MED-EL (Austria)

Einleitung: In der klinischen Routine werden elektrisch evozierte Summenaktionspotenziale (ECAPs) gemessen und für die Beurteilung der Elektroden-Nervenschnittstelle sowie für die Anpassung des Sprachprozessors verwendet. Die Messung ist durch die elektrische Stimulation zwangsläufig [zum vollständigen Text gelangen Sie über die oben angegebene URL]

Adults with severe to profound hearing loss have limited access to cochlear implants (CIs). The objective of this study was to assess the evidence to establish whether the uptake rate of CIs has changed over the past decade. A PubMed search, supplemented with manual searching, identified 15 relevant papers published from 2000 to 4 February 2025 reporting the uptake rate of CIs in adults. In addition, new calculations of uptake rates were made for 2019, based on total numbers of CIs implanted and the prevalence of hearing loss from the 2019 Global Burden of Disease Study. There was a lack of published data on the uptake rates for cochlear implants, with very little consensus in the methods used across studies. The overall uptake rates for adults and children combined, calculated for 2019 using the Lancet Global Burden of Disease Study, showed that uptake is still ≤20% for those with profound to complete hearing loss in most high-income countries. When the global population is considered (including high- to low-income countries), it is merely 2.5%. Despite the cochlear implant awareness activities of recent years, the percentage of profoundly deaf individuals with cochlear implants, even in high-income countries, remains low. Uptake rates are much worse than those for hearing aid use for severe to profound deafness. Better and more accurate data must be gathered on the number of CI recipients to meet the reporting requirements of the World Health Organisation's report on hearing.

Objective:To confirm the long-term safety and performance of the Bonebridge BCI 602 in patients suffering from conductive or mixed hearing loss (CMHL) or single-sided deafness (SSD) over a 12-month period post-implantation.Study design:Multicentric, multinational, ambidirectional, observational Post-Market Clinical Follow-Up (PMCF) study.Setting:Eight tertiary referral hospitals.Participants:Fifty-two participants in 3 categories: adults CMHL (N=24), children CMHL (N=17), and SSD (N=11; 9 adults and 2 children).Intervention:Participants were implanted with the Bonebridge BCI 602 device.Main outcome measure(s):Outcome measures focused on sound field thresholds (SF), word recognition scores (WRS), speech reception thresholds (SRT) in both quiet and noise, adverse events, and subjective satisfaction (SSQ and AQoL questionnaires) at initial activation and at 3-month and 12-month post-implantation.Results:Safety was established by stable bone conduction (BC) thresholds and a low adverse event rate with no unanticipated events. Safety was underlined by clinically relevant improvements in the health-related assessment of Quality of Life (AQoL) questionnaire of mean+0.1 (adults and children CMHL) and +0.07 (SSD). Hearing significantly improved in sound field thresholds with mean functional gains of 24.05±8.68 dB (adults CMHL), 21.34±25.43 dB (children CMHL), and 32.89±25.87 dB (SSD). Mean word recognition scores improved by 65.83±28.62 percent points (PP) for adult CMHL and 65.77±27.53 PP for children CMHL and speech reception thresholds (SRT) in quiet by 15.4±9.34 dB and 19.96±14.66 dB, respectively. SRT in noise improved by −5.57±4.23 dB (adults; S0°N0°), −5.12±5.08 dB (children, S0°N0°), and −3.05±3.06 dB (SSD, SSSDNNH). Subjective hearing ability tested with the Speech, Spatial, and Qualities (SSQ) of Hearing questionnaire improved and was clinically relevant for the adult (+2.23) and children (+1.51) CMHL groups.Conclusions:The Bonebridge BCI 602 demonstrates significant enhancements in hearing and speech understanding 12 months postoperatively, showing high user satisfaction and safety.

There is a significant gap in routine clinical data concerning cochlear implant (CI) users, particularly regarding real-world outcomes. To address this, the present study focuses on the MED-EL Hearing Solution (MEHS) multicenter registry, which covers 5 clinics in Germany. Participants were users of a SONNET 2 or SONNET 2 EAS audio processor. Anonymized data that were routinely collected were extracted and analyzed by a third-party organization. Speech test outcomes (monosyllables and numbers), hours of daily use, self-perceived level of auditory benefit, and safety were assessed. Outcomes from 361 SONNET 2 (or SONNET 2 EAS) users, including 57 bilateral users, were extracted and analyzed. Speech test outcomes increased significantly from pre-operatively to 1 year of CI use in monosyllables (median 10.0% to 65.0%) and numbers (median 77.8% to 100.0%) (both p < 0.001). The majority (79%) of people used their device for at least 9 hours a day. The level of self-perceived auditory benefit was "moderate". Safety was assessed as per participant self-report: 17 minor clinical events were reported, none were new or unresolved. The data obtained from the MEHS registry offers valuable real-life evidence from routine clinical evaluations, which can support clinicians in developing more informed guidelines and treatment plans. The SONNET 2 (EAS) is effective and safe to use. Registries have the potential to provide a wealth of data that can be used to improve hearing health care. However, the success of registries depends on consistent participation and adherence to standardized protocols by clinical centers. Variability in clinical practices, demographic factors, and reporting standards across centers poses significant challenges to achieving homogeneous and usable data.

