Influence of cochlear implantation on the working ability of hearing-impaired patients: A prospective study on potential influencing factors.

PURPOSE: This study evaluates the effect of cochlear implantation (CI) on work ability. The influences of quality of life (QOL), age, mental health, and hearing were analyzed. METHODS: Seventy-nine patients undergoing CI surgery were evaluated preoperatively and 12 months postoperatively. Work ability was evaluated using the Work Ability Index (WAI). QOL was assessed with the Nijmegen Cochlear Implant Questionnaire (NCIQ) and the WHOQOL-BREF. Mental health was assessed with the Patient Health Questionnaire. RESULTS: The WAI was unaffected by CI (Δ 0.8 ± 6.8, p = 0.42). No significant changes in WAI were observed for employees (Δ - 1.1 ± 5.7, p = 0.25) and pensioners (Δ -0.4 ± 7.8, p = 0.73). Patients without elevated depressiveness, stress, or somatoform symptoms had significantly better WAI.The multiple regression analyses show that WHOQOL-BREF (ß = 0.49, p ≤ 0.001), age (ß = -0.34, p ≤ 0.001), and depressiveness (ß = 0.33, p = 0.04) were significantly associated with WAI. In the employee group, the NCIQ (ß = 0.58, p = 0.008) had the strongest association with the WAI. CONCLUSION: Age, mental health, and QOL are predictive factors for work ability. This should be considered in the consultation and the rehabilitation process.

Validation of the German language version of the Chronic Ear Survey and its psychometric comparison with an established German measurement instrument.

BACKGROUND: With the Chronic Ear Survey (CES), a validated measurement instrument for the assessment of disease-specific health-related quality of life (HRQoL) has been available internationally since 2000. The aim of this study was to provide a validated German version of this international instrument and to compare it with the German Chronic Otitis Media Outcome Test 15 (COMOT-15). METHODOLOGY: The CES was translated into German via a forward-backward translation process. For validation, 79 patients with COM undergoing middle ear surgery were prospectively included. HRQoL was determined preoperatively and 6 months postoperatively using the CES and the COMOT-15. Pure tone audiometry was also performed at both measurement time points. In the control examination, an additional retrospective assessment of the preoperative situation was additionally performed using the CES and the COMOT-15 to assess the response shift. The determined psychometric characteristics were internal consistency, test-retest reliability, discrimination validity, agreement validity, responsiveness, and response shift for both measurement instruments. Convergent validity of both measurement instruments was assessed using linear regression. RESULTS: On the basis of the CES, patients with COM could be reliably distinguished from patients with healthy ears. The CES showed satisfactory reliability with high internal consistency (Cronbach α 0.65-0.85) and high retest reliability (r > 0.8). The global assessment of HRQoL impairment correlated very well with the scores of the CES (r = 0.51). In addition, it showed a high sensitivity to change (standardized response mean -0.86). Compared to the COMOT-15, it showed a lower response shift (effect size -0.17 vs. 0.44). Both measurement instruments correlated only slightly with air conduction hearing threshold (r = 0.29 and r = 0.24, respectively). The concordant validity of both measurement instruments was high (r = 0.68). CONCLUSION: The German version of the CES shows satisfactory psychometric characteristics, so that its use can be recommended. The CES focuses on the influence of ear symptoms on HRQoL, whereas the COMOT-15 also includes functional and psychological aspects. Due to only minor response shift effects, the CES is particularly suitable for studies with multiple repeat measurements.

Value of patient-reported outcome measures for evaluating the benefit of speech processor upgrading in patients with cochlear implants.

