Effectiveness of active middle ear implant placement methods in pathological conditions: basilar membrane vibration simulation.

Active middle ear implants (AMEI) amplify mechanical vibrations in the middle ear and transmit them to the cochlea. The AMEI includes a floating mass transducer (FMT) that can be placed using two different surgical approaches: "oval window (OW) vibroplasty" and "round window (RW) vibroplasty." The OW and RW are windows located on the cochlea. Normally, sound stimulus is transmitted from the middle ear to cochlea via the OW. RW vibroplasty has been suggested as an alternative method due to the difficulty of applying OW vibroplasty in patients with ossicle dysfunction. Several reports compare the advantages of each approach through pre and postoperative hearing tests. However, quantitatively assessing the treatment effect is challenging due to individual differences in pathologies. This study investigates the vibration transmission efficiency of each surgical approach using a finite-element model of the human cochlea. Vibration of the basilar membrane (BM) of the cochlea is simulated by applying the stimulus through the OW or RW. Pathological conditions, such as impaired stapes mobility, are simulated by increasing the stiffness of the stapedial annular ligament. RW closure due to chronic middle ear diseases is a common clinical occurrence and is simulated by increasing the stiffness of the RW membrane in the model. The results show that the vibration amplitude of the BM is larger when the stimulus is applied to the RW compared to the OW, except for cases of RW membrane ossification. The difference in these amplitudes is particularly significant when stapedial mobility is limited. These results suggest that RW vibroplasty would be advantageous, especially in cases of accompanying stapedial mobility impairment. Additionally, it is suggested that transitioning to OW vibroplasty could still ensure a sufficient level of vibratory transmission efficiency when placing the FMT on the RW membrane is difficult due to anatomical problems in the tympanic cavity or confirmed severe pathological conditions around the RW.

Insidious Cases of Enlarged Vestibular Aqueduct (EVA) Syndrome Resembling Otosclerosis: Clinical Features for Differential Diagnosis and the Role of High-Resolution Computed Tomography in the Pre-Operative Setting.

BACKGROUND: Enlarged vestibular aqueduct (EVA) syndrome can mimic otosclerosis in adults, presenting with an air-bone gap (ABG) and even absent stapedial reflexes. The ABG in inner-ear disorders is currently the object of several authors' studies and seems to be related to a third mobile window (TMW) phenomenon. This can lead to misdiagnosis and inappropriate treatment. Given that it would be inappropriate and harmful to perform CT scans in all patients with a clinical diagnosis of otosclerosis, this study aims to highlight some clinical features useful for the differential diagnosis between otosclerosis and these rare cases of EVA presenting with an ABG, thus enabling the identification of suspected cases to be tested with CT scans. METHODS: Between April and May 2024, a narrative review was conducted focusing on the differential diagnosis between some rare cases of EVA and otosclerosis. Clinical, audiological, and radiologic features of both conditions were investigated. RESULTS: This review demonstrates the diagnostic challenge in differentiating atypical cases of EVA from otosclerosis in a subset of patients. Clinical and audiological features are important for differential diagnosis, but may not always be sufficient. Therefore, high-resolution computed tomography (HRCT) of the temporal bone plays a pivotal role in definitive diagnosis. CONCLUSIONS: In some specific cases, pre-operative imaging assessment using HRCT emerges as an essential tool for differentiating these two conditions and avoiding unnecessary stapes surgery.

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.

Piezoelectric Bone Conduction Hearing Implant: A Case Series of Audiological, Surgical and Patient-Reported Outcomes.

