Surgical results and quality of life after subtotal petrosectomy.

PURPOSE: Few data are available regarding subjective complaints and quality of life (QoL) after subtotal petrosectomy (STP). The purpose of our study was to assess long-term surgical results after STP, and to evaluate disease-specific, patient-reported outcomes including QoL and subjective hearing. METHODS: A retrospective cohort study, including a postal survey, was performed in the Amsterdam University Medical Centers (Amsterdam UMC) location Academic Medical Centre (AMC). All patients who underwent a STP between 1990 and 2018 were included. Patient characteristics, indication for surgery, adverse events, disease recidivism, and patient-reported health outcomes were evaluated. RESULTS: 181 patients (183 ears) underwent a STP for several indications. The main indication was chronic otitis media (COM) with or without cholesteatoma (69%). In the total cohort, 8 residual cholesteatoma (5%) and 6 inclusion cholesteatoma 4% were detected. Postoperative (functional) health outcomes showed a significant negative impact on QoL in the STP cohort compared to normative data. Compared to patients without ear problems, the postoperative STP patients scored worse on almost all domains of the Chronic Ear Survey (CES) (p < 0.001). SF-36 scores of postoperative STP data showed negative Z-scores in almost all subscales, indicating lower levels of QoL compared to Dutch reference values. Most subscales of the Amsterdam Inventory for Auditory Disability and Handicap (AIADH) demonstrate a large-effect size in disadvantage of the STP cohort when compared to Dutch reference values. CONCLUSION: STP is a suitable technique to tackle severe ear disease. Despite its favourable surgical results, STP has a negative impact on several domains of patient's QoL.

Surgery for chronic otitis media in the elderly.

PURPOSE: To evaluate the effectiveness and safety of surgery for chronic otitis media in elderly patients, compared to younger adults and children. METHODS: Patients with chronic otitis media with and without cholesteatoma formation were assessed. Patients aged 65 years and older were included and compared to adults aged 35-55 and to children. Effectiveness was evaluated by comparing postoperative dry and safe ears in ages groups, safety was assessed by comparing postoperative adverse events. RESULTS: Postoperative success and adverse events did not differ between age groups. Children had more recurrent cholesteatoma than adults. No difference in recurrent cholesteatoma between adults was observed. CONCLUSION: Surgical treatment for chronic otitis media with and without cholesteatoma in elderly patients is safe and effective. Age has no influence on postoperative adverse events and treatment outcomes in chronic otitis media. Cholesteatoma recurrence was not different between adult age groups.

Comparison of Long-Term Microscopic and Endoscopic Audiologic Results After Total Ossicular Replacement Prosthesis Surgery.

OBJECTIVE: To compare short-term and long-term outcomes after transcanal endoscope-assisted with microscope-assisted ossiculoplasty using the Fisch titanium total prosthesis (FTTP). STUDY DESIGN: Retrospective chart review. SETTING: Tertiary referral center. PATIENTS: Pediatric (<18 yr of age) and adult patients undergoing ossiculoplasty with the FTTP between January 2016 and December 2019. INTERVENTION: Transcanal endoscope-assisted (n = 30) or microscope-assisted (n = 76) ossiculoplasty with the FTTP. In the microscopic group, 48 were performed through the ear canal and 28 by retroauricular approach. MAIN OUTCOME MEASURE: Short-term (3 mo) and long-term (average 20.2 mo) PTA 0.5-2kHz air and bone conduction thresholds were evaluated. RESULTS: In total, 106 patients were included. Nine of 30 (30.0%) of endoscopic and 15 of 76 (19.7%) of microscopic patients were pediatric. Endoscopic preoperative air conduction PTA 0.5-2kHz was 52.1 ± 15.8 dB and 52.2 ± 17.9 dB for the microscopic group ( p > 0.05). Three months postoperative endoscopic air conduction PTA 0.5-2kHz was 37.6 ± 17.4 dB (14.5 dB improvement) and 44.6 ± 19.9 dB (7.6 dB improvement) in the microscopic group ( p > 0.05). Three months postoperative endoscopic PTA 0.5-2kHz ABG was 26.8 ± 16.6 dB and 28.4 ± 14.7 dB in the microscopic group ( p > 0.05). Latest follow-up endoscopic air conduction PTA 0.5-2kHz audiogram (mean follow-up, 20.6 ± 10.4 mo) was 36.1 ± 18.2 dB (16.0 dB improvement) and 40.1 ± 16.8 dB (12.1 dB improvement) in the microscopic group (mean follow-up, 19.9 ± 10.3 mo)( p > 0.05). For endoscopic air conduction PTA 0.5-2kHz , between the 3 months and latest follow-up audiogram, 25.0% showed improvement, 50.0% remained stable, and 25.0% deteriorated. In the microscopic group, 26.7% improved, 46.6% remained stable, and 26.7% deteriorated ( p > 0.05). CONCLUSION: Our study shows that hearing results with the Fisch titanium total prosthesis are in line with literature. Endoscope-assisted total ossiculoplasty proves to be a suitable technique with comparable results to the microscopic approach.

