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.

Development and Evaluation of the Italian Version of the Dichotic Digit Test: Insights from 39 Normal-Hearing Children Aged 11 to 13 years.

BACKGROUND The dichotic digit test (DDT) is one of the tests for the behavioral assessment of central auditory processing. Dichotic listening tests are sensitive ways of assessing cortical structures, the corpus callossum, and binaural integration mechanisms, showing strong correlations with learning difficulties. The DDT is presently available in a number of languages, each appropriate for the subject's native language. However, there is presently no test in the Italian language. The goal of this study was to develop an Italian version of the one-pair dichotic digit test (DDT-IT) and analyze results in 39 normal-hearing Italian children 11 to 13 years old. We used 2 conditions of presentation: free recall and directed attention (left or right ear), and looked at possible effects of sex and ear side. MATERIAL AND METHODS This study involved 3 steps: creation of the stimuli, checking their quality with Italian speakers, and assessment of the DDT-IT in our subject pool. The study involved 39 children (26 girls and 13 boys), aged 11-13 years. All participants underwent basic audiological assessment, auditory brainstem response, and then DDT-IT. RESULTS Results under free recall and directed attention conditions were similar for right and left ears, and there were no sex or age effects. CONCLUSIONS The Italian version of DDT (DDT-IT) has been developed and its performance on 39 normal-hearing Italian children was assessed. We found there were no age or sex effects for either the free recall condition or the directed attention condition.

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.

Holistic assessment of cochlear implant outcomes using the international classification of functioning disability and health model: data analysis of a longitudinal prospective multicenter study.

PURPOSE: To study outcome after cochlear implantation using the Cochlear Implant (CI) outcome assessment protocol based on the International Classification of Functioning, Disability and Health (ICF) model (CI-ICF). METHODS: Raw data of a prospective, longitudinal, multicenter study was analyzed. Seventy-two CI candidates were assessed preoperatively and six months postoperatively using the CI-ICF protocol. Following tools were used: (1) Work Rehabilitation Questionnaire (WORQ), (2) Abbreviated Profile of Hearing Aid Benefit (APHAB), (3) Audio Processor Satisfaction Questionnaire (APSQ), (4) Speech, Spatial, and Qualities of Hearing Scale (SSQ12), (5) Hearing Implant Sound Quality Index (HISQUI19), (6) Nijmegen CI Questionnaire (NCIQ) (7) pure tone audiometry, (8) speech audiometry, (9) sound localization. RESULTS: There was a significant improvement of speech discrimination in quiet (p = 0.015; p < 0.001) and in noise (p = 0.041; p < 0.001), sound detection (p < 0.001), tinnitus (p = 0.026), listening (p < 0.001), communicating with-receiving-spoken messages (p < 0.001), conversation (p < 0.001), family relationships (p < 0.001), community life (p = 0.019), NCIQ total score and all subdomain scores (p < 0.001). Subjective sound localization significantly improved (p < 0.001), while psychometric sound localization did not. There was no significant subjective deterioration of vestibular functioning and no substantial change in sound aversiveness. CI users reported a high level of implant satisfaction postoperatively. CONCLUSION: This study highlights the positive impact of cochlear implantation on auditory performance, communication, and subjective well-being. The CI-ICF protocol provides a holistic and comprehensive view of the evolution of CI outcomes.

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.

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.

Effectiveness of transcutaneous vagus nerve stimulation for the treatment of tinnitus: an interventional prospective controlled study.

OBJECTIVES: The aim of this interventional non-randomised prospective controlled study was to assess the effectiveness of transcutaneous vagus nerve stimulation (tVNS) in human subjects with tinnitus. DESIGN: The ParasymTM tVNS device was paired with an auditory stimulation. Treatment and observations were conducted over 12 weeks. Audiological evaluation was performed. Responses from a set of questionnaires and quantitative electroencephalography (qEEG) before and after treatment were collected. Voice measurements were done to assess possible side-effects of tVNS. STUDY SAMPLE: The study involved 29 adults who had chronic tinnitus (15 patients who underwent tVNS paired with sounds and a control group of 14 patients who did not). RESULTS: In general, subjective and objective measurements of tinnitus showed no improvement in the study group compared to the controls, although certain parameters as gauged by the questionnaires did statistically improve. The loudness and frequency of tinnitus remained the same in both groups. For the qEEG, activity in the theta band increased significantly in the study group compared to the control group. CONCLUSIONS: The tVNS was not effective in reducing tinnitus symptoms in our study group. However, changes in the theta band suggest there might be cortical effects that might, with sustained treatment, lead to improvements.

