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.

The Oticon Ponto System in Adults With Severe-to-Profound and Mixed Hearing Loss: Audiologic Outcomes and Patient Satisfaction.

OBJECTIVE: To measure audiologic outcomes and self-assessed satisfaction with the Ponto system in a group of patients who had severe to profound and mixed hearing loss. STUDY DESIGN: Retrospective case review. SETTING: Tertiary referral center. PATIENTS: Sixteen patients aged 21 to 74 years with severe-to-profound and mixed hearing loss (bone conduction thresholds, ≥45 dB HL). INTERVENTIONS: Ponto implant surgery. MAIN OUTCOME MEASURES: Pure-tone audiometry, free-field hearing thresholds, effective gain, word recognition score in quiet, and speech reception threshold (SRT) in noise were assessed. Patient-reported outcomes were collected using the Clinical Global Impression Scale, Glasgow Benefit Inventory, and Abbreviated Profile of Hearing Aid Benefit. Information concerning any medical complications was also gathered. RESULTS: Both word recognition score and SRT were significantly better after 12 months compared with before surgery. At normal speech level (65 dB SPL), 12 of 16 users had speech discrimination ≥70%. However, at the 12-month follow-up, the average effective gain was -6.2 dB. In general, the self-report outcomes showed good satisfaction in most patients. Postoperatively, skin complications were noted in six patients, of whom two underwent reoperation. All patients were still using the Ponto after an average observation time of 2.7 years. CONCLUSION: Although skin complications were not uncommon, the Ponto system seems to be an effective method of improving hearing performance and provides subjective satisfaction in real-life situations in patients with severe-to-profound and mixed hearing loss. However, considering the significantly increased bone conduction thresholds and the risk of their further deterioration, long-term follow-up is still needed.

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.

Resumption of Cochlear Implant Surgery under COVID-19 Pandemic Conditions.

(1) Background: The novel coronavirus COVID-19 has been recognized by the World Health Organization as a public health emergency of international concern and has caused cancellation of elective cochlear implantation in many countries. This article sets out our experience with resuming cochlear implant (CI) surgery under COVID-19 conditions over a period of 3 months. In addition, early results of hearing preservation (HP) after CI surgery are presented; (2) Methods: We adopted epidemic management policies and procedures according to the National Consultant for Infectious Diseases recommendations. During preoperative visits, all patients were tested for COVID-19 with a RT-PCR test. One month postoperatively, HP values in the Partial Deafness Treatment (PDT) group of patients was established using the HEARRING group formula; (3) Results: Between January and March 2021, we performed 312 CI procedures in adult and pediatric patients. Of these, none were subsequently re-admitted to hospital and found to be COVID-19 positive. Postoperative audiometric results showed that complete or partial HP was achieved in more than half the PDT patients; (4) Conclusion: Cochlear implantation during the coronavirus disease pandemic is essential and, with careful planning, is perfectly feasible.

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.

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.

Prevalence and Severity of Tinnitus in Otosclerosis: Preliminary Findings from Validated Questionnaires.

OBJECTIVES: In addition to progressive hearing loss, subjective tinnitus is one of the primary symptoms of the otosclerosis development. The aim of this study was to evaluate the prevalence and severity of preoperative tinnitus among a group of consecutive adult patients with otosclerosis, using standardized research tools. MATERIALS AND METHODS: The study included 157 cases of clinical otosclerosis (106 women, 51 men). All patients were tested using pure-tone audiometry. The preoperative prevalence and severity of tinnitus were tested using three validated questionnaires: The Tinnitus and Hearing Survey (THS-POL), Tinnitus Handicap Inventory (THI-POL), and Tinnitus Functional Index (TFI-Pl). RESULTS: Preliminary results showed that 107 of 157 patients with otosclerosis (68.2%) had preoperative tinnitus. Of them, 51 (47.7%) had unilateral tinnitus (in the ear that qualified for stapes surgery), and 56 (52.3%) had bilateral tinnitus. The THS results showed that for 23.4% patients, tinnitus was a problem equal to or greater than hearing loss. The average result of the TFI-Pl questionnaire was 31.6 points, and for THI-POL, it was 38.6 points, indicating that preoperative tinnitus was moderately severe. The statistical analysis did not reveal a correlation between the tinnitus severity and audiometric results (p>0.05). The severity of tinnitus did not differ significantly between men and women (p>0.05), although the TFI-Pl and THI-POL questionnaires indicated that the tinnitus severity generally increased with age in women, while it decreased in men. CONCLUSION: This is a scientific study conducted to evaluate the prevalence and severity of preoperative tinnitus in Polish patients with otosclerosis, using three validated questionnaires.