BACKGROUND: Patients with a cochlear implant (CI) should be evaluated for a new speech processor every 6 years. The aim of this analysis was to assess the subjective and audiological benefit of upgrades. METHODS: Speech understanding and subjective benefit were analyzed in 99 patients with the old and the new speech processor after 4 weeks of wearing. Speech understanding was assessed using the Freiburg monosyllabic test in quiet (FBE) at 65 dB and 80 dB, and the Oldenburg Sentence Test (OLSA) at 65 dB noise with adaptive speech sound level. The Abbreviated Profile of Hearing Aid Benefit (APHAB) was used to assess subjective hearing impairment, and the Audio Processor Satisfaction Questionnaire (APSQ) was used to assess subjective satisfaction. RESULTS: The speech processor upgrade resulted in a significant improvement of speech understanding in quiet at 65 dB (mean difference 8.9 ± 25.9 percentage points, p < 0.001) and 80 dB (mean difference 8.1 ± 29.7 percentage points, p < 0.001) and in noise (mean difference 3.2 ± 10.7 dB signal-to-noise ratio [S/N], p = 0.006). Using the APHAB, a significant improvement (mean difference 0.07 ± 0.16, p < 0.001) in hearing impairment was demonstrated in all listening situations. The APSQ showed significantly higher patient satisfaction with the new speech processor (mean difference 0.42 ± 1.26, p = 0.006). A comparative assessment of the benefit based on subjective and speech audiometric results identified a proportion of patients (35-42%) who subjectively benefited from the upgrade but had no measurable benefit based on speech audiometry. CONCLUSION: There was a significant improvement in audiologically measurable and subjectively reflected speech understanding and patient satisfaction after the upgrade. In patients with only a small improvement in audiologically measurable speech understanding, the subjective benefit should also be assessed with validated measurement instruments in order to justify an upgrade to the payers in the health sector.

Influence of depressive disorders, stress, and personality traits on quality of life after cochlear implantation.

PURPOSE: This study aimed to determine whether preoperative depressiveness, stress, and personality influence quality of life (QOL) after cochlear implant (CI) surgery. METHODS: In this prospective study, 79 patients undergoing CI surgery were evaluated preoperatively and 12 months postoperatively. Disease-specific QOL was assessed with the Nijmegen Cochlear Implant Questionnaire (NCIQ) and general QOL with the WHOQOL-BREF. Depressiveness and stress were assessed with the Patient Health Questionnaire (PHQ-D). The Charlson Comorbidity Index (CCI) was used to classify comorbidities. The Big Five Personality Test (B5T) was used to assess the basic personality dimensions. Speech comprehension was evaluated in quiet with the Freiburg monosyllable test and in noise with the Oldenburg sentence test. RESULTS: After CI surgery, the total NCIQ score improved significantly (Δ 17.1 ± 14.7, p < 0.001). General QOL (WHOQOL-BREF, Δ 0.4 ± 9.9, p = 0.357), stress (Δ 0.25 ± 3.21, p = 0.486), and depressiveness (Δ 0.52 ± 3.21, p = 0.121) were unaffected by CI surgery. Patients without elevated depressiveness (p < 0.01) or stress (p < 0.001) had significantly better total NCIQ scores. The results of the multiple regression analyses show that, after adjusting for the CCI, personality, age, and mental health stress (ß = - 0.495, p < 0.001) was significantly associated with postoperative NCIQ outcome scores. Depressiveness and neuroticism had the strongest influence on the generic QOL (ß = - 0.286 and ß = - 0.277, p < 0.05). CONCLUSION: Stress symptoms and personality traits are significant predictive factors for disease-specific QOL, as well as hearing status. This should be considered in the preoperative consultation and in optimizing the rehabilitation process.

[Value of patient-reported outcome measures for evaluating the benefit of speech processor upgrading in patients with cochlear implants. German version]. / Wertigkeit von Patient-Reported Outcome Measures zur Bewertung des Versorgungsvorteils der Sprachprozessorumversorgung bei Patient/-innen mit Cochleaimplantaten.

BACKGROUND: Patients with a cochlear implant (CI) should be evaluated for a new speech processor every 6 years. The aim of this analysis was to assess the subjective and audiological benefit of upgrades. METHODS: Speech understanding and subjective benefit were analyzed in 99 patients with the old and the new speech processor after 4 weeks of wearing. Speech understanding was assessed using the Freiburg monosyllabic test in quiet (FBE) at 65 dB and 80 dB, and the Oldenburg Sentence Test (OLSA) at 65 dB noise with adaptive speech sound level. The Abbreviated Profile of Hearing Aid Benefit (APHAB) was used to assess subjective hearing impairment, and the Audio Processor Satisfaction Questionnaire (APSQ) was used to assess subjective satisfaction. RESULTS: The speech processor upgrade resulted in a significant improvement of speech understanding in quiet at 65 dB (mean difference 8.9 ± 25.9 percentage points, p < 0.001) and 80 dB (mean difference 8.1 ± 29.7 percentage points, p < 0.001) and in noise (mean difference 3.2 ± 10.7 dB signal-to-noise ratio [S/N], p = 0.006). Using the APHAB, a significant improvement (mean difference 0.07 ± 0.16, p < 0.001) in hearing impairment was demonstrated in all listening situations. The APSQ showed significantly higher patient satisfaction with the new speech processor (mean difference 0.42 ± 1.26, p = 0.006). A comparative assessment of the benefit based on subjective and speech audiometric results identified a proportion of patients (35-42%) who subjectively benefited from the upgrade but had no measurable benefit based on speech audiometry. CONCLUSION: There was a significant improvement in audiologically measurable and subjectively reflected speech understanding and patient satisfaction after the upgrade. In patients with only a small improvement in audiologically measurable speech understanding, the subjective benefit should also be assessed with validated measurement instruments in order to justify an upgrade to the payers in the health sector.

