Bone-anchored Hearing Aid Implantation Research Articles

Very Early Loading of a Bone-Anchored Hearing System Is Safe.

To investigate the feasibility of early sound processor loading with two separate bone-anchored hearing aid implants 1 to 2 weeks after implantation. Secondary endpoints included registration of any postoperative complications, skin reactions, and any adverse events. Prospective, nonrandomized, noncontrolled, multicenter clinical trial. Tertiary referral center. Sixty adult patients, eligible for bone-anchored hearing aid surgery, were enrolled. Implantation of the bone-anchored hearing aid implants were done using minimally invasive surgery with tissue preservation. Implant stability quotient (ISQ) values were recorded using resonance frequency analysis. Follow-ups were scheduled 5 to 12 days, 4 to 8 weeks, 6 months, and 12 months postoperatively. Differences between the lowest ISQ values (ISQ low) over time were analyzed by paired-samples t test with a significance level of 0.05. Skin and soft tissue reactions were assessed according to Holger's classification. Loading time of the Ponto Wide implant was 11.6 ± 1.4 days (SD) in average (median, 12 d; range, 7-19 d). Loading of the Ponto BHX implant was done 9.7 ± 3.5 days (SD) postoperatively (median, 9 d; range, 5-19 d). The implant stability increased significantly during the 12-month study period with both implants. One Ponto BHX implant was lost. Skin and soft tissue reactions were few in both groups. Across all planned follow-up visits, no skin and soft tissue reactions were observed in 86% (Ponto BHX implant) and 85% (Ponto Wide implant). Very early loading of sound processors after percutaneous bone-anchored hearing system surgery is safe already 1 to 2 weeks postoperatively.

Pros and cons of a bone-conduction device implanted in the worse hearing ear of patients with asymmetric hearing loss

PurposeBone-conduction devices can be considered a viable treatment option for patients experiencing asymmetric hearing loss (AHL), especially those with severe to profound hearing loss (HL) present in one ear. However, there are only a few reports on the effects of bone-anchored hearing aids (BAHAs) on patients with AHL. This retrospective study analyzed in detail the effects of BAHA on softer sounds than other hearing aids and identified situations in which BAHA had a negative effect.MethodsPatients with AHL, characterized by severe to profound hearing loss in one ear with a difference of ≥45 dB from that of the contralateral ear, underwent BAHA implantation in the ear with worse hearing. The BAHA effects were evaluated by assessing the word recognition score (WRS) and speech reception threshold (SRT) using the Japanese Oldenburg Sentence Test for various signal settings and noise directions. For a subjective analysis, the Speech, Spatial and Qualities of Hearing Scale (SSQ12) score was determined.ResultsThirteen patients who underwent BAHA implantation at the Miyazaki University Hospital between 2007 and 2021 were included. The BAHA demonstrated a significant improvement in the WRS from 40 to 70 dB sound pressure levels. Although the SRT showed significant improvement in noisy environments when speech was presented to the BAHA-wearing side, it worsened significantly when noise was presented to this side. In the survey of subjective hearing ability, both the total and subscale SSQ12 scores improved significantly after wearing the BAHA.ConclusionThis study identified scenarios in which BAHAs were beneficial and detrimental to individuals with AHL. Generally used audiological tests, such as the WRS with fixed sound pressure, may underestimate the effectiveness of BAHAs for softer sounds. In addition, depending on the direction of the noise, BAHAs may have adverse effects. These results could help patients comprehend the potential benefits and limitations of bone-conduction devices for their hearing.

Surgical results of transcutaneous bone-anchored hearing aid comparing the C-shaped and linear incision techniques.

The aim of the study is to compare the operative time and postoperative complication outcomes for bone-anchored hearing aid (BAHA) implants using two different techniques: the C-shaped incision technique and the linear incision technique. An analysis was carried out of 38 patients implanted with transcutaneous BAHAs during a 4-year period in a single otolaryngology department. The implantation was carried out under general anesthesia. Operative time was significant lower with the linear technique compared to the C-shaped technique (76.55min, SD 16.75 vs. 93.17min, SD 19.82; p = 0.007). There was no difference in postoperative complications between the two techniques. The use of linear incision for transcutaneous BAHA system implantation is associated with a reduced surgery time compared to the C-shaped technique, with no increase in postoperative complications.

