable-platelet-rich- fibrin (53 vs. 56 & 57 dB-HL, respectively; p = 0.04; η2 = 0.33). Mean postoperative BC-PTA3 did not significantly differ between patients (41.4 vs. 41.8 dB-HL; p = 0.77). A total of 7% of the patients required intraoperative readjustment of the FMT based on unsatisfactory intraoperative ABR threshold. CONCLUSION: Intraoperative ABR measurement resulted in significantly better postoperative CQ. Cartilage-counter-bearing and cartilage-housing were observed to have superior CQ. A total of 7% of the patients could be spared revision-Vibroplasty due to intraoperative ABR measurement.

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.

Beyond the surface: exploring contributing factors to bone anchored hearing implant complications.

INTRODUCTION: Bone anchored hearing implants (BAHI) are considered for conductive and mixed hearing loss, relying on osseointegration of a titanium implant. Limitations relate to constant skin contact, with resultant percutaneous infections and granulation. This study investigates whether patient characteristics and implant-specifications contribute to BAHIs' skin complications in a cohort with a uniform surgical approach. METHODS: A 10 year (2014-2024) retrospective cohort study was conducted on BAHI procedures that were undertaken using a tissue-preserving 'punch' technique. Data on patient demographics, co-morbidities, implant type, surgical approach, and complications were collected. Poisson regression analysis was used to identify predictors of complications. RESULTS: A total of 53 patients undergoing 55 BAHI surgeries by three ENT consultants were included. Factors that greatly increased implant-related percutaneous infections included the Cochlear™ BIA400 implant when compared to the Ponto™ BHX implant (twofold, CI 2.03-2.16), abutment sizes ≤ 10 mm (fourfold, CI 3.99-4.12) and male gender (9%, CI 1.07-1.12). Granulation episodes were affected by cardiovascular disease (CVD) status (1.5-fold, CI 0.26-0.78), BIA400 implant (threefold, CI 8.8.-9.2) and abutment sizes ≤ 10 mm (fourfold, CI 3.6-3.73). Revision surgery episodes increased with diabetic status (1.2-fold, CI 0.06-0.37) and abutment sizes ≤ 10 mm (threefold, 3.303-3.304). CONCLUSIONS: Larger cohort studies are required to confirm findings, particularly for implant and abutment size contributions. However, the findings suggest that using a larger abutment size when skin thickness meassuremets are borderline, improved hygiene education in male patients, pre-operative optimisation of CVD and diabetes, and adjusted patient follow-up based on risk stratification of the contributing factors to complication rates could reduce complication rates.

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.

Evaluation of a super powerful bone-anchored hearing system and its users: A retrospective study.

INTRODUCTION: Although the Baha 5SP has been commercially available for six years, very few studies have been performed on the device's efficacy. The current study aims to evaluate the characteristics and audiological results in patients with severe-to-profound mixed hearing loss fitted with this superpower sound processor. METHODS: This retrospective evaluation was conducted at a tertiary referral centre where a series of 82 adult patients with severe-to-profound mixed hearing loss were implanted with a percutaneous bone-anchored hearing system and fitted with a superpower sound processor between 2016 and 2019. Patients with incomplete or unreliable audiological data (n = 24) were excluded, resulting in 58 data sets for analysis. The main outcome measures were unaided and aided pure-tone thresholds and aided free-field speech perception in quiet. RESULTS: The median unaided air conduction (AC) threshold averaged across 0.5, 1 and 2 kHz (PTA0.5-2kHz) of all patients was 75 dB hearing loss (HL); the median unaided AC averaged across 1, 2 and 4 kHz (PTA1-4kHz) was 84 dB HL. For bone conduction and direct bone conduction, the median PTA0.5-2kHz was 52 and 47 dB HL, respectively. With the superpower device, the median free-field speech reception threshold was 54 dB sound pressure level (SPL), and the median speech perception score at 65 dB SPL was 80%. CONCLUSIONS: At least 75% of the patients reached a maximum phoneme score of 70%. For patients with lower scores, the superpower device still provides a substantial hearing benefit. This makes the superpower device particularly suitable for patients with severe-to-profound mixed hearing loss with a contraindication for conventional hearing aids and/or cochlear implants.

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.

