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Purpose: This multicentric, retrospective study provides safety and performance data of the MED-EL total ossicular replacement prostheses (TORP). Methods: Patients underwent tympanoplasty with mXACT Total Prosthesis Center, mXACT Total Prosthesis Offcenter or mXACT PRO Total Prosthesis. The clinical data were retrospectively analyzed. Follow-up examination included access to the medical record (for adverse events) of the patients, ear microscopy and pure-tone audiometry to determine the post-operative pure tone average of the frequencies 0.5, 1, 2 and 3 kHz (PTA4). The post-operative PTA4 air bone gap (ABG) was used to evaluate the audiological outcome. A post-operative minimum and maximum follow-up period was not defined. Results: 103 patients were implanted with a TORP. 102 (88 adults, 14 children; 37 CHL, 64 MHL, 1 not specified) patients were analyzed for safety and 92 (79 adults, 13 children) patients for performance of the prostheses. Adverse events results (N = 102): In 1 patient (child, mXACT Total Prosthesis Offcenter) a prosthesis dislocation was reported, which lead to a revision surgery. No prosthesis extrusion or migration was reported. Audiological results (N = 92): 49 (53.3%) of the 92 patients had a PTA4 ABG of ≤ 20 dB and therefore a successful rehabilitation. The mean post-operative PTA4 ABG of all 92 patients was 21.0 ± 9.7 dB. The first endpoint, improvement in post-operative PTA4 ABG of ≤ 20 dB by ≥ 25% of the patients was achieved. The individual Δ BC PTA4 (post-operative minus pre-operative BC PTA4) thresholds were stable (within ± 5 dB HL) in 91 (98.9%) patients. 1 patient had a BC PTA4 deterioration of 11.3 dB HL. Conclusion: The MED-EL TORPs are safe and effective for middle ear reconstruction. Trial registration number NCT05565339, September 09, 2022, retrospectively registered. [ABSTRACT FROM AUTHOR]

Purpose: This multicentric, retrospective study aimed to analyze the short-term safety and effectiveness of the mCLIP Partial Prosthesis. Methods: Patients underwent tympanoplasty with implantation of a mCLIP Partial Prosthesis. Follow-up examination included ear microscopy and pure-tone audiometry to determine the post-operative pure tone average of the frequencies 0.5, 1, 2 and 3 kHz (PTA4). The post-operative PTA4 air bone gap (ABG) was used to evaluate the audiological outcome. A post-operative minimum and maximum follow-up period was not defined. Thus, the follow-up times of each study center were different, which resulted in different follow-up times for the audiological analysis and for adverse events (AE). Results: 72 (66 adults, 6 children) patients were implanted with the mCLIP Partial Prosthesis. 68 (62 adults, 6 children) patients underwent audiological examination; all 72 patients were examined for adverse events. All patients (N = 68): 72.1% of the patients showed a PTA4 ABG of ≤ 20 dB. Individual post-operative bone conduction (BC) PTA4 thresholds were stable in 67 patients. The mean post-operative follow-up time was 78 ± 46 days. Children (N = 6): 5 out of 6 children showed a PTA4 ABG of ≤ 20 dB. None of the children reported a BC PTA4 deterioration of > 10 dB HL after the implantation. The mean post-operative follow-up time was 101 ± 45 days. Adverse events (all patients, N = 72): 15 (14 adults, 1 child) patients had AEs (27 AEs and 2 Follow-Ups). The mean post-operative follow-up time was 375 days. Conclusion: Clinical data show satisfactory audiological parameters after implantation of the mCLIP Partial Prosthesis. The prosthesis is safe and effective for implantation in children and adults. Trial registration number: NCT05565339, 09 September 2022, retrospectively registered. [ABSTRACT FROM AUTHOR]

Purpose: Our aim was to investigate the course of the hearing capacity of the better-hearing ear in single-sided deafness (SSD) and asymmetric hearing loss (AHL) over time, in a multicenter study. Methods: We included 2086 pure-tone audiograms from 323 patients with SSD and AHL from four hospitals and 156 private practice otorhinolaryngologists. We collected: age, gender, etiology, duration of deafness, treatment with CI, number and monosyllabic speech recognition, numerical rating scale (NRS) of tinnitus intensity, and the tinnitus questionnaire according to Goebel and Hiller. We compared the pure tone audiogram of the better-hearing ear in patients with SSD with age- and gender-controlled hearing thresholds from ISO 7029:2017. Results: First, individuals with SSD showed a significantly higher hearing threshold from 0.125 to 8 kHz in the better-hearing ear compared to the ISO 7029:2017. The duration of deafness of the poorer-hearing ear showed no relationship with the hearing threshold of the better-hearing ear. The hearing threshold was significantly higher in typically bilaterally presenting etiologies (chronic otitis media, otosclerosis, and congenital hearing loss), except for Menière's disease. Second, subjects that developed AHL did so in 5.19 ± 5.91 years and showed significant reduction in monosyllabic word and number recognition. Conclusions: Individuals with SSD show significantly poorer hearing in the better-hearing ear than individuals with NH from the ISO 7029:2017. In clinical practice, we should, therefore, inform our SSD patients that their disease is accompanied by a reduced hearing capacity on the contralateral side, especially in certain etiologies. [ABSTRACT FROM AUTHOR]