Objective: To examine the surgical, audiological and patient-reported outcomes of the Osia 2 implant. Methods: Data from 14 consecutive subjects undergoing implantation between April 2022 and November 2023 were reviewed. Ten subjects had conductive hearing loss, three had mixed hearing loss and one had single-sided deafness (SSD). Warble tone thresholds, Pure Tone Average (PTA4) and Speech Discrimination Score (SDS) in quiet and in noise were determined unaided and aided. The subjective outcome was determined from two standardized questionnaires: (1) International Outcome Inventory for Hearing Aids (IOI-HA) and (2) Speech, Spatial and Qualities of Hearing Scale 12 (SSQ12b). Results: Unexpected postoperative pain was found in four cases. The warble tone thresholds exhibited a consistent reduction across all frequencies, contributing to a mean decrease of 27 dB in the aided PTA4. SDS demonstrated notable improvements, with a 57.3% increase at 50 dB and a 55.6% increase at 65 dB. In noise, SDS exhibited a 43.9% improvement. The mean IOI-HA Score was 3.8, and the mean overall score for SSQ12b was 6.6, with consistent findings across the subgroups. Conclusions: The Osia device emerges as a promising recommendation for individuals with conductive or mixed hearing loss, possibly also for those with SSD. Its safety and efficacy profile aligns with the broader category of active transcutaneous devices, demonstrating a reduced risk of wound infection compared to percutaneous alternatives. Both audiological assessments and subjective evaluations revealed positive outcomes.

A novel homozygous RSPH4A variant in a family with primary ciliary dyskinesia and literature review.

Introduction: Primary ciliary dyskinesia (PCD) is a rare heterogeneous disease caused by abnormalities in motile cilia. In this case report, we first analyzed the clinical and genetic data of a proband who was suspected of having PCD on the basis of her clinical and radiological findings. Methods: Whole-exome sequencing was performed, and a variant in the RSPH4A gene was identified in the proband. Sanger sequencing was used for validation of RSPH4A variants in the proband, her sister, her daughter and her parents. Finally, the phenotypic features of the patient were analyzed, and the current literature was reviewed to better understand the gene variants in PCD related to hearing loss and the clinical manifestations of the RSPH4A variant in PCD. Results: The chief clinical symptoms of this proband included gradual mixed hearing loss, otitis media, anosmia, sinusitis, recurrent cough and infertility. Her DNA sequencing revealed a novel homozygous T to C transition at position 1321 within exon 3 of RSPH4A according to genetic testing results. This variant had never been reported before. The homozygous variant resulted in an amino acid substitution of tryptophan by arginine at position 441 (p.Trp441Arg). The same variant was also found in the proband's sister, and a heterozygous pathogenic variant was identified among immediate family members, including the proband's daughter and parents. Discussion: A literature review showed that 16 pathogenic variants in RSPH4A have been reported. Hearing loss had only been observed in patients with the RSPH4A (c.921+3_6delAAGT) splice site mutation, and the specific type of hearing loss was not described.

Clinical Outcomes of an Active, Transcutaneous, Bone Conduction Hearing Device: A Retrospective Study.

OBJECTIVE: The purpose of this study was to review patient demographics, indications, intraoperative findings, complications/adverse events, and audiological outcomes related to the implantation of the Osia 2 device. STUDY DESIGN: Retrospective case series. SETTING: Single tertiary institutional experience. METHODS: Patients who had undergone Osia 2 implantation by the senior author were identified from 2019 to present. Information was extracted from patient charts concerning patient demographics, indications for implantation, surgical findings, audiological outcomes, and adverse events. RESULTS: Sixty patients and 67 implants were included. The median age was 51 years (R: 11-92). Fifty-five percent of patients had mixed hearing loss (HL), 30% had single-sided deafness, and 15% had conductive HL. The mean operative time was 53.9 minutes. Only 4.5% of patients required bone polishing, and 3.0% required tissue thinning. The mean pure-tone averages 4 gain from unaided conditions was 41.2 dB. Mean gain at 6 and 8 kHz from unaided conditions was 35.42 and 40.67 dB, respectively. Mean improvement in speech recognition threshold and word recognition score was significant in noise and quiet conditions. The all-cause adverse event/complication rate in our series was 10.4%. The most common complications were infections (4.5%) and poorly controlled postoperative pain (3.0%). Hematomas occurred in 1.5% of patients. Reoperation was required in 4 patients; explant in 1. CONCLUSION: Use of the Osia 2 device in our series has resulted in good hearing outcomes, particularly in terms of high frequency gain. Complication rates were low. To our knowledge, this is the largest study to date reporting on Osia 2 outcomes.