Functional and patient-reported outcomes of bone-anchored hearing aids (BAHA): A prospective case series study

ObjectiveThe purpose of this study was to evaluate the functional and patient-reported outcomes, and their correlation, after percutaneous bone-anchored hearing aid (BAHA) implantation. MethodsA prospective study was conducted between January 2018 and December 2020 in a tertiary care center. All adult patients who were implanted with a percutaneous BAHA device during this evaluation period were included in the study. Complete auditory function and patients reported outcome measures (PROMs) were assessed in the preoperative period and 6 months after the implant activation. The PROMs included a generic form (Medical Outcome Study 36 Short Form Healthy Survey (MOS SF-36)), and three disease-specific forms (Hearing Handicap Inventory (HHI), Satisfaction with Amplification in Daily Life Scale (SADLS), and Tinnitus Handicap Inventory (THI)). ResultsTwenty-two patients with an average age of 53 years were included in the study. The overall functional gain with the BAHA in sound-field pure tone average (PTA) was 29 dB, with no statistically significant differences according to surgical indication (F(3,18) = 2.319, p = 0.110). The greater the preoperative air-bone gap, the greater the functional gain obtained (r = 0.505, p < 0.05). In the PROMs, we found a significant improvement in HHI scores (p < 0.005) and a significant increase in overall SADLS scores (p < 0.05) with the use of percutaneous BAHA devices. We did not verify any statistically significant correlation between functional and PROMs results. ConclusionsThe BAHA is a safe and effective alternative hearing rehabilitation option in selected patients. The PROMs results prove patient's overall satisfaction.

Cortical emissary vein: An important vessel to look for before bone anchored hearing aid implantation

Cortical emissary vein: An important vessel to look for before bone anchored hearing aid implantation

Bioinstructive Micro-Nanotextured Zirconia Ceramic Interfaces for Guiding and Stimulating an Osteogenic Response In Vitro.

Osseous implantology’s material requirements include a lack of potential for inducing allergic disorders and providing both functional and esthetic features for the patient’s benefit. Despite being bioinert, Zirconia ceramics have become a candidate of interest to be used as an alternative to titanium dental and cochlear bone-anchored hearing aid (BAHA) implants, implying the need for endowing the surface with biologically instructive properties by changing basic parameters such as surface texture. Within this context, we propose anisotropic and isotropic patterns (linear microgroove arrays, and superimposed crossline microgroove arrays, respectively) textured in zirconia substrates, as bioinstructive interfaces to guide the cytoskeletal organization of human mesenchymal stem cells (hMSCs). The designed textured micro-nano interfaces with either steep ridges and microgratings or curved edges, and nanoroughened walls obtained by direct femtosecond laser texturing are used to evaluate the hMSC response parameters and osteogenic differentiation to each topography. Our results show parallel micro line anisotropic surfaces are able to guide cell growth only for the steep surfaces, while the curved ones reduce the initial response and show the lowest osteogenic response. An improved osteogenic phenotype of hMSCs is obtained when grown onto isotropic grid/pillar-like patterns, showing an improved cell coverage and Ca/P ratio, with direct implications for BAHA prosthetic development, or other future applications in regenerating bone defects.

Experience with the use of the navigation system for ear surgeries: A cohort study

Objectives: Image guidance has been well characterized in spinal, orthopedic, sinonasal, and skull base surgery, but there is limited information on the use of these systems in cochlear implant and ear surgery. The aim of this study was to evaluate the use of image guidance systems to facilitate cochlear and bone-anchored hearing aid (BAHA) implant surgery. Study Design: Cohort. Materials and Methods: Eleven patients, including 10 who underwent cochlear implantation and 1 who underwent BAHA implantation with the assistance of the navigation system, were included in the study. Patient's data (age, gender, type and cause of hearing loss, and type of surgery), preoperative computed tomography scan findings, accuracy of the navigation system, operating time, and postoperative complications were collected and analyzed. Results: All 11 patients underwent uneventful surgeries finding the desired sites for implantation with ease by using the navigation system. All surgeries were completed without any complications. Conclusion: Performing cochlear and BAHA implantation with the assistance of the navigation system is a safe way to treat patients with normal or abnormal anatomy. In particular, it is helpful for identifying the round window for electrode insertion in cochlear implantation and for choosing the site with the thickest bone for BAHA implantation.