Assessing the Prognostic Value of the ChOLE Classification in Predicting the Severity of Acquired Cholesteatoma.

OBJECTIVE: To assess the prognostic value of the ChOLE classification in predicting the severity of acquired cholesteatoma. METHOD: A retrospective chart review of patients undergoing primary cholesteatoma surgery in our tertiary referral center. The primary outcome measures were analyzed in three groups of follow up (FU): residual cholesteatoma in group A, FU > 52 weeks after last-look surgery or MRI-DWI; recurrent cholesteatoma in group B, FU > 52 weeks after last outpatient visit; and adverse events (AE) in group C, FU > 12 weeks after surgery. Cholesteatomata were staged according to the ChOLE classification. Kaplan-Meier curves were used to determine the prognostic value of the classification in predicting cholesteatoma severity, while correcting for FU. RESULTS: No significant differences were observed between the various stages of the ChOLE classification and residual or recurrent cholesteatoma rate, nor the occurrence of AE. Cholesteatoma extension to the sinus tympani or widespread in the mastoid, as well as absence of the stapes superstructure were predictive of residual disease. Sclerotic mastoids had a lower risk of residual disease than mastoids with good or poor pneumatization and ventilation. Poorly ventilated and poorly pneumatized mastoids were associated with increased risk of recurrence. Widespread cholesteatoma in the mastoid as well as presence of preoperative extracranial complications were correlated with an increased risk of AE. CONCLUSION: The ChOLE classification does not predict residual nor recurrent disease, nor the occurrence of AE, in our study population. Risk factors for severe cholesteatoma were identified, potentially useful for the development of future classifications.

Identifying epithelial borders in cholesteatoma surgery using narrow band imaging.

PURPOSE: To quantify changes in the perceived epithelial border with narrow band imaging (NBI) and white light imaging (WLI) during cholesteatoma surgery and to objectify possible benefits of NBI in otology. METHODS: Perioperative digital endoscopic images were captured during combined approach tympanoplasty at our tertiary referral center using WLI and NBI (415 nm and 540 nm wavelengths). Sixteen otologic surgeon defined the epithelial borders within 16 identical WLI and NBI photos. Pixels of these selections were calculated to analyze the quantitative difference between WLI and NBI. A questionnaire also analyzed the qualitative differences. RESULTS: Sixteen otologic surgeons participated in the study. Stratified per photo, only two photos yielded a significant difference: less pixels were selected with NBI than WLI. A Bland-Altman plot showed no systemic error. Stratified per otologist, four participants selected significantly more pixels with WLI than with NBI. Overall, no significant difference between selected pixels was found. Sub-analyses of surgeons with more than 5 years of experience yielded no additional findings. Despite these results, 60% believed NBI could be advantageous in defining epithelial borders, of which 83% believed NBI could reduce the risk of residual disease. CONCLUSION: There was no objective difference in the identification of epithelial borders with NBI compared to WLI in cholesteatoma surgery. Therefore, we do not expect the use of NBI to evidently decrease the risk of residual cholesteatoma. However, subjective assessment does suggest a possible benefit of lighting techniques in otology.

