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.

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.

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.

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.

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.

Auditory processing in normally hearing individuals with and without tinnitus: assessment with four psychoacoustic tests.

PURPOSE: In most cases, tinnitus co-exists with hearing loss, suggesting that poorer speech understanding is simply due to a lack of acoustic information reaching the central nervous system (CNS). However, it also happens that patients with tinnitus who have normal hearing also report problems with speech understanding, and it is possible to suppose that tinnitus is to blame for difficulties in perceptual processing of auditory information. The purpose of the study was to evaluate the auditory processing abilities of normally hearing subjects with and without tinnitus. METHODS: The study group comprised 97 adults, 54 of whom had normal hearing and chronic tinnitus (the study group) and 43 who had normal hearing and no tinnitus (the control group). The audiological assessment comprised pure-tone audiometry and high-frequency pure-tone audiometry, impedance audiometry, and distortion product oto-acoustic emission assessment. To evaluate possible auditory processing deficits, the Frequency Pattern Test (FPT), Duration Pattern Test (DPT), Dichotic Listening Test (DLT), and Gap Detection Threshold (GDT) tests were performed. RESULTS: The tinnitus subjects had significantly lower scores than the controls in the gap detection test (p < 0.01) and in the dichotic listening test (p < 0.001), but only for the right ear. The results for both groups were similar in the temporal ordering tests (FPT and DPT). Right-ear advantage (REA) was found for the controls, but not for the tinnitus subjects. CONCLUSION: In normally hearing patients, the presence of tinnitus may be accompanied with auditory processing difficulties.

How to Interpret Tinnitus Functional Index Scores: A Proposal for a Grading System Based on a Large Sample of Tinnitus Patients.

OBJECTIVES: The Tinnitus Functional Index (TFI) is considered the gold standard in measuring tinnitus severity. The aim of the study was to establish reference values to improve the interpretability of TFI scores. DESIGN: Results from 1114 patients with tinnitus were retrospectively analyzed. The participants were consecutive patients who attended our tertiary referral Ear, Nose, and Throat Center. The eligibility criteria were: at least 18 years old, persistent tinnitus, completed pure-tone audiometry, and answered all 25 items on the TFI. Hearing status (normal hearing vs. hearing impairment) was established according to the recommendation of the Bureau International d'Audiophonologie. Means (M) and SD on the TFI were the basis for grading tinnitus severity on four levels: low, lower moderate, upper moderate, and high. To gauge individual scores in clinical practice, percentiles are also proposed. RESULTS: All 1114 patients (586 women and 528 men) were Caucasian and aged from 19 to 87 years (M = 50.96; SD = 13.10 years). Tinnitus duration ranged from 0.5 to 50 years (M = 7.17; SD = 7.71 years). There were 258 patients with normal hearing and 856 patients with hearing loss. A score of above 65 points on TFI was established as the cutoff point for diagnosing high tinnitus severity. A regression model associating tinnitus severity with gender, age, tinnitus duration, and hearing loss was statistically significant: F(4,1109) = 8.99; p < 0.001, but the effect was very small (R2adj = 0.028) and only gender and age were associated with TFI global score, while tinnitus severity was not related to tinnitus duration or hearing loss. CONCLUSIONS: The reference values proposed here support those reported previously by Meikle et al. They are empirically based and can be used as benchmarks in clinical practice and scientific research. They make it possible to assess tinnitus severity, evaluate individual scores, and categorize individuals with tinnitus. This allows researchers to set inclusion or exclusion criteria when assigning patients to specific groups during clinical trials involving tinnitus intervention strategies.

Can preoperative results predict the need for future reintervention following injection laryngoplasty for unilateral vocal fold paralysis?