[Validation of the German language version of the Chronic Ear Survey and its psychometric comparison with an established German language measurement instrument. German version]. / Validierung der deutschsprachigen Version des Chronic Ear Survey und dessen psychometrischer Vergleich mit einem etablierten deutschsprachigen Messinstrument.

BACKGROUND: With the Chronic Ear Survey (CES), a validated measurement instrument for the assessment of disease-specific health-related quality of life (HRQoL) has been available internationally since 2000. The aim of this study was to provide a validated German version of this international instrument and to compare it with the German Chronic Otitis Media Outcome Test 15 (COMOT-15). METHODOLOGY: The CES was translated into German via a forward-backward translation process. For validation, 79 patients with COM undergoing middle ear surgery were prospectively included. HRQoL was determined preoperatively and 6 months postoperatively using the CES and the COMOT-15. Pure tone audiometry was also performed at both measurement time points. In the control examination, an additional retrospective assessment of the preoperative situation was additionally performed using the CES and the COMOT-15 to assess the response shift. The determined psychometric characteristics were internal consistency, test-retest reliability, discrimination validity, agreement validity, responsiveness, and response shift for both measurement instruments. Convergent validity of both measurement instruments was assessed using linear regression. RESULTS: On the basis of the CES, patients with COM could be reliably distinguished from patients with healthy ears. The CES showed satisfactory reliability with high internal consistency (Cronbach α 0.65-0.85) and high retest reliability (r > 0.8). The global assessment of HRQoL impairment correlated very well with the scores of the CES (r = 0.51). In addition, it showed a high sensitivity to change (standardized response mean -0.86). Compared to the COMOT-15, it showed a lower response shift (effect size -0.17 vs. 0.44). Both measurement instruments correlated only slightly with air conduction hearing threshold (r = 0.29 and r = 0.24, respectively). The concordant validity of both measurement instruments was high (r = 0.68). CONCLUSION: The German version of the CES shows satisfactory psychometric characteristics, so that its use can be recommended. The CES focuses on the influence of ear symptoms on HRQoL, whereas the COMOT-15 also includes functional and psychological aspects. Due to only minor response shift effects, the CES is particularly suitable for studies with multiple repeat measurements.

Influence of the Coupling on the Hearing Outcome After Implantation of an Active Middle Ear Implant: Comparison of the Transmission Behavior in Temporal Bone Experiments With Clinical Data.