Long-term soft tissue outcomes for hydroxyapatite-coated bone-anchored hearing implant surgery.

To investigate skin-related postoperative outcomes following a tissue preservation technique in percutaneous hydroxyapatite-coated bone-anchored hearing aid (BAHA) abutment implantation. A retrospective medical records review of adult patients, who underwent single-stage BAHA implantation between July 2013 and November 2017 at a tertiary centre was conducted. Surgical procedures were performed by a single surgeon using a linear incision soft tissue preservation technique. Patients were reviewed at 1week, 4weeks, 3months, 6months, and annually postoperatively and soft tissue reactions were graded using Holger's score RESULTS: There were 102 patients included with a slight female preponderance (female:male 56:46). There were 586 follow-up episodes during the study period. From the recorded follow-up episodes, Holger's scores were documented as follows: Holger score 0 (89%); 1 (7%); 2 (2%); 3 (1.9%). Three patients (3%) required peri-abutment soft tissue excision (Holger 3) and insertion of longer abutments. One patient (1%) reported atraumatic implant loss. The BAHA was re-implanted in two patients (2%) due to traumatic dislodgement. There was a statistically significant association (p = 0.009) when the mean time to minor skin complications was compared with mean time to a significant skin reaction. Tissue preservation technique is the procedure of choice for BAHA abutment implant surgery. It confers excellent soft tissue outcomes and an excellent implant survival rate.

Clinical outcomes following Cochlear™ BIA300 bone anchored hearing aid implantation in children

ObjectiveBone anchored hearing implants (BAHI) have been in use for over 30 years, and are commonly implanted in children for a range of indications. The Cochlear™ BIA300 system was launched in 2010 and used at The Birmingham Children's Hospital from 2011. Here we report the long-term outcomes of children implanted with the Cochlear™ BIA300 BAHI system in our centre. MethodsA retrospective case note analysis was performed to identify outcomes in all children who underwent BIA300 implantation between 2011 and 2013. Results52 children with a total of 78 implants were included. Mean age at implantation was 8.7 years. Mean follow-up was 43.5 months. Overall, 60 (77%) implants developed soft tissue complications requiring treatment. Forty-eight (62%) required topical treatment; 27 (35%) required systemic treatment; and 27 (35%) required surgical soft tissue revision under general anaesthesia. ConclusionsThe Cochlear™ BIA300 system appears to be associated with higher than expected rates of soft tissue reaction in children, with late as well as early soft tissue complications requiring both medical and surgical treatment.

A Comparison of the Operative Techniques and the Postoperative Complications for Bone-Anchored Hearing Aid Implantation.

Introduction Bone anchored hearing aids (BAHA) represent a useful surgical option for patients with single sided deafness. Objectives To compare multiple techniques for BAHA implantation regarding postoperative complications, operative time, and duration between the surgery and the first use of the BAHA. Methods A retrospective study was conducted of all patients receiving implantation of a BAHA from August of 2008 to October of 2014. Data collected included: patient age, gender, side operated, abutment length, operative time, duration until first use of the BAHA, operative technique, and postoperative complications. The statistical analysis was performed using analysis of variance (ANOVA), Tukey pairwise comparison, chi-square, and paired t -test. Statistical significance was determined using a level of p < 0.05. Results A total of 88 patients (43 female and 45 male) were included in the data analysis. A total of 80 complications were documented, and these complications were classified according to the Holgers criteria. A significant difference in the total postoperative complications existed between the six techniques used (ANOVA; p < 0.01). In addition, there was also a significant difference among the six techniques employed regarding the operative time (ANOVA; p < 0.01). The average time duration until fitting of the BAHA processor among the various techniques trended toward but did not reach statistical significance (ANOVA; p = 0.16). Conclusions Significant differences in the operative outcomes exist among the various techniques for BAHA implantation. Based on the statistical analysis of our data, the BAHA Attract system (Cochlear Ltd., Sidney, Australia) requires greater operative time, but it is associated with less postoperative complications than percutaneous techniques and its processor may be fitted significantly sooner.