Outcomes of Cochlear Implantation Using FLEX26 Electrode: Audiological Results and Quality of Life after 12 Months.

INTRODUCTION: The electrode length is one of the many factors impacted on results of cochlear implantation. Among lateral wall flexible electrode arrays the latest one is FLEX26 (MED-EL GmbH, Innsbruck, Austria). The main aim of the study was to evaluate the preservation of residual hearing, the level of speech understanding, and quality of life after cochlear implantation with FLEX26 electrode array. METHODS: The study was conducted in a tertiary referral centre. Fifty-two patients implanted unilaterally with FLEX26, including 10 EAS patients (electric acoustic stimulation) and 42 ES patients (electric stimulation). The intervention was minimally invasive cochlear implantation via the round window. Pure-tone audiometry (0.125-8 kHz) was performed preoperatively and at 1, 6, and 12 months postoperatively. Twelve-month hearing preservation was established using HEARRING group formula. Quality of life was measured with AQoL-8D (Assessment of Quality of Life-8 Dimensions) pre- and postoperatively. RESULTS: Residual hearing was preserved in 88.8% EAS patients. Quality of life was significantly better postoperatively in comparison to preoperative period (the effect size for overall quality of life was 0.49). Especially, it increased in relationships and senses dimensions (the effect sizes 0.47 and 0.44, respectively). CONCLUSION: Preservation of residual hearing can be achieved in the majority of patients implanted with FLEX26. Improvement of quality of life was also documented. FLEX26 seems to be an option for surgeons who seek an electrode providing sufficient cochlear coverage.

Electrophysiological Testing for an Auditory Processing Disorder and Reading Performance in 54 School Students Aged Between 8 and 12 years.

BACKGROUND Learning to read and write depends on the effective functioning of various sensory systems, including the auditory system. Auditory information processing involves behavioral and electrophysiological processes. Electrophysiological procedures are used to investigate activity in the auditory pathway in response to sound stimuli, and the associated cortical activity in discrimination, integration, and attention. The study evaluated electrophysiological testing for an auditory processing disorder and reading performance in 54 school students aged between 8 and 12 years. MATERIAL AND METHODS The study involved 54 public school students aged between 8 and 12 years, who were divided into a study group and control group. All children underwent basic audiological assessment, rating of reading and writing ability, non-verbal intelligence, auditory brainstem response, long-latency auditory-evoked potentials (LLAEP), frequency following responses (FFR), and auditory training (AT). RESULTS The basic audiological evaluation showed a statistically significant difference between groups only for the frequency of 6 kHz. The LLAEP response had a statistically significant difference between groups for N1 latency, P300 latency, and amplitude. Finally, there was a statistically significant difference between pre-AT and post-AT to LLAEP for latencies of P2, N2, and P300 and amplitudes of N2 and P300, and to FFR for latency of wave C. CONCLUSIONS This study showed that electrophysiological tests are sensitive tools for identifying deficits in the auditory pathway. Moreover, latency measures can detect improvements from an auditory training program. In this way, an auditory intervention program might help children with reading and writing difficulties.

New technology can benefit established middle ear implant users: Samba 2 vs previous models of audio processors for Vibrant Soundbridge.

INTRODUCTION: The Vibrant Soundbridge (VSB) is a semi-implantable hearing aid for patients with various types of hearing loss and has been available for over 25 years. Recently, new audio processors with advanced signal processing, noise reduction, and multi-microphone technology have appeared. The aim of this study is to compare the benefits of using the newest Samba 2 processor to the previous generation processors in a group of experienced VSB users. METHODS: There were 22 experienced VSB users (mean time of using VSB was 9 years, SD = 2) who had their processor (D404 or Amadé) upgraded to the newest model (Samba 2). The mean age of the subjects was 56 years (SD = 20). Assessments were made by free-field audiometry, speech reception in quiet and noise, and Patient-Reported Outcome Measures (PROMs). RESULTS: Hearing tests in free field showed statistically significant improvements in hearing sensitivity and speech discrimination in quiet and noise with the Samba 2 audio processor compared to the earlier technology. PROMs confirmed the benefits of using the newest audio processor and there was more satisfaction in terms of usability. CONCLUSIONS: Access to modern technology for VSB patients provides measurable benefits.

Can an individual with low frequency hearing in the candidate ear benefit from a cochlear implant even if they have normal hearing in the other ear?