Transmastoid Occlusion Surgery for Superior Semicircular Canal Dehiscence Syndrome Improves Patient-Reported Quality-of-Life Measures and corrects cVEMP Thresholds and Amplitudes.

OBJECTIVE: To determine the pre- and postoperative clinical, audiological, vestibular, and patient-reported measures in patients undergoing transmastoid occlusion surgery for superior canal dehiscence syndrome (SCDS). STUDY DESIGN: Retrospective case review. SETTING: Tertiary referral centre, UK. PATIENTS: All primary transmastoid occlusion surgeries for SCDS were included (tertiary centre, single-surgeon), January 2008 to July 2019. INTERVENTIONS: Transmastoid superior canal occlusion surgery for SCDS. MAIN OUTCOME MEASURES: We collated audiological (pure tone audiogram), vestibular (cervical vestibular evoked myogenic potentials [cVEMPs]), and patient-reported outcome measures (Dizziness Handicap Inventory and subjective symptom grading). RESULTS: Fifty-two patients (55 ears) met the inclusion criteria. Thirty-one (56%) were female. Mean age was 47 years (range 29-63) and mean follow-up of 11.2 months. Six patients had bilateral disease, four of whom underwent sequential, bilateral surgery.Autophony was the most frequent presenting symptom, improving in 92%.Significant improvements were self-reported in patients' autophony (p < 0.0001), pressure- and noise-induced dizziness (p < 0.0001 and p < 0.0001), aural fullness (p = 0.0159), pulsatile tinnitus (p < 0.0001), perceived hearing loss (p = 0.0058), and imbalance (p = 0.0303).Overall Dizziness Handicap Inventory scores reduced from 45.9 to 27.4 (p < 0.0001), and across all subgroups of functional (p = 0.0003), emotional (p < 0.0001), and physical handicap (p = 0.0005).A 6.4-dB HL improvement in the air-bone gap (500-1000 Hz) occurred (95% confidence intervals 3.3-9.4 dB HL, p < 0.0001). There were no dead ears. cVEMP thresholds, when recordable, normalized in all except two ears. CONCLUSIONS: Transmastoid occlusion is effective at improving patient-reported outcomes and normalizing cVEMP thresholds, though some symptoms, notably disequilibrium, persist to a variable degree.

Evaluation of Long-term Cholesteatoma Recidivism: Using the JOS, EAONO-JOS, and STAMCO Cholesteatoma Staging Systems.

OBJECTIVE: To assess the prognostic value of the Japanese Otological Society (JOS), EAONO-JOS, and STAMCO classifications in predicting the severity of acquired cholesteatoma and to identify other factors that could influence residual and recurrent cholesteatoma, as well as adverse events (AE). METHOD: A retrospective chart review of patients undergoing primary cholesteatoma surgery in our tertiary referral center. Primary outcome measures were based on three groups of follow-up (FU): Group A, studying residual cholesteatoma, FU > 52 weeks of last-look surgery or magnetic resonance imaging, diffusion-weighted imaging; group B, studying recurrent disease, FU > 52 weeks of last outpatient clinic visit; and group C, studying AE, FU > 12 weeks after surgery. Cholesteatomata were staged according to the JOS, EAONO-JOS, and STAMCO classifications. Kaplan-Meier curves were used to determine the prognostic value of the various classifications and to identify other determining factors, while correcting for FU. RESULTS: FU was found to be a significant confounder. No correlation was found between staging and the occurrence of residual or recurrent disease, nor the occurrence of AE. Type of surgery was a significant determinant of all three primary outcome measures. A higher age was associated with a lower risk of residual disease. CONCLUSION: In our population the JOS, EAONO-JOS, and STAMCO classifications have limited prognostic value. Three main confounders were identified that pose a challenge in developing a universal classification: FU, surgery type, and age. Cholesteatoma staging should be postponed until a system is developed which significantly correlates cholesteatoma stage to cholesteatoma severity, to have implications for management strategies.

Pain After Ear Surgery: A Prospective Evaluation of Endoscopic and Microscopic Approaches.

