A Novel Method to Determine the Maximum Output of Individual Patients for an Active Transcutaneous Bone Conduction Implant Using Clinical Routine Data.

OBJECTIVES: The maximum output provided by a bone conduction (BC) device is one of the main factors that determines the success when treating patients with conductive or mixed hearing loss. Different approaches such as sound pressure measurements using a probe microphone in the external auditory canal or a surface microphone on the forehead have been previously introduced to determine the maximum output of active transcutaneous BC devices that are not directly accessible after implantation. Here, we introduce a method to determine the maximum output hearing level (MOHL) of a transcutaneous active BC device using patients' audiometric data. DESIGN: We determined the maximum output in terms of hearing level MOHL (dB HL) of the Bonebridge using the audiometric and direct BC threshold of the patient together with corresponding force levels at hearing threshold and the maximum force output of the device. Seventy-one patients implanted with the Bonebridge between 2011 and 2020 (average age 45 ± 19 years ranging from 5 to 84 years) were included in this study. The analyses of MOHLs were performed by (1) dividing patients into two groups with better or worse average audiometric BC threshold (0.5, 1, 2, 4 kHz), on the ipsilateral side or (2) by separating the MOHLs based on better or worse frequency-by-frequency specific audiometric BC thresholds on the ipsilateral (implanted) side. RESULTS: When using a frequency-by-frequency analysis obtained average ipsilateral MOHLs were in the range between 51 and 73 dB HL for frequencies from 0.5 to 6 kHz in the group with better audiometric BC threshold on the ipsilateral ears. The average contralateral MOHLs in the group with better contralateral hearing were in the range from 43 to 67 dB HL. The variability of the data was approximately 6 to 11 dB (SDs) across measured frequencies (0.5 to 6 kHz). The average MOHLs were 4 to 8 dB higher across frequencies in the group with better audiometric BC threshold on the ipsilateral ears than in the group with better audiometric BC threshold on the contralateral ears. The differences between groups were significant across measured frequencies ( t test; p < 0.05). CONCLUSIONS: Our proposed method demonstrates that the individual frequency-specific MOHL on the ipsilateral and contralateral side of individual patients with a transcutaneous BC device can be determined mainly using direct and audiometric BC threshold data of the patients from clinical routine. The average MOHL of the implant was found 4 to 8 dB higher on the ipsilateral (implanted) side than on the contralateral side.

International Consensus Statements on Intraoperative Testing for Cochlear Implantation Surgery.

OBJECTIVES: A wide variety of intraoperative tests are available in cochlear implantation. However, no consensus exists on which tests constitute the minimum necessary battery. We assembled an international panel of clinical experts to develop, refine, and vote upon a set of core consensus statements. DESIGN: A literature review was used to identify intraoperative tests currently used in the field and draft a set of provisional statements. For statement evaluation and refinement, we used a modified Delphi consensus panel structure. Multiple interactive rounds of voting, evaluation, and feedback were conducted to achieve convergence. RESULTS: Twenty-nine provisional statements were included in the original draft. In the first voting round, consensus was reached on 15 statements. Of the 14 statements that did not reach consensus, 12 were revised based on feedback provided by the expert practitioners, and 2 were eliminated. In the second voting round, 10 of the 12 revised statements reached a consensus. The two statements which did not achieve consensus were further revised and subjected to a third voting round. However, both statements failed to achieve consensus in the third round. In addition, during the final revision, one more statement was decided to be deleted due to overlap with another modified statement. CONCLUSIONS: A final core set of 24 consensus statements was generated, covering wide areas of intraoperative testing during CI surgery. These statements may provide utility as evidence-based guidelines to improve quality and achieve uniformity of surgical practice.

Short-term safety and effectiveness of the mCLIP partial prosthesis.

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.

Safety and performance of the new med-el total ossicular replacement prostheses.

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.

Minimum intraoperative testing battery for cochlear implantation: the international practice trend.

PURPOSE: In cochlear implantation (CI) surgery, there are a wide variety of intraoperative tests available. However, no clear guide exists on which tests must be performed as the minimum intraoperative testing battery. Toward this end, we studied the usage patterns, recommendations, and attitudes of practitioners toward intraoperative testing. METHODS: This study is a multicentric international survey of tertiary referral CI centers. A survey was developed and administered to a group of CI practitioners (n = 34) including otologists, audiologists and biomedical engineers. Thirty six participants were invited to participate in this study based on a their scientific outputs to the literature on the intraoperative testing in CI field and based on their high load of CI surgeries. Thirty four, from 15 countries have accepted the invitation to participate. The participants were asked to indicate the usage trends, perceived value, influence on decision making and duration of each intraoperative test. They were also asked to indicate which tests they believe should be included in a minimum test battery for routine cases. RESULTS: Thirty-two (94%) experts provided responses. The most frequently recommended tests for a minimum battery were facial nerve monitoring, electrode impedance measurements, and measurements of electrically evoked compound action potentials (ECAPs). The perceived value and influence on surgical decision-making also varied, with high-resolution CT being rated the highest on both measures. CONCLUSION: Facial nerve monitoring, electrode impedance measurements, and ECAP measurements are currently the core tests of the intraoperative test battery for CI surgery.