Early Results With the New Active Bone-Conduction Hearing Implant: A Systematic Review and Meta-Analysis.

OBJECTIVE: The bone conduction implant (BCI) 602 is a new transcutaneous BCI with smaller dimensions. However, limited patient numbers restrict the statistical power and generalizability of the current studies. The present systematic review and meta-analysis summarize early audiological and medical outcomes of adult and pediatric patients implanted with the BCI 602 due to mixed or conductive hearing loss. DATA SOURCE: Following the Preferred Reporting items for Systematic Reviews and Meta-analyses guidelines, 108 studies were reviewed, and 6 (5.6%) were included in the meta-analysis. REVIEW METHOD: The data on study and patient characteristics, surgical outcomes, and audiological test results were extracted from each article. Meta-analysis employed the fixed-effect and random-effects models to analyze the mean differences (MDs) between pre- and postoperative performances. RESULTS: In total, 116 patients were evaluated, including 64 (55%) adult and 52 (45%) pediatric patients. No intraoperative adverse events were reported, while postoperative complications were reported in 2 (3.1%) adult and 2 (3.8%) pediatric patients. Studies consistently showed significant improvements in audiological outcomes, quality of life, and sound localization in the aided condition. In the meta-analysis, we observed a significant difference in the unaided compared to the aided condition in sound field thresholds (n = 112; MD, -27.05 dB; P < 0.01), signal-to-noise ratio (n = 96; MD, -6.35 dB; P < 0.01), and word recognition scores (n = 96; MD, 68.89%; P < 0.01). CONCLUSION: The implantation of the BCI 602 was associated with minimal surgical complications and excellent audiological outcomes for both the pediatric and the adult cohort. Therefore, our analysis indicates a high level of safety and reliability. Further research should focus on direct comparisons with other BCIs and long-term functional outcomes.

Audiological and Speech and Language Characteristics of a Case with Hunter's Syndrome.

Hearing loss is a common manifestation of Hunter's syndrome, with reported rates ranging from 67.3 to 94%. The aim is to highlight the audiological profile and pathophysiology of mixed hearing loss in individuals with hunter's syndrome. A 7.6-year-old male child was brought to the department of audiology with a complaint of not responding to name call and regression in the speech and language skills. Detailed audiological showed severe to profound mixed hearing loss. REELS and 3DLAT results showed RLA to be 9 to 10 months and ELA to be 6 to 7 months. Owing to the progressive nature and high prevalence of hearing loss in hunter's syndrome, this case report highlights the importance of middle ear evaluation in the pediatric hearing assessment apart from OAE and ABR. Speech- language therapy must be considered with a focus on functional communication.

Clinical performance, safety, and patient-reported outcomes of an active osseointegrated bone-conduction hearing implant system at 24-month follow-up.

PURPOSE: To investigate 2-year post-operative hearing performance, safety, and patient-reported outcomes of hearing-impaired adults treated with the Osia® 2 System, an active osseointegrated bone-conduction hearing implant that uses piezoelectric technology. METHODS: A prospective, multicenter, open-label, single-arm, within-subject clinical study conducted at three tertiary referral clinical centers located in Melbourne, Sydney and Hong Kong. Twenty adult recipients of the Osia 2 System were enrolled and followed up between 12 and 24 months post-implantation: 17 with mixed or conductive hearing loss and 3 with single-sided sensorineural deafness. Safety data, audiological thresholds, speech recognition thresholds in noise, and patient-reported outcomes were collected and evaluated. In addition, pre-and 6-month post-implantation data were collected retrospectively for this recipient cohort enrolled into the earlier study (ClinicalTrials.gov NCT04041700). RESULTS: Between 6- and 24-month follow-up, there was no statistically significant change in free-field hearing thresholds or speech reception thresholds in noise (p = > 0.05), indicating that aided improvements were maintained up to 24 months of follow-up. Furthermore, improvements in health-related quality of life and daily hearing ability, as well as clinical and subjective measures of hearing benefit remained stable over the 24-month period. No serious adverse events were reported during extended follow-up. CONCLUSIONS: These study results provide further evidence to support the longer term clinical safety, hearing performance, and patient-related benefits of the Osia 2 System in patients with either a conductive hearing loss, mixed hearing loss, or single-sided sensorineural deafness. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04754477. First posted: February 15, 2021.

