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.

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.

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.

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.

Initial Experience With Two Active Transcutaneous Bone-Anchored Hearing Implants.

OBJECTIVE: To analyze our institutional experience with two active transcutaneous bone-anchored hearing aids. STUDY DESIGN: Retrospective cohort study. SETTING: Tertiary academic otology-neurotology practice. PATIENTS: Patients with conductive or mixed hearing losses meeting criteria to receive active transcutaneous bone-anchored hearing aids. INTERVENTIONS: Implantation with one of two active transcutaneous bone-anchored hearing aids. OUTCOME MEASURES: Operative time, dural exposure and decompression, use of lifts, implant position, ease of use, qualitative patient satisfaction, complication rates. RESULTS: Ten patients received Implant 1 and 11 patients received Implant 2. The most common underlying etiologies of hearing loss were chronic suppurative otitis media in 33.3%, atresia/microtia in 23.8%, and cholesteatoma in 23.8%. Average operative times were 99.3 minutes for Implant 1 and 80.9 minutes for Implant 2 ( p = 0.263). Implant 1 required lifts in 60%, dural exposure in 50%, and dural compression in 30%. Overall, placement was difficult in 47.6% of cases. There were no intraoperative complications. There were higher rates of issues with sound quality (27.3% versus 0.0%, p = 0.123) and poor cosmesis (36.4% versus 10.0%, p = 0.360) with Implant 2. Functional gain was not recorded, but all patients derived qualitative benefit from their implant. Three patients had local wound complications that self-resolved or were treated with antibiotics. One patient implanted at an outside institution required explant because of multiple infections. CONCLUSIONS: There were no statistically significant differences in outcomes comparing Implants 1 and 2; however, Implant 2 had much higher rates of issues with audio quality and poor cosmesis. Placing Implant 1 often required special techniques.

The Oticon Ponto System in Adults With Severe-to-Profound and Mixed Hearing Loss: Audiologic Outcomes and Patient Satisfaction.

OBJECTIVE: To measure audiologic outcomes and self-assessed satisfaction with the Ponto system in a group of patients who had severe to profound and mixed hearing loss. STUDY DESIGN: Retrospective case review. SETTING: Tertiary referral center. PATIENTS: Sixteen patients aged 21 to 74 years with severe-to-profound and mixed hearing loss (bone conduction thresholds, ≥45 dB HL). INTERVENTIONS: Ponto implant surgery. MAIN OUTCOME MEASURES: Pure-tone audiometry, free-field hearing thresholds, effective gain, word recognition score in quiet, and speech reception threshold (SRT) in noise were assessed. Patient-reported outcomes were collected using the Clinical Global Impression Scale, Glasgow Benefit Inventory, and Abbreviated Profile of Hearing Aid Benefit. Information concerning any medical complications was also gathered. RESULTS: Both word recognition score and SRT were significantly better after 12 months compared with before surgery. At normal speech level (65 dB SPL), 12 of 16 users had speech discrimination ≥70%. However, at the 12-month follow-up, the average effective gain was -6.2 dB. In general, the self-report outcomes showed good satisfaction in most patients. Postoperatively, skin complications were noted in six patients, of whom two underwent reoperation. All patients were still using the Ponto after an average observation time of 2.7 years. CONCLUSION: Although skin complications were not uncommon, the Ponto system seems to be an effective method of improving hearing performance and provides subjective satisfaction in real-life situations in patients with severe-to-profound and mixed hearing loss. However, considering the significantly increased bone conduction thresholds and the risk of their further deterioration, long-term follow-up is still needed.

Speech in Noise With Bilateral Active Bone Conduction Implant for Conductive and Mixed Hearing Loss.

OBJECTIVE: To evaluate speech in noise results and subjective benefit in bilateral active bone conduction implant (ABCI) for bilateral mixed hearing loss. STUDY DESIGN: Prospective, comparative. SETTING: Ear, Nose and Throat Unit, Department of Surgical Sciences, University of Turin. PATIENTS: Seven patients with conductive/mixed hearing loss. INTERVENTIONS: Patients underwent simultaneous or sequential bilateral surgery for ABCI. MAIN OUTCOME MEASURES: The speech intelligibility in noise was assessed with the Ita Matrix test in summation, squelch and head shadow settings. First, the tests were performed with one device activated in the ear with lower speech recognition score, then with both devices. Patients filled in an Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire to investigate the hearing aid benefit. RESULTS: When bilateral devices were activated, an improvement of signal-to-noise ratio was observed in all settings. The difference between bilateral and unilateral stimulation is 4.66 dB ( p = 0.016) in the summation, 2.24 dB ( p = 0.047) in the squelch, 7.50 dB ( p = 0.016) in the head shadow setting.Looking at the APHAB global score (GS), patients report lower mean scores, hence less difficulties, when using two devices (GS, 21.9%; standard deviation (SD), 8.28) rather than one (GS, 33.0%; SD, 10.24) ( p = 0.018). CONCLUSION: In symmetric mixed bilateral hearing loss, rehabilitation with an ABCI fitted bilaterally shows audiologic advantages in speech perception in noise, not only thanks to the summation effect and by reducing head shadow but also by improving the binaural unmasking based on the squelch effect. Audiometric outcomes are confirmed by the GSs obtained in the APHAB questionnaire.