PURPOSE: To determine hearing preservation and subjective benefit after cochlear implant (CI) surgery in patients with low frequency hearing in the ear to be implanted (i.e., they have partial deafness, PD) and close to normal hearing in the other. METHODS: There were two study groups. The test group was made up of 12 adult patients (mean age 43.4 years; SD 13.6) with normal hearing or mild hearing loss in one ear, and with PD in the ear to be implanted. The reference group consisted of 12 adult patients (mean age 44.5 years; SD 14.1) who had PD in both ears and who underwent unilateral implantation in their worse ear. Hearing preservation was assessed 1 and 14 months after CI surgery using the Skarzynski Hearing Preservation Classification System. The APHAB questionnaire was used to evaluate the benefit from the CI. RESULTS: The differences in HP% between the groups were not significant: mean hearing preservation (HP%) in the test group was 82% one month after CI surgery and 75% some 14 months after implantation; corresponding results in the reference group were 71% and 69%. However, on the APHAB background noise subscale, the benefit in the test group was significantly larger than in the reference group. CONCLUSION: To a large extent it was possible to preserve low-frequency hearing in the implanted ear. This means that individuals with low frequency hearing in the implanted ear (partial deafness) and with normal hearing in the other generally received more benefits from cochlear implantation than did patients with partial deafness in both ears. We conclude that residual low frequency hearing in the ear to be implanted should not be considered a contraindication for a CI in a patient with single-sided deafness.

Differential item functioning of the tinnitus handicap inventory across gender groups and subjects with or without hearing loss.

OBJECTIVES: Tinnitus is a phantom sound sensation without an external sound source. Due to its subjective and multifaceted nature it is measured using multi-item self-reported instruments. Many well-validated tinnitus-related questionnaires are available for clinical practice and scientific research, but so far no attention has been paid to their measurement invariance. The study aimed to examine measurement invariance of the Tinnitus Handicap Inventory with regard to gender and hearing impairment, and to identify the items that show differential item functioning (DIF) across the groups. DESIGN: This is a retrospective study using medical data from patients with tinnitus. They completed the Tinnitus Handicap Inventory (THI) and underwent pure-tone audiometry. STUDY SAMPLE: 1106 adult patients with tinnitus (554 women and 552 men; 320 with normal hearing and 786 with hearing loss), aged 19-84 years. RESULTS: In the analysis, multi-group confirmatory factor analysis, hybrid ordinal logistic regression, Kernel smoothing in Item Response Theory, and lasso regression were applied. Measurement invariance was demonstrated across gender, but across hearing status the measurement was non-invariant. Five items were found to have DIF. CONCLUSIONS: Researchers and clinicians should be aware of the potential risk of response bias when tinnitus severity is evaluated.

Audiometric and Self-Reported Outcomes in Patients with Otosclerosis and a Small Air-Bone Gap after Stapes Surgery.

INTRODUCTION: The main determinant in deciding on stapes surgery in patients with otosclerosis is the degree of hearing loss, specifically the size of the preoperative air-bone gap (ABG). The debate over the minimum ABG centers on the risk-to-benefit ratio of stapes surgery in patients with small ABG (sABG). The aim of this study was to measure the audiological outcomes and self-assessed satisfaction in a group of otosclerosis patients with an sABG who underwent stapedotomy. METHODS: There were 83 patients with preoperative sABG ≤25 dB HL (mean of 500, 1,000, 2,000, 4,000 Hz) included in this study. Audiometry was performed before surgery and 6 months and 12-36 months after surgery. Self-reported patient outcomes before and after surgery were collected using questionnaires. RESULTS: At the 6-month follow-up, the ABG was closed within 10 dB in 63 (78.8%) cases. Preoperatively, tinnitus was present in 70% of patients, of which 66% reported that tinnitus was a moderate or severe problem. Postoperatively, 71% of patients experienced a significant reduction in tinnitus severity and 34% of them reported complete disappearance. The self-report outcomes relating to quality of life and hearing reflected a good level of satisfaction in most patients. CONCLUSION: The possibility of reducing bothersome tinnitus after stapes surgery, and thus improving the patient's quality of life, should be taken into account when making a decision on stapes surgery in these patients.

A Systematic Review of the Literature Between 2009 and 2019 to Identify and Evaluate Publications on the Effects of Age-Related Hearing Loss on Speech Processing.