This document is a correction notice for an article titled "Long-term data of the new transcutaneous partially implantable bone conduction hearing system Osia®" published in the European Archives of Oto-Rhino-Laryngology. The correction addresses several errors in the original publication, including incorrect sentences and phrases, as well as inaccuracies in figure captions. The corrected information provides accurate data on the improvement of hearing-related quality of life and speech recognition scores in patients with Osia implants. The correction notice emphasizes the largest benefit for patients with over three years of Osia experience and clarifies the outcomes for different patient groups. [Extracted from the article]

Purpose: The new active transcutaneous partially implantable osseointegrated system Cochlear™ Osia® System is indicated in case of conductive or mixed hearing loss (CHL/MHL) with a maximum average bone conduction hearing loss of 55 dB, or in single-sided deafness (SSD). The implant directly stimulates the bone via a piezoelectric transducer and is directed by an external sound processor. We conducted a monocentric retrospective longitudinal within-subject clinical study at our tertiary academic referral center. The aim was to investigate long-term data (2017–2021) on audiological outcomes and hearing-related quality of life for the Osia system. Methods: Between 2017 and 2020, 22 adults (18: CHL/MHL; 3: SSD) were implanted with the Osia100 implant; seven received bilateral implants. As of 10/2020, the sound processor was upgraded to Osia 2. Results: Mean Osia system use by 04/2021 was 30.9 ± 8.6 months (range 17–40 months). Unaided bone conduction thresholds were unchanged postoperatively. One patient had to be explanted because of prolonged wound infection. Aided hearing thresholds were significantly lower compared to the unaided thresholds preoperatively, along with a marked increase in speech recognition in quiet. Speech processor upgrade resulted in a stable benefit. Patients with CHL/MHL and SSD showed a similar improvement in self-rated hearing performance revealed by SSQ, APHAB, and HUI questionnaires. Conclusion: The Osia system is a safe, effective and sustainable option for treatment of conductive and mixed hearing loss or single-sided deafness. [ABSTRACT FROM AUTHOR]

Purpose: The aim of this study is to examine the scalar dislocation rate in straight and perimodiolar electrode arrays in relation to cochlear morphology. Furthermore, we aim to analyze the specific dislocation point of electrode arrays depending on their design and shape and to correlate these results to postoperative speech perception. Methods: We conducted a comparative analysis of patients (ears: n = 495) implanted between 2013 and 2018 with inserted perimodiolar or straight electrode arrays from Cochlear™ or MED-EL. CBCT (cone beam computed tomography) was used to determine electrode array position (scalar insertion, intra-cochlear dislocation, point of dislocation and angular insertion depth). Furthermore, cochlear morphology was measured. The postoperative speech discrimination was compared regarding electrode array dislocation, primary scalar insertion and angular insertion depth. Results: The electrode array with the highest rate of primary SV insertions was the CA; the electrode array with the highest rate of dislocations out of ST was the FlexSoft. We did not find significantly higher dislocation rates in cochleostomy-inserted arrays. The angle of dislocation was electrode array design-specific. A multivariate nonparametric analysis revealed that the dislocation of the electrode array has no significant influence on postoperative speech perception. Nevertheless, increasing angular insertion depth significantly reduced postoperative speech perception for monosyllables. Conclusion: This study demonstrates the significant influence of electrode array design on scalar location, dislocation and the angle of dislocation itself. Straight and perimodiolar electrode arrays differ from each other regarding both the rate and place of dislocation. Insertion via cochleostomy does not lead to increased dislocation rates in any of the included electrode arrays. Furthermore, speech perception is significantly negatively influenced by angular insertion depth. [ABSTRACT FROM AUTHOR]

