Bone-anchored Hearing Aid Surgery 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.

Cortical Emissary Vein

Bone anchored hearing aid (BAHA) is a device that combines a sound processor with a small titanium fixture implanted at the mastoid area. It is indicated for those having conductive hearing loss, especially in those not suitable for hearing aids. Emissary veins are residual connections between intracerebral veins and their extracranial drainage. The vein may be injured at the time of drilling procedure such as during insertion of implant at the mastoid area. We report a case of difficult BAHA surgery after encounter with cortical emissary vein. Mastoid emissary vein is a rare but definite entity which if not diagnosed preoperatively could be a cause of severe hemorrhage intraoperatively.

Comparison between linear incision and punch techniques for bone anchored hearing aid surgery.

SUMMARYObjectivesTo evaluate mean surgical time, incidence of soft tissue reactions, implant survival and intraoperative complications in both minimally invasive ponto surgery (MIPS) and the linear incision with tissue preservation technique (LT).MethodsA retrospective review was carried out on 48 bone anchored hearing system (BAHS) patients between 2014 and 2019: 13 patients had undergone LT and formed one group, while 35 patients had undergone MIPS and formed the second group. Mean surgical time, intraoperative complications, implant loss and skin reaction were assessed at each post-operative examination. The Mann-Whitney U test was used for statistical analysis.ResultsThe difference in the mean surgical time of 15 mins for MIPS and 36 mins for LT was statistically significant. No intraoperative complications were reported and implant survival was 100% in both groups. The incidence of adverse skin reactions was 7.7% for the LT group and 0% for the MIPS group at first follow-up examination.ConclusionsSurgical mean time is shorter for MIPS, making this procedure more suitable for local anaesthesia and more cost effective. Moreover, both LT and MIPS demonstrate good surgical outcomes in terms of skin reactions according to Holgers score and equally excellent implant survival.

Tissue Preservation Techniques for Bone-Anchored Hearing Aid Surgery.

Compare outcomes of surgical techniques in percutaneous bone-anchored hearing implant surgery. Matched retrospective cohort study. Tertiary referral center. Electronic review of adult and pediatric patients who underwent bone conduction device surgery by either the Minimally-invasive Ponto Surgery (MIPS) technique or the linear incision with no soft tissue removal (LnSTR) technique or between August 2015 and April 2018 at our facility. Patients in MIPS group underwent Minimally invasive Ponto Surgery (MIPS) technique, while those in LnSTR group underwent LnSTR technique. Major outcome was presence/severity of localized skin reaction. Secondary outcomes included cosmetic outcome, revision surgery, minor adverse events, device utilization, and postoperative aided speech recognition thresholds (SRTs) across 250 to 4000 Hertz (Hz). Fifty patients met inclusion criteria. There was a significantly lower rate of localized cutaneous reactions for the MIPS group (4.5%) compared with LnSTR group (33.3%; p = 0.026). Rate of revision surgery was significantly less for MIPS (13.6%) compared with LnSTR (20.8%; p = 0.008). Occurrence of poor cosmetic outcome was noted significantly less for the MIPS group (9.1%) compared with LnSTR patients (20.8%; p = 0.005). Minor adverse events and aided SRTs were comparable between groups. MIPS leads to a statistically significant decrease in localized cutaneous reaction compared with LnSTR. Both the LnSTR and MIPS techniques are safe and effective in the treatment of hearing loss, however MIPS may be superior in certain cases by offering improved healing, decreasing needs for wound care, and possibly decreasing need for frequent follow up.

Difficult airway challenge in a pediatric patient with Goldenhar syndrome and atrial septal defect for bone anchored hearing aid surgery

Goldenhar syndrome is ocular-auriculo-vertebral dysplasia with cardiac, renal, visceral, and facial abnormalities. Presence of craniofacial and vertebral anomalies increases the risk of difficult airway. Here, we present a case report of a child with Goldenhar syndrome and atrial septal defect (ASD) posted for bone anchored hearing aid surgery. The case report highlights a successful awake retrograde intubation under conscious sedation and topical airway anesthesia, in an 11-year-old child with Goldenhar syndrome and ASD.

Hearing Rehabilitation through Bone-Conducted Sound Stimulation: Preliminary Results.