OBJECTIVES: The active middle ear implant, Vibrant Soundbridge (VSB), can be implanted with a variety of couplers. Hearing outcome after implantation has been investigated in both temporal bone (TB) experiments and patient studies, but the relationship between experimental and clinical data is still weak in the literature. Therefore, experimental data from TB experiments should be compared with patient data in a retrospective study, in which the floating mass transducer is used with couplers of the third generation. Actuator coupling structures included the long (LP coupler) and short (SP coupler) incus process, the stapes head (Clip coupler), and the round window membrane (RW soft coupler). METHODS: In the TB experiments, the sound transmission after vibroplasty on the above-mentioned actuator coupling structures was determined in 32 specimens by means of laser Doppler vibrometry on the stapes footplate. Data of 69 patients were analyzed. The main target audiometric parameters were the postoperative aided word recognition score (WRS) in the free field at 65 dB SPL (WRS 65 dB in %), the preoperative and postoperative pure-tone average (PTA4, including the frequencies 0.5, 1, 2, and 4 kHz) of the bone conduction hearing threshold (PTA4BC), the aided postoperative air conduction hearing threshold in the free field (PTA4FF) and the direct threshold (Vibrogram) at least 6 months postoperatively. The coupling efficiency of the actuator (Vibrogram-PTA4BC) as well as the effective hearing gain (PTA4FF-PTA4BC) was compared between the couplers. RESULTS: The analysis in the main speech range (0.5-4 kHz) indicated that in the TB experiments, the LP coupler tends to have the best coupling quality at low frequencies (500-1000 Hz). This was up to 15 dB above the worst actuator (RW soft coupler). However, the results missed the significance level ( p > 0.05). In the high frequencies (2000-4000 Hz), the Clip coupler showed the best coupling quality. This was 15 dB above the worst actuator (SP coupler). However, the results missed the significance level ( p > 0.05), too. The postoperative WRS at 65 dB SPL and the postoperative PTA4FF were independent of the actuator coupling structure. The PTA4BC was stable at 6 months postoperatively. For the PTA4 of the coupling efficiency, there were no significant differences between the actuator coupling structures (LP 8.9 dB ± 12.9; SP 9.5 ± 6.5 dB; Clip 5.2 ± 10.5 dB; RW 12.7 ± 11.0 dB). However, the tendential inferiority of the RW soft coupler with regard to transmission in the low-frequency range and the tendential superiority of the Clip coupler in the high-frequency range that have already been displayed experimentally could be confirmed in the clinical results. However, the clinical results missed the significance level, too ( p > 0.05). CONCLUSIONS: In vivo, there are no significant differences in the postoperative outcome stratified according to coupling the target structure. The differences known from the experimental setting were repressed by individual biasing factors. However, to ensure sufficient postoperative speech intelligibility, the frequency-specific transmission behavior of the couplers should be taken into account when setting the indication for VSB implantation.

Word Recognition with a Cochlear Implant in Relation to Prediction and Electrode Position.

BACKGROUND: the word recognition score (WRS) achieved with cochlear implants (CIs) varies widely. To account for this, a predictive model was developed based on patients' age and their pre-operative WRS. This retrospective study aimed to find out whether the insertion depth of the nucleus lateral-wall electrode arrays contributes to the deviation of the CI-achieved WRS from the predicted WRS. MATERIALS AND METHODS: patients with a pre-operative maximum WRS > 0 or a pure-tone audiogram ≥80 dB were included. The insertion depth was determined via digital volume tomography. RESULTS: fifty-three patients met the inclusion criteria. The median WRS achieved with the CI was 70%. The comparison of pre- and post-operative scores achieved with a hearing aid and a CI respectively in the aided condition showed a median improvement of 65 percentage points (pp). A total of 90% of the patients improved by at least 20 pp. The majority of patients reached or exceeded the prediction, with a median absolute error of 11 pp. No significant correlation was found between the deviation from the predicted WRS and the insertion depth. CONCLUSIONS: our data support a previously published model for the prediction of the WRS after cochlear implantation. For the lateral-wall electrode arrays evaluated, the insertion depth did not influence the WRS with a CI.

Results and Quality of Life after Implantation of Active Middle Ear Implants. / Ergebnisse und Lebensqualität nach Implantation aktiver Mittelohrimplantate.

The provision of implantable hearing aids represents an area with high development and innovation potential. On the one hand, this review article provides an overview of current indication criteria for the treatment with active middle ear implants. On the other hand, outcome parameters as well as functional results after implantation of active middle ear implants are demonstrated and discussed. The focus is mainly placed on audiological results as well as the subjective health status. "Patient Reported Outcome Measures" (PROMs) have become an integral part of the evaluation of hearing implant treatment. Due to low evidence level criteria, the study situation regarding audiological as well as subjective outcome parameters is not satisfactory. The lack of an international consensus on accepted outcome parameters makes a meta-analytical analysis of results immensely difficult. In the studies published to date, patients with sensorineural hearing loss and patients with conductive or mixed hearing loss offered better speech recognition after implantation of an active middle ear implant compared to conventional hearing aids. Current analyses show a significant improvement in general as well as hearing-specific quality of life after implantation of an active middle ear implant. To date, no validated, hearing-specific quality-of-life measurement instruments exist for assessing the success of fitting in children. Especially in children with complex malformations of the outer ear and the middle ear, excellent audiological results were shown. However, these results need to be substantiated by quality-of-life measurements in future.

Comparison of two disease­specific instruments assessing health-related quality of life in patients with chronic otitis media.