An easy method to determine crucial AMEI performance parameters from clinical routine data in individuals - Part 1: maximum output.

OBJECTIVE: The frequency specific maximum output (MO) of active middle ear implants is the most crucial parameter for speech intelligibility. We determined individual MO from clinical routine data in round window (RW) coupling of the Vibrant Soundbridge (VSB). DESIGN: Monocentric, retrospective analysis. STUDY SAMPLE: 68 ears implanted with the VSB at the RW were analysed. Using bone conduction and direct threshold, MO was determined for combinations of implants (VORP502, VORP503) and processors (Samba, Amadé). Coupling modes were: (A) without coupler (N = 28), (B) spherical coupler (N = 19), (C) soft coupler (N = 10) or (D) custom-made "Hannover coupler" (N = 11). RESULTS: The MO frequency dependence was similar for coupling types (A-D) with a maximum at 1.5 kHz. No differences between groups were observed, although the average MO of the soft coupler was 10 dB lower. The average MO (0.5, 1.0, 2.0, 4.0 kHz) was (A) 77.6 ± 15.0 dB HL, (B) 81.0 ± 11.1 dB HL, (C) 67.6 ± 17.9 dB HL (C), and (D) 79.6 ± 11.7 dB HL (D). CONCLUSION: The individual MO can be determined from patients' clinical data. It permits in-depth analyses of patient outcomes and definition of evidence-based indication and decision criteria.

An easy method to determine crucial AMEI performance parameters from clinical routine data in individuals - Part 2: dynamic range.

OBJECTIVE: The dynamic range (DR) available to the patient is a central parameter to determine speech intelligibility in quiet. DESIGN: In this retrospective study, the DR for the Vibrant Soundbridge implanted in individual patients was calculated using in situ thresholds of the patients and technical data of the implant system. The average DR across frequencies (0.5, 1, 2, 4 kHz) was correlated with the patients' assigned word recognition score (WRS) in quiet. STUDY SAMPLE: A data set of 66 cases (4 bilateral and 2 revised cases) from 60 implanted patients between 14.3-81.8 years were analysed. RESULTS: The relationship between DR and WRS was described by a sigmoidal growth function with R2=0.6371 and a maximum WRS (upper asymptote) of 93.5%. Word recognition scores in quiet improved with increasing DR. A significant shift in performance was detected from DR bin 2 (10-20 dB, median WRS 55%) to bin 3 (20-30 dB, median WRS 80%) and from DR bin 4 (30-40 dB, median WRS 82.5%) to bin 5 (40-50 dB, median WRS 90%). CONCLUSION: A minimum DR of 20 dB can yield sufficient speech intelligibility in quiet in implanted patients, however, an optimum DR is suggested to be 40 dB.

Physical Trace Gas Identification with the Photo Electron Ionization Spectrometer (PEIS).

Chemosensor technology for trace gases in the air always aims to identify these compounds and then measure their concentrations. For identification, traceable methods are sparse and relate to large appliances such as mass spectrometers. We present a new method that uses the alternative traceable measurement of the ionization energies of trace gases in a way that can be miniaturized and energetically tuned. We investigate the achievable performance. Since tunable UV sources are not available for photoionization, we take a detour via impact ionization with electrons, which we generate using the photoelectric effect and bring to sharp, defined energies on a nanoscale in the air. Electron impact ionization is thus possible at air pressures of up to 900 hPa. The sensitivity of the process reaches 1 ppm and is equivalent to that of classic PID. With sharpened energy settings, substance identification is currently possible with an accuracy of 30 meV. We can largely explain the experimental observations with the known quantum mechanical models.

Effect of Immunophilin Inhibitors on Cochlear Fibroblasts and Spiral Ganglion Cells.