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

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

Emergence of Rapid-Onset Ototoxicity Following Three Doses of Vancomycin: A Unique Case Report in the Context of Normal Renal Function and Therapeutic Dosing.

Vancomycin, a potent glycopeptide antibiotic renowned for its efficacy against methicillin-resistant Staphylococcus aureus, also harbors the potential for adverse reactions. While its use is often associated with infusion-related events and nephrotoxicity, ototoxicity has emerged as a noteworthy but rare concern. This adverse effect, characterized by a spectrum of transient to permanent hearing loss or damage, typically surfaces in patients receiving excessive doses, those undergoing concomitant therapy with other ototoxic agents such as aminoglycosides, or individuals with baseline hearing impairment or renal dysfunction. This report highlights the possibility of ototoxicity in the setting of normal renal function and therapeutic dosing. We report a case of a 58-year-old male patient with a complex medical history, who presented with sepsis, respiratory failure, and a constellation of underlying conditions. His treatment regimen encompassed intravenous vancomycin administration, which led to an unexpected development-severe-to-profound bilateral conductive and sensorineural hearing loss after three doses. The absence of concurrent ototoxic agents and Bayesian dosing software predicting an acceptable AUC/MIC ratio complicates the understanding of this adverse event. Amid this complex scenario, the case underscores the evolving landscape of vancomycin-induced ototoxicity, encouraging heightened vigilance, thorough audiometric monitoring, and an in-depth exploration of potential mechanisms underlying this adverse reaction. Early audiometric testing and referral to otolaryngology may allow for early intervention with high-dose steroids to mitigate the ototoxicity.

[Prediction of speech understanding with the transcutaneous partially implantable bone conduction hearing system Osia®. German Version]. / Vorhersage des postoperativen Sprachverstehens mit dem transkutanen teilimplantierbaren Knochenleitungshörsystem 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 with conductive (CHL) or mixed hearing loss (MHL) with an average bone conduction (BC) hearing loss of 55 dB or less, or with 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 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 (21 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 unaided and with the test system and postoperatively with Osia. The maximum monosyllabic score (mEV) unaided and the monosyllabic score with the test system at 65 dB SPL were correlated with the postoperative monosyllabic score with Osia at 65 dB SPL. RESULTS: Preoperative prediction of postoperative outcome with Osia was better using the mEV than the EV at 65 dB SPL with the test device on the softband. Postoperative EV was most predictive for patients with CHL and least predictive for patients with mixed hearing loss with 4PTA BC ≥ 40 dB HL. For the test device at softband, results tended to show the minimum achievable outcome and the mEV tended 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 EV with Osia, for which the most accurate prediction is obtained using the preoperative mEV. Prediction accuracy decreases from a BC-4PTA of ≥ 40 dB.

Hearing Outcome and Predictors after Implanting Bone Conduction or Middle Ear Implants in Ears with Refractory Otitis Media.

Bone conduction implants (BCIs) and middle ear implants (MEIs) are promising options for individuals with persistent chronic inflammation of the middle or outer ear. However, the structure of the middle ear is often altered in patients who undergo mastoidectomy or posterior wall removal for refractory otitis media, leaving uncertainty regarding the efficacy of hearing devices. Only a few studies have examined auditory outcomes based on the etiology of hearing impairment. We investigated hearing outcomes, including speech audiometry, in patients who underwent implantation after surgery for refractory otitis media. Our findings indicated that patients who received BCIs or MEIs achieved favorable hearing outcomes. Furthermore, a correlation was observed between the preoperative bone-conduction threshold at 1 kHz in the better ear and the sound-field threshold at 1 kHz with BCIs, whereas no correlation was observed between the preoperative bone-conduction threshold and the sound-field threshold with MEIs. This study highlights the positive impact of BCIs and MEIs in patients who undergo implantation after surgery for refractory otitis media. Additionally, our study identified parameters that predict postoperative efficacy.

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.

How Does Preoperative Pure Tone Audiometry Relate to the Findings at Surgery to Explain the Hearing Status in Chronic Otitis Media?

Objective: Pure tone audiometry (PTA) guides surgical decision-making in chronic otitis media (COM), and PTA values depend upon the type and extent of COM. Methods: Our cross-sectional study included patients with COM with/without cholesteatoma who were scheduled for surgery. Findings on examination of the middle ear under the microscope and at surgery which could explain the hearing loss were corroborated with preoperative PTA through appropriate statistical methods. Results: The study included 114 patients (mean age: 31.07 years; range: 7-57). Following preoperative PTA, 50% of patients had moderate hearing loss and ~73% had air-bone gap (ABG) <35 dB. Conductive hearing loss affected 109 patients (97.61%); five had mixed hearing loss. At surgery, 27 patients (23.68%) had ossicular discontinuity, with the incus being the most affected. Twenty-one patients in this group had ABG ≥35 dB. Perforations involving the anterior and posterior halves of the pars tensa, and subtotal perforations, demonstrated the maximum mean hearing loss [45.39±8.29 dB HL (p=0.075), 51.08±12.51 dB HL (p=0.26), respectively]. The mean pure tone average in the intact ossicles group was 43.62±8.07 dB HL and that in the absent/eroded ossicles group was 58.15±11.05 dB HL (p<0.0001); the mean ABG was 27.89±4.77 dB and 38.88±6.47 dB, respectively (p<0.0001). Conclusions: Hearing loss was significantly associated with the size but not the site of the central perforation. With ossicular discontinuity, hearing loss and ABG deteriorated significantly. The findings re-establish the relationship between preoperative PTA and the middle ear status which should help surgeons plan surgery and counsel patients regarding hearing outcomes.

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.

Socio-demographic and Audiological Profile of the Board-Reviewed Applicants for Hearing Handicap Certification in a Tertiary Care Teaching Institute in Eastern India.

To analyze the socio-demographic and audiological profile of the applicants for hearing handicap certification in the Medical Board (henceforth, "Board") of a tertiary care teaching institute. This is a retrospective record review (March 2019-February 2020) from the archival computer database of the institutional Board. The procedure for audiological assessment prior to Board review and thereafter, the evaluation at the Board (computation of hearing impairment) for eligibility for certification was discussed. The socio-demographic profile of the applicants (age, gender, faith) and the types of hearing impairment [HI%; organic (sensorineural, mixed), non-organic (malingering)] were analyzed with relevant statistical parameters. A HI% scale was introduced to classify the severity of the hearing deficit. Of the 163 applicants, 148 had organic hearing loss (average age: 35.4 years; 1.9 times male preponderance) and 15 were malingerers (average age: 35.7 years; 14 times male preponderance). The left ear contributed more to the hearing handicap. Most applicants having sensorineural hearing loss (SNHL; n = 124) were within 10-19 years and 40-49 years (19.35% each), with 12% being ≧ 60 years (age-associated hearing loss). Of the 13 applicants of age ≦ 12 years, eight were diagnosed with brainstem evoked response audiometry, and 10 had HI score of ≥ 70%. Muslim population with SNHL tended to avail certification 1.34 times more than the Hindus. Most of the applicants with mixed hearing loss (MHL; n = 24) were in their fifth and sixth decades (29.2% each), with three times male preponderance. Among the malingerers, the average malingering impairment was 66% (median: 61%; range 44-100%). Among the SNHL population, ~ 30% had HI at 90-100% in contrast to the MHL population of whom 8% had HI at > 90% and 29% had HI at 40- < 55%. Ten applicants among the organic hearing loss group (6.76%) (two with SNHL; eight with MHL) had HI scores of < 40% and were considered ineligible for certification. The outcomes of the review provided a comprehensive account of the socio-demographic profile of the applicants for handicap certification and the type of hearing loss prevailing in a given population. These data, and the severity stratification of the hearing disability through the HI% scale would provide the policymakers and stakeholders with proper directions to work upon.