PURPOSE: Evaluating the current health state in chronic otitis media (COM), audiologic results are complemented by subjective outcomes, such as health-related quality of life (HRQoL). Two disease-specific instruments assessing HRQoL in COM in German-speaking patients exist, i.e., the chronic otitis media outcome test (COMOT-15) and the Zurich chronic middle ear inventory (ZCMEI-21). Since the psychometric properties of these questionnaires in a concurrent application are unknown, the aim of this study was to compare the COMOT-15 and the ZCMEI-21. METHODS: HRQoL was assessed in adult COM patients using the COMOT-15 and the ZCMEI-21. Psychometric properties were determined, including response distribution, concurrent validity, internal consistency, correlation to hearing and gender differences. RESULTS: In 173 patients (mean age 51.5 years), both questionnaires showed normally distributed scores without strong floor and ceiling effects. The total scores and subscores of both questionnaires exhibited satisfactory internal consistency (Cronbach's α 0.7-0.9) with the exception of the COMOT-15 hearing subscore (α = 0.94) and the ZCMEI-21 medical resource subscore (α = 0.66). Fair correlations between the air conduction pure-tone average and the total scores were found (COMOT-15: r = 0.36, p < 0.0001; ZCMEI-21: r = 0.34, p < 0.0001). CONCLUSION: In the first study comparing the COMOT-15 and the ZCMEI-21, both questionnaires exhibited satisfactory psychometric properties with several subtle differences. The COMOT-15 has a strong focus on hearing with a probably redundant content of the hearing subscore and may be suited for hearing-focused research questions. The ZCMEI-21 provides a comprehensive assessment of the COM symptom complex and may therefore also be used in research settings, where ear discharge, vertigo or pain should be covered.

[Update cochlear-implantation: indications and surgical aspects]. / Update Cochlea-Implantation: Indikationsstellung und Operation.

In childhood, inadequately rehabilitated hearing loss leads to impaired language acquisition and social, mental and emotional development. In adults, social withdrawal due to limited communication skills is often a consequence of unsatisfactory hearing rehabilitation. Therefore, in patients with profound hearing loss, the indication for cochlear implantation should be considered. Technical advances in cochlear implant development, as well as in microsurgical techniques and the rehabilitation process, have led to an expansion of indications in recent years. Adequate hearing rehabilitation is associated not only with an improvement in hearing function and speech understanding, but also with an increase in quality of life at all ages. In patients with unilateral profound hearing loss, cochlear implantation leads to an improvement of speech understanding and localization ability as well as to a reduction of the head shadow effect and tinnitus. The indication process, surgical treatment and the subsequent rehabilitation process require interprofessional cooperation in specialized centers.

Impact of depressive disorders on quality of life after middle ear surgery in patients with chronic otitis media.

PURPOSE: The aim of this study was to determine whether preoperative depressive symptoms influence health-related quality of life (HRQOL) after middle ear surgery in patients with chronic otitis media (COM). METHODS: This prospective clinical case study was conducted at a tertiary referral center. All 102 patients who had undergone middle ear surgery for COM were assessed clinically and by audiometric testing (pure tone audiometry) in pre- and postoperative settings. Disease-specific HRQOL was assessed by the validated chronic otitis media outcome test 15 (COMOT-15) and the Zurich chronic middle ear inventory (ZCMEI-21). General HRQOL was measured using the short form 36 (SF-36). Depressive symptoms were assessed using the patient health questionnaire (PHQ-D). The Charlson comorbidity index (CCI) was used to classify comorbidities. The middle ear status was determined using the ossiculoplasty outcome parameter staging (OOPS) index. RESULTS: After middle ear surgery, the total COMOT-15 and ZCMEI-21 scores improved significantly (p < 0.001). General HRQOL (total SF-36 score) was unaffected by surgery (p < 0.05). Patients without elevated depressive symptoms had significantly better total scores for the COMOT-15 (p < 0.01), ZCMEI-21 (p < 0.001), and for SF-36 (p < 0.001) postoperatively. The results of the multiple regression analyses show that, after adjusting for the OOPS, CCI, and hearing improvement, preoperative depressiveness was significantly associated with worse postoperative COMOT-15 and ZCMEI-21 outcome scores (ß = 0.425 and ß = 0.362, p < 0.001). CONCLUSION: Preoperative depressiveness was an essential predictive factor for HRQOL in patients with COM. This should be considered during patient selection to provide more suitable preoperative counseling.