Purpose: The aim of the study was to compare long-term results after 1 year in patients with single-sided deafness (SSD) who were fitted with different hearing aids. The participants tested contralateral routing of signals (CROS) hearing aids and bone-anchored hearing systems (BAHS). They were also informed about the possibility of a cochlear implant (CI) and chose one of the three devices. We also investigated which factors influenced the choice of device. Methods: Prospective study with 89 SSD participants who were divided into three groups by choosing BAHS, CROS, or CI. All participants received test batteries with both objective hearing tests (speech perception in noise and sound localisation) and subjective questionnaires. Results: 16 participants opted for BAHS-, 13 for CROS- and 30 for CI-treatment. The greater the subjective impairment caused by SSD, the more likely patients were to opt for surgical treatment (BAHS or CI). The best results in terms of speech perception in noise (especially when sound reaches the deaf ear and noise the hearing ear), sound localization, and subjective results were achieved with CI. Conclusion: The best results regarding the therapy of SSD are achieved with a CI, followed by BAHS. This was evident both in objective tests and in the subjective questionnaires. Nevertheless, an individual decision is required in each case as to which SSD therapy option is best for the patient. Above all, the patient's subjective impairment and expectations should be included in the decision-making process. [ABSTRACT FROM AUTHOR]

Purpose: The purpose of this retrospective study was to investigate the outcome and critical age of cochlear implantation in congenital single-sided deafness (SSD). Methods: 11 children with congenital SSD were implanted with a cochlear implant (CI). Auditory performance was measured through the results of speech discrimination, subjective assessment by the Categories of auditory performance (CAP) score, the Speech, Spatial and Qualities scale questionnaire (SSQ) and the German version of the IOI-HA [Internationales Inventar zur Evaluation von Hörgeräten (IIEH, version for CI)]. Results: Long-term follow-up [median: 3 years and 5 months (3;5 years)] revealed that nine children use their CI (> 8 h/day) and two became nonusers. In children aged below 3;2 years at surgery, there was a substantial long-term increase in speech discrimination and subjective benefit. Children over 4;4 years of age at CI surgery improved partially in audiological/subjective measurements. Among children above 5 years, the SSQ score did not improve despite further slight improvement in speech discrimination long-term. Conclusion: Our data suggest a critical age for CI surgery below 3 years in children with congenital SSD for successful hearing rehabilitation. It is mandatory to identify children with SSD as early as bilaterally deaf children. [ABSTRACT FROM AUTHOR]

Purpose: We investigated the long-term results of cochlear implant (CI) recipients with asymmetric hearing loss (AHL) or single-sided deafness (SSD). We focused on wearing behavior, audiometric hearing rehabilitation, and subjective benefits of the CI. CI is expected to improve audiological results, subjective hearing perception, and tinnitus burden. Methods: Speech recognition in background noise and sound localization were assessed preoperatively and after at least six years of CI experience. Validated questionnaires determined the subjective benefit of CI use and the subjective evaluation of tinnitus. Results: Over 80% of the included AHL and SSD CI recipients used their CI between 6 and 10 h daily; four subjects with SSD were non-users. Speech recognition in background noise and sound localization improved significantly compared with the unaided preoperative situation. Additionally, CI improved subjective speech intelligibility and spatial hearing impression while reducing tinnitus burden. Conclusion: Subjects with AHL and SSD benefit from CI, subjectively and audiologically. Cochlear implant is a successful long-term treatment for AHL and SSD. [ABSTRACT FROM AUTHOR]

Purpose: The primary objective of the retrospective study was to collect speech intelligibility data on children and adolescents implanted with the vibrating ossicular prosthesis (VORP) 503. Methods: This was a retrospective, multicentre study on 55 children and adolescents from 6 German clinics aged between 5 and 17 years suffering from mixed or conductive hearing loss implanted with a VORP 503. Pre- and postoperative bone-conduction pure tone thresholds were measured at 0.5, 1, 2 and 4 kHz, and word recognition scores in the unaided and VORP 503-aided conditions using monosyllabic speech intelligibility tests measured at 65-dB sound pressure level (SPL) were determined. Results: Mean pre- and postoperative bone-conduction thresholds remained unchanged, showing the preservation of inner ear hearing. Speech intelligibility assessed in quiet at 65-dB SPL improved on average from 24.5% (SD ± 25.4) unaided to 86.4% (SD ± 13.4) aided. The average improvement of 61.9% (SD ± 25.3) was clinically and statistically significant. A total of three complications were found in the medical records of 55 subjects. The responsible investigators judged these events as procedure related. Conclusion: The treatment of children suffering from conductive or mixed hearing loss with the VORP 503 implant demonstrates excellent aided benefit in terms of speech understanding and only minor complications. [ABSTRACT FROM AUTHOR]