Introduction The bone-anchored hearing aid (BAHA) is a bone conduction system that transmits the sound directly to the inner ear by surpassing the skin impedance and the subcutaneous tissue. It is indicated for patients with mixed, conductive and unilateral sensorineural hearing loss who did not benefit from conventional hearing aids (HAs). Although the benefits from BAHA are well demonstrated internationally, this field still lacks studies in Brazil. Objective To assess the auditory rehabilitation process in BAHA users through audiological, speech perception and tinnitus aspects. Methods Individuals with hearing loss were assessed before and after the implantation. The participants were subjected to pure tone audiometry in free field, functional gain audiometry, speech perception tests, tinnitus handicap inventory (THI) in open format, and to the visual analog scale (VAS). Results It was found that the participants benefited from the use of BAHA. The difference in the performance of the participants before and after the BAHA surgery was significant in terms of hearing acuity. There was no statistically significant difference in the speech perception tests. The tinnitus assessment showed that 80% of the participants scored slight tinnitus severity in THI after using a BAHA. Eighty percent of the participants classified their tinnitus as absent to mild in the VAS after the surgery. Conclusion Based on the results of the current study, we can conclude that the participants improved both the auditory perception and the tinnitus handicap.

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.

Soft tissue reactions in patients with bone anchored hearing aids.

To establish the incidence and correlation between the degree of soft tissue reaction and the body mass index (BMI) according to age and gender after a bone anchored hearing aid (BAHA) implant. We did a 1-9-year follow-up for the all the patients who underwent surgery in our department with BAHA implant system. Soft tissue reactions were classified in accordance with the Holgers classification on regular patient visits. BMI was calculated for each patient, and changes were recorded at least once a year. 47 patients were evaluated. 58% were operated on for chronic otitis with mixed or conductive hearing loss; 20% had unilateral or bilateral atresia and 16% had single sided deafness (SSD); other indications were otosclerosis and syndromic patients. The grade of Holgers classification significantly correlated at a 0.001 level with BMI (Spearmans rho 0.452). Holgers grade also differed significantly between the sexes-skin reactions in females were less frequent. An ANOVA test did not reveal any statistical difference between patients with dissimilar indications for BAHA. If performed carefully, BAHA surgery produces a favorable outcome. The Holgers grade may change as time passes. If skin reactions appear, they can be treated through local or systemic therapy, and they may turn into a normal grade. Adipose patients should be treated with special care because they are more prone to soft tissue reactions.

A novel implantable catheter system with transcutaneous port for intermittent convection-enhanced delivery of carboplatin for recurrent glioblastoma

Context: Inadequate penetration of the blood–brain barrier (BBB) by systemically administered chemotherapies including carboplatin is implicated in their failure to improve prognosis for patients with glioblastoma. Convection-enhanced delivery (CED) of carboplatin has the potential to improve outcomes by facilitating bypass of the BBB.Objective: We report the first use of an implantable CED system incorporating a novel transcutaneous bone-anchored port (TBAP) for intermittent CED of carboplatin in a patient with recurrent glioblastoma.Materials and methods: The CED catheter system was implanted using a robot-assisted surgical method. Catheter targeting accuracy was verified by performing intra-operative O-arm imaging. The TBAP was implanted using a skin-flap dermatome technique modeled on bone-anchored hearing aid surgery. Repeated infusions were performed by attaching a needle administration set to the TBAP. Drug distribution was monitored with serial real-time T2-weighted magnetic resonance imaging (MRI).Results: All catheters were implanted to within 1.5 mm of their planned target. Intermittent infusions of carboplatin were performed on three consecutive days and repeated after one month without the need for further surgical intervention. Infused volumes of 27.9 ml per day were well tolerated, with the exception of a single seizure episode. Follow-up MRI at eight weeks demonstrated a significant reduction in the volume of tumor enhancement from 42.6 ml to 24.6 ml, and was associated with stability of the patient’s clinical condition.Conclusion: Reduction in the volume of tumor enhancement indicates that intermittent CED of carboplatin has the potential to improve outcomes in glioblastoma. The novel technology described in this report make intermittent CED infusion regimes an achievable treatment strategy.

The importance of an extended preoperative trial of BAHA in unilateral sensorineural hearing loss: a prospective cohort study

