Bone-anchored Hearing Implant Research Articles

Evaluation of Clinical Performance of Ponto Implantation Using a Minimally Invasive Surgical Technique-A Prospective Multicenter Study.

To investigate the clinical outcomes of bone-anchored hearing implant surgery using the MONO procedure. Multicenter, multinational, single-arm, prospective trial with a 12-month follow-up. Seven European university hospitals from the United Kingdom, Sweden, Denmark, and The Netherlands. Fifty-one adult patients requiring surgical intervention for bone conduction hearing. Bone-anchored hearing implant surgery using the MONO procedure. The primary endpoint assessed implant usability 3 months after surgery. Implant status, soft tissue reactions, pain and numbness, postoperative events, and sound processor usage were assessed at all follow-up visits. Hearing-related quality of life was evaluated using the Glasgow Benefit Inventory (GBI). At 3 months, 94.2% of the implant/abutment complexes provided reliable anchorage for sound processor usage. No severe intraoperative complications occurred. Sixty-nine percent of surgeries were performed under local anesthesia, with surgery lasting 10 minutes on average. Four implants were lost due to trauma (n = 2), spontaneous loss of osseointegration (n = 1), or incomplete insertion (n = 1). Adverse soft tissue reactions occurred in 2.6% of visits, with a maximum Holgers grade of 3 (n = 1) and grade 2 (n = 5) across patients. Hearing-related quality of life at 3 months improved in 96% of patients. The MONO procedure provides a safe and efficient surgical technique for inserting bone-anchored hearing implants with few and minor intra- and postoperative complications.

Beyond the surface: exploring contributing factors to bone anchored hearing implant complications.

Bone anchored hearing implants (BAHI) are considered for conductive and mixed hearing loss, relying on osseointegration of a titanium implant. Limitations relate to constant skin contact, with resultant percutaneous infections and granulation. This study investigates whether patient characteristics and implant-specifications contribute to BAHIs' skin complications in a cohort with a uniform surgical approach. A 10year (2014-2024) retrospective cohort study was conducted on BAHI procedures that were undertaken using a tissue-preserving 'punch' technique. Data on patient demographics, co-morbidities, implant type, surgical approach, and complications were collected. Poisson regression analysis was used to identify predictors of complications. A total of 53 patients undergoing 55 BAHI surgeries by three ENT consultants were included. Factors that greatly increased implant-related percutaneous infections included the Cochlear™ BIA400 implant when compared to the Ponto™ BHX implant (twofold, CI 2.03-2.16), abutment sizes ≤ 10mm (fourfold, CI 3.99-4.12) and male gender (9%, CI 1.07-1.12). Granulation episodes were affected by cardiovascular disease (CVD) status (1.5-fold, CI 0.26-0.78), BIA400 implant (threefold, CI 8.8.-9.2) and abutment sizes ≤ 10mm (fourfold, CI 3.6-3.73). Revision surgery episodes increased with diabetic status (1.2-fold, CI 0.06-0.37) and abutment sizes ≤ 10mm (threefold, 3.303-3.304). Larger cohort studies are required to confirm findings, particularly for implant and abutment size contributions. However, the findings suggest that using a larger abutment size when skin thickness meassuremets are borderline, improved hygiene education in male patients, pre-operative optimisation of CVD and diabetes, and adjusted patient follow-up based on risk stratification of the contributing factors to complication rates could reduce complication rates.

Tissue Classification After Bone-Anchored Hearing Implant Surgery: A Machine Learning Approach to Monitoring Skin Response.