Fully Implantable Active Middle Ear Implants After Subtotal Petrosectomy With Fat Obliteration: Preliminary Clinical Results.

OBJECTIVES: In patients with chronic middle ear disease, especially after revision surgery for ventilation problems and mixed hearing loss, active middle ear implants may provide an alternative treatment option. The fully implantable active middle-ear implant (FI-AMEI) is designed for implantation in a ventilated mastoid with an intact posterior canal wall. Until now, there have been no reports on audiometric results after implantation of a FI-AMEI in a fat-obliterated cavity after subtotal petrosectomy (SPE). STUDY DESIGN: Retrospective case review. SETTING: Tertiary referral center. PATIENTS: Twelve patients were included after numerous previous tympanoplasty surgeries for severe mixed hearing loss and FI-AMEI implantation. INTERVENTION: In five patients, the FI-AMEI was implanted in a cavity, with fat obliteration, after SPE. Seven patients received FI-AMEI implantation after intact canal wall (ICW) surgery. MAIN OUTCOME MEASURE(S): Audiometric results (pure-tone audiometry, Freiburger monosyllables) are demonstrated for 12 patients after an observation period of 3 months. RESULTS: The improvement in monosyllable score was 40 to 85% for the 12 patients. Free-field-aided thresholds showed high heterogeneity. CONCLUSION: FI-AMEI implantation combined with SPE provides an alternative approach to hearing rehabilitation to non-FI-AMEI implantation. Studies with a high number of patients and long-term observation periods are necessary to statistically verify these results.

The vibrating ossicular prosthesis in children and adolescents: a retrospective study.

PURPOSE: The primary objective of the retrospective study was to collect speech intelligibility data on children and adolescents implanted with the vibrating ossicular prosthesis (VORP) 503. METHODS: This was a retrospective, multicentre study on 55 children and adolescents from 6 German clinics aged between 5 and 17 years suffering from mixed or conductive hearing loss implanted with a VORP 503. Pre- and postoperative bone-conduction pure tone thresholds were measured at 0.5, 1, 2 and 4 kHz, and word recognition scores in the unaided and VORP 503-aided conditions using monosyllabic speech intelligibility tests measured at 65-dB sound pressure level (SPL) were determined. RESULTS: Mean pre- and postoperative bone-conduction thresholds remained unchanged, showing the preservation of inner ear hearing. Speech intelligibility assessed in quiet at 65-dB SPL improved on average from 24.5% (SD ± 25.4) unaided to 86.4% (SD ± 13.4) aided. The average improvement of 61.9% (SD ± 25.3) was clinically and statistically significant. A total of three complications were found in the medical records of 55 subjects. The responsible investigators judged these events as procedure related. CONCLUSION: The treatment of children suffering from conductive or mixed hearing loss with the VORP 503 implant demonstrates excellent aided benefit in terms of speech understanding and only minor complications.

Outcome parameters in speech audiometry: retrospective analysis of data and reporting quality in clinical studies.

OBJECTIVES: The use of standardized outcome parameters is essential for the comparability of clinical studies. Pure-tone audiometry and speech audiometry are widely used, but there is no systematic evaluation of the outcome parameters in clinical application. Nevertheless, there is presumably a great heterogeneity especially in the field of speech audiometry. This study presents a snapshot of the current situation of documentation and usage of outcome parameters in otologic research. STUDY DESIGN: Retrospective study of existing literature analyzing common speech audiometric test material and procedure MAIN OUTCOME MEASURES: Intervention Studies from 2012 to 2016 concerning hearing ability were eligible for evaluation. Studies were analyzed with regard to study design, pathology and intervention, speech audiometric parameters, pure-tone audiometry, implementation of reporting standards and journal related data. RESULTS: 279 studies were included. Over 50% of the analyzed studies lacked proper documentation. In the remaining studies, there was a broad variance concerning the documented speech audiometric parameters, most often with a fixed presentation level of 65 dB SPL. CONCLUSION: The lack of generally used standards for reporting hearing outcomes makes it difficult to compare results of different clinical studies. An adequate description of the methods would be a first and important step in improving reports on audiological outcomes.

Panel 5: Impact of otitis media on quality of life and development.