The influence of an extended preoperative trial of bone-anchored hearing aid (BAHA) and headband on the decision to proceed with surgery in cases of unilateral sensorineural hearing loss is studied. In this prospective study, the headband was introduced after assessment confirmed suitable candidacy. Those who had an initially favourable response to the headband trial were encouraged to complete a 2-week home trial of device and headband. Patients were asked to pay special attention to situations where they perceived high demands on their hearing, e.g. at the dinner table, in the car, walking outside etc. Counselling regarding the BAHA placement, the need for daily care of the implant site and the financial implications of acquiring the device was also given. Tertiary university hospital. Patients with unilateral sensorineural hearing loss, fulfilling criteria for BAHA surgery, with favourable response to initial 'office trial' of headband. After 2-week home trial, BAHA and headband were returned with a statement of the patient's intentions. Sixteen of 50 (32%) patients who expressed definite interest in BAHA surgery after a positive introduction to the headband in the office did not wish to proceed to surgery having completed a more thorough 2-week trial of device at home. Most patients cited a failure of the device to meet their hearing requirements. Subsequently, we found further attrition with nine more patients (18%) deciding at a still later date, not to proceed with surgery. Ultimately, just 25 of 50 (50%) of our initially enthusiastic group chose not to proceed to surgery. In the group who did proceed, there were no non-users. We propose the importance of an extended preoperative trial where BAHA is considered in the rehabilitation of unilateral sensorineural hearing loss. The trial may foster more realistic expectations of device performance in this challenging group. A 'cooling-off' period before surgery also appears to lead to further attrition with the ultimate reward of no non-users in those proceeding to surgery.

Outcome of the Bone-Anchored Hearing Aid Procedure Without Skin Thinning

To evaluate the outcome of Bone-Anchored Hearing Aid surgery without skin thinning, a test group with direct implantation without such thinning was compared with a control group that underwent the traditional procedure. This was a single-center, prospective clinical trial designed to evaluate a novel approach to Bone-Anchored Hearing Aid implantation. Eligible patients were enrolled consecutively in the test group or selected to be age-matched controls. University Hospital. Eighteen adult patients, suffering from hearing loss, suitable for implantable hearing aid. Single-step surgery was performed on 18 patients under local anesthesia. In 9 of these, a linear incision was made, a hole was punched through the skin above the bone-anchored implant, and a longer abutment (8.5-12 mm) was introduced, whereas the other 9 were subjected to the standard protocol, using a dermatome and skin thinning. All of the patients were followed for 12 months. The test group exhibited good preservation of the tissue, no increasing skin reactions and no adverse events. The time required for this surgery was reduced, as was their healing time. These patients also experienced less numbness and pain in the surrounding area and had an improved cosmetic outcome. MAIN OUTCOME AND CONCLUSION: This clinical trial indicates that introduction of the abutment to the osseointegrated screw directly through the skin, without skin thinning, could be beneficial. This approach had fewer negative effects than the conventional procedure during the 12- month follow-up period.

Implant survival rate in bone-anchored hearing aid users: long-term results

To investigate the long-term survival rate of bone-anchored hearing aid implants, and to assess the number of patients who stop using their bone-anchored hearing aid. Patients who underwent bone-anchored hearing aid surgery between September 1977 and December 1986 were identified from a prospective database. Data were collected from patient records. During the study period, 143 patients were fitted with a bone-anchored hearing aid. Records from 132 patients were found, with a mean follow up of nine years. A total of 150 implants were installed in these patients. A total of 41 implants (27 per cent) were lost during follow up: 17 lost osseointegration, 16 were removed and eight were lost due to direct trauma. At the end of follow up, 119/132 (90 per cent) patients were still using their bone-anchored hearing aid. Despite a high incidence of implant loss over time, a large number of patients still continued to use their bone-anchored hearing aid.

先天性外耳道閉鎖症例における埋め込み型骨導補聴器（Ｂｏｎｅ‐Ａｎｃｈｏｒｅｄ Ｈｅａｒｉｎｇ Ａｉｄ：ＢＡＨＡ）の有効性に関する検討

The effectiveness of bone anchored hearing aid (BAHA) for the patients with congenital aural atresia was evaluated by multicenter clinical study in Japan. Twenty patients (17 bilateral and 3 hemilateral) of congenital auricular atresia were registered for this study and finally, 18 of them (15 bilateral and 3 unilateral) were subjected to further evaluation. Primary endpoint of this study was free sound-field pure-tone audiometory and speech threshold hearing test in quiet and noisy circumstances. Secondary endpoint of this study was patient's satisfaction based upon APHAB (Abbreviated Profile of Hearing Aid Benefit) questionnaire survey. These results were compared between before and 12 weeks after BAHA surgery. Both hearing level of pure tone and speech threshold significantly improved after BAHA surgery. APHAB scores also suggested the improvement of the QOL after BAHA usage, except for the scores that concerned with unpleasantness of noisy sound. BAHA is one of the useful options for the treatment of congenital auricular atresia.