Here, we aim to 1) expand the available evidence for the use of machine learning techniques for soft tissue classification after BCD surgery and 2) discuss the implications of such approaches toward the development of classification applications to aid in tissue monitoring. The application of machine learning techniques in the soft tissue literature has become a large field of study. One of the most commonly reported outcomes after percutaneous bone-conduction device (BCD) surgery is soft tissue health. Unfortunately, the classification of tissue around the abutment as healthy versus not healthy is a subjective process, even though such decisions can have implications for treatment (i.e., topical steroid versus surgical revision) and resources (e.g., clinician time). We built and tested a convolutional neural network (CNN) model for the classification of tissues that were rated as "green" (i.e., healthy), "yellow" (i.e., unhealthy minor), and "red" (i.e., unhealthy severe). Representative image samples were gathered from a regional bone-conduction amplification site (N = 398; 181 samples of green; 144 samples of yellow; 73 samples of red). The image samples were cropped, zoomed, and normalized. Feature extraction was then implemented and used as the input to train an advanced CNN model. Accuracy of image classification for the healthy ("green") versus not healthy ("yellow" and "red") model was approximately 87%. Accuracy of image classification for the unhealthy ("yellow") versus unhealthy ("red") model was approximately 94%. Monitoring tissue health is an ongoing challenge for BCD users and their clinicians not trained in soft tissue management (e.g., audiologists). If machine learning can aid in the classification of tissue health, this would have significant implications for stakeholders. Here we discuss how machine learning can be applied to tissue classification as a potential technological aid in the coming years.

Resonance Frequency Analysis Identifies Implant- and Host-Related Factors Associated With Bone-Anchored Hearing Implant Stability.

Resonance frequency analysis (RFA) is a reliable, noninvasive method to assess the stability of bone-anchored hearing implants (BAHIs), although surgical-, implant-, and host-related factors can affect its outcome. BAHI plays an important role in restoring hearing function. However, implant- and host-related factors contribute to premature implant extrusion. To mitigate this, noninvasive methods to assess implant stability, along with a better understanding of factors contributing to BAHI failure, are needed. We evaluated the utility of RFA to quantify implant stability in sawbone (bone mimicking material), 29 human cadaveric samples, and a prospective cohort of 29 pediatric and 27 adult participants, and identified factors associated with implant stability. To validate the use of RFA in BAHI, we compared RFA-derived implant stability quotient (ISQ) estimates to peak loads obtained from mechanical push-out testing. ISQ and peak loads were significantly correlated (Spearman rho = 0.48, p = 0.0088), and ISQ reliably predicted peak load up to 1 kN. We then showed that in cadaveric samples, abutment length, internal table bone volume, and donor age were significantly associated with implant stability. We validated findings in our prospective patient cohort and showed that minimally invasive Ponto surgery (MIPS; versus linear incision), longer implantation durations (>16 wk), older age (>25 yr), and shorter abutment lengths (≤10 mm) were associated with better implant stability. Finally, we characterized the short-term reproducibility of ISQ measurements in sawbone and patient implants. Together, our findings support the use of ISQ as a measure of implant stability and emphasize important considerations that impact implant stability, including surgical method, implant duration, age, and abutment lengths.

An algorithm for the surgical approach to spontaneous temporal bone CSF leak

ObjectiveTo suggest a comprehensive algorithm for the surgical approach for correcting of sources of temporal bone CSF leaks. MethodsA case series for patients operated in a single academic tertiary referral center between 2011 and 4.2022. Included in the study were 46 patients, 5 of whom had a bilateral problem, resulting in 51 pathologic temporal bones. The presentation was an active CSF leak (38 patients) or bacterial otogenic meningitis (8 patients). Follow up ranged from 8 months to 5 years. ResultsOf the 42 ears operated via the default middle fossa approach, 37 were successful (88 %) in controlling CSF leak. None had intracranial complications or sensorineural hearing loss. Location, number and size of the defects, hearing status, associated superior semicircular canal dehiscence, additional intra-temporal or intra-cranial pathologies may indicate a transmastoid approach. Of the six ears that had a canal wall up mastoidectomy as a primary procedure, one required revision due to ongoing CSF leak. Five revision cases and three primary cases were effectively sealed with a subtotal petrosectomy and obliteration. One was lost to follow-up. Hearing was reconstructed with bone-anchored hearing implants in 6 out of these 8 ears. ConclusionsThe middle fossa approach could be used as a default approach for sealing TD. There are a number of indications for transmastoid approaches in both primary and revision cases. Obliteration of the ear was used in all revision cases. The suggested algorithm can help in planning surgery for temporal bone CSF leaks or a history of otogenic meningitis.