Influence of the Coupling on the Hearing Outcome After Implantation of an Active Middle Ear Implant: Comparison of the Transmission Behavior in Temporal Bone Experiments With Clinical Data.

OBJECTIVES: The active middle ear implant, Vibrant Soundbridge (VSB), can be implanted with a variety of couplers. Hearing outcome after implantation has been investigated in both temporal bone (TB) experiments and patient studies, but the relationship between experimental and clinical data is still weak in the literature. Therefore, experimental data from TB experiments should be compared with patient data in a retrospective study, in which the floating mass transducer is used with couplers of the third generation. Actuator coupling structures included the long (LP coupler) and short (SP coupler) incus process, the stapes head (Clip coupler), and the round window membrane (RW soft coupler). METHODS: In the TB experiments, the sound transmission after vibroplasty on the above-mentioned actuator coupling structures was determined in 32 specimens by means of laser Doppler vibrometry on the stapes footplate. Data of 69 patients were analyzed. The main target audiometric parameters were the postoperative aided word recognition score (WRS) in the free field at 65 dB SPL (WRS 65 dB in %), the preoperative and postoperative pure-tone average (PTA4, including the frequencies 0.5, 1, 2, and 4 kHz) of the bone conduction hearing threshold (PTA4BC), the aided postoperative air conduction hearing threshold in the free field (PTA4FF) and the direct threshold (Vibrogram) at least 6 months postoperatively. The coupling efficiency of the actuator (Vibrogram-PTA4BC) as well as the effective hearing gain (PTA4FF-PTA4BC) was compared between the couplers. RESULTS: The analysis in the main speech range (0.5-4 kHz) indicated that in the TB experiments, the LP coupler tends to have the best coupling quality at low frequencies (500-1000 Hz). This was up to 15 dB above the worst actuator (RW soft coupler). However, the results missed the significance level ( p > 0.05). In the high frequencies (2000-4000 Hz), the Clip coupler showed the best coupling quality. This was 15 dB above the worst actuator (SP coupler). However, the results missed the significance level ( p > 0.05), too. The postoperative WRS at 65 dB SPL and the postoperative PTA4FF were independent of the actuator coupling structure. The PTA4BC was stable at 6 months postoperatively. For the PTA4 of the coupling efficiency, there were no significant differences between the actuator coupling structures (LP 8.9 dB ± 12.9; SP 9.5 ± 6.5 dB; Clip 5.2 ± 10.5 dB; RW 12.7 ± 11.0 dB). However, the tendential inferiority of the RW soft coupler with regard to transmission in the low-frequency range and the tendential superiority of the Clip coupler in the high-frequency range that have already been displayed experimentally could be confirmed in the clinical results. However, the clinical results missed the significance level, too ( p > 0.05). CONCLUSIONS: In vivo, there are no significant differences in the postoperative outcome stratified according to coupling the target structure. The differences known from the experimental setting were repressed by individual biasing factors. However, to ensure sufficient postoperative speech intelligibility, the frequency-specific transmission behavior of the couplers should be taken into account when setting the indication for VSB implantation.

Clinical performance, audiological outcomes, and quality of life of the Cochlear Osia ® system.

OBJECTIVE: The Cochlear Osseointegrated Steady-State Implant Bone Anchored Hearing Device (Osia) is a surgically implanted titanium apparatus that utilizes a piezoelectric actuator under the skin to address conductive and mixed hearing loss as well as single-sided deafness. The purpose of this study is to examine the clinical, audiologic, and quality-of-life outcomes in patients who underwent Osia implantation. METHODS: This is a retrospective study analyzing 30 adult patients (age 27-86) with conductive healing loss (CHL), mixed hearing loss (MHL), or single-sided deafness (SSD) who were implanted with the Osia device from January 2020 to April 2023 at a single institution by the senior author. Preoperative speech score testing (CNC, AzBio in quiet, AzBio in noise) were performed in all subjects while unaided, wearing conventional air conduction hearing aids, and wearing a softband BAHA. These preoperative speech scores were then compared to post-implantation speech scores using paired t-test analysis to assess for degree of speech improvement. In order to analyze quality of life after Osia implantation, each patient filled out the Glasgow Benefit Inventory (GBI) survey. The GBI is a series of 18 questions answered using a five-point Likert scale that addresses the changes in general health status, physical health status, psychosocial health status, and social support after a medical intervention. RESULTS: CHL, MHL, and SSD patients had significant improvement in hearing and speech recognition scores after Osia implantation compared to preoperative unaided hearing: CNC (14 % vs 80 %, p < 0.0001), AzBio in Quiet (26 % vs 94 %, p < 0.0001), and AzBio in Noise (36 % vs 87 %, p = 0.0001). Preoperative speech scores using the softband BAHA were accurate predictors of post-implantation speech scores and can serve to determine surgical candidacy for the Osia. Post-implantation Glasgow Benefit Inventory patient surveys demonstrated significant improvement in quality of life with patients scoring an average increase of +54.1 points in heath satisfaction. CONCLUSION: Adult patients with CHL, MHL, and SSD can receive significant improvement in speech recognition scores after implantation with the Osia device. This translates to improved quality of life, which was confirmed on the post-implantation Glasgow Benefit Inventory patient surveys.