Clinical Performance, Safety, and Patient-Reported Outcomes of an Active Osseointegrated Steady-State Implant System.

OBJECTIVE: To investigate the clinical performance, safety, and patient-reported outcomes of an active osseointegrated steady-state implant system that uses piezoelectric technology. STUDY DESIGN: A prospective, multicenter, open-label, single-arm, within-subject clinical investigation. SETTING: Three tertiary referral clinical centers located in Melbourne, Sydney, and Hong Kong. PATIENTS: Twenty-nine adult subjects, 24 with mixed hearing loss or conductive hearing loss and 5 with single-sided sensorineural deafness. INTERVENTION: Implantation with the Cochlear Osia 2 System. MAIN OUTCOME MEASURES: Audiological threshold evaluation and speech recognition in quiet and in noise. Patient satisfaction and safety. RESULTS: At 6-month follow-up after surgery, a mean improvement in pure-tone average of 26.0 dB hearing level and a mean improvement of 8.8 dB signal-to-noise ratio in speech reception threshold in noise was achieved with the investigational device as compared with the unaided situation. Usability of the investigational device was rated 71.4/100 mm for sound processor retention and 81.4/100 mm for overall comfort using a visual analog scale. CONCLUSION: These outcomes confirm the clinical safety, performance, and benefit of an innovative active transcutaneous bone conduction implant using a piezoelectric transducer design in subjects with conductive hearing loss, mixed hearing loss, or single-sided sensorineural deafness.

The bone conduction implant BONEBRIDGE increases quality of life and social life satisfaction.

PURPOSE: Transcutaneous active bone conduction hearing aids represent an alternative approach to middle ear surgery and conventional hearing aids for patients with conductive or mixed hearing loss. The aim of this study was to determine quality of life, subjective hearing experience and patients' satisfaction after implantation of a bone conduction hearing aid. METHODS: This monocentric and retrospective study included twelve adult patients who received a bone conduction hearing aid (Bonebridge, MedEL) consisting of an extracorporeal audio processor and a bone conduction implant (BCI) between 2013 and 2017. On average 40 months after implantation, the patients were asked to answer three questionnaires regarding quality of life (AqoL-8D), self-reported auditory disability (SSQ-12-B) and user's satisfaction (APSQ) after implantation of the Bonebridge (BB). A descriptive statistical analysis of the questionnaires followed. RESULTS: 12 patients aged 26-85 years (sex: m = 7, w = 5) were recruited. The quality of life of all patients after implantation of the BB (AqoL 8D) averaged an overall utility score of 0.76 (SD ± 0.17). The mean for 'speech hearing' in the SSQ-12-B was + 2.43 (SD ± 2.03), + 1.94 (SD ± 1.48) for 'spatial hearing' and + 2.28 (SD ± 2.32) for 'qualities of hearing'. 11 out of 12 patients reported an improvement in their overall hearing. The APSQ score for the subsection 'wearing comfort' was 3.50 (SD ± 0.87), 'social life' attained a mean of 4.17 (SD ± 1.06). The 'device inconveniences' reached 4.02 (SD ± 0.71) and 'usability' of the device was measured at 4.23 (SD ± 1.06). The average wearing time of the audio processor in the cohort was 11 h per day, with 8 of 12 patients reporting the maximum length of 12 h per day. CONCLUSION: BB implantation results in a gain in the perceived quality of life (AqoL 8D). The SSQ-12-B shows an improvement in subjective hearing. According to the APSQ, it can be assumed that the BB audio processor, although in an extracorporeal position, is rated as a useful instrument with positive impact on social life. The majority stated that they had subjectively benefited from BB implantation and that there were no significant physical or sensory limitations after implantation.

Consensus Statement on Bone Conduction Devices and Active Middle Ear Implants in Conductive and Mixed Hearing Loss.

ABSTRACT: Nowadays, several options are available to treat patients with conductive or mixed hearing loss. Whenever surgical intervention is not possible or contra-indicated, and amplification by a conventional hearing device (e.g., behind-the-ear device) is not feasible, then implantable hearing devices are an indispensable next option. Implantable bone-conduction devices and middle-ear implants have advantages but also limitations concerning complexity/invasiveness of the surgery, medical complications, and effectiveness. To counsel the patient, the clinician should have a good overview of the options with regard to safety and reliability as well as unequivocal technical performance data. The present consensus document is the outcome of an extensive iterative process including ENT specialists, audiologists, health-policy scientists, and representatives/technicians of the main companies in this field. This document should provide a first framework for procedures and technical characterization to enhance effective communication between these stakeholders, improving health care.