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.

Hearing Preservation With the Use of Flex20 and Flex24 Electrodes in Patients With Partial Deafness.

OBJECTIVE: To evaluate the impact of electrode length on hearing preservation (HP) in Partial Deafness Treatment-Electrical Complement (PDT-EC) subjects. STUDY DESIGN: Retrospective case review. SETTING: Tertiary referral center. PATIENTS: Twenty-three PDT-EC patients (with preoperative air-conduction thresholds ≤30 dB up to 500 Hz) were divided into two groups: Flex20 electrode (Med-EL GmbH, Innsbruck, Austria) (12 patients) and Flex24 electrode (Med-EL GmbH, Innsbruck, Austria) (11 patients). INTERVENTIONS: All participants were subjected to minimally invasive cochlear implantation using the round window approach. MAIN OUTCOME MEASURE(S): Pure tone audiometry (125-8000 Hz) was performed preoperatively and at 1, 6, 12, and 24 months postoperatively. HP was established using the HEARRING group formula. Speech understanding was assessed preoperatively and at 12 and 24 months postoperatively. RESULTS: Analysis of HP for every individual indicates that more than half the patients with Flex20 and Flex24 had complete HP at 6 months follow-up. None of the patients from either group had complete loss of hearing. At activation, average air-conduction thresholds for low frequencies (125-500 Hz) were slightly better for the short electrode (M = 29.03) than for the long (M = 39.10) but the difference was not statistically significant (p = 0.067). The effect of electrode (Flex20 versus Flex24) was not significant in terms of pure tone audiometry and speech recognition at long-term follow-up. CONCLUSIONS: In the early postoperative period, complete HP was possible in a majority of patients from both groups, but slightly better HP outcomes were achieved by Flex20. In the long term, the length of the electrodes does not affect the degree of HP or speech understanding.

Tinnitus Severity Change Following Stapedotomy in Patients With Otosclerosis.

OBJECTIVE: To determine whether stapedotomy was effective in reducing tinnitus severity. In addition, the relationship between reduction in tinnitus and improvement in hearing after stapedotomy was analyzed. STUDY DESIGN: Prospective clinical study. SETTING: Tertiary referral center. PATIENTS: A group of 168 otosclerosis patients diagnosed with chronic tinnitus. INTERVENTION: Stapedotomy. MAIN OUTCOME MEASURES: The Tinnitus Functional Index questionnaire (TFI) was used to assess tinnitus severity before surgery, and at 3 and 6 months postoperatively. Pure-tone audiometry was conducted before surgery and 6 months postoperatively. RESULTS: The TFI Total score before the operation was M = 34.5 (standard deviation [SD] = 1.6) points, and decreased 3 months after stapedotomy to M = 17.5 (SD = 1.7), a statistically significant change (T = -8.200; p < 0.001). A weak correlation was found between the pre- and postoperative difference of TFI Total score and air-conduction thresholds (r = 0.21; p = 0.013) as well as between the TFI Total score and the size of the air-bone gap (r = 0.21; p = 0.013). Preoperatively, 86 patients tinnitus was a not or small problem, and for 82 it was moderate to very big. After stapedotomy, 93 (55%) of patients experienced a significant reduction in tinnitus severity. Of the whole group, 62 patients (37%) reported complete disappearance of their tinnitus. No change in tinnitus severity was reported by 63 patients (38%), and an increase was observed by 12 patients (7%). CONCLUSION: Stapedotomy not only improves hearing but also reduces tinnitus severity. The current results extend knowledge of postoperative results in terms of tinnitus severity, and might benefit patients undergoing tinnitus counseling. It might also be useful to otolaryngologists when making decisions regarding qualification criteria.

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.

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.

Electro-natural Stimulation (ENS) in Partial Deafness Treatment: Pediatric Case Series.

OBJECTIVE: To report the improvement in hearing preservation and speech understanding of five pediatric patients who received cochlear implantation via Electro-natural Stimulation Partial Deafness Treatment, the largest group so far treated. STUDY DESIGN: Retrospective case review. SETTING: Tertiary referral center. PATIENTS: A series of five children aged 9 to 16 years old with bilateral normal hearing at 125 to 1500 Hz and severe-to-profound hearing loss above 1500 Hz, who were subjected to unilateral cochlear implantation. INTERVENTION: All the patients underwent unilateral cochlear implantation by the same senior otosurgeon. Surgery involved six principal steps using an approach to scala tympani through the round window and use of an extremely delicate electrode with active length of up to 21 mm. MAIN OUTCOME MEASURES: Pre- and postoperative hearing for air- and bone-conduction was assessed using pure-tone audiometry. Speech understanding was evaluated with the Pruszewicz monosyllabic word test in free field. Hearing preservation was assessed using the Hearing Preservation Calculator developed by the HEARRING group. RESULTS: Over the 3-year observation period, preoperative hearing thresholds were completely preserved in three children (60%) and partially in the remaining two (40%). A useful improvement in speech understanding of about 30% (compared with the best fitted hearing aids in the preoperative period) was observed in both quiet and noise. CONCLUSIONS: Cochlear implantation seems to be a successful way of restoring hearing ability in ENS-Partial Deafness Treatment patients who are beyond the scope of effective rehabilitation with hearing aids. Excellent results of hearing preservation in ENS patients encourage discussion on extending the inclusion criteria for cochlear implantation.