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.

Comparison of two different bone anchored hearing instruments.

PURPOSE: To compare the audiological performances of Turkey's most up-to-date bone conduction implant processors. METHODS: Twenty-six bone-anchored hearing instrument users, thirteen in each group, were evaluated for speech understanding in quiet and several signal-to-noise ratios. RESULTS: We noticed the differences at 0.5 and 1 kHz measurements in free field frequency specific test, aided SRT scores, non-adaptive and adaptive matrix test results for a few conditions created a statistically significant difference in favor of Baha-6®. CONCLUSIONS: Both processors offer positive gains to their users in noisy and silent conditions. However, the data showed statistically significant differences for some measurements that may be critical for patients in daily practice.

A comparative study of audiological outcomes and compliance between the Osia system and other bone conduction hearing implants.

PURPOSE: To examine the subjective and objective audiological benefits of the Osia system compared to devices commonly implanted prior to the introduction of this system. METHODS: Osia recipients with either conductive hearing loss (CHL/MHL) (n = 9) or single-sided deafness (SSD) (n = 8) who underwent surgery from February 2021 to March 2022 were prospectively recruited. The audiological outcomes and usage rate of Osia implantees were compared with those of retrospectively recruited patients implanted with other devices (n = 50). The subjective satisfaction of the Osia implantees was also evaluated through questionnaires. RESULTS: All users of the Osia system were classified as regular users. In the CHL/MHL group, the effective gain of the Osia system (11.1 ± 14.9 dB) surpassed that of the Baha and Bonebridge (- 2.7 ± 12.6 dB) at 2 kHz (p = 0.01, Mann-Whitney U test). Among the devices, the Osia system tended to tolerate the worst bone conduction thresholds, up to the level of 61 dB. In the SSD group, the functional gain of Osia at 4 kHz (37.5 ± 3.1 dB) was higher than that of the Baha and Bonebridge group (26.9 ± 3.0 dB) (p = 0.05, Mann-Whitney U test). CONCLUSION: The Osia system yielded larger audiological gain than the Baha Attract and Bonebridge devices, especially at high frequencies, leading to substantially higher compliance. The Osia system tended to have the strongest tolerance to aggravated bone conduction thresholds among the available transcutaneous bone conduction hearing implants. Therefore, the Osia system could potentially be a good option for CHL/MHL patients with bone conduction thresholds of 50 dB HL or more, as well as patients with SSD.

How I do it: Cochlear Osia 2 System surgery placement.

BACKGROUND: The Cochlear™ Osia® 2 System is an active transcutaneous bone-anchored hearing implant with a newly developed piezoelectric transducer that is fixed to a titanium implant (BI300). METHODS: It uses digital piezoelectric stimulation to bypass non-functional areas of the natural hearing system and send sound directly to the cochlea. This device is designed to meet the needs of patients with unilateral and bilateral conductive or mixed hearing loss and single-sided deafness. CONCLUSION: We show step by step how to place the new active transcutaneous bone conduction implant, Cochlear™ Osia® 2 System, which utilizes a piezoelectric actuator anchored to the mastoid bone through an osseointegrated screw.

Bonebridge® bone conduction implant. Hearing outcomes and quality of life in patients with conductive/mixed hearing loss.