INTRODUCTION: Loss of hair cells and degeneration of spiral ganglion neurons (SGN) lead to severe hearing loss or deafness. The successful use of a cochlear implant (CI) depends among other factors on the number of surviving SGN. Postoperative formation of fibrous tissue around the electrode array causes an increase in electrical impedances at the stimulating contacts. The use of immunophilin inhibitors may reduce the inflammatory processes without suppressing the immune response. Here, we report on in vitro experiments with different concentrations of immunophilin inhibitors MM284 and compound V20 regarding a possible application of these substances in the inner ear. METHODS: Standard cell lines (NIH/3T3 fibroblasts), freshly isolated SGN, and fibroblasts from neonatal rat cochleae (p3-5) were incubated with different concentrations of immunophilin inhibitors for 48 h. Metabolic activity of fibroblasts was investigated by MTT assay and cell survival by counting of immunochemically stained neurons and compared to controls. RESULTS: MM284 did not affect SGN numbers and neurite growth at concentrations of 4 × 10-5 mol/L and below, whereas V20 had no effect at 8 × 10-6 mol/L and below. Metabolic activity of fibroblasts was unchanged at these concentrations. CONCLUSION: Especially MM284 might be considered as a possible candidate for application within the cochlea.

Summating Potential as Marker of Intracochlear Position in Bipolar Electrocochleography.

OBJECTIVES: Cochlear implantation criteria include subjects with residual low-frequency hearing. To minimize implantation trauma and to avoid unwanted interactions of electric- and acoustic stimuli, it is often recommended to stop cochlear implantation before the cochlear implant (CI) reaches the cochlear partition with residual hearing, as determined by an audiogram. For this purpose, the implant can be used to record acoustically evoked signals during implantation, including cochlear compound action potentials (CAP), cochlear microphonics (CMs), and summating potentials (SPs). The former two have previously been used to monitor residual hearing in clinical settings. DESIGN: In the present study we investigated the use of intracochlear, bipolar SP recordings to determine the exact cochlear position of the contacts of implanted CIs in guinea pig cochleae (n = 13). Polarity reversals of SPs were used as a functional marker of intracochlear position. Micro computed tomography (µCT) imaging and a modified Greenwood function were used to determine the cochleotopic positions of the contacts in the cochlea. These anatomical reconstructions were used to validate the SP-based position estimates. RESULTS: The precision of the SP-based position estimation was on average within ± 0.37 octaves and was not impaired by moderate hearing loss caused by noise exposure after implantation. It is important to note that acute hearing impairment did not reduce the precision of the method. The cochleotopic position of CI accounted for ~70% of the variability of SP polarity reversals. Outliers in the dataset were associated with lateral CI positions. Last, we propose a simplified method to avoid implantation in functioning parts of the cochlea by approaching a predefined frequency region using bipolar SP recordings through a CI. CONCLUSIONS: Bipolar SP recordings provide reliable information on electrode position in the cochlea. The position estimate remains reliable after moderate hearing loss. The technique presented here could be applied during CI surgery to monitor the CI approach to a predefined frequency region.

Variability in Cochlear Implantation Outcomes in a Large German Cohort With a Genetic Etiology of Hearing Loss.

OBJECTIVES: The variability in outcomes of cochlear implantation is largely unexplained, and clinical factors are not sufficient for predicting performance. Genetic factors have been suggested to impact outcomes, but the clinical and genetic heterogeneity of hereditary hearing loss makes it difficult to determine and interpret postoperative performance. It is hypothesized that genetic mutations that affect the neuronal components of the cochlea and auditory pathway, targeted by the cochlear implant (CI), may lead to poor performance. A large cohort of CI recipients was studied to verify this hypothesis. DESIGN: This study included a large German cohort of CI recipients (n = 123 implanted ears; n = 76 probands) with a definitive genetic etiology of hearing loss according to the American College of Medical Genetics (ACMG)/Association for Molecular Pathology (AMP) guidelines and documented postoperative audiological outcomes. All patients underwent preoperative clinical and audiological examinations. Postoperative CI outcome measures were based on at least 1 year of postoperative audiological follow-up for patients with postlingual hearing loss onset (>6 years) and 5 years for children with congenital or pre/perilingual hearing loss onset (≤6 years). Genetic analysis was performed based on three different methods that included single-gene screening, custom-designed hearing loss gene panel sequencing, targeting known syndromic and nonsyndromic hearing loss genes, and whole-genome sequencing. RESULTS: The genetic diagnosis of the 76 probands in the genetic cohort involved 35 genes and 61 different clinically relevant (pathogenic, likely pathogenic) variants. With regard to implanted ears (n = 123), the six most frequently affected genes affecting nearly one-half of implanted ears were GJB2 (21%; n = 26), TMPRSS3 (7%; n = 9), MYO15A (7%; n = 8), SLC26A4 (5%; n = 6), and LOXHD1 and USH2A (each 4%; n = 5). CI recipients with pathogenic variants that influence the sensory nonneural structures performed at or above the median level of speech performance of all ears at 70% [monosyllable word recognition score in quiet at 65 decibels sound pressure level (SPL)]. When gene expression categories were compared to demographic and clinical categories (total number of compared categories: n = 30), mutations in genes expressed in the spiral ganglion emerged as a significant factor more negatively affecting cochlear implantation outcomes than all clinical parameters. An ANOVA of a reduced set of genetic and clinical categories (n = 10) identified five detrimental factors leading to poorer performance with highly significant effects ( p < 0.001), accounting for a total of 11.8% of the observed variance. The single strongest category was neural gene expression accounting for 3.1% of the variance. CONCLUSIONS: The analysis of the relationship between the molecular genetic diagnoses of a hereditary etiology of hearing loss and cochlear implantation outcomes in a large German cohort of CI recipients revealed significant variabilities. Poor performance was observed with genetic mutations that affected the neural components of the cochlea, supporting the "spiral ganglion hypothesis."