OBJECTIVES/HYPOTHESIS: Assumed advantages of a minimally invasive endoscopic transmeatal approach in ear surgery are less postoperative pain, faster healing, and preservation of functional anatomy. We evaluated pain after ear surgery and compared endoscopic transmeatal, microscopic endaural, and retroauricular approaches. STUDY DESIGN: Prospective cohort study. METHODS: A prospective evaluation of pain during 3 weeks after ear surgery was performed. Three groups were defined: endoscopic transmeatal, microscopic endaural, and retroauricular. Data from 20 fully completed questionnaires (Brief Pain Inventory-Short Form) per group were analyzed with Bayesian and frequentist statistics. RESULTS: For all approaches, low pain scores were found, not exceeding 4 on a scale of 0 to 10. Analysis of the worst, least, and average pain scores documented per 24 hours showed no statistically significant difference nor equality between groups. With Bayesian statistics, a Bayes factor of 1.07, 0.25, and 0.51 was found, respectively. With frequentist statistics a p value of .092, .783, and 0.291 was found, respectively. Small, but statistically significant, differences were found for sleep, natural sleeping position, normal work, and pain medication taken. The location of pain correlates with the incision site. CONCLUSIONS: The results of this study show that the surgical approach has no clinically relevant influence on postoperative pain after ear surgery. The statistically significant differences on natural sleeping position, sleep, normal work, and amount of pain medication taken are small and should be interpreted with caution. Therefore, these should not be decisive factors in the choice of surgical approach in ear surgery. LEVEL OF EVIDENCE: 3 Laryngoscope, 131:1127-1131, 2021.

Hearing and hearing rehabilitation after obliteration of troublesome mastoid cavities.

PURPOSE: The purpose of this study is the evaluation of post-operative hearing threshold after revision surgery and obliteration of troublesome canal wall down mastoidectomy cavities (CWDMCs). The ability to use and tolerate conventional hearing aids (CHAs) was also evaluated. METHODS: A retrospective chart analysis of 249 patients with chronically draining CWDMCs who underwent revision surgery including obliteration of the mastoid cavity between 2007 and 2017 at the AMC location of the Amsterdam University Medical Centers (Amsterdam UMC) was performed. Patient characteristics, pre- and post-operative Merchant grade, surgical outcomes, pre- and post-operative hearing thresholds, and the ability/necessity to use a CHA or the ability/necessity to use a Bone Conduction Device (BCD) were recorded. RESULTS: Dry ears were found in 95% of the total cohort. Residual disease was detected in 1.6% during MRI follow-up with no residual cholesteatoma in the obliterated area. In 3.2% of the patients, recurrent disease was found. A significant improvement in mean air conduction level, mean bone conduction level, and mean air-bone gap (ABG) was found post-operatively (p < 0.05). For all types of ossicular chain reconstruction, a significant improvement in mean Pure Tone Average was observed (p < 0.05). The percentage of patients with an indication for CHA was similar pre- and post-operatively (67% both pre- and post-operatively). The ability to use a CHA improved from 3% pre-operatively to 57% post-operatively (p < 0.001). CONCLUSION: This study shows that revision surgery and obliteration of CWDMCs enable successful CHA rehabilitation post-operatively. Upon this type of surgery, hearing thresholds improve significantly, but the need for rehabilitation with a CHA remains necessary in most cases.

Canal wall up surgery with mastoid and epitympanic obliteration in acquired cholesteatoma.