OBJECTIVE: To summarize recent advances in knowledge on otitis media (OM) and quality of life (QoL) and development by synthesizing relevant research in this field published between June 1., 2015 until June 1., 2019. DATA SOURCES: Systematic searches of PubMed, Embase and the Cochrane Library using predefined database-specific syntaxes. REVIEW METHODS: Articles selected were randomized controlled trials and observational studies with an adequate control group estimating treatment effects of OM including acute OM (AOM), recurrent AOM (RAOM), OM with effusion (OME), chronic OM (COM) and chronic suppurative OM (CSOM). Items included were Health Status, Health Status Indicators, Quality of Life, Functional Status, Specific Learning Disorder, Developmental Disabilities, Language Development Disorders, and Problem Behavior. RESULTS: The electronic database searches yielded a total of 699 records. After screening titles and abstracts, we identified 34 potentially eligible articles. Of these, 18 were excluded. This left 15 articles suitable for inclusion. CONCLUSIONS: Although evidence is accumulating that OM may significantly impair children's QoL and development as well as caregiver's QoL, studies on this topic are relatively scarce and vary substantially in terms of methodological quality and outcome measurement instruments (OMI) used. In this review, studies have used 10 different OMIs capturing a wide range of OM symptoms as well as generic and disease-specific QoL outcomes. OM was associated with negative effects on auditory processing, language and speech development, school readiness, social competence, psychosocial wellbeing, and sleep. We found only four relevant randomized controlled trials, which mostly failed to demonstrate superiority of interventions in terms of QoL improvement and reports on reversibility are lacking. This underpins the urgent need for high quality studies in this field using validated and uniform OMIs. To facilitate interpretation and harmonization of study findings, we suggest and support the development of a core outcome set for the various OM entities that should include the most reliable and meaningful QoL and developmental OMIs.

The Obliteration of Noncritical Size Bone Defects With Bone Dust or Bone Replacement Material (Bioactive Glass S53P4).

HYPOTHESIS: Bone dust (BD) harvested during operation may be suitable as an autologous obliteration material for noncritical size defects. Bioactive glass (BA) can be an alternative. BACKGROUND: To treat noncritical size defects, BD and BA are commonly used for obliteration techniques. However, the optimal harvesting method and parameters for BD have not been examined. In this study, we analyzed the osseoregenerative potential of both materials. METHODS: Thirteen female merino sheep (7-yr old) underwent surgery on the frontal calvaria. Three defects were inserted. The first defect was considered a reference and remained unfilled, the second defect was filled with BD from the calvaria bone, and the third defect was filled with BA S53P4. The animals were sacrificed after 3 weeks. To evaluate bone regeneration, we used digital volume tomography, bone density measurement, fluorochrome sequence labeling, and histological analysis. RESULTS: All analyses showed quantitative and qualitative bone regeneration 3 weeks after operation. The control blank defect showed significantly less new bone growth than the BD-filled defect. Moreover, bone regeneration occurred from the surrounding bone and showed only a defect bridge in the BD-filled defect. The BA completely filled the defect and had the highest density although the same amount of new mineralized bone generated as in the reference. CONCLUSION: BD and BA seemed to be suitable bone replacement materials for obliteration techniques because they completely filled the defects. Thus, BD harvested under standardized conditions provided a higher level of osteoreparation potential for the generation of woven bone and establishment of defect bridges.

Living with otosclerosis: disease-specific health-related quality-of-life measurement in patients undergoing stapes surgery.

INTRODUCTION: Otosclerosis is associated with hearing disability, leading to communication deficits and social and psychological restrictions. The objective of our study was to analyze disease-specific health-related quality of life (HRQOL) after stapes surgery and compare the outcome of HRQOL with audiometric parameters. SUBJECTS AND METHODS: Our clinical case study was conducted at two tertiary referral centers. All the 37 patients who had undergone stapes surgery were analyzed clinically and by audiometric testing (pure tone and speech audiometry) in the pre- and postoperative settings. Disease-specific HRQOL was assessed by the validated Stapesplasty Outcome Test 25 (SPOT-25) pre- and postoperatively. The subjective hearing disability was evaluated by the hearing handicap inventory for adults (HHIA). The postinterventional benefit was measured by the Glasgow Benefit Inventory (GBI). RESULTS: Disease-specific HRQOL improved significantly after stapes surgery in all scales of the SPOT-25. Postoperatively, the total score and the subscore "hearing function" correlated well with the audiometric data. The subscores "tinnitus", "social restrictions", and "mental condition" did not show significant association with audiometric parameters. The comparison of pre- and postoperative HHIA offered a significant improvement in the hearing disability. The scores of the HHIA correlated very well with the audiometric data. The GBI showed a postoperative benefit for each individual patient. CONCLUSION: Stapes surgery leads to a significant improvement in the hearing handicap and of disease-specific HRQOL. The audiometric parameters were shown as not being a sufficient indicator of social and mental well-being. HRQOL outcome measuring instruments should be used routinely in clinical practice to provide an individualized postoperative assessment.