The original article can be found online at https://doi.org/10.1007/s00405-021-07160-2. Correction to: European Archives of Oto-Rhino-Laryngology https://doi.org/10.1007/s00405-021-... In the original publication of the article, some values for the electrode arrays Flex SP 24 sp and Flex SP 28 sp (MED EL) have been interchanged in Tables 1 and 2 in the original manuscript. [Extracted from the article]

The aim of the study was to investigate the option of cochlear implantation (CI) in resultant single-sided deafness associated with unilateral translabyrinthine resection of sporadic vestibular schwannoma (VS). This is a retrospective study performed at Tertiary Care Academic Centre. Following extensive counselling regarding the potential for delayed CI, translabyrinthine VS resection was performed and an intracochlear placeholder was inserted to allow later CI in 11 patients who showed intraoperative microscopic confirmation of preserved cochlear nerve anatomy. Follow-up magnetic resonance imaging (MRI) and promontory testing were performed 1 year after surgery to confirm the absence of VS recurrence and viable cochlea. Confirmed CI candidates underwent a second procedure where the placeholder was removed and the CI inserted (4/11). Preimplant unaided and CI-aided evaluations at 12 and 24 months were performed for subjective and objective hearing outcomes. Tinnitus suppression was also measured for implant on and off effects. Available audiological data for three patients demonstrated significant hearing benefits for 'speech from deaf/implanted side, noise from the normal-hearing side' in all three patients and localisation ability improved for 2/3 patients. Subjective findings presented similar results. For the two patients with preimplant tinnitus, complete suppression occurred during active CI. CI is beneficial for hearing rehabilitation and tinnitus reduction in SSD patients with remaining viable cochlear nerve after translabyrinthine VS surgery. Counselling on the risks of intracochlear placeholder insertion and the inherent limitations for ongoing MRI investigations of VS recurrence is essential. [ABSTRACT FROM AUTHOR]

The Bonebridge (BB, Med-El) is a newly designed transcutaneous active bone conductive implant with functional outcome similar to percutaneous bone-anchored hearing systems (BAHS). It is currently approved only for patients ≥18 years. Since the BB allows the skin to remain intact and therefore should be able to overcome some of the issues related to percutaneous BAHS including skin reactions, wound infection and implant extrusion, it would be especially attractive for use in children. We present a preliminary series of the first three cases of BB implantation in children/adolescents (10-16 years). Two subjects were affected by conductive hearing loss (CHL) and one subject by single-sided deafness (SSD). The surgical procedure with transmastoid approach was completed in all cases without complications. Both subjects with CHL showed an increase in speech perception thresholds in quiet from preoperative unaided to 6 months postoperatively with BB of 37 dB, respectively, of 12 dB. The adolescent with SSD attained -3.1 dB unaided vs. -5.6 dB with the BB in the 'speech and noise from the front' presentation and +0.5 unaided vs. -5.0 dB with the BB in the 'speech from the unilateral deaf side/noise from the normal hearing side' presentation using the adaptive Oldenburg Sentence Test. The results show a straightforward surgical procedure and satisfactory functional gain after BB implantation also in children/adolescents. BB implantation in patients ≤18 years is currently an 'off-label use' so that detailed information about alternative treatment options, operation risks and the lack of approval for use in children is essential. [ABSTRACT FROM AUTHOR]

In immunocompromised patients, symptoms and the pathogen spectrum of sinusitis are frequently atypical. If progressive loss of vision occurs, an infection of the anterior skull base or nasal sinuses should be considered. We report on four patients with orbit-associated symptoms. CT-imaging revealed bony defects in sinus borders to orbits or endocranium. In all the cases immediate surgical drainage was performed because complications following sinusitis were suspected. Histopathological diagnosis revealed two cases of aspergillosis and mucormycosis. The possibility of opportunistic infections by saprophytic fungi must be taken into account in immunocompromised patients, as they may endanger both vision and survival. Immediate diagnosis and therapy are essential. Nowadays, therapeutic success can be achieved due to advances in antimicrobial therapy, hyperbaric oxygen therapy and treatment of the underlying disease. Radical procedures like orbital exenteration must be considered in all cases. The current state of diagnostics, therapy and prognosis is discussed based on these case reports and the recent literature. [ABSTRACT FROM AUTHOR]

This document is a correction notice for an article titled "Long-term data of the new transcutaneous partially implantable bone conduction hearing system Osia®" published in the European Archives of Oto-Rhino-Laryngology. The correction addresses several errors in the original publication, including incorrect sentences and phrases, as well as inaccuracies in figure captions. The corrected information provides accurate data on the improvement of hearing-related quality of life and speech recognition scores in patients with Osia implants. The correction notice emphasizes the largest benefit for patients with over three years of Osia experience and clarifies the outcomes for different patient groups. [Extracted from the article]