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.

Drilling accuracy evaluation of a mouldable surgical targeting system for minimally invasive access to anatomic targets in the temporal bone.

PURPOSE: Minimally invasive cochlear implant surgery using a micro-stereotactic surgical targeting system with on-site moulding of the template aims for a reliable, less experience-dependent access to the inner ear under maximal reduction of trauma to anatomic structures. We present an accuracy evaluation of our system in ex-vivo testing. METHODS: Eleven drilling experiments were performed on four cadaveric temporal bone specimens. The process involved preoperative imaging after affixing the reference frame to the skull, planning of a safe trajectory preserving relevant anatomical structures, customization of the surgical template, execution of the guided drilling and postoperative imaging for determination of the drilling accuracy. Deviation between the drilled and desired trajectories was measured at different depths. RESULTS: All drilling experiments were successfully performed. Other than purposely sacrificing the chorda tympani in one experiment, no other relevant anatomy, such as facial nerve, chorda tympani, ossicles or external auditory canal were harmed. Deviation between the desired and achieved path was found to be 0.25 ± 0.16 mm at skulls' surface and 0.51 ± 0.35 mm at the target level. The closest distance of the drilled trajectories' outer circumference to the facial nerve was 0.44 mm. CONCLUSIONS: We demonstrated the usability for drilling to the middle ear on human cadaveric specimen in a pre-clinical setting. Accuracy proved to be suitable for many applications such as procedures within the field of image-guided neurosurgery. Promising approaches to reach sufficient submillimetre accuracy for CI surgery have been outlined.

Randomized, placebo-controlled study on efficacy, safety and tolerability of drug-induced defibrinogenation for sudden sensorineural hearing loss: the lessons learned.

PURPOSE: Disturbance of cochlear microcirculation is discussed as final common pathway of various inner ear diseases. Hyperfibrinogenemia causing increased plasma viscosity is a possible factor for a critical reduction of cochlear blood flow that might lead to sudden sensorineural hearing loss (SSHL). The aim was to determine the efficacy and safety of drug-induced defibrinogenation by ancrod for SSHL. METHODS: Double-blind, randomized, placebo-controlled, multicenter, parallel group, phase II (proof-of-concept) study (planned enrollment: 99 patients). Patients received an infusion of ancrod or placebo (day 1) followed by subcutaneous administrations (day 2, 4, 6). Primary outcome was the change in pure tone audiogram air conduction average until day 8. RESULTS: The study was terminated early due to slow recruiting (31 enrolled patients: 22 ancrod, 9 placebo). A significant improvement of hearing loss was registered in both groups (ancrod: - 14.3 dB ± 20.4 dB, - 39.9% ± 50.4%; placebo: - 22.3 dB ± 13.7 dB, - 59.1% ± 38.0%). A statistically significant group-difference was not detected (p = 0.374). Placebo response of 33.3% complete and 85.7% at least partial recovery was observed. Plasma fibrinogen levels were reduced significantly by ancrod (baseline: 325.2 mg/dL, day 2: 107.2 mg/dL). Ancrod was tolerated well, no adverse drug reaction was of severe intensity, no serious adverse events occurred. CONCLUSION: Ancrod reduced fibrinogen levels that support its mechanism of action. The safety profile can be rated positively. Since the planned number of patients could not be enrolled, no efficacy conclusion can be drawn. The high rate of placebo response challenges clinical trials for SSHL and needs to be considered in future investigations. Trial registrations This study was registered in the EU Clinical Trials Register, EudraCT-No. 2012-000066-37 at 2012-07-02.