Introduction:Age related hearing loss is in the top ten contributors to the global burden of disease and one of the largest modifiable risk factors for age-related dementia. However, awareness of the consequences of untreated hearing loss is poor and many adults do not seek hearing assessment. Despite World Health Organisation recommendations, no EU country currently has a national adult screening programme.Method:The aim of this trial was to raise awareness of hearing loss by providing screening audiograms in a range of community settings. Results were explained to every participant and professional advice given. Seven hundred participants came forward for testing with a mean age of 60 to 70 years old.Results:Data was recorded from 597 individuals (51% female and 49% male), 44% had a disabling hearing loss (≥35 dB HL in the better ear) and 15% of individuals had a moderately severe loss or greater. No participants currently wore or had been fitted with a hearing aid. Both the proportion of those with hearing loss and the severity of the hearing loss increased with age. Tinnitus was present in 38% of the sample and wax occlusion in 24%.Conclusion:Many individuals came forward who had not accessed the audiological services currently provided. This indicates a need for more awareness of hearing care in the population and an unmet need for audiological services.

The first aim was to develop a simple, yet effective adult hearing screening protocol, based on the existing World Health Organization recommendations. Secondary aim was to gain insight in the possibilities and potential obstacles for implementation of national adult hearing screening programs across the globe. An expert working group was formed with 14 experts from six countries. Based on their recommendations a HEARRING screening protocol was devised and shared with all HEARRING group members. A survey was sent out to 62 clinicians from 22 countries to hear their considerations and the potential challenges they expect for the introduction of national adult hearing screening programs. The proposed adult hearing screening protocol is made as simple and least time consuming as possible. The tablet-based screening tool consists of two red flag questions, followed by the Hearing Handicap Inventory for the Elderly Screening (HHIE-S) questionnaire and the Digits-in-Noise test, and is developed to be implemented in the primary care setting. The results of our survey indicate that most participants deem a national adult hearing screening to be cost-effective, but the major concerns regarding costs and funding, and infrastructure have to be discussed. The HEARRING screening protocol is developed to assist clinicians and policy makers in their efforts to initiate effective local and national adult hearing screening programs.

Cochlear implantation is the standard of care for individuals with severe-to-profound sensorineural hearing loss. However, implantation itself can degrade residual hearing, for example due to insertional trauma and subsequent inflammatory processes. One potential method to mitigate this loss of residual hearing is through the local and sustained delivery of anti-inflammatory drugs released from the electrode array. To this end, a dexamethasone eluting electrode array (FLEX28 DEX) was developed by MED-EL. Here we present the results from a first-in-human feasibility study of the CIDEXEL system (the Mi1200 SYNCHRONY cochlear implant combined with the FLEX28 DEX array). A single-arm, exploratory, open-label, prospective, longitudinal, and monocentric study design with sequential block enrolment was used. Nine participants were implanted with the CIDEXEL and were followed up to 9 months post first fitting. The primary aim was to evaluate the safety of the device. The secondary aims were to assess: 1) electrode impedance levels; 2) hearing preservation rates; 3) speech perception outcomes; and 4) subjective feedback from the surgeons regarding their experience with the device during the operation. There were no device- or procedure-related serious adverse events. Low and stable impedance levels were observed across all electrode sites (basal, medial and apical). In the majority of participants, good preservation of residual hearing (≤15 dB hearing loss) was achieved. The participants showed speech perception test results which were comparable to those with a non-eluting FLEX28 array. Surgeons reported that the CIDEXEL had similar handling and insertion properties to a conventional electrode array.

Growing numbers of children and adults who are deaf are eligible to receive cochlear implants (CI), which provide access to everyday sound. CIs in both ears (bilateral CIs or BiCIs) are becoming standard of care in many countries. However, their effectiveness is limited because they do not adequately restore the acoustic cues essential for sound localization, particularly interaural time differences (ITDs) at low frequencies. The cochlea, the auditory sensory organ, typically transmits ITDs more effectively at the apical region, which is specifically “tuned” to low frequencies. We hypothesized that effective restoration of robust ITD perception through electrical stimulation with BiCIs depends on targeting cochlear locations that transmit information most effectively. Importantly, we show that these locations can occur anywhere along the cochlea, even on the opposite end of the frequency map from where ITD cues are most dominantly encoded in an acoustic hearing system.