PURPOSE: The aim of this study was to analyze the hearing outcomes and quality of life in a series of 52 patients affected by conductive or mixed hearing loss and treated with Bonebridge®. METHODS: 52 of 71 patients implanted with Bonebridge® between October 2012 and January 2022, were included in the study. We compared the air conduction thresholds at the frequencies 500, 1000, 2000, 3000, 4000 Hz, the SRT50% and the World Recognition Score at an intensity of 50 dB with and without the implant. The Abbreviated Profile of Hearing Aid Benefit (APHAB) was employed to assess the quality of life of patients. RESULTS: The liminal tone audiometry (free field) pure tone average for air conduction after 6 months with the implant was 35.12 dB, obtaining a mean gain of 31.83 dB. With Bonebridge®, the mean SRT was 34.17 dB, whereas before the surgery no patient achieved 50% of correct answers at a sound intensity of 50 dB. The world recognition score at 50 dB changed from 11% without the implant to 85% with it. We observed one case of implant failure and one case of implant exposure. The APHAB questionnaire showed an improvement after implantation in practically all the subscales. CONCLUSIONS: The hearing outcomes and the subjective benefits reported by patients obtained in our study are similar to those published in the literature. Bonebridge® represents an excellent method for the rehabilitation of patients with conductive and mixed hearing loss, showing a low rate of complications.

Hearing rehabilitation and microbial shift after middle ear surgery with Vibrant Soundbridge in patients with chronic otitis media.

INTRODUCTION: Patients with otitis media (OM) encounter significant functional hearing impairment with conductive, or a combined hearing loss and long-term sequelae involving impaired speech/language development in children, reduced academic achievement and irreversible disorders of middle and inner ear requiring a long time therapy and/or multiple surgeries. In its persistent chronic form, Otitis media (COM) can often only be treated by undergoing ear surgery for hearing restoration. The persistent inflammatory reaction plays a major role, often caused by multi-resistant pathogens in the ear. Herein, we present outcomes of patients implanted with currently the only FDA approved active Middle Ear Implant Vibrant Soundbridge (VSB), suffering from persistent COM. METHODS: The study enrolled 42 patients, treated by performing middle ear (ME) surgery to different extents and implanted with the VSB to various structures in the ME. Included were 17 children and 25 adults that had recurrent and/or persisting OM and significant hearing loss. Preoperative and postoperative patients' audiometric data were evaluated and the benefit with VSB assessed using the Glasgow Benefit Inventory for adults and pediatric cohorts. The microbial spectrum of pathogens was assessed before and after surgery, exploring the colonization of the otopathogens, as well as the intestinal microbiome from individually burdened patients. RESULTS: The mean functional gain is 29.7 dB HL (range from 10 to 56.2 dB HL) with a significant improvement in speech intelligibility in quiet. Following VSB implantation, no significant differences in coupling were observed at low complication rates. Postoperatively patients showed significantly increased benefit with VSB compared to the untreated situation, including less otorrhea, pain, medical visits, and medication intake, with no recurrent OM and significant bacterial shift in otopathogens. The analysis of the intestinal microbiome displayed a high abundance of bacterial strains that might be linked to chronic and persistent inflammation. CONCLUSIONS: Functional ear surgery including rehabilitation with a VSB in patients suffering from COM present to be safe and effective. The successful acceptance accompanied by the improved audiological performance resulted in significant benefit with VSB, with a shift in the ear pathogens and altered microbiome and thus is a great opportunity to be treated.

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.

Comparison between incus short process and long process coupling of the vibrant soundbridge in human temporal bones.

OBJECTIVE: The Vibrant Soundbridge (VSB) is one of the most widely used implantable hearing devices. It consists of a vibrating floating mass transducer (FMT) that is connected to a middle ear structure. The standard coupling devices for sensorineural hearing loss are short process (SP) or long process (LP) couplers. DESIGN AND STUDY SAMPLE: This study directly compared the electro-mechanical performance of the SP- and LP-coupled FMT of the VSB in the same temporal bone specimen (n = 10). We measured velocity magnitudes and total harmonic distortions (THD) of the stapes (ST) and the round window (RW) using laser Doppler Vibrometry (LDV). RESULTS: Comparison shows a maximally 10 dB higher magnitude for the LP coupler at ST and RW for frequencies below 600 Hz, whereas the SP coupler shows a maximally 20 dB higher magnitude at the ST and RW for frequencies above 600 Hz. THD show similar behaviour with less distortion at 500 Hz for the LP coupler and less distortions for the SP coupler in higher frequencies. CONCLUSIONS: Our experiments showed that the SP coupling may be mechanically favourable, in terms of magnitude and distortion, for the transmission of FMT vibrations at higher frequencies.