Healthcare consumption among subjects with otitis media undergoing middle ear surgery-analysis of cost drivers.

PURPOSE: To map healthcare utilized by subjects with chronic otitis media, with or without cholesteatoma and perform a cost analysis to determine key drivers of healthcare expenditure. METHODS: A registry study of 656 adult subjects with chronic otitis media that underwent a middle ear surgery between 2014 and 2018. Healthcare contacts related to all publicly funded specialist ENT care, audiological care and primary care for a disease of the ear and mastoid process were extracted. The data are extracted from the Swedish National Patient Registry on subjects that reside in western Sweden. RESULTS: Subjects made 13,782 healthcare contacts at a total cost 61.1 million SEK (6.0 million EUR) between 2014 and 2018. The mean cost per subject was 93,075 SEK (9071 EUR) and ranged between 3971 SEK (387 EUR) and 468,711 SEK (45,683 EUR) per individual. In the most expensive quartile of subjects, mean cost was 192,353 SEK (18,747 EUR) over the 5-year period. These subjects made 3227 ENT contacts (roughly four each year) and 60% of total costs were associated with in-patient ENT care. CONCLUSION: Patients with chronic otitis media are associated with high ENT resource utilization that does not diminish after surgical intervention and the disease places a long-term burden on healthcare systems. Significant costs are attributed to revision surgeries, indicating that these patients could be managed more effectively. In many such cases, reoperation cannot be avoided, especially due to recurrence of cholesteatoma. However, in some patients, when the indication for subsequent surgery is only hearing improvement, alternative options, such as hearing aids or implants, should also be considered. This is especially true in difficult cases, where revision ossiculoplasty is likely.

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.

Impedance development after implantation of hybrid-L24 cochlear implant electrodes.

OBJECTIVE: Shorter and thinner electrodes were developed for preserving residual hearing after cochlear implantation by minimising trauma. As trauma is regarded as one of the causes of fibrous tissue formation after implantation, and increase in impedance is considered to be connected to fibrous tissue formation, the aim of the current study was to evaluate impedance development after implantation of Hybrid-L electrodes. DESIGN: Impedance values were retrospectively collected from our clinical database and evaluated for all active contacts and basal, middle and apical contacts separately for up to 10 years. STUDY SAMPLES: All 137 adult patients received a Hybrid-L electrode and had to be implanted for at least 1 year. RESULTS: On average impedances increased to 13 kOhm before first fitting and dropped to 5-7 kOhm under electrical stimulation with lower values measured on apical contacts. Mean values remained stable over years, but variability increased. Values before first fitting were independent of age at implantation whereas lower values were found later in patients of higher age at implantation. CONCLUSION: Despite smaller contacts, impedance values after start of electrical stimulation were comparable to published values of Contour electrodes. This might suggest less tissue growth with the Hybrid-L electrode array.

[Transcutaneous bone conduction implant with self-drilling screws : A new method for fixation of an active transcutaneous bone conduction implant. German version]. / Knochenleitungsimplantat mit selbstbohrenden Schrauben : Neue Methode der Fixation eines aktiven transkutanen Knochenleitungshörimplantats.

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

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

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

[Hypertrophy of lingual tonsil following tonsillectomy and correlation with BMI]. / Zungengrundhyperplasie nach Tonsillektomie und Korrelation mit dem BMI.

OBJECTIVE: The hyperplasia of the lingual tonsil is a rare and at the same time potentially dangerous change in the area of the upper respiratory tract. The pathogenesis of the lingual tonsillar hyperplasia is still largely unknown. In this study, we investigated if there is a compensatory lingual tonsil hyperplasia after tonsillectomy. MATERIAL AND METHODS: 300 patients were examined consecutively in the ENT clinic of the Hannover Medical School. In the context of indirect laryngoscopy, the lingual tonsil, the visibility of the larynx and its subregions were assessed according to a scheme. The data were then evaluated depending on the status of the palatal tonsils. In addition, the body mass index (BMI) was determined and compared with the results of laryngoscopy. RESULTS: Out of 300 patients, 89 (29.6%) were in condition after bilateral tonsillectomy. In the total population, a greatly enlarged lingual tonsil was only detectable in 14 cases (4.6%). Of these 14 patients, 4 had a history of tonsillectomy. In patients with severe lingual tonsil hyperplasia the mean BMI was 27.3 compared to 24.4 in patients with a normal lingual tonsil. CONCLUSION: In our population the incidence of severe lingual tonsil hyperplasia is 4.7%. We couldn't prove s a connection between a condition after tonsillectomy and compensatory lingual hyperplasia statistically. However, there was a significant relationship between BMI and lingual tonsil hyperplasia.