Outcomes of Bone Anchored Hearing Aid Implant at Universiti Kebangsaan Malaysia Medical Centre (UKMMC).

The cross sectional study was conducted in Universiti Kebangsaan Malaysia Medical Center (UKMMC), Malaysia from August 2012 to December 2013. All patients implanted with in UKMMC from December 2001 until December 2012 was included. Glasgow Benefit Inventory (GBI) questionnaires and UKMMC questionnaires were used as part of the assessment tool. The GBI is a scoring which measures the change in health status produced by surgical interventions. UKMMC questionnaires was invented by our department to assess questions related to social and life style of patients and also the cosmetic perspective Baha implant and other daily related activities. The audiological assessment was assessed using hearing aid gain threshold. Complication with regards to skin reaction was graded using Holger Skin Classification. A total of 40 patients underwent Baha implant were recruited but only 35 patients fulfilled the criteria and included in this study for analysis. Age of patients ranged from 5year old to 38year old, with median of 13years old. There were 22 patients (62.8%) were male and 13 patients (37.1%) were females. Almost all cases were canal atresia except one adult patient was a case of bilateral chronic discharging ear with chronic irritation with ear mould. Majority of patients 21 (60%) have hearing level of moderate to severe hearing loss (40-89dB) and 14 patients (40%) have mild to moderate hearing loss (20-39dB). The level of hearing was retested post operatively. All of the patients have improvement in their aided hearing with the range of 10-25dBL which is statistically significant at p value of <0.05. The GBI was scored positively in all subscales. Majority of patients (91.4%) used BAHA more than 4h per day and 88.6% agreed that BAHA is cosmetically acceptable. All patients experienced some form of skin irritation (Holger grade 1-2) however only 20% required surgical intervention. All our patients have range of 10-25dB improvement of their aided hearing which is statistically significant at p value of <0.05. BAHA has been proven to show significant benefit in audiological improvement and quality of life.

Efficacy of Bone-Anchored Hearing Aids in Single-Sided Deafness: A Systematic Review.

Bone-anchored hearing aids (BAHAs) have been known to partially restore some of the functions lost in subjects with single-sided deafness (SSD). Our aims in this systemic review were to analyze the present capabilities of BAHAs in the context of SSD, and to evaluate the efficacy of BAHAs in improving speech recognition in noisy conditions, sound localization, and subjective outcomes. A systematic search was undertaken until August 2015 by two independent reviewers, with disagreements resolved by consensus. Among 286 references, we analyzed 14 studies that used both subjective and objective indicators to assess the capabilities of a total of 296 patients in the unaided and aided situations. Although there was "no benefit" of BAHA implantation for sound localization, BAHAs certainly improved subjects' speech discrimination in noisy circumstances. In the six studies that dealt with sound localization, no significant difference was found after the implantation. Twelve studies showed the benefits of BAHAs for speech discrimination in noise. Regarding subjective outcomes of using the prosthesis in patients with SSD (abbreviated profile of hearing aid benefit [APHAB] and the Glasgow hearing aid benefit profile [GHABP], etc.), we noticed an improvement in the quality of life. This systematic review has indicated that BAHAs may successfully rehabilitate patients with SSD by alleviating the hearing handicap to a certain degree, which could improve patients' quality of life. This report has presented additional evidence of effective auditory rehabilitation for SSD and will be helpful to clinicians counseling patients regarding treatment options for SSD.

In Vitro Assessment of MRI Safety at 1.5T and 3.0T for Bone-Anchored Hearing Aid Implant

In Vitro Assessment of MRI Safety at 1.5T and 3.0T for Bone-Anchored Hearing Aid Implant

A Retrospective Review of Temporal Bone Imaging With Respect to Bone-Anchored Hearing Aid Placement.

Current bone-anchored hearing aid (BAHA) guidelines recommend placement of the titanium implant 5 to 7 cm posterior to the ear canal. Previous studies show that bone conducted hearing is maximized the closer the transducer is to the cochlea. We aim to investigate the position of the sigmoid sinus with respect to BAHA implants to determine whether they may be safely placed closer to the ear canal in patients with chronic ear disease, enhancing the amplification available to the patient. We performed a retrospective review of high-resolution temporal bone computed tomographies (CTs), comparing multiple measurements between ears with chronic ear disease and normal controls. Images were obtained at a single academic medical center. Eighty patients (160 ears) with temporal bone CTs performed between 2006 and 2009 were measured. Patients with chronic ear disease were identified by international statistical classification of diseases and related health problems, revision 9 code and confirmation by review of the imaging. Measurements were made on axial CT slices from a point 1 cm posterior to the sigmoid sinus to the posterior margin of the external canal. The squamous temporal bone thickness was also measured at this point. Forty-seven patients (55 ears) had chronic ear disease. Distance from the posterior canal was significantly different between normal and diseased ears (36.3 mm versus 33.5 mm, p < 0.001). Squamous temporal bone thickness varied widely, and was similar between groups (6.9 mm versus 6.8 mm, p = 0.76). According to our data, titanium implants for bone-anchored hearing aids may be safely placed closer to the external canal than the current recommendations. This could allow for better transduction as well as sound localization in BAHA patients.

Pediatric unilateral sensorineural hearing loss: implications and management.

The purpose of this review is to summarize current studies detailing the impact of unilateral sensorineural hearing loss in children and the most current modalities of treatment used in its management. Current studies corroborate historic views on the impact of unilateral sensorineural hearing loss on patient wellbeing and academic success and stress the use of additional surveillance and studies to diagnose those patients that may pass standard screening practices and suffer from lack of prompt and proper care. With respect to management, notable findings include the continuous development of improved conventional and contralateral routing of signal amplification devices that may act to provide alternatives to percutaneous bone-anchored hearing aid implantation. These include improvements in more conventional hearing aid technology, so as to bridge the performance gap with the classical bone-anchored hearing aid implant, and the development of partially implanted transcutaneous bone conduction hearing devices. Due to dissatisfaction with sound localization, a new and significant development is the burgeoning accumulation of research on cochlear implantation for the treatment of unilateral sensorineural hearing loss in children. With advances in technology in historic modalities of treatment, and the advent of new modalities such as cochlear implantation, the clinician has a wide armamentarium by which to provide treatment to patients based on clinical circumstances and patient desires.

Has the use of the linear incision reduced skin complications in bone-anchored hearing aid implantation?

To compare the skin-related complications of the traditional skin flap method with a linear incision method of implantation. All cases of bone-anchored hearing aid surgery performed by a single surgeon (n = 117) were compared over two periods: 1999-2011, when the traditional method of skin flap and soft tissue removal was used (group 1; n = 86), and 2012-2013, when linear incision without soft tissue removal was used (group 2; n = 31). All patients were followed up for one year and complications were recorded for that period. There were 21 (24.4 per cent) skin-related complications in group 1 (skin overgrowth = 12, wound infection = 8 and numbness = 1) and 3 (9.7 per cent) complications in group 2 (wound infection = 3). Analysis using independent t-tests showed the results to be significant (p < 0.05; 95 per cent confidence interval = 0.0800-0.4473). The linear incision without soft tissue removal method for bone-anchored hearing aid implantation reduces skin complication rates.

Surgical and Audiologic Comparison Between Sophono and Bone-Anchored Hearing Aids Implantation.

Objectives Bone-anchored hearing aids (BAHA) occasionally cause soft tissue problems due to abutment. Because Sophono does not have abutment penetrating skin, it is thought that Sophono has no soft tissue problem relating to abutment. On the other hand, transcutaneous device’s output is reported to be 10 to 15 dB lower than percutaneous device. Therefore, in this study, Sophono and BAHA were compared to each other from surgical and audiological points of view.Methods We retrospectively reviewed the medical records of 9 Sophono patients and 10 BAHA patients. In BAHA cases, single vertical incision without skin thinning technique was done. We compared Sophono to BAHA by operation time, wound healing time, postoperative complications, postoperative hearing gain after switch on, and postoperative air-bone gap.Results The mean operation time was 60 minutes for Sophono and 25 minutes for BAHA. The wound healing time was 14 days for Sophono and 28 days for BAHA. No major intraoperative complication was observed. Skin problem was not observed in the 2 devices for the follow-up period. Postoperative hearing gain of bilateral aural atresia patients was 39.4 dB for BAHA (n=4) and 25.5 dB for Sophono (n=5). However, the difference was not statistically significant. In all patients included in this study, the difference of air-bone gap between two groups was 16.6 dB at 0.5 kHz and 18.2 dB at 4 kHz. BAHA was statistically significantly better than Sophono.Conclusion Considering the audiologic outcome, BAHA users were thought to have more audiologic benefit than Sophono users. However, Sophono had advantages over BAHA with abutment in cosmetic outcome. Sophono needed no daily skin maintenance and soft tissue complication due to abutment would not happen in Sophono. Therefore, a full explanation about each device is necessary before deciding implantation.

Bone-anchored hearing aids in conductive and mixed hearing losses: why do patients reject them?

This study aimed to report the bone-anchored hearing aid uptakerate and the reasons for their rejection by patients with conductive and mixed hearing losses. A retrospective review was performed of 113 consecutive patients with unilateral or bilateral conductive or mixed hearing loss referred to the Greater Manchester bone-anchored hearing aid (BAHA) programme between September 2008 and August 2011. 98 (86.7%) patients were deemed audiologically suitable for BAHA implantation. Of these, 38 (38.8%) had BAHA implanted; 60 (61.2%) patients declined. Of those who declined, 27 (45%) cited anxiety over surgery, 18 (30%) cited cosmetic reasons, 16 (26.7%) perceived limited benefit from the device and six (10%) preferred conventional hearing aids. Our study highlights a 38.8% BAHA uptake rate in audiologically suitable patients. The main reasons cited for rejection of BAHA were anxiety over surgery and cosmetic concerns. It is important that clinicians address these early during consultation with prospective BAHA recipients and avoid rushing to implant these patients with a bone-anchored hearing aid.

Skin reactions caused by bone-anchored hearing aid (BAHA) implantation

ObjectiveTo report a case of intractable skin reactions caused by bone-anchored hearing aid (BAHA) implantation to improve our understanding and treatment of BAHA implantation-caused skin reactions. MethodsWe reported a case of severe skin reactions caused by BAHA implantation. Related literature were also reviewed. ResultsWe found grade IV skin reactions, including hyperplasia around the implant, which led to the removal of the BAHA implant 10 months after implantation. The findings indicated poor skin hygiene, allergy to titanium and inadequate surgicals skills as the possible causes of the skin reaction. ConclusionSkin adverse reactions, usually rare in BAHA implantation patients, may cause implant removal and implantation failure. We suggest to further investigate the mechanisms underlying titanium allergy.

Successful bone-anchored hearing aid implantation in a patient with osteogenesis imperfecta

To report a case of successful bone-anchored hearing aid implantation in an adult patient with type III osteogenesis imperfecta, which is commonly regarded as a contraindication to this procedure. A 45-year-old man with type III osteogenesis imperfecta presented with mixed hearing loss. There was a mild sensorineural component in both ears, with an air-bone gap between 45 and 50 dB HL. He was implanted with a bone-anchored hearing aid. The audiological outcome was good, with no complications and good implant stability (as measured by resonance frequency analysis). To our knowledge, this is the first recorded case of bone-anchored hearing aid implantation in a patient with osteogenesis imperfecta.