PURPOSE: The objective was to investigate whether a patient's preoperative test results can predict the need for future reoperation in unilateral vocal fold paralysis (UVFP). METHODS: A single-centre retrospective study was performed. The study group consisted of 18 patients with UVFP who had been treated with injection laryngoplasty but who required further treatment and were augmentated again within 36 months. The control group consisted of 33 injected patients who had not required reintervention up to 36 months later. RESULTS: Only glottal gap was associated with a relative risk for reinjection. Glottal gap was found to be severe in 77.8% of the patients from the study group compared to 42.4% of the controls, and the difference was statistically significant. The kind of injected material (calcium hydroxylapatite or hyaluronic acid), age, and voice assessment (perceptual, objective, or subjective) did not seem to affect the likelihood of reoperation being needed. There were no between-group statistically significant differences in individual aspects of the GRBAS scale. The global score was slightly higher in the study group, but it did not reach statistical significance (U = 198.5; p = 0.09). A comparison of VHI scores did not yield statistically significant differences between the study and control groups. No significant differences in objective acoustic voice parameters were observed between the groups. CONCLUSION: Only glottal gap occurred to be associated with a relative risk for reinjection. A kind of injected material (CaHA or HA), age, perceptual, objective and subjective voice assessment do not seem to impact the likelihood of reoperation in patients with UVFP.

Two-phase survey on the frequency of use and safety of MRI for hearing implant recipients.

PURPOSE: Magnetic resonance imaging (MRI) is often used to visualize and diagnose soft tissues. Hearing implant (HI) recipients are likely to require at least one MRI scan during their lifetime. However, the MRI scanner can interact with the implant magnet, resulting in complications for the HI recipient. This survey, which was conducted in two phases, aimed to evaluate the safety and performance of MRI scans for individuals with a HI manufactured by MED-EL (MED-EL GmbH, Innsbruck, Austria). METHODS: A survey was developed and distributed in two phases to HEARRING clinics to obtain information about the use of MRI for recipients of MED-EL devices. Phase 1 focused on how often MRI is used in diagnostic imaging of the head region of the cochlear implant (CI) recipients. Phase 2 collected safety information about MRI scans performed on HI recipients. RESULTS: 106 of the 126 MRI scans reported in this survey were performed at a field strength of 1.5 T, on HI recipients who wore the SYNCHRONY CI or SYNCHRONY ABI. The head and spine were the most frequently imaged regions. 123 of the 126 scans were performed without any complications; two HI recipients experienced discomfort/pain. One recipient required reimplantation after an MRI was performed using a scanner that had not been approved for that implant. There was only one case that required surgical removal of the implant to reduce the imaging artefact. CONCLUSION: Individuals with either a SYNCHRONY CI or SYNCHRONY ABI from MED-EL can safely undergo a 1.5 T MRI when it is performed according to the manufacturer's safety policies and procedures.

Prevalence of tinnitus in a sample of 43,064 children in Warsaw, Poland.

OBJECTIVE: Tinnitus affects both adults and children. Children rarely complain spontaneously of tinnitus, and their parents are not aware of the condition. The prevalence of tinnitus in children differs considerably between studies, and large studies are needed to reliably estimate how many children experience tinnitus symptoms. The goal of the study was to estimate the prevalence of tinnitus in a large sample of schoolchildren. DESIGN: This study was population-based, epidemiological research, conducted in the general, paediatric population of school-age children in Warsaw, Poland. Pure-tone audiometric testing was done, and hearing thresholds were determined from 0.5 to 8 kHz. Both the children and parents answered questions about the presence of tinnitus in the child. STUDY SAMPLE: Results from 43,064 children aged 11 to 13 years old, as well as their parents, were collected. RESULTS: The study showed that tinnitus affected 3.1% of the children, but it was significantly more frequent (9%) in children with hearing loss. We found that 1.4% of the parents were aware of the presence of tinnitus in their children. CONCLUSIONS: Children should be routinely asked whether they experience tinnitus and if so, they should be included in the thorough assessment and management of the condition.

Three-year audiological outcomes of the latest generation middle ear transducer (MET) implant.