Evaluation of postural stability and vestibulo-ocular reflex in adults with chronic suppurative otitis media.

PURPOSE: To evaluate the vestibulospinal reflex and vestibulo-ocular reflex (VOR) in patients with chronic suppurative otitis media (CSOM) using posturography and the video head impulse test (vHIT). METHODS: Sixty-five patients with CSOM and 65 healthy participants as controls were included. Patients with CSOM were instructed to complete the dizziness handicap inventory (DHI). All participants underwent otoscopy, pure-tone audiometry, posturography sensory organization test (SOT), and vHIT. RESULTS: Patients with CSOM exhibited a high prevalence of dizziness. The CSOM group had poor SOT vestibular scores compared to the control group. Patients with CSOM had worse sways in the antero-posterior and mediolateral planes. The CSOM group was divided into two subgroups according to the type of hearing loss. SOT vestibular scores were significantly poorer in the mixed hearing loss group than those in the conductive hearing loss group. We found a positive correlation between disease duration and poor SOT vestibular scores. Moreover, poor SOT vestibular scores correlated with high DHI scores. We found abnormalities in the vHIT results in the CSOM group in the form of low VOR gain and corrective saccades. CONCLUSION: Our study provides clinical evidence of dizziness, poor postural control, and VOR abnormalities in patients with CSOM. The presence of sensory elements of hearing loss in patients with CSOM appears to be positively associated with vestibular dysfunction.

Prevalence of hearing loss in patients with Sjögren syndrome: a systematic review and meta-analysis.

Sjögren syndrome (SS) is a multisystem autoimmune disease, primarily targeting salivary and lacrimal glands; skin, nasal and vaginal dryness, along with musculoskeletal pain and fatigue are the most commonly reported symptoms. Hearing loss is hypothesized to be frequent as well. The purpose of this systematic review was to estimate the prevalence of Hearing loss and its different subtypes in patients with Sjögren syndrome. PRISMA guidelines were followed to ensure highest quality for our systematic review. A random effects model meta-analysis and meta-regression was conducted using I2 as heterogeneity indicator. Eleven observational studies were included in this systematic review. Ten of them were cross-sectional, while one study was case-control. Studies were assessed for risk of bias: all were rated to a moderate level, except for two rated to a low level. Pooled prevalence of any type of hearing loss was 52.2%. After excluding studies rated to moderate bias, the pooled prevalence of hearing loss was 36.7%. We also conducted a subgroup analysis depending on type of hearing loss. Pooled prevalence of sensorineural hearing loss was 42.6%., while pooled prevalence of conductive hearing loss and mixed hearing loss were 5% and 2.3%, respectively. Meta-regression was conducted in an effort to identify possible variables capable to explain high heterogeneity between studies. Sample size and year of study were separately found to account for a portion of heterogeneity between studies of sensorineural hearing loss. Year of study was also found to account for a portion of heterogeneity between studies of conductive hearing loss. In conclusion, sensorineural hearing loss, is highly prevalent in patients with Sjögren syndrome. On this basis, early screening and follow-up of patients with Sjögren syndrome by pure tone audiometry is important.

New Osia® OSI200 active transcutaneous bone-anchored hearing device: how I do it.

INTRODUCTION: The new Osia® OSI200 implant incorporates a receiver coil and Piezo Power™ Transducer into one monolithic unit. Appropriate planning and surgical approach is needed for suitable positioning of the device. METHOD: To optimise the surgical field and provide tension-free wound closure our team have adopted a versatile 'Sheffield-S' post-auricular incision which remains hidden within the hairline. CONCLUSION: This incision provides adequate exposure for device placement and bone polishing/recessing. The soft tissue approach has resulted in improved operative efficacy particularly in those patients with irregular cortical bone or where pre-existing osseointegrated implants need to be removed or avoided.