埋め込み型骨導補聴器の聴覚成績と術中，術後合併症の検討

The bone-anchored hearing aid (BAHA) has advantages over conventional hearing aids in sound quality and speech reception in silence, but requires surgery and may have peri-and postoperative complications. We evaluated audiological findings and complications in 12 subjects (13 ears)-8 men and 4 women aged 20-71--undergoing BAHA surgery from September 2001 to October 2005. Surgery was for single-sided deafness in one subject. Mean warble tone thresholds with BAHA were 29.9dB and 65.2dB without. Functional gains ranged from 16 to 52dB (mean: 35.3dB). Dural exposure or venous hemorrhage was seen in 4 ears, and mastoid cells opened and a skin flap was damaged in 1 ear each. No severe complications occurred perioperatively. Skin reactions categorized into grade 1 or more were recognized in nearly 70% of ears during the first postoperative year but most were a grade 1 reaction and skin reactions decreased with time. Skin overgrowth occurred in 1 ear immediately after an abutment separated accidentally from the fixture. All complications were treated in outpatient clinics. No fixture extrusion occurred. The decision to proceed with BAHA surgery thus required fully informed consent based on knowledge of peri-and postoperative complications.

Traumatic Impact to Bone-Anchored Hearing Aid Resulting in Epidural Hematoma

In the present case we describe (to our knowledge) the previously unreported complication of epidural hematoma resulting from head trauma in a child with a bone-anchored hearing aid (BAHA) implant. Although rare, such a potentially devastating complication merits rectient ognition in the literature because it has implications for preoperative counseling and patient consent. Specifically, parents of children undergoing BAHA surgery should be aware of the increased danger associated with trauma to the osseointegrated implant.

Skin reactions following BAHA surgery using the skin flap dermatome technique

The objectives of the study were to determine the incidence of skin reactions and complications associated with bone-anchored hearing aid (BAHA) implantation. The study is a retrospective case review done in a tertiary referral center. One hundred thirty-eight consecutive patients between 1998 and 2008 underwent implantation of a BAHA and were regularly seen for follow-up. Indications included conductive or mixed hearing loss where a hearing aid cannot be used and since 2000 also had contralateral single-sided perceptive hearing loss. BAHA implantation was done by creating a pedicled flap using the skin flap dermatome technique. Postoperative incidence of skin reactions and complications were measured. Significant postoperative complications requiring revision surgery occurred 37 times in 30 patients. Normal skin healing was seen in 52 patients (63.4%), while abnormal skin healing occurred in 30 patients (36.6%). This study showed that skin problems occur more often than expected. Because of the skin problems with the skin flap technique, the authors have switched to the linear incision technique, hoping to decrease the incidence of skin problems.

Measurement of Skull Bone Thickness for Bone-Anchored Hearing Aids

A-mode ultrasound scanning with coded signals allows bone thickness measurements at the site of bone-anchored hearing aid surgery as compared to computed tomographic scanning and mechanical measurements. Adequate bone thickness is a prerequisite for successful, long-lasting osseointegration of titanium fixtures for bone-anchored hearing aids. Computed tomography can be used to measure bone thickness but has several drawbacks. Bone thickness was measured at the site of bone-anchored hearing aids surgery in 28 formaldehyde-preserved human cadaver temporoparietal bones. Four blinded investigators used a hand-held, A-mode ultrasound system with direct coupling at 2.25 MHz transducer using coded signals (SonoPointer) and repeated the measurements twice. Comparisons were made with high-resolution computed tomographic scanning and mechanical micrometer caliper measurements. There was significant anatomical variation in the temporoparietal bones. Computed tomography was in good agreement with the mechanical reference. All specimens could be measured by the SonoPointer. The mean difference between the mechanical control and ultrasound scanning averaged for all measurements by all investigators was 0.3 mm (standard deviation, 1.2 mm). Trained ultrasound experts yielded better results (mean difference, 0.3 mm; standard deviation, 1.0 mm). Agreement was best for bone thickness up to 5 mm. Outliers occurred in bones thicker than 7.5 mm. The SonoPointer is a promising, noninvasive, hand-held tool for real-time measurement of bone thickness in bone-anchored hearing aid surgery, especially for children. Even disregarding the absolute thickness reading, the SonoPointer could be used to search intraoperatively for a local maximum of bone thickness.

High Body Mass Index as a Risk Factor for Skin Overgrowth With the Bone-Anchored Hearing Aid

To identify whether an increased body mass index (BMI) predisposes patients to more soft tissue problems after placement of a Bone-Anchored Hearing Aid implant. We retrospectively reviewed 88 adult patients who met criteria for inclusion in the study. Ten (11.4%) of the 88 patients had significant soft tissue reaction requiring excision, revision of the skin graft, or placement of a longer abutment (8.5 mm). Of these 10 patients, 4 required placement of a longer abutment, whereas 4 underwent revision skin grafting. All 10 patients had scar excisions in the office. Of the 10 patients, 9 were considered obese with a BMI of 30 lb/in or greater. One patient was considered overweight with a BMI of 28.1 lb/in. The mean BMI for those patients with significant soft tissue reactions was 34.2 lb/in. The mean BMI for patients with no reaction or minor reactions was 27.6 and 27 lb/in, respectively. No patient lost an implant due to soft tissue reaction during the follow-up period. Our study demonstrates that after Bone-Anchored Hearing Aid surgery, most patients (78/88, 88.6%) had no soft tissue reaction or had only a mild reaction that was easily treated. However, there are a definite percentage of patients who may develop significant scarring over time. This study identified a significant relationship between obesity (BMI > 30 lb/in) and extensive soft tissue reaction around the implant site.

Spectrum of Hearing Disorders and Their Management in Children With CHARGE Syndrome

The CHARGE syndrome is associated with ear anomalies and deafness in addition to other malformations. Deformations of the ossicles or aplasia of the semicircular canals, cochlear hypoplasia, hypoplasia or aplasia of the VIIIth cranial nerve and abnormal routing of the VIIth cranial nerve, sigmoid sinus, and emissaries are typical findings. The aim of this study is to explore the feasibility and procedure of cochlear implantation in patients with CHARGE syndrome and to assess the outcome. Retrospective case review. Tertiary referral center; cochlear implant program. Ten patients with CHARGE syndrome and 3 patients with CHARGE-like syndrome treated in our center due to hearing impairment. Eleven patients were congenitally deaf, 1 patient had progressive hearing loss, and 1 patient had mixed hearing loss. Computed tomography of temporal bones and magnetic resonance imaging of the brain; bone-anchored hearing aid surgery, cochlear implantation, rehabilitation results. Surgical suitability and hearing rehabilitation. We illustrate the management of preoperative diagnostics, surgical planning, and hearing rehabilitation. One patient with mixed hearing loss underwent bilateral bone-anchored hearing aid surgery. Because 2 patients had bilateral aplasia of the auditory nerves, we recommended an auditory brainstem implant. The unilateral cochlear implantation was performed in 9 patients and bilateral in 1 patient. In selected cases, it was helpful to plan the operation using a simulator for temporal bone surgery. Complex malformations, such as in CHARGE syndrome, with an increased intraoperative risk for complications should be facilitated by using intraoperative digital volume tomography-assisted navigation and intraoperative digital volume tomography control of electrode position. The results after CI surgery vary due to the differing extent of additional disabilities such as developmental delay, intellectual delay, and visual impairment. Nine of our patients showed improved responsiveness with the cochlear implant. Open speech comprehension could not be observed in 8 patients, whereas the follow-up period was less than 1 year in 4 patients. The relatively high age of our patients at implantation might be an important factor. Careful planning of the treatment of CHARGE syndrome patients with sensorineural hearing loss can, to a limited extent, lead to auditory benefit without increasing surgical complications. Cochlear implantation is therefore indicated after critical assessment.

Hearing Rehabilitation with Bone Anchored Hearing Aid: Experience in 14 Patients

Background and Objectives : Bone anchored hearing aid (BAHA) is an alternative method applicable to patients with chronic draining ear, congenital aural atresia and single sided deafness, who cannot benefit from conventional air conduction hearing aids. The objective of this study was to evaluate the experience of 14 patients who underwent BAHA surgery. Subjects and Method : We retrospectively reviewed the medical records of 14 patients who underwent BAHA surgery. Preoperative pure tone air and bone conduction thresholds and air-bone gap, postoperative BAHA-aided thresholds were measured. Hearing improvement as a result of implantation and complications related to implant were evaluated. Results : The most common indication for BAHA was congenital aural atresia (8 patients) and the rest consisted of chronic otitis media (3 patients) and unilateral sensorineural hearing loss (3 patients). The average threshold improvement with BAHA was 40 dB and 34 dB in patients with congenital aural atresia and chronic otitis media, respectively. Patients with unilateral hearing loss had a postoperative aided threshold of 25 dB. Complications were limited to the periabutment skin problem in two patients. One patient received revision surgery replacing the diseased skin with split-thickness skin graft from a thigh and the other patient received surgery to remove the abutment and the wound was closed with rotation flap, leaving the fixture underneath the skin. Conclusion : BAHA could be one of the safe and reliable treatment options available for auditory rehabilitation. Systematic evaluation for candidate selection might be needed to increase hearing gain and decrease co-morbidity.