PURPOSE: To evaluate the long-term audiological outcomes and safety of the latest generation of middle ear transducer (MET) among a group of Polish patients. METHODS: Ten patients aged 48-72 years with bilateral sensorineural hearing loss (n = 8) and mixed hearing loss (n = 2) were included in this study. Pure tone audiometry, sound thresholds, word recognition scores in quiet and speech reception thresholds in noise were assessed. Medical and technical complication information was gathered. RESULTS: All the patients underwent unilateral implantation with the latest generation Cochlear MET between 2014 and 2016. Mean length of follow-up was 3.7 years. Compared to the unaided condition, the implant provided significant functional gain (mean M = 26.1 dB) at 12 months follow-up. Compared to before surgery, average word recognition in quiet at 65 dB and at 80 dB SPL, as well as speech reception threshold in noise, were significantly better at 12 months. However, postoperative air conduction thresholds 6 months after implantation worsened by 10.3 dB (standard deviation SD = 5.8 dB). Postoperatively, three patients had skin problems around the processor, and one of them completely resigned from using the device 5 months after activation. Technical failures occurred in 4 cases. There were 9 out of 10 patients who still used the MET, but only 5 of them used the processor regularly (every day). CONCLUSION: Despite changes in the transducer implemented by the manufacturer, we observed a significant number of adverse events in users of the latest generation of MET.

A revised grading system for the Tinnitus Handicap Inventory based on a large clinical population.

Objective: Tinnitus Handicap Inventory (THI) is one of the world's most commonly used tools to assess tinnitus severity. The aim of the current study was to establish a revised THI grading system using standard Z-scores and percentiles.Design: Cross-sectional observational study.Study sample: Adult patients (1042 participants - 518 (49.7%) female and 524 (50.3%) male) reporting tinnitus duration of a minimum of 6 months with complete documentation on patient's clinical status (age, gender, tinnitus duration and laterality, tinnitus handicap based on THI and hearing status based on pure-tone audiometry) were included in the study.Results: Multivariate analysis of variance was used to analyse the effects of gender and hearing loss on THI scores and revealed there was a significant effect of both. Consequently, separate grading systems for women and men, as well as for subjects with normal hearing and hearing loss, is proposed.Conclusions: Our findings are generally consistent with existing grading. Normative values proposed for THI scores, based on a large group of tinnitus patients, could be useful to guide decisions about appropriate intervention options or to evaluate treatment outcomes.

The Bonebridge in Adults with Mixed and Conductive Hearing Loss: Audiological and Quality of Life Outcomes.

BACKGROUND: Considering that hearing loss has a significant impact on social functioning, everyday activity and a person's emotional state, one of the most important goals of hearing rehabilitation with bone conduction devices is improvement in a patient's quality of life. OBJECTIVES: To measure self-assessed quality of life in patients implanted with the Bonebridge, a bone conduction device. METHOD: Prospective, observational, longitudinal study with one treatment group. Twenty-one patients with mixed or conductive hearing loss were included, and each individual served as its own control. The Abbreviated Profile of Hearing Aid Benefit (APHAB) was used to measure patient-reported quality of life before intervention and at 3 and 6 months after activation of the device. At the same time frames, pure-tone audiometry and speech understanding in quiet and in noise were tested. RESULTS: Hearing-specific quality of life increased significantly after intervention and remained stable up to 6 months. Both word recognition in quiet and speech reception threshold in noise were significantly better after 6 months compared to before surgery. Outcomes of aided speech understanding were independent of initial bone conduction thresholds and equally high (word recognition score >75%) across the device's indication range. CONCLUSIONS: The Bonebridge provides not only significant audiological benefit in both speech understanding in quiet and in noise, but also increases self-perceived quality of life in patients suffering from mixed and conductive hearing loss. Together with a very low rate and minor nature of adverse events, it is the state-of-the-art solution for hearing rehabilitation in patients with mixed or conductive hearing loss up to a bone conduction threshold of 45 dB HL.

Effect on vestibular function of cochlear implantation by partial deafness treatment-electro acoustic stimulation (PDT-EAS).

PURPOSE: Although the cochlear implantation procedure does not interfere with vestibular structures directly, both the vestibulum and the cochlea share the same inner ear fluid space, and this fluid may be responsible for transferring possibly damaging forces from one to the other. The purpose of the study is to assess postoperative vestibular function after partial deafness treatment-electro-acoustic stimulation (PDT-EAS) cochlear implantation. METHODS: Fifty-five patients were included in the study (30 females, 25 males, age 11-80, mean 41.8 ± 19.35). cVEMP and oVEMP were performed preoperatively and 1-3 months after cochlear implantation. Caloric and vHIT tests were conducted preoperatively and 4-6 months after cochlear implantation. RESULTS: Our study shows that, based on a wide range of electrodes, use of PDT-EAS is protective in terms of preserving vestibular function. It gives a rate of saccular damage of 15.79%, utricular damage of 19.04%, and a horizontal semicircular canal response reduction of 15.79%. CONCLUSIONS: PDT-EAS is protective in terms of preserving vestibular function. Nevertheless, it should be emphasized that the risk of vestibular damage cannot be totally eliminated even when hearing preservation techniques are adopted.

Prevalence and severity of tinnitus in Polish otosclerosis patients qualified for stapes surgery.

PURPOSE: To assess the prevalence and severity of tinnitus among a group of Polish patients with otosclerosis who qualified for stapes surgery. A secondary objective was to gauge the relationship between tinnitus severity and hearing thresholds. METHODS: Based on the eligibility criteria, 460 adults with otosclerosis (236 women, 134 men) were included in the study. The Tinnitus Functional Index (TFI) was used to assess tinnitus severity. Hearing thresholds for air and bone conduction were established using clinical pure-tone audiometry in a soundproof cabin. RESULTS: Based on the medical interview, tinnitus was the first symptom of otosclerosis in 35% of the participants and 65% of all patients with otosclerosis experienced clinically significant, chronic tinnitus before stapes surgery. For 59% of patients, tinnitus was a significant or severe problem. The degree of hearing loss seemed to be marginally related to the severity of tinnitus reported by the patient. CONCLUSIONS: Tinnitus is a common complaint among patients with otosclerosis, being a significant or severe problem for more than half of them. For this reason, it is worth considering in the future the implementation of standardized questionnaires for the assessment of tinnitus severity as a routine procedure in the diagnostic process of patients with otosclerosis, as well as in the postoperative period, which will be the next stage of our study.

Changes in Hearing Threshold and Tinnitus Severity after Stapes Surgery: Which Is More Important to the Patient's Quality of Life?

BACKGROUND: Stapes surgery is a common method of treatment of otosclerosis, and its effectiveness is reported based on audiometric hearing thresholds. Audiometric tests do not gauge the impact of tinnitus severity and auditory function on quality of life (QOL) after stapes surgery. OBJECTIVE: To measure self-assessed QOL in otosclerosis patients after stapedotomy in terms of three major factors: change in audiometric hearing threshold, subjective hearing benefit, and tinnitus severity. METHOD: This prospective clinical study included 191 patients who underwent stapedotomy between April and October 2017 due to otosclerosis. All patients were tested by pure tone audiometry and filled in a questionnaire before surgery and 6 months afterwards. Subjective hearing was assessed with the Abbreviated Profile for Hearing Aid Benefit (APHAB); tinnitus severity was established using the Tinnitus Functional Index (TFI), and the QOL was measured by the Glasgow Benefit Inventory (GBI). RESULTS: Statistical analysis showed that the average GBI total score (mean = 33.7; SD = 23.7) was statistically significantly higher than zero (t = 19.7; p < 0.001). Based on a regression model, all the three variables studied - audiometric hearing thresholds change, APHAB change, and TFI change - had a significant effect on QOL after stapedotomy. Interestingly, the highest beta value (b = 0.040; p < 0.001) was for TFI change, implying that TFI change had the greatest effect on QOL. CONCLUSION: Although the improvement of QOL after stapes surgery undoubtedly depended on improvement in both audiometric and self-reported hearing, the reduction of tinnitus severity had the greatest impact on increase in QOL.

Electro-Natural Stimulation in Partial Deafness Treatment of Adult Cochlear Implant Users: Long-Term Hearing Preservation Results.

BACKGROUND: Due to the constant development of technology and medicine, the eligibility criteria for cochlear implantation (CI) are undergoing gradual expansion. OBJECTIVES: To provide long-term hearing preservation (HP) results for partial deafness treatment (PDT) of a group of adults using electro-natural stimulation (ENS). METHODS: We examined a database of medical records of patients who underwent CI in a single ENT center. We identified 12 adults (3 men and 9 women) who fitted the PDT-ENS classification. To calculate HP, we used the -HEARRING consensus and conducted statistical analyses using SPSS v24. RESULTS: In the long-term follow-up, 7 of 12 patients had complete HP and the remaining 5 had partial HP. None of the patients experienced significant hearing impairment. A significant improvement in speech understanding in both quiet and noise conditions was also observed. CONCLUSIONS: The use of minimally invasive surgery leads to excellent HP results in PDT-ENS patients, enabling them to enjoy the benefits of good speech discrimination which they would be unable to get from traditional hearing aids. Our findings support extending the inclusion criteria for CI to include this new group of patients who would otherwise obtain only limited benefit from conventional hearing aids.

Audiological and clinical outcomes of a transcutaneous bone conduction hearing implant: Six-month results from a multicentre study.

OBJECTIVES: To compare the hearing performance of patients with conductive and mild mixed hearing loss and single-sided sensorineural deafness provided with a new transcutaneous bone conduction hearing implant (the Baha Attract System) with unaided hearing as well as aided with a sound processor on a softband. Furthermore, to evaluate safety and subjective benefit before and after implantation of the test device. PARTICIPANTS: Fifty-four adult patients in five participating centres were enrolled in this prospective study. Baseline data were collected during a pre-operative visit, and after a softband trial, all patients were implanted unilaterally. Follow-up visits were scheduled at 10 days, 4, 6, 12 weeks and 6 months. MAIN OUTCOME MEASURES: Free-field hearing thresholds pure-tone average (PTA4 in dB HL; mean threshold at 500, 1000, 2000, 4000 Hz; primary outcome measure). Individual free-field hearing thresholds, speech recognition in quiet and in noise, soft tissue status during follow-up and subjective benefit as measured with the Abbreviated Profile of Hearing Aid Benefit (APHAB), Speech, Spatial and Qualities of Hearing Scale (SSQ) and Health Utilities Index (HUI) questionnaires. RESULTS: Implantation of the Baha Attract System resulted in favourable audiological outcomes compared to unaided conditions. On the primary outcome parameter, a statistically significant improvement was observed compared to unaided hearing for the patients with conductive/mixed hearing loss (mean PTA4 difference -20.8 dB HL, SD 9.8; P < 0.0001) and for the patients with single-sided sensorineural deafness (SSD) (mean PTA4 difference -21.6 dB HL, SD 12.2; P < 0.0001). During all audiology tests, the non-test ear was blocked. Statistically significant improvements were also recorded in speech tests in quiet and noise compared to unaided hearing for the conductive/mixed hearing loss group and for speech in quiet in the SSD group. Compared to the pre-operative measurement with softband, no significant differences were recorded in the PTA4 free-field hearing threshold or the other audiological outcomes in either of the groups (P > 0.05). Soft tissue-related issues observed during follow-up included numbness, pain/discomfort at the implant site and to a lesser extent pressure-related skin complications. A declining trend was noted in the rate of these complications during follow-up. Approximately 20% of patients reported some degree of numbness and 38% (slight) pain/discomfort at final follow-up of 6 months. Good results on the subjective benefit questionnaires were observed, with statistically significant improvements on APHAB and SSQ questionnaires, and on the hearing attribute of HUI3. CONCLUSIONS: The Baha Attract System provided a significant improvement in hearing performance and subjective benefit compared to the pre-operative unaided condition (with the non-test ear blocked). Hearing performance of the Baha Attract was similar to a test situation with the same sound processor on a softband. A proportion of the patients reported numbness and pain/discomfort at the implant site during follow-up, especially during the first post-operative weeks. Based on the results of the current multicentre study, the Baha Attract can be considered as a treatment option for patients with the aforementioned hearing losses. Especially in the SSD patients, a careful selection procedure is warranted. Therefore, a pre-operative trial should be part of the decision-making process before fitting a patient with the Baha Attract System.