Changes in central auditory processing due to aging in normal-hearing elderly patients, as well as age-related hearing loss, are often associated with difficulties in speech processing, especially in unfavorable acoustic environments. Speech processing depends on the perception of temporal and spectral features, and for this reason can be assessed by recordings of phase-locked neural activity when synchronized to transient and periodic sound stimuli frequency-following responses (FFRs). An electronic search of the PubMed and Web of Science databases was carried out in July 2019. Studies that evaluated the effects of age-related hearing loss on components of FFRs were included. Studies that were not in English, studies performed on animals, studies with cochlear implant users, literature reviews, letters to the editor, and case studies were excluded. Our search yielded 6 studies, each of which included 30 to 94 subjects aged between 18 and 80 years. Latency increases and significant amplitude reduction of the onset, offset, and sloop V/A components of FFRs were observed. Latency and amplitude impairment of the fundamental frequency, first formant, and high formants were related to peripheral sensorineural hearing loss in the elderly population. Conclusions: Temporal changes in FFR tracing were related to the aging process. Hearing loss also impacts the envelope fine structure, producing poorer speech comprehension in noisy environments. More research is needed to understand aspects related to hearing loss and cognitive aspects common to the elderly.

Latency and Interpeak Interval Values of Auditory Brainstem Response in 73 Individuals with Normal Hearing.

BACKGROUND Auditory brainstem response (ABR) potential is important for audiological diagnosis, reflecting the integrity of the structures of the auditory system up to the brainstem. The click stimulus is the best known and is most used in clinical practice. However, different devices and examiners may yield distinct results, and each institution tends to use its own parameters. We aimed to analyze the latency values of wave I, III, V, and interpeak intervals I-III, III-V, I-V values obtained in assessing ABR using a new device. MATERIAL AND METHODS We performed a cross-sectional study of 73 participants with normal hearing thresholds and no hearing problems. All underwent basic audiological (air and bone conduction, Speech Recognition Threshold, Speech Recognition Index, acoustic reflex, and tympanometry) and electrophysiological evaluation (ABR assessment). RESULTS Absolute latency and interpeak values from ABR showed earlier responses in women, faster than international standards suggest. The responses were similar to other studies carried out previously, with the exception of wave I values, which were a little earlier in females. CONCLUSIONS We assessed normative data from measurement of latency values of wave I, III, V, and interpeak intervals I-III, III-V, and I-V applying 2 standard deviations in the assessment of ABR using the new Neuro-Audio/ABR device created by Neurosoft.

Implantation of two generations of Bonebridge after mastoid obliteration with bioactive glass S53P4.

PURPOSE: After radical surgery for chronic cholesteatoma (CWD mastoidectomy), patients have the option to have the posterior wall of their external auditory canal surgically reconstructed with S53P4 bioactive glass. The procedure eliminates some of the restrictions related to having a postoperative cavity and extends the options for a hearing prosthesis. If classic reconstruction is not possible and a hearing aid is not used, we suggest use of a Bonebridge implant. METHODS: This study describes, over 18 months of follow-up, 16 patients after a two-stage surgical procedure: obliteration of the mastoid cavity with bioactive glass followed by Bonebridge implantation. There were 7 patients who received the first generation implant (BCI 601) and 9 who used the second (BCI 602). Before and after implantation, pure tone audiometry, sound field thresholds, and free-field audiometry were performed. Speech reception thresholds in noise were assessed using the Polish Sentence Matrix Test. Subjective assessment of benefits was done using the APHAB (Abbreviated Profile of Hearing Aid Benefit) questionnaire. RESULTS: During the observation period, no serious complications were found. The study demonstrated the safety and validity of the procedures and confirmed the safety of using S53P4 bioactive glass in otosurgery (antibacterial effect, nonrecurrence of cholesteatoma, and no effect on the inner ear). The audiological benefits expected from using the Bonebridge implant processor were also confirmed. CONCLUSION: It is concluded that, after reconstructing the posterior wall of the external auditory canal with bioactive glass, two-stage implantation of a Bonebridge implant in a typical site is a safe solution for patients who have difficult anatomical conditions following their CWD mastoidectomy.

Validation of AQoL-8D: a health-related quality of life questionnaire for adult patients referred for otolaryngology.

PURPOSE: The purpose of the study was to validate the AQoL-8D questionnaire in the adult population of patients referred to an otolaryngology clinic. METHODS: AQoL-8D was translated into Polish. 463 patients (age18-80 years) with otolaryngological conditions were assessed with the AQoL-8D, SF-6D, and SWLS questionnaires. We investigated the item content-relevance, factor structure by means of Confirmatory Factor Analysis, corrected item-total correlations, Cronbach's alpha, Pearson correlation of the AQoL-8D scores with results from SF-6D and from the SWLS questionnaires. Finally, ANOVA was used to test the AQoL-8D ability to group the HRQoL of patients in terms of their otolaryngological management type. RESULTS: The median score of item content-relevance was 5.0 for all AQoL-8D items. Confirmatory Factor Analysis revealed the following fit indices: Comparative Fit Index = 0.81; Tucker-Lewis Index = 0.80; and Root Mean Square Error of Approximation = 0.07. Cronbach's alpha for AQoL-8D dimensions ranged from 0.48 to 0.79. Mean item-total correlations over all dimensions, super dimensions, and the instrument overall were higher than 0.3. There was a significant Pearson correlation between the results obtained with AQoL-8D and SF-6D (r = 0.68), and with AQoL-8D and SWLS (r = 0.43). A one-way ANOVA showed a significant effect of management type on HRQoL as measured by AQoL-8D [F(4,458) = 6.12, p < 0.001] CONCLUSION: AQoL-8D provides valid and reliable measures of HRQoL in patients undergoing otolaryngological treatment. Because it is a generic questionnaire, it is possible to make general comparisons of otolaryngology outcomes with those from other subspecialties.

Evaluation of the Bonebridge BCI 602 active bone conductive implant in adults: efficacy and stability of audiological, surgical, and functional outcomes.

PURPOSE: (1) To assess the effectiveness and safety of a bone-conduction implant, the Bonebridge BCI 602, in adults with conductive or mixed hearing loss. (2) To investigate whether the Bonebridge BCI 602 is at least as effective as the Bonebridge BCI 601 in such patients. METHODS: The study group included 42 adults who had either conductive or mixed hearing loss. All patients underwent Bonebridge BCI 602 implant surgery. Before and after implantation, pure-tone audiometry, speech recognition tests (in quiet and noise), and free-field audiometry were performed. Word recognition scores were evaluated using the Polish Monosyllabic Word Test. Speech reception thresholds in noise were assessed using the Polish Sentence Matrix Test. Subjective assessment of benefits was done using the APHAB (Abbreviated Profile of Hearing Aid Benefit) questionnaire. RESULTS: The APHAB questionnaire showed that difficulties in hearing decreased after BCI 602 implantation. Both word recognition in quiet and speech reception threshold in noise were significantly better after BCI 602 implantation and remained stable for at least 12 months. A significant advantage of the device is a reduced time for surgery while maintaining safety. In this study, the mean time for BCI 602 implantation was 28.3 min ± 9.4. CONCLUSIONS: The second-generation Bonebridge BCI 602 implant is an effective hearing rehabilitation device for patients with conductive or mixed hearing loss. Patient satisfaction and audiological results confirm its efficacy and safety. Its new shape and dimensions allow it to be used in patients previously excluded due to insufficient or difficult anatomical conditions. The new BCI 602 implant is as effective as its predecessor, the BCI 601.

The COVID-19 pandemic and upgrades of CI speech processors for children: part II-hearing outcomes.

PURPOSE: To gauge the benefits to children of upgrading speech processors during the COVID-19 pandemic. METHODS: The study involved 297 children, aged from 7.3 to 18.0 years, whose processors were upgraded to either Nucleus 7 or Kanso 2, or to Sonnet 2 or Rondo 3. To document the benefits of the upgrades, a speech-in-noise discrimination test and Patient Reported Outcome Measures (PROMs) were used. RESULTS: There was a significant benefit from the newer processors in terms of speech discrimination in noise. Patient Reported Outcome Measures (PROMs) indicated less hearing disability, a higher level of functioning in everyday life situations, and more satisfaction with the new speech processor in social situations. CONCLUSION: There is a measurable improvement in performance when the devices are upgraded to the new technology.

The COVID-19 pandemic and upgrades of CI speech processors for children: part I-procedure of speech processor upgrade.

PURPOSE: To demonstrate the feasibility of upgrading speech processors during the COVID-19 pandemic. METHODS: Adopting concepts from "lean thinking", we optimized hospital workflows to allow speech processors to be upgraded despite the obstacles arising from national guidelines for COVID-19 prevention. The study involved 297 children, aged from 7.3 to 18.0 years, whose processors were upgraded on five consecutive Saturdays during a time of peak COVID-19 in Poland. RESULTS: The optimized workflow allowed us to conduct speech processor upgrades during a time of peak COVID-19 in Poland. The upgrades were conducted as scheduled, patient flow was smooth, appropriate social distancing was kept, and no reports of COVID-19 infection in our patients in the 2 weeks after their visit were received. CONCLUSION: Upgrading of speech processors in children is still feasible under coronavirus conditions.