Clinically important change in tinnitus sensation after stapedotomy.

BACKGROUND: When measuring the treatment effect in tinnitus with multi-item outcome instruments, it is crucial for both clinical and research purposes to take into consideration clinical importance of the outcome scores. The aim of the present study is to determine minimal important change (MIC) in tinnitus which is clinically meaningful to patients with otosclerosis. METHODS: The study population was 95 patients with otosclerosis, suffering from tinnitus. They completed the Tinnitus Functional Index before stapedotomy and 3 months after the surgery. The minimal important change was estimated with the Clinical Global Impression Scale as the external criterion (anchor). The mean change method and the receiver operating characteristic (ROC) method were used to determine minimal important change in tinnitus sensation. RESULTS: The improvement in tinnitus after stapedotomy was reported by 69.4% of the patients with otosclerosis. Minimal important change in tinnitus was estimated as reduction of 8.8 points in the Tinnitus Functional Index. CONCLUSIONS: The anchor-based approach using an external criterion (anchor) allows to determine change in tinnitus sensation which is meaningful to patients after stapedotomy. The value of 8.8 points in Tinnitus Functional Index could be used as benchmark of stapedotomy effectiveness in otosclerosis patients suffering from tinnitus. Hearing difficulties comorbid with tinnitus could affect the perception of tinnitus change.

Tinnitus in patients with hearing loss due to mitochondrial DNA pathogenic variants.

PURPOSE: Tinnitus described as individual perception of phantom sound constitutes a significant medical problem and has become an essential subject of many studies conducted worldwide. In the study, we aimed to examine the prevalence of tinnitus among Polish hearing loss (HL) patients with identified mitochondrial DNA (mtDNA) variants. METHODS: Among the selected group of unrelated HL patients with known mtDNA pathogenic variants, two questionnaires were conducted, i.e. Tinnitus Handicap Inventory translated into Polish (THI-POL) and Visual Analogue Scale (VAS) for measuring subjectively perceived tinnitus loudness, distress, annoyance and possibility of coping with this condition (VASs). Pathogenic mtDNA variants were detected with real-time PCR and sequencing of the whole mtDNA. RESULTS: This is the first extensive tinnitus characterization using THI-POL and VASs questionnaires in HL patients due to mtDNA variants. We have established the prevalence of tinnitus among the studied group at 23.5%. We found that there are no statistically significant differences in the prevalence of tinnitus and its characteristic features between HL patients with known HL mtDNA variants and the general Polish population. In Polish HL patients with tinnitus, m.7511T>C was significantly more frequent than in patients without tinnitus. We observed that the prevalence of tinnitus is lower in Polish patients with m.1555A>G as compared to other available data. CONCLUSIONS: Our data suggest that the mtDNA variants causative of HL may affect tinnitus development but this effect seems to be ethnic-specific.

Expanding pediatric cochlear implant candidacy: A case study of electro-natural stimulation (ENS) in partial deafness treatment.

BACKGROUND: Some adolescents have hearing impairments characterized by normal or slightly elevated thresholds in the low and mid-frequency bands (below 1500 Hz) and nearly total deafness in the high frequency range. These patients often remain beyond the scope of effective hearing aid treatment. CASE REPORT: This study presents the case of a 16-year-old adolescent with good hearing in the range 125-1500 Hz and deafness at other frequencies. An implant was used to restore hearing at high frequencies, while preserving low and mid frequency acoustic hearing in the implanted ear. This is described as electro-natural stimulation (ENS) of the inner ear. CONCLUSIONS: The results demonstrate that low and mid frequency hearing (up to 1500 Hz) can be preserved using the round window surgical technique. A substantial improvement in speech discrimination was also observed when electrical stimulation on one side was combined with acoustic stimulation on both sides. There is scope to extend qualifying criteria for cochlear implantation to include adolescents who are suited to ENS.