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

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. Retrospective cohort study. Mean follow-up period of 3.8 years. Tertiary referral center. 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. Soft tissue reaction, implant survival, revision surgery, and BCD usage. 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. 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.

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). Single-center retrospective cohort study. Large general teaching hospital. A total of 231 adult patients were included between August 2005 and October 2020, with a minimum follow-up time of 6 months. The test group received a BAHI using the LIT-TP (N = 147). The control group underwent surgery using the LIT-TR (N = 84). 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). 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. This large-scale study demonstrates that the LIT-TP shows excellent long-term outcomes, including a low incidence of implant failure.

Music Perception in Bone-Anchored Hearing Implant Users.

Music is a highly complex acoustic stimulus in both spectral and temporal contents. Accurate representation and delivery of high-fidelity information are essential for music perception. However, it is unclear how well bone-anchored hearing implants (BAHIs) transmit music. The study objective is to establish music perception performance baselines for BAHI users and normal hearing (NH) listeners and compare outcomes between the cohorts. A case-controlled, cross-sectional study was conducted among 18 BAHI users and 11 NH controls. Music perception was assessed via performance on seven major musical element tasks: pitch discrimination, melodic contour identification, rhythmic clocking, basic tempo discrimination, timbre identification, polyphonic pitch detection, and harmonic chord discrimination. BAHI users performed comparably well on all music perception tasks with their device compared with the unilateral condition with their better-hearing ear. BAHI performance was not statistically significantly different from NH listeners' performance. BAHI users performed just as well, if not better than NH listeners when using their control contralateral ear; there was no significant difference between the two groups except for the rhythmic timing (BAHI non-implanted ear 69% [95% CI: 62%-75%], NH 56% [95% CI: 49%-63%], p = 0.02), and basic tempo tasks (BAHI non-implanted ear 80% [95% CI: 65%-95%]; NH 75% [95% CI: 68%-82%, p = 0.03]). This study represents the first comprehensive study of basic music perception performance in BAHI users. Our results demonstrate that BAHI users perform as well with their implanted ear as with their contralateral better-hearing ear and NH controls in the major elements of music perception. 3 Laryngoscope, 134:1381-1387, 2024.

Minimally invasive surgery as a new clinical standard for bone anchored hearing implants-real-world data from 10 years of follow-up and 228 surgeries.

To explore the clinical practice development of different surgical techniques when installing bone-anchored hearing implants and their associated trends in outcomes. Retrospective study of 228 bone-anchored hearing implants in 200 patients, performed over a 10-year period between 2012 and 2022 in a referral hospital. Real-world data of demography, etiology, surgical setup, complications, and audiological outcomes were collected. Eligibility criteria from clinical practice were applied. The minimally invasive technique is associated with shorter surgery duration, 20 vs. 44 min as compared to a linear incision technique. The minimally invasive technique was also associated with a lower occurrence of complications when compared to linear incision techniques (intraoperative; 1.8% vs. 4.9%, postoperative; 49% vs. 66%). Most differences were seen in complications relating to skin and wound healing. Adoption of a minimally invasive surgical technique for the installations of bone-anchored hearing implants can reduce surgical complexity without compromising safety aspects or clinical benefits.

Percutaneous Bone-Anchored Hearing Implant Surgery: Do Syndromic Children Have More Adverse Perioperative Outcomes?

To evaluate and compare perioperative outcomes of percutaneous bone-anchored hearing implant (BAHI) surgery in syndromic and nonsyndromic pediatric patients. Retrospective cohort study. McGill University Health Centre in Montreal, Quebec, Canada. Forty-one pediatric patients (22 syndromic, 19 nonsyndromic) who underwent percutaneous BAHI surgery between March 2008 and April 2021. Percutaneous BAHI surgery. Patient demographics (age at surgery, gender, implant laterality), operative information (American Society of Anesthesia [ASA] score, anesthesia type, surgical technique, implant/abutment characteristics), and postoperative outcomes (implant stability, soft tissue integrity, surgical revisions, implant failure). The most frequent syndromes among implanted patients were Treacher Collins (27.3%), Goldenhