Stapedotomy Versus Cochlear Implantation for Far Advanced Otosclerosis: Insights From a Patient With Matched Preoperative and Postoperative Function.

OBJECTIVE: To examine patient preference after stapedotomy versus cochlear implantation in a unique case of a patient with symmetrical profound mixed hearing loss and similar postoperative speech perception improvement. PATIENTS: An adult patient with bilateral symmetrical far advanced otosclerosis, with profound mixed hearing loss. INTERVENTION: Stapedotomy in the left ear, cochlear implantation in the right ear. MAIN OUTCOME MEASURE: Performance on behavioral audiometry, and subjective report of hearing and intervention preference. RESULTS: A patient successfully underwent left stapedotomy and subsequent cochlear implantation on the right side, per patient preference. Preoperative audiometric characteristics were similar between ears (pure-tone average [PTA] [R: 114; L: 113 dB]; word recognition score [WRS]: 22%). Postprocedural audiometry demonstrated significant improvement after stapedotomy (PTA: 59 dB, WRS: 75%) and from cochlear implant (PTA: 20 dB, WRS: 60%). The patient subjectively reported a preference for the cochlear implant ear despite having substantial gains from stapedotomy. A nuanced discussion highlighting potentially overlooked benefits of cochlear implants in far advanced otosclerosis is conducted. CONCLUSION: In comparison with stapedotomy and hearing aids, cochlear implantation generally permits greater access to sound among patients with far advanced otosclerosis. Though the cochlear implant literature mainly focuses on speech perception outcomes, an underappreciated benefit of cochlear implantation is the high likelihood of achieving "normal" sound levels across the audiogram.

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.

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.

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.

The Stapes Head Coupler-A Flexible and Safe Option for Vibroplasty.

OBJECTIVE: To investigate the surgical approach and the audiological outcome of a stapes head coupler in active middle ear implant surgery. STUDY DESIGN: Retrospective data analysis. SETTING: Tertiary referral center with a large active middle ear implant program. PATIENTS: Twelve patients with active middle ear implant surgery. INTERVENTIONS: Therapeutic surgical approach for hearing rehabilitation in human subjects. MAIN OUTCOME MEASURES: Auditory brainstem response, sound field thresholds, vibrogram, speech perception in the Freiburger monosyllabic word test. RESULTS: The stapes head was attached safely in different coupling situations. Audiological outcomes were similar to the audiological performance of established vibroplasty couplers presented in the literature. CONCLUSION: The stapes head coupler is a new and safe tool for vibroplasty with a good audiological outcome.

Long-Term Follow-Up in Active Transcutaneous Bone Conduction Implants.

OBJECTIVE: To evaluate long-term outcomes of active transcutaneous bone conduction implants (atBCIs) regarding safety, hearing, and quality of life. STUDY DESIGN: A clinical study with retrospective medical record analysis combined with prospective audiometry and quality of life questionnaires. SETTING: Three secondary to tertiary care hospitals. PATIENTS: All subjects operated with an atBCI in three regions in Sweden were asked for informed consent. Indications for atBCI were single-sided deafness (SSD) and conductive or mixed hearing loss (CMHL). INTERVENTION: Evaluation of atBCI. MAIN OUTCOME MEASURES: Pure tone and speech audiometry and Glasgow Benefit Inventory (GBI). RESULT: Thirty-three subjects were included and 29 completed all parts. The total follow-up time was 124.1 subject-years. Nineteen subjects had CMHL and in this group, pure tone averages (PTA4) were 56.6 dB HL unaided and 29.6 dB HL aided, comparable with a functional gain of 26.0 dB. Effective gain (EG) was -12.7 dB. With bilateral hearing, Word Recognition Scores (WRS) in noise were 36.5% unaided and 59.1% aided. Fourteen subjects had SSD or asymmetric hearing loss (AHL) and in this group, PTA4 were >100 dB HL unaided and 32.1 dB HL aided with the contralateral ear blocked. EG was -9.1 dB. With bilateral hearing, WRSs were 53.2% unaided and 67.9% aided. The means of the total GBI scores were 31.7 for CMHL and 23.6 for SSD/AHL. CONCLUSION: Few complications occurred during the study. The atBCI is concluded to provide a safe and effective long-term hearing rehabilitation.

Factors associated with delayed referral and hearing rehabilitation for congenital sensorineural hearing loss.