Data and Reporting Quality in Tympanoplasty and Ossiculoplasty Studies.

Objective The objective of our study was to check the documentation of hearing outcome parameters and influencing factors (surgical, pathological, and methodological) in published literature evaluating hearing outcome after tympanoplasty. We aimed to assess how effectively the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) 1995 guidelines were applied. Study Design Retrospective noncontrolled study. Setting Ear research center. Subjects and Methods This study was based on a PubMed research, including peer-reviewed English-speaking original studies published from January 2005 to December 2015. In total, 169 studies were checked for correct description of study population, surgical methodology, study design, and documentation of the hearing outcome. In addition, the correct application of AAO-HNS 1995 criteria was checked. Results Pre- and postoperative air-bone gap were shown as mean ± standard deviation in half of all series (52% vs 56%). The recommended frequency spectrum (0.5-3 kHz) was used in 46%, while a documentation of frequency spectrum was available in 85%. Whereas a statement on presence of stapes suprastructure (81%) and initial pathology was usually available, mucosa status (17%) and aeration (8%) were only shown in few series. Revision cases, staged cases, and myringoplasty graft material were documented in 46% to 57%. Type and material of prosthesis were represented in 74% to 82%. None of the publications analyzed fulfilled all 10 AAO-HNS criteria. In 10%, 7 to 9 criteria were used correctly. Conclusion A heterogeneous description of surgical and pathological findings and the application of minimal reporting standards are essential preconditions to enable comparisons between different studies and to generate meta-analysis.

Hearing outcome after sequential cholesteatoma surgery.

The objective of this study was to assess hearing outcome after sequential cholesteatoma surgery stratified for exclusively transcanal technique (ETC), combined transcanal and transmastoidal technique (TCM) and canal wall down surgery (CWD) and to analyze the impact of ossicular reconstruction technique (partial ossicular replacement prostheses/PORP and total ossicular replacement prostheses/TORP) on hearing outcome. This study is a retrospective case review and clinical case study conducted in a tertiary referral center. Patients who underwent 376 cholesteatoma surgeries (2007-2009) and 92 ears in clinical re-examination at least 12 months postoperatively were included. Sequential cholesteatoma surgery with ETC, TCM, or CWD; ossiculoplasty with PORP or TORP were the interventions administered. Pre- and postoperative air-bone gap (ABG) and air conduction threshold (AC) for 0.5-3 kHz were the main outcome measures. Overall, the mean preoperative ABG decreased from 25.3 ± 1.3 to 19.8 ± 0.9 dB with a mean ABG closure of 5.4 ± 1.3 dB (p ≤ 0.001). According to surgical technique, the postoperative ABG after CWD 23.5 ± 2.1 was significantly worse compared to ETC (17.3 ± 1.0 dB, p < 0.05) and TCM (19.4 ± 1.3 dB). A significant ABG closure was observed after ETC (6.8 ± 2.0 dB, p < 0.01) and TCM (6.5 ± 2.0 dB, p < 0.01) contrary to CWD (2.1 ± 2.9 dB, p > 0.05). Patients receiving PORP showed a significantly less ABG postoperatively (19.0 ± 0.9 dB, p ≤ 0.05) compared to the TORP group (24.1 ± 2.5 dB). However, a significant hearing gain was assessed after PORP- (4.7 ± 1.6 dB, p ≤ 0.01) and TORP- implantation (10.4 ± 3.7 dB, p ≤ 0.01). Sequential cholesteatoma surgery allowed for an excellent hearing outcome postoperatively. An intact posterior canal wall and a present stapes suprastructure were identified to predict a significantly superior hearing result. In addition to the technical and prosthetic considerations, the audiological outcome was confounded by the attending middle ear pathology.