OBJECTIVES/HYPOTHESIS: The objective of this study was to evaluate surgical outcome and residual and recurrence rates of canal wall up (CWU) surgery with obliteration of the mastoid and epitympanum. STUDY DESIGN: Retrospective cohort study in a tertiary referral center. METHODS: Patients with (sequelae of) acquired cholesteatoma treated with primary or revision CWU surgery with obliteration of the epitympanum and mastoid were identified retrospectively from 2010 to 2014. Obliteration was performed with cartilage chips or a periosteal midtemporal flap in combination with bone pâté and/or hydroxyapatite. Patients were followed up with micro-otoscopy and magnetic resonance imaging (MRI) with diffusion-weighted imaging (DWI). RESULTS: Ninety-nine ears in 96 patients were managed with obliteration of the epitympanum and mastoid following CWU surgery. Mean postoperative follow-up was 39.6 (standard deviation [SD] = 16.3). Mean follow-up until the last MRI-DWI was 29.7 months (SD = 16.0). In total, 74 ears in 72 adult patients (mean age = 46.8 years) were operated and 25 ears in 24 pediatric patients (mean age = 12.8 years). The overall recurrence rate was 7.1%, and the residual rate was 7.1%. In comparison, before the introduction of obliteration, the residual rate in our clinic was 24.4% and the recurrence rate 39.7%. After CWU surgery with obliteration, recurrence in pediatric patients (16.0%) was more frequent than in adults (4.1%). Although this difference was not statistically significant, a trend was observed (P = .066). CONCLUSIONS: Obliteration of the epitympanum and mastoid is a reliable and safe technique following CWU surgery for cholesteatoma, resulting in low residual and recurrence rates. LEVEL OF EVIDENCE: 4 Laryngoscope, 129:981-985, 2019.

Success Rate of Tympanic Membrane Closure in the Elderly Compared to Younger Adults.

OBJECTIVE: To assess the effectiveness and safety of tympanoplasty in elderly patients and the effect of frailty on the results. STUDY DESIGN: Retrospective chart review. SETTING: Tertiary referral center. PATIENTS: Thirty-one ears in 30 patients aged 65 years and older were included and matched with 31 controls, based on the type of surgery, of a pool of 133 patients aged 35 to 55 years. INTERVENTION: Therapeutic. MAIN OUTCOME MEASURE: Success was defined as tympanic membrane closure and resolution of presenting complaints. Complications were assessed. Frailty was defined by assessing multimorbidity and polypharmacy. Fisher's exact test was used to compare success and complication rates between the age groups. Linear logistic regression analysis using generalized linear models was performed on success and complication rate. RESULTS: Success rates in both the groups were 84%. Complication rate in the elderly group was 16% versus 6% in the control group. This difference was not statistically significant in the Fisher's exact test. In the generalized linear model analysis age group, multimorbidity and polypharmacy had no significant influence on both success and complication rate. CONCLUSION: There was no difference in success and complication rate in elderly undergoing tympanoplasty compared with younger adults. Having multimorbidity or polypharmacy did not correlate with failure of the tympanic membrane closure or a higher complication rate.

A Retrospective Cohort Study on the Influence of Comorbidity on Soft Tissue Reactions, Revision Surgery, and Implant Loss in Bone-anchored Hearing Implants.

OBJECTIVE: To identify risk factors for complications after bone-anchored hearing implant (BAHI) surgery. STUDY DESIGN: Retrospective cohort study. SETTING: Tertiary referral center. PATIENTS: All adult patients who received titanium bone-anchored hearing implants at our clinic between September 1, 1988 and December 31, 2007 were approached to fill out a questionnaire on comorbidity factors. A total of 581 patients with 669 implants were included in the analysis. MAIN OUTCOME MEASURES: Implant loss, soft tissue reactions, and revision surgery after BAHI implantation. RESULTS: Skin disease and profound learning difficulties were risk factors for time to first soft tissue reaction, hazard rate ratio of 3.41 (95% CI 1.45-8.01) and 3.42 (1.03-11.39), respectively. Female gender showed a trend toward a negative risk for time to first soft tissue reaction, hazard rate ratio 0.60 (0.35-1.03). In multivariable analysis, skin disease and female gender were observed as independent associative factors, adjusted hazard ratio 3.08 (1.32-7.16) and 0.56 (0.33-0.94). For revision surgery, female gender and cardiovascular disease were identified as negative risk factors in univariable analysis, and smoking showed a trend toward a negative risk, with hazard ratios of 0.15 (0.07-0.32), 0.07 (0.03-0.20), and 0.51 (0.24-1.07), respectively. In multivariable analysis, smoking and female gender were observed as independent associative factors, adjusted hazard ratio 0.45 (0.22-0.95) and 0.14 (0.06-0.30). Smoking could be identified as a risk factor for implant loss with a hazard ratio of 3.32 (1.36-8.09). CONCLUSION: Retrospective analysis of comorbidity factors and clinical outcomes revealed risk factors for postoperative complications after BAHI surgery.

Long-term stability, survival, and tolerability of a novel osseointegrated implant for bone conduction hearing: 3-year data from a multicenter, randomized, controlled, clinical investigation.

OBJECTIVE: To compare the 3-year stability, survival, and tolerability of 2 osseointegrated implants for bone conduction hearing: a wide 4.5-mm-diameter moderately roughened implant with a rounded 6-mm abutment (test) and a 3.75-mm diameter as-machined implant with a conically shaped 5.5-mm abutment (control). STUDY DESIGN: In this randomized, prospective, controlled, multicenter clinical study, 77 adult patients were included. Test and control implants were randomly assigned in proportions of 2:1. The implants were loaded with the sound processor from 6 weeks postimplantation. Follow-up after surgery was conducted at 10 days; at 4, 6, 8, and 12 weeks; and at 6, 12, 24, and 36 months after surgery. At every visit, implant stability quotient (ISQ) values were recorded by means of resonance frequency analysis (RFA), and skin reactions were evaluated according to Holgers' classification. RESULTS: Statistically significantly higher mean ISQ values were recorded for the test implant compared with the control implant at each evaluation time point. Between 2 and 3 years after surgery, ISQ values decreased but remained above baseline values. Implant survival was high for both implants: 96.2% of the test implants and 100% of the control implants survived these 3 years. Statistically significantly improved soft tissue outcomes were observed in the test implant group. CONCLUSION: This extensive long-term clinical investigation demonstrated that the test implant is more stable in terms of ISQ-values and provides high tolerability for the soft tissue. The results show that implant loading at 6 weeks is safe.

Benefit of Baha in the elderly with single-sided deafness.

The objective of this study is to determine the benefits of bone-anchored hearing aid (Baha) contralateral routing of signal (CROS) in the older adult population with single-sided deafness. Five questionnaires [general usage questionnaire, Glasgow benefit inventory (GBI), Abbreviated profile of hearing aid benefit (APHAB), Nijmegen cochlear implant questionnaire and the hearing handicap inventory for the elderly-screening version (HHIE-S)] were used to evaluate Baha use. Consecutive patients over 60 years of age with SSD fitted with a Baha CROS between April 1990 and April 2007 not using a conventional hearing aid in the better-hearing ear were identified. Nine out of 11 patients (82 %) were still using their Baha CROS, and 7 of the 11 patients (64 %) were still satisfied. The patients experienced no to little problems with handling and cleaning of the device. The GBI scores show good benefit in domains total (14 ± 11) and general (19 ± 17). The APHAB shows that, overall, 3 out of the 11 patients (27 %) experienced significant benefit, while all others experienced no significant benefit and no drawbacks. The HHIE-S shows that the patients experienced severe (18 %), mild to moderate (46 %) or no handicap (36 %) when using the Baha CROS. In conclusion, the benefit of a Baha CROS for elderly patients with SSD is evident in the majority of patients.

Analysis of factors predicting the success of the bone conduction device headband trial in patients with single-sided deafness.

OBJECTIVE: To determine factors predicting whether patients with single-sided deafness (SSD) opt for a bone conduction device (BCD) for the contralateral routing of sound (CROS) after a regular trial with a BCD on a headband. DESIGN: Retrospective case-control study. SETTING: Nijmegen, the Netherlands. PATIENTS: Thirty consecutive patients with SSD. INTERVENTIONS: Patients received a trial with a BCD headband as part of the regular workup for SSD. The patients were divided into 2 groups according to their decision to opt for a BCD (BCD+) or not (BCD-). MAIN OUTCOME MEASURES: Patients completed a questionnaire on satisfaction with the BCD headband, patient- and BCD-related factors, and benefit in listening situations. RESULTS: Fourteen patients (47%) chose a percutaneous BCD application after the BCD headband trial. Hearing loss of the contralateral ear at 4.0 kHz was significantly larger in the BCD+ group for bone and air conduction (P = .05 and P = .02, respectively). Patients in the BCD+ group experienced more problems in several listening situations and used the BCD headband more frequently than patients did in the BCD- group. CONCLUSIONS: Several individual factors influence the decision of patients with SSD to opt for a BCD. Hearing loss in the contralateral ear at high frequencies seems to be a relevant factor to predict the success of the BCD headband trial. It is advisable to offer all patients with SSD the option to participate in the BCD headband trial for at least 1 week and create a realistic expectation for patients based on their unaided subjective hearing handicaps.

Titanium fixtures for bone-conduction devices and the influence of type 2 diabetes mellitus.

OBJECTIVE: The aim of this study is to evaluate whether diabetes mellitus (DM) is a risk factor for titanium fixture loss in bone-conduction devices (BCDs) because of osseointegration failure. STUDY DESIGN: Retrospective case study. SETTING: Tertiary referral center. PATIENTS: All patients who received a BCD at Nijmegen between January 1, 1988, and December 31, 2007, were analyzed. The analyses were performed on 833 patients (993 implants) and a subpopulation of patients aged 40 years or older consisting of 641 patients (739 implants). METHODS: Patients received a questionnaire asking about the presence of DM at the time of implantation. Data concerning implant loss were retrieved from medical records and the Nijmegen BCD database. RESULTS: The total survival rate of the BCD implant in this population was 90.6%. The prevalence of DM was 9.3%. In the subpopulation of patients aged 40 years or older, the non-DM group lost 5.1% of their implants versus 14% of Type 2 DM patients, a statistically significantly difference (p = 0.003). Spontaneous loss, loss due to a Grade 4 Holgers skin reaction, and trauma accounted for 2.2% versus 4.7% (p = 0.13), 0.5% versus 2.3% (p = 0.1), and 0.6% versus 4.7% (p = 0.007), respectively, of implant losses in non-DM versus Type 2 DM patients. CONCLUSION: The prevalence of DM among the Nijmegen BCD population is higher than the general Dutch prevalence. A statistically significantly higher implant loss was observed during the study period for Type 2 DM patients than non-DM BCD wearers.

Assessment of more than 1,000 implanted percutaneous bone conduction devices: skin reactions and implant survival.

OBJECTIVE: This study assesses soft tissue reactions and implant stability of 1,132 percutaneous titanium implants (970 patients) for bone conduction devices (BCDs). In addition, it examines BCD usage and comparisons between different patient groups. STUDY DESIGN: Retrospective survey. Mean follow-up time of 4.6 years. SETTING: Tertiary care referral center. PATIENTS: The surveyed cohort was divided into 3 different age groups (children, adults, and the elderly). In addition, 4 groups with variable loading times (i.e., the time between placement of the implant and loading the BCD sound processor) were identified as well as a subgroup of patients with mental retardation. MAIN OUTCOME MEASURES: Soft tissue reactions around the percutaneous implants as classified by the Holgers grading system, implant failure, and revision surgery rates. RESULTS: In 95.5% of the 7,415 observations of 1,132 implants, there were no adverse soft tissue reactions. Implant loss was 8.3%. Significantly more soft tissue reactions and implant failures were observed in children compared with adults and the elderly (p < 0.05). Implant survival was lower in patients with mental retardation compared with patients without mental retardation (p = 0.001). The loading time did not influence the occurrence of soft tissue reactions and implant survival rates. CONCLUSION: Children and patients with mental retardation are the most vulnerable to soft tissue reactions and implant losses. Additional and more frequent care needs to be given during outpatient consultations. Because loading as early as 3 to 5 weeks did not negatively affect skin reactions or implant survival, full BCD installation can occur earlier without risk.

Stability, survival, and tolerability of a novel baha implant system: six-month data from a multicenter clinical investigation.

OBJECTIVE: Determination of the difference in implant stability between a novel Baha implant system (test) and the previous-generation implant system (control). METHODS: In an open, randomized, prospective multicenter clinical investigation, 77 adult patients with Baha implants were included. Test and control implants were randomly assigned in proportions of 2:1. Implant stability quotient (ISQ) values were recorded using resonance frequency analysis at the time of implantation and at 10 days, at 4, 6, 8, and 12 weeks, and at 6 months after surgery. Skin reactions were evaluated according to the Holgers classification. Sound processor fitting was performed from 6 weeks after implantation. RESULTS: Significantly higher mean ISQ values, measured between 0 and 6 months, were obtained for test compared to control implants (70.4 versus 65.4, p < 0.0001). Statistically significant differences were obtained for the study population as a whole and for the subgroup of patients loaded at 6 ± 1 weeks after implant surgery (63.6% of patients). Up to 12 weeks, Holgers rates were comparable, whereas at 6 months, more skin reactions (Grades 1 and 2) were observed in the control implant group. No reduction in mean ISQ values was observed after implant loading. CONCLUSION: The test implant showed higher mean ISQ values at the time of placement and over time. The level of osseointegration reached with the implants in adults as early as 6 weeks after implantation was sufficient to support the sound processor. The test implant system is expected to provide additional benefits related to the improvement of the degree of osseointegration, especially for patients with thin or compromised bone.

An overview of different systems: the bone-anchored hearing aid.

In the past 30 years, a large amount of clinical and audiological research on bone conduction hearing devices has been performed. In this review, we give a brief history of the developments in indications, surgical techniques and sound processors with respect to implantable bone conduction devices like the bone-anchored hearing aid or Baha. Starting with the use of Baha in patients with bilateral conductive or mixed hearing loss (HL), the indications for such devices have been extended to patients with unilateral HL, children and moderate mentally retarded patients. Bilateral fitting has been shown to be beneficial in restoring binaural hearing in patients with bilateral acquired or congenital conductive HL. In addition, the surgical techniques used to implant the titanium fixture for Baha application have been modified and further developed to reach two main goals: (a) optimal osseointegration, and (b) preparation of the implant site to minimize the occurrence of soft tissue reactions. Currently, the most used techniques are the pedicled skin flap, dermatome and linear incision techniques. Several generations of the Baha(®) sound processor have been developed by Cochlear(TM) to provide sufficient amplification in different hearing situations. Improvements in sound quality, aesthetics and handling have been major points of interest. The Baha sound processors most often used today are the Baha(®) Divino, the Baha(®) Intenso and the Baha(®) Cordelle. Recently, the more flexible Baha(®) BP100 sound processor was launched.

Benefit and quality of life after bone-anchored hearing aid fitting in children with unilateral or bilateral hearing impairment.

OBJECTIVE: To evaluate the benefits of a bone-anchored hearing aid (BAHA) in the daily lives of hearing-impaired children. DESIGN: Retrospective questionnaire study. SETTING: Nijmegen Medical Centre, Nijmegen, the Netherlands. PATIENTS: Thirty-eight BAHA users with a minimum age of 4 years at BAHA fitting and 1 to 4 years of use, divided into groups with bilateral conductive or mixed hearing loss and either normal cognition or mental disability and a group with unilateral conductive hearing loss. MAIN OUTCOME MEASURES: Scores on the Glasgow Children's Benefit Inventory, Abbreviated Profile of Hearing Aid Benefit, and Health Utilities Index Mark 3. RESULTS: The Glasgow Children's Benefit Inventory showed a subjective overall benefit of +32, +16, and +26 in the 3 groups (on a scale of -100 to +100). The Abbreviated Profile of Hearing Aid Benefit also showed an overall mean benefit in the groups. On an individual level, a clinically significant benefit was reported by more children in the group with bilateral hearing loss and normal cognition (7 patients [70%]) than in the unilateral hearing loss group (4 patients [27%]). Overall mean health utility scores and disability index scores on the Health Utility Index Mark 3 were comparable among the 3 groups. CONCLUSION: Overall, BAHA fitting can be considered effective and beneficial in children with bilateral or unilateral hearing loss.