A bone conduction implant using self-drilling screws : Self-drilling screws as a new fixation method of an active transcutaneous bone conduction hearing implant.

BACKGROUND: The active transcutaneous bone conduction implant (tBCI; BONEBRIDGE™ BCI 601; MED-EL, Innsbruck, Austria) is fixed to the skull with two self-tapping screws in predrilled screw channels. The aim of this prospective study was to evaluate the safety and effectiveness of fixation with self-drilling screws instead of the self-tapping screws, in order to simplify the surgical procedure. MATERIALS AND METHODS: Nine patients (mean age 37 ± 16 years, range 14-57 years) were examined pre- and 12 months postoperatively for word recognition scores (WRS) at 65 dB SPL, sound-field (SF) thresholds, bone conduction thresholds (BC), health-related quality of life (Assessment of Quality of Life, AQOL-8D questionnaire), and adverse events (AE). RESULTS: Due to avoidance of one surgical step, the surgical technique was simplified. Mean WRS in SF was 11.1 ± 22.2% (range 0-55%) pre- and 77.2 ± 19.9% (range 30-95%) postoperatively; mean SF threshold (pure tone audiometry, PTA4) improved from 61.2 ± 14.3 dB HL (range 37.0-75.3 dB HL) to 31.9 ± 7.2 dB HL (range 22.8-45.0 dB HL); mean BC thresholds were constant at 16.7 ± 6.8 dB HL (range 6.3-27.5 dB HL) pre- and 14.2 ± 6.2 dB HL (range 5.8-23.8 dB HL) postoperatively. AQOL-8D mean utility score increased from 0.65 ± 0.18 preoperatively to 0.82 ± 0.17 postoperatively. No device-related adverse events occurred. CONCLUSION: Implant fixation by means of self-drilling screws was safe and effective in all nine patients. There was significant audiological benefit 12 months after implantation.

Long-Term Safety and Quality of Life after Vibroplasty in Sensorineural Hearing Loss: Short/Long Incus Process Coupler.

OBJECTIVE: The study shows the long-term effectiveness, safety, and quality of life after Vibrant Soundbridge (VSB) implantation in sensorineural hearing loss (SNHL) using the short process coupler (SP) or the long process coupler (LP). METHODS: This retrospective study evaluated 77 VSB cases. Follow-up (F/U) time-dependent objective measurements (audiological outcomes), subjective data collection (quality-of-life questionnaire), and safety measures are presented. RESULTS: Sixty-two ears were included in the analysis with up to 116 months of postsurgical F/U data (mean 32.15 ± 37.97 months LP and SP coupler). Fifty-three ears (13 bilateral cases) received the LP coupler and 9 subjects the SP coupler. The post-operative bone conduction thresholds remained stable and, in both groups, <10 dB. The benefit in word recognition scores measured at 65 dB SPL and 80 dB SPL showed no significant difference between the couplers (p = 0.559 and p = 0.088, respectively). The functional gain was not significantly different (p > 0.05) with a mean of 20.91 ± 9.77 and 17.19 ± 5.75 for LP and SP coupler, respectively. The utility score deciphered from the Assessment of Quality-of-life Questionnaire-8 dimensions revealed a mean score of 0.75 ± 0.16 which is not significantly different to the age- and sex-matched healthy control group with 0.81 ± 0.02 (p = 0.3547). CONCLUSION: The Incus Vibroplasty utilizing both couplers is a safe and effective method to treat mild-to-severe SNHL. Both fixation methods of the floating mass transducer exhibit good clinical and audiological outcomes with high patient quality of life. The SP coupling method can be a good alternative when the long process is anatomically inaccessible, or the approach is limited due to anatomical reasons.