OBJECTIVES: To identify the impact of social determinants of health and clinical status on referral and intervention for congenital sensorineural hearing loss. STUDY DESIGN: Retrospective chart review of children with confirmed sensorineural or mixed hearing loss between 2013 and 2021 at a single academic medical institution. METHODS: Referral rates and timing for hearing rehabilitation, rates and timing of completed evaluation, and rate and timing of amplification were recorded. Patient demographics included gestational age, race, ethnicity, sex, hearing loss severity, and CMV status. RESULTS: There were 216 children with confirmed sensorineural or mixed hearing loss, of which 77 had a unilateral hearing loss and 89 a severe or profound hearing loss. Delayed referral for hearing aid evaluation was noted in premature patients (median 375 days premature, median 147 term; p < 0.01) and publicly insured patients (median 215 days, median 123 private; p = 0.04). Delayed time to hearing aid fitting was noted for non-white patients (median 325 days, median 203 white patients; p < 0.01), publicly insured patients (median 309 days, median 212 private insurance; p < 0.02), and premature patients (median 462 days, median 224 term; p = 0.03). White patients were more likely to be referred for cochlear implant (p = 0.03).Privately insured patients and patients with a positive CMV test were more likely to be referred for cochlear implant evaluation, be seen in the cochlear implant clinic, and undergo implantation (p < 0.05). Non-white patients had a delay in cochlear implantation referral (median 928 days, median 398 days white patients; p = 0.05). Prolonged interval between evaluation in cochlear implant clinic to implantation was noted for privately insured patients (median 125 days; median 78 days publicly insured; p = 0.05). CONCLUSIONS: Sociodemographic factors were significantly associated with hearing amplification referral rates and time until amplification for children with identified congenital sensorineural hearing loss. For cochlear implantation, insurance type, CMV status were significantly associated with rate and timing of cochlear implant pathway.

Round-Window Vibroplasty: Systematic Review and Meta-Analysis of Audiological Effectiveness With Different Round-Window Coupling Techniques.

OBJECTIVE: Active middle ear implants can be directly coupled to the round-window (RW) membrane via RW Vibroplasty. The objectives of this systematic review were to summarize data on different RW coupling techniques and to investigate their effect on audiological and safety outcomes using meta-analyses. DATABASES REVIEWED: PubMed (MEDLINE), Cochrane Library, and Embase (DIMDI). METHODS: All publications reporting on audiological outcomes in human patients after RW Vibroplasty were included. Two independent reviewers carried out screening and data extraction. Meta-analyses and meta-regression were used to evaluate the potential effects of surgical and demographic parameters on primary audiological outcomes. Adverse events were extracted and tabulated for qualitative analysis. RESULTS: Fourteen different combinations of surgical coupling parameters were identified in 61 included publications. Overall, data from 23 publications could be used for meta-analyses. Significantly better aided sound-field thresholds were reported for RW Vibroplasty performed without a dedicated coupler and using fascia as interponate, compared with RW Vibroplasty with an RW coupler or without an interponate. These effects were not found in other outcomes (i.e., functional gain, word recognition score). Reporting of adverse events was relatively heterogeneous, with 32 explicit mentions of revision surgery after the loss of coupling efficacy. CONCLUSION: There are numerous publications investigating the effectiveness of coupling active middle ear implants to the RW membrane. However, studies are typically undersampled and of low evidence level. Using meta-analyses, weighted means, and qualitative analyses enabled a summary of the existing literature on audiological and safety outcomes after RW Vibroplasty. Individual selection of the most appropriate coupling modality with standardized intraoperative measurement and careful patient follow-up may be considered key factors for achieving effective RW coupling.

[Comparative study of surgical effects on patients with mixed deafness and otosclerosis with different air bone conduction differences].

Objective: To analyze the surgical efficacy of patients with mixed hearing loss and otosclerosis with different air bone gap (ABG) before surgery, and to provide reference for the prognosis evaluation of otosclerosis surgery. Methods: The clinical data of 108 cases(116 ears) of otosclerosis who had undergone stapes fenestration technique artificial stapes implantation in Xiangya Hospital of Central South University from November 2013 to May 2020 and had mixed hearing loss before surgery were collected, including 71 women(76 ears)and 37 men (40 ears), with an average age of 38.5 years. According to preoperative pure tone audiometry ABG, they were divided into three groups: group S, 15 dB≤ABG<31 dB, a total of 39 ears; group M, 31 dB≤ABG<46 dB, a total of 58 ears; and group L, ABG≥46 dB, 19 ears in total. The hearing outcomes of three groups of patients at 6-12 months after surgery were compared and analyzed using SPSS 24.0 statistical software. Results: A total of 3 patients (group S: 2 cases; group L: 1 case) experienced severe sensorineural hearing loss after surgery and were not included in the statistical analysis. After surgery, the pure tone hearing threshold of patients with otosclerosis in each group was significantly improved compared to before surgery, with an average air conduction threshold improvement of(21.6±13.4) dB. The difference between before and after surgery was statistically significant(t=17.13, P<0.01). The average bone conduction threshold improved by(3.7±7.6) dB, and the difference was statistically significant before and after surgery(t=5.20, P<0.01). The postoperative ABG was(18.3±9.3) dB, which was significantly reduced compared to preoperative(36.2±8.6)dB. Among the three groups of patients, the L group had the highest improvement in air conduction threshold[(29.9±10.8)dB], while the S group had the lowest improvement[(15.7±11.4)dB]. There was no statistically significant difference in post operative pure tone hearing thresholds between the three groups(P>0.05). The postoperative ABG in group S was the smallest[(16.5±9.0)dB], while in group L, the postoperative ABG was the largest[(20.5±10.0)dB]. Compared with group S, group M and group L still had a large residual ABG at 2 000 Hz after surgery. The bone conduction threshold of both S and M groups improved to some extent after surgery compared to before (P<0.01). Conclusions: Surgery can benefit patients with mixed hearing loss and otosclerosis with different preoperative ABG. Patients with small preoperative ABG have better surgical results and ideal ABG closure at all frequencies after surgery. Patients with large preoperative ABG can significantly increase the gas conduction threshold during surgery, but certain frequencies of ABG may still be left behind after surgery. The improvement effect of surgery on bone conduction threshold is not significant. Patients should be informed of treatment methods such as hearing aids based on their actual situation for selection.

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.

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.

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

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

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.

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.

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.

Advances in auditory implants.

Auditory implants are classified into bone conduction (BAHA and Bonebridge; BB) and active middle ear implants (Vibrant Soundbridge; VSB) that stimulate cochlear hair cells, and cochlear implants (CIs) that stimulate neural structures. CIs should be performed as early as possible, and bilateral CIs have become popular because sound localization and speech recognition can be improved. CI is also considered a desirable treatment option for patients with single-sided deafness. VSB provides a safe and effective option for patients with conductive or mixed hearing loss and moderate to severe sensorineural hearing loss (SNHL); however, it use in patients with conductive or mixed hearing loss have only been approved in Japan. BAHA and BB implants have been approved by national insurance in Japan as bone conduction implants for patients with conductive or mixed hearing loss. Two fully implantable devices (Cochlear Carina and Envoy Esteem) are provided for patients with SNHL.

Comparative study of surgical effects on patients with mixed deafness and otosclerosis with different air bone conduction differences / 中华耳鼻咽喉头颈外科杂志

Objective: To analyze the surgical efficacy of patients with mixed hearing loss and otosclerosis with different air bone gap (ABG) before surgery, and to provide reference for the prognosis evaluation of otosclerosis surgery. Methods: The clinical data of 108 cases(116 ears) of otosclerosis who had undergone stapes fenestration technique artificial stapes implantation in Xiangya Hospital of Central South University from November 2013 to May 2020 and had mixed hearing loss before surgery were collected, including 71 women(76 ears)and 37 men (40 ears), with an average age of 38.5 years. According to preoperative pure tone audiometry ABG, they were divided into three groups: group S, 15 dB≤ABG<31 dB, a total of 39 ears; group M, 31 dB≤ABG<46 dB, a total of 58 ears; and group L, ABG≥46 dB, 19 ears in total. The hearing outcomes of three groups of patients at 6-12 months after surgery were compared and analyzed using SPSS 24.0 statistical software. Results: A total of 3 patients (group S: 2 cases; group L: 1 case) experienced severe sensorineural hearing loss after surgery and were not included in the statistical analysis. After surgery, the pure tone hearing threshold of patients with otosclerosis in each group was significantly improved compared to before surgery, with an average air conduction threshold improvement of(21.6±13.4) dB. The difference between before and after surgery was statistically significant(t=17.13, P<0.01). The average bone conduction threshold improved by(3.7±7.6) dB, and the difference was statistically significant before and after surgery(t=5.20, P<0.01). The postoperative ABG was(18.3±9.3) dB, which was significantly reduced compared to preoperative(36.2±8.6)dB. Among the three groups of patients, the L group had the highest improvement in air conduction threshold[(29.9±10.8)dB], while the S group had the lowest improvement[(15.7±11.4)dB]. There was no statistically significant difference in post operative pure tone hearing thresholds between the three groups(P>0.05). The postoperative ABG in group S was the smallest[(16.5±9.0)dB], while in group L, the postoperative ABG was the largest[(20.5±10.0)dB]. Compared with group S, group M and group L still had a large residual ABG at 2 000 Hz after surgery. The bone conduction threshold of both S and M groups improved to some extent after surgery compared to before (P<0.01). Conclusions: Surgery can benefit patients with mixed hearing loss and otosclerosis with different preoperative ABG. Patients with small preoperative ABG have better surgical results and ideal ABG closure at all frequencies after surgery. Patients with large preoperative ABG can significantly increase the gas conduction threshold during surgery, but certain frequencies of ABG may still be left behind after surgery. The improvement effect of surgery on bone conduction threshold is not significant. Patients should be informed of treatment methods such as hearing aids based on their actual situation for selection.