Long-Term Outcomes of a Percutaneous Wide-Diameter Bone-Anchored Hearing Implant: A Clinical Evaluation of More than 800 Implants.

OBJECTIVE: This study evaluates the clinical outcomes of 807 percutaneous wide-diameter bone-anchored hearing implants (BAHIs) in 701 patients. In addition, it compares patient groups and examines bone conduction device (BCD) usage. STUDY DESIGN: Retrospective cohort study. Mean follow-up period of 3.8 years. SETTING: Tertiary referral center. PATIENTS: All patients implanted with a percutaneous wide-diameter BAHI until December 2020 were included. Patients were divided into age groups, "loading-time" groups, and, if applicable, specific subgroups thought to be at risk for complications postsurgery, e.g., intellectual disability and comorbidities. MAIN OUTCOME MEASURES: Soft tissue reaction, implant survival, revision surgery, and BCD usage. RESULTS: In 9.1% of the 5,188 observations of 807 implants, an adverse soft tissue reaction was reported according to the Holgers' scale. Significantly more (adverse) soft tissue reactions were observed in children and intellectually disabled (ID) patients (p < 0.05). Comorbidity subgroups showed no significant differences in soft tissue reactions. Implant loss percentage, including explantations, was 6.2%. Implant survival was significantly worse in patients with ID (14.1%; p = 0.021). Pediatric age, early loading, or comorbidities did not significantly influence implant survival. At least 592 implants (73.4%) were used for bone conduction hearing, of which 65.4% were used daily. CONCLUSION: Both children and ID patients are more prone to (adverse) soft tissue reactions, ID patients only have a higher risk of implant loss. The rate of implant loss in children seemed to be reduced compared to previous studies and thus more comparable to adults since using wide-diameter implants.

Long-Term Results of the Linear Incision Technique With Tissue Reduction Versus Tissue Preservation for Inserting Bone-Anchored Hearing Implants: The Ongoing Optimization in Bone Implant Surgery.

OBJECTIVE: To compare the long-term outcomes of the linear incision technique with tissue reduction (LIT-TR) and the linear incision technique with tissue preservation (LIT-TP) for inserting bone-anchored hearing implants (BAHIs). STUDY DESIGN: Single-center retrospective cohort study. SETTING: Large general teaching hospital. PATIENTS: A total of 231 adult patients were included between August 2005 and October 2020, with a minimum follow-up time of 6 months. INTERVENTION: The test group received a BAHI using the LIT-TP (N = 147). The control group underwent surgery using the LIT-TR (N = 84). MAIN OUTCOME MEASURES: Soft tissue reactions, skin thickening, postoperative complications (e.g., wound dehiscence), and implant loss were compared between the test and control group. Furthermore, Cochlear Bone Anchored Solutions AB (Mölnlycke, Sweden) and Oticon Medical AB (Askim, Sweden) implants/abutments within the LIT-TP cohort were compared. Validated questionnaires were used to quantify patients' health-related quality of life (HRQoL). RESULTS: Significantly more cases with wound dehiscence and adverse soft tissue reactions (Holgers ≥2) were observed in the LIT-TR cohort (p < 0.001). However, the LIT-TP cohort showed significantly more cases with skin thickening (requiring treatment) within the first 2 years after implantation. There were no differences in implant loss rates, overall soft tissue reactions (Holgers >1), and overall HRQoL between the two patient groups. Significant improvement in the patients' HRQoL after implementation of a BAHI was found in both techniques. The Ponto Wide implant/abutment showed less frequent skin thickening (requiring treatment) and fewer soft tissue reactions compared with the BIA400 implant/abutment. CONCLUSION: This large-scale study demonstrates that the LIT-TP shows excellent long-term outcomes, including a low incidence of implant failure.

Post-implantation clinical cost analysis between transcutaneous and percutaneous bone conduction devices.

INTRODUCTION: Bone conduction devices (BCD) are effective for hearing rehabilitation in patients with conductive and mixed hearing loss or single-sided deafness. Transcutaneous bone conduction devices (tBCD) seem to lead to fewer soft tissue complications than percutaneous BCDs (pBCD) but have other drawbacks such as MRI incompatibility and higher costs. Previous cost analyses have shown a cost advantage of tBCDs. The purpose of this study is to compare long-term post-implantations costs between percutaneous and transcutaneous BCDs. MATERIALS AND METHODS: Retrospective data from 77 patients implanted in a tertiary referral centre with a pBCD (n = 34), tBCD (n = 43; passive (tpasBCD; n = 34) and active (tactBCD; n = 9) and a reference group who underwent cochlear implantation (CI; n = 34), were included in a clinical cost analysis. Post-implantation costs were determined as the sum of consultation (medical and audiological) and additional (all post-operative care) costs. Median (cumulative) costs per device incurred for the different cohorts were compared at 1, 3 and 5 years after implantation. RESULTS: After 5 years, the total post-implantation costs of the pBCD vs tpasBCD were not significantly different (€1550.7 [IQR 1174.6-2797.4] vs €2266.9 [IQR 1314.1-3535.3], p = 0.185), nor was there a significant difference between pBCD vs tactBCD (€1550.7 [1174.6-2797.4] vs €1428.8 [1277.3-1760.4], p = 0.550). Additional post-implantation costs were significantly highest in the tpasBCD cohort at all moments of follow-up. CONCLUSION: Total costs related to post-operative rehabilitation and treatments are comparable between percutaneous and transcutaneous BCDs up to 5 years after implantation. Complications related to passive transcutaneous bone conduction devices appeared significantly more expensive after implantation due to more frequent explantations.

Subjective Fatigue in Children With Unaided and Aided Unilateral Hearing Loss.

OBJECTIVES: Fatigue is frequently observed in children with chronic diseases and can affect the quality of life (QoL). However, research in children with unilateral hearing loss (UHL) is scarce. Subsequently, no studies investigated the effects of hearing aids on fatigue in children. This study investigates subjective fatigue and hearing-related QoL in children with UHL. Furthermore, it evaluates the influence of hearing aids, subject-specific factors, and respondent-type on subjective fatigue. STUDY DESIGN: A cross-sectional study was conducted from June 2020 until September 2020 at the department of otorhinolaryngology in a tertiary referral center. METHODS: The primary outcome was the difference in subjective fatigue and hearing-related QoL between children with unaided UHL, aided UHL, and normal hearing. Subjective fatigue and hearing-related QoL were measured using the Pediatric Quality of Life Inventory™ Multidimensional Fatigue Scale (PedsQL™-MFS) and Hearing Environments and Reflection on Quality of Life (HEAR-QL™) questionnaires. RESULTS: Along with 36 aided children with UHL, 34 unaided and 36 normal-hearing children were included. Child reports revealed significantly more cognitive fatigue in children with aided UHL than children with normal hearing (median difference 12.5, P = .013). Parents reported more fatigue in children with UHL compared to normal-hearing siblings. Especially children with aided UHL seemed at increased risk for fatigue. Children with UHL scored lower on hearing-related QoL than children with normal hearing. No apparent differences were found in fatigue and QoL between children with unaided and aided UHL. CONCLUSION: Children with unaided and even aided UHL seem to experience more subjective fatigue and lower hearing-related QoL than children with normal hearing. Prospective longitudinal studies are required to investigate the influence of hearing aids on fatigue and QoL in individual patients. LEVEL OF EVIDENCE: 3 Laryngoscope, 2021 Laryngoscope, 133:189-198, 2023.

Healthcare consumption among subjects with otitis media undergoing middle ear surgery-analysis of cost drivers.

PURPOSE: To map healthcare utilized by subjects with chronic otitis media, with or without cholesteatoma and perform a cost analysis to determine key drivers of healthcare expenditure. METHODS: A registry study of 656 adult subjects with chronic otitis media that underwent a middle ear surgery between 2014 and 2018. Healthcare contacts related to all publicly funded specialist ENT care, audiological care and primary care for a disease of the ear and mastoid process were extracted. The data are extracted from the Swedish National Patient Registry on subjects that reside in western Sweden. RESULTS: Subjects made 13,782 healthcare contacts at a total cost 61.1 million SEK (6.0 million EUR) between 2014 and 2018. The mean cost per subject was 93,075 SEK (9071 EUR) and ranged between 3971 SEK (387 EUR) and 468,711 SEK (45,683 EUR) per individual. In the most expensive quartile of subjects, mean cost was 192,353 SEK (18,747 EUR) over the 5-year period. These subjects made 3227 ENT contacts (roughly four each year) and 60% of total costs were associated with in-patient ENT care. CONCLUSION: Patients with chronic otitis media are associated with high ENT resource utilization that does not diminish after surgical intervention and the disease places a long-term burden on healthcare systems. Significant costs are attributed to revision surgeries, indicating that these patients could be managed more effectively. In many such cases, reoperation cannot be avoided, especially due to recurrence of cholesteatoma. However, in some patients, when the indication for subsequent surgery is only hearing improvement, alternative options, such as hearing aids or implants, should also be considered. This is especially true in difficult cases, where revision ossiculoplasty is likely.

Hearing Rehabilitation of Patients with Chronic Otitis Media: A Discussion of Current State of Knowledge and Research Priorities.

Although chronic otitis media is a major cause of conductive and mixed hearing loss, auditory rehabilitation is currently not optimal for this patient group. Planning for hearing rehabilitation must accompany strategies for infection control when surgically managing patients with chronic otitis media. Several barriers prevent adequate hearing restoration in such a heterogeneous patient population. A lack of standardized reporting of surgical interventions, hearing, and quality of life outcomes impedes meta-analyses of existing data and the generation of high- quality evidence, including cost-effectiveness data, through prospective studies. This, in turn, prevents the ability of clinicians to stratify patients based on prognostic indicators, which could guide the decision-making pathway. Strategies to improve reporting standards and methods have the potential to classify patients with chronic otitis media preoperatively, which could guide decision-making for hearing restoration with ossicu- loplasty versus prosthetic hearing devices. Appropriately selected clinical guidelines would not only foster directed research but could enhance patient-centered and evidence-based decision-making regarding hearing rehabilitation in the surgical planning process.

Investigating Real-World Benefits of High-Frequency Gain in Bone-Anchored Users with Ecological Momentary Assessment and Real-Time Data Logging.

PURPOSE: To compare listening ability (speech reception thresholds) and real-life listening experience in users with a percutaneous bone conduction device (BCD) with two listening programs differing only in high-frequency gain. In situ real-life experiences were recorded with ecological momentary assessment (EMA) techniques combined with real-time acoustical data logging and standard retrospective questionnaires. METHODS: Nineteen experienced BCD users participated in this study. They all used a Ponto 4 BCD from Oticon Medical during a 4-week trial period. Environmental data and device parameters (i.e., device usage and volume control) were logged in real-time on an iPhone via a custom iOS research app. At the end of the trial period, subjects filled in APHAB, SSQ, and preference questionnaires. Listening abilities with the two programs were evaluated with speech reception threshold tests. RESULTS: The APHAB and SSQ questionnaires did not reveal any differences between the two listening programs. The EMAs revealed group-level effects, indicating that in speech and noisy listening environments, subjects preferred the default listening program, and found the program with additional high-frequency gain too loud. This finding was corroborated by the volume log-subjects avoided the higher volume control setting and reacted more to changes in environmental sound pressure levels when using the high-frequency gain program. Finally, day-to-day changes in EMAs revealed acclimatization effects in the listening experience for ratings of "sound quality" and "program suitability" of the BCD, but not for ratings of "loudness perception" and "speech understanding". The acclimatization effect did not differ among the listening programs. CONCLUSION: Adding custom high-frequency amplification to the BCD target-gain prescription improves speech reception in laboratory tests under quiet conditions, but results in poorer real-life listening experiences due to loudness.

Success rates in restoring hearing loss in patients with chronic otitis media: A systematic review.

OBJECTIVE: To assess the effectiveness of tympanoplasty in treating chronic otitis media-related hearing loss, published literature was systematically reviewed to determine the clinical success rate of tympanoplasty at restoring hearing in chronic otitis media patients at a minimum follow-up period of 12-months. DATA SOURCES: PubMed, Embase and the Cochrane Library. METHODS: Two independent reviewers performed literature searches. Publications reporting long-term (≥12-month) hearing outcomes and complications data on adult and pediatric patients with chronic otitis media were included and assessed for risk of bias and strength of evidence. To assess how tympanoplasty influences long-term hearing outcomes, data on pure tone audiometry (air-bone gap) and complications were extracted and synthesized. RESULTS: Thirty-nine studies met the inclusion criteria. Data from 3162 patients indicated that 14.0% of patients encountered postoperative complications. In adult patients, mean weighted air-bone gap data show closure from 26.5 dB hearing level (HL) (preoperatively) to 16.1 dB HL (postoperatively). In studies that presented combined adult and pediatric data, the mean preoperative air-bone gap of 26.7 dB HL was closed to 15.4 dB HL. In 1370 patients with synthesizable data, 70.7% of patients had a postoperative air-bone gap ˂ 20 dB HL at long-term follow-up. Finally, subgroup analysis identified that mean improvement in ABG closure for patients with and without cholesteatoma was 10.0 dB HL and 12.4 dB HL, respectively. CONCLUSION: In patients with chronic otitis media, tympanoplasty successfully closed the air-bone gap to within 20 dB HL in 7/10 cases and had an overall complication rate of 14.0%. LEVEL OF EVIDENCE: 2a.

Results of a 2-Year Prospective Multicenter Study Evaluating Long-term Audiological and Clinical Outcomes of a Transcutaneous Implant for Bone Conduction Hearing.

OBJECTIVE(S): To evaluate 2-year audiological and clinical outcomes of a transcutaneous implant for bone conduction hearing of a previously published 6-month evaluation. DESIGN: Fifty-four unilaterally implanted adult patients with conductive or mild mixed hearing loss or single-sided sensorineural deafness were included in this prospective multicenter study. Follow-up visits were scheduled post-surgery at 10 days; 4, 6, and 12 weeks; 6, 12, and 24 months. Main outcomes were audiological benefit, patient-reported outcomes (PROs), soft tissue status, pain, numbness, implant survival, and daily usage. RESULTS: In the study population, the transcutaneous implant resulted in statistically significant improvement in objective hearing test and PROs compared with the unaided situation. Soft tissue complications were observed in 4.6% of the patients per visit. Pain/discomfort and numbness were initially reported in the majority of the patients, but declined over time; approximately 9% of patients reported some degree of numbness and 15% (slight) pain/discomfort after 2 years. During the 24-month period, two implant magnets were removed (3.7%), while two other implants were converted to the percutaneous counterpart (3.7%). At the final visit, 89.6% (n = 42 out of 47) of the patients used their sound processor, with a median daily usage of 6 h/d (range, 0-18 h/d). CONCLUSIONS: After 24 months, the transcutaneous implant provided statistically significant mean improvement in objective and subjective hearing performance as well as PROs compared with the preoperative unaided condition and had a low soft tissue complication rate. The test device could be considered as an alternative treatment option for appropriately selected and counseled patients.

Six-Month Clinical Outcomes for Bone-Anchored Hearing Implants: Comparison Between Minimally Invasive Ponto Surgery and the Linear Incision Technique With Tissue Preservation.

OBJECTIVES: The aim of this study is to investigate and compare the clinical outcomes of minimally invasive ponto surgery (MIPS) to the linear incision technique with soft tissue preservation (LIT-TP) for percutaneous bone-anchored hearing implants (BAHI). STUDY DESIGN: Prospective cohort study with a historical control group. SETTING: Tertiary referral center. PATIENTS: Twenty-five patients were prospectively included in the test group. The control group consisted of 25 patients who previously participated in another clinical trial and already underwent BAHI surgery. INTERVENTION: All patients were implanted with a 4.5-mm-wide implant, using MIPS in the test group and the LIT-TP in the control group. Follow-up visits were scheduled 7 days, 21 days (sound processor fitting), 12 weeks and 6 months after surgery. MAIN OUTCOME MEASURES: The primary outcome measure was skin sensibility around the abutment 6 months after surgery. Secondary outcomes were subjective numbness, surgery time, wound healing, adverse soft tissue reactions, cosmetic outcomes, implant stability quotient (ISQ), implant survival, and sound processor use. RESULTS: Skin sensibility, adverse soft tissue reactions, and sound processor use were comparable between groups. The test group had a shorter surgery time and better cosmetic outcomes. More skin dehiscences and a statistically nonsignificant higher implant loss rate (12% vs 0%, p = 0.079) were observed in the test group. CONCLUSION: MIPS is comparable to the LIT-TP regarding skin sensibility at 6 months and soft tissue tolerability. With MIPS, surgery time is further reduced and better cosmetic outcomes are reported. More research into MIPS, exact drill protocol, used instruments, and associated implant loss is warranted.

The Merits of Bilateral Application of Bone-Conduction Devices in Children With Bilateral Conductive Hearing Loss.

OBJECTIVES: This study aims to characterize lateralization of sounds and localization of sounds in children with bilateral conductive hearing loss (BCHL) when listening with either one or two percutaneous bone conduction devices (BCDs). DESIGN: Sound lateralization was measured with the minimum audible angle test in which children were asked to indicate from which of the two visible speakers the sound originated. Sound localization was measured with a test in which stimuli were presented from speakers that were not visible to the children. In the sound localization test, 150 ms broadband noise bursts were presented, and sound level was roved over a 20-dB range. Because speakers were not visible the localization response was not affected by any visual cue. The sound localization test provides a clear distinction between lateralization and localization of sounds. Ten children with congenital BCHL and one child with acquired BCHL participated. RESULTS: Both lateralization and sound localization were better with bilateral BCDs compared with the unilaterally aided conditions. In the bilateral BCD condition, lateralization was close to normal in nearly all the children. The localization test demonstrated lateralization rather than sound localization behavior when listening with bilateral BCDs. Furthermore, in the unilateral aided condition, stimuli presented at different sound levels were mainly perceived at the same location. CONCLUSIONS: This study demonstrates that, in contrast to listening with two BCDs, children demonstrated difficulties in lateralization of sounds and in sound localization when listening with just one BCD (i.e., one BCD turned off). Because both lateralization and sound localization behavior were tested, it could be demonstrated that these children are more able to lateralize than localize sounds when listening with bilateral BCDs. The present study provides insight in (sub-optimal) sound localization capabilities of children with congenital BCHL in the unilateral-aided and bilateral-aided condition. Despite the sub-optimal results on sound localization, this study underlines the merits of bilateral application of BCDs in such children.

Economic Evaluation of Percutaneous Titanium Implants for Bone Conduction Hearing: A Cost-benefit Analysis.

INTRODUCTION: Developments in bone-anchored hearing implants have resulted in fewer complications, and, thus, lower complication-related costs. However, a weighing of the potential clinical benefits with higher implant purchase price is lacking. METHODS: A mathematical Markov model was used to evaluate the total costs (complication costs, implant purchase price, and standard costs) of three widely used current generation implants with expected similar outcomes, compared to a previous generation implant in adult patients over a 10-year time horizon from a healthcare perspective. Parameter estimates were derived from published clinical literature. Missing parameter estimates were based on expert opinion. Implant costs were derived from manufacturer catalogues, while standard and complication costs related to the BAHI were derived from a Dutch University Hospital and Dutch guideline for cost-effectiveness research. RESULTS: The average total costs of the treatment with a previous generation implant was &OV0556;4.967 (SD ±â€Š&OV0556;134) per patient over a 10-year time horizon, compared to &OV0556;4.678 (SD ±â€Š&OV0556;83) with a current generation implant. This implant type is potentially up to &OV0556;506 more beneficial per patient over a 10-year horizon. By further improving implant survival, an additional &OV0556;645 (SD ±â€Š&OV0556;86) per patient could be saved over 10 years. CONCLUSION: Despite a higher initial purchase price, the current generation implants are potentially cost-beneficial compared with previous generation implants. More data on current generation implants is needed to be able to determine which of the newer implants is most cost-beneficial. Focussing future developments on improving implant survival is likely to have more impact on costs compared with developments on improving soft tissue tolerability.

Hearing Results of Surgery for Acquired Atresia of the External Auditory Canal.

OBJECTIVE: To evaluate short- and long-term hearing results of surgery for acquired atresia of the external auditory canal (EAC) in a large patient cohort and to define preoperative audiometric conditions useful for patient counseling. STUDY DESIGN: Retrospective cohort study. SETTING: Academic tertiary referral center. PATIENTS: Seventy-eight ears from 72 patients with postinflammatory acquired atresia of the EAC who underwent canal- and meatoplasty were included. Patients with involvement of the ossicular chain, (syndromic) external ear malformations, or congenital aural atresia were excluded. INTERVENTION: Canal- and meatoplasty. MAIN OUTCOME MEASURES: Mean pure-tone averages of thresholds at 0.5, 1, 2, and 3 kHz (PTA0.5,1,2,3) for air conduction (AC), bone conduction, and air-bone gap (ABG) were calculated preoperatively and at short-term (≤0.55 yr) and long-term follow-up (>0.55 yr). Additionally, the numbers of ears with a closed ABG ≤10 dB and ≤20 dB, and with Social hearing (defined as: AC PTA0.5,1,2,3 ≤35 dB) were assessed. RESULTS: At short-term follow-up AC PTA0.5,1,2,3 improved by 18 dB. Social hearing was obtained in 81% of the ears. Postoperatively, 35% of the ears had a closed ABG ≤10 dB, 83% was closed ≤20 dB. During follow-up, significant deterioration of 5 to 7 dB occurred for AC thresholds at 0.25, 0.5, and 1 kHz. CONCLUSIONS: Surgery for acquired atresia of the EAC is often beneficial. This study suggests overall advantageous surgery when the preoperative indication criteria ABG PTA0.5,1,2,3 >20 dB and AC PTA0.5,1,2,3 >35 dB are applied.

Auricular prostheses attached to osseointegrated implants: multidisciplinary work-up and clinical evaluation.

PURPOSE: Not long after the introduction of osseointegrated implants outside the oral cavity, auricular prostheses are retrained on osseointegrated implants. New insights have been gained with the next-generation percutaneous osseointegrated titanium implants for bone conduction hearing since its introduction in 2010. As a result, the same technology was introduced in the Vistafix® system (VXI implant) to retain auricular prostheses. The aim of this study is to evaluate the surgical procedure, clinical outcome, and satisfaction of the patient of osseointegration-retained auricular prosthesis using VXI implants. MATERIALS AND METHODS: 11 patients who received an auricular prosthesis using VXI implants between December 2012 and November 2017 were evaluated retrospectively. The patient's medical files were reviewed to assess clinical complications and the necessity for revision surgery. The subjective outcome was measured using the Glasgow benefit inventory (GBI). RESULTS: In total, 31 implants were placed in 11 patients. None of these implants were lost nor revision surgery needed. An adverse skin reaction was observed in 13.0% of the implants and in 27.2% of the patients, adequately treated with an antibiotic ointment. The average follow-up time was 2 years and 7 months. The GBI displayed a positive score in every patient. CONCLUSIONS: The VXI implants used are a safe and reliable treatment option for retaining auricular prostheses in patients with an absent auricle. Patients were satisfied with their auricular prosthesis and showed benefit in quality of life. Studies with larger numbers and preferably a prospective character are needed to draw statistically significant conclusions.

Sound-localization performance of patients with single-sided deafness is not improved when listening with a bone-conduction device.

An increased number of treatment options has become available for patients with single sided deafness (SSD), who are seeking hearing rehabilitation. For example, bone-conduction devices that employ contralateral routing of sound (CROS), by transmitting acoustic bone vibrations from the deaf side to the cochlea of the hearing ear, are widely used. However, in some countries, cochlear implantation is becoming the standard treatment. The present study investigated whether CROS intervention, by means of a CROS bone-conduction device (C-BCD), affected sound-localization performance of patients with SSD. Several studies have reported unexpected moderate to good unilateral sound-localization abilities in unaided SSD listeners. Listening with a C-BCD might deteriorate these localization abilities because sounds are transmitted, through bone conduction to the contralateral normal hearing ear, and could thus interfere with monaural level cues (i.e. ambiguous monaural head-shadow cues), or with the subtle spectral localization cues, on which the listener has learned to rely on. The present study included nineteen SSD patients who were using their C-BCD for more than five months. To assess the use of the different localization cues, we investigated their localization abilities to broadband (BB, 0.5-20 kHz), low-pass (LP, 0.5-1.5 kHz), and high-pass filtered noises (HP, 3-20 kHz) of varying intensities. Experiments were performed in complete darkness, by measuring orienting head-movement responses under open-loop localization conditions. We demonstrate that a minority of listeners with SSD (5 out of 19) could localize BB and HP (but not LP) sounds in the horizontal plane in the unaided condition, and that a C-BCD did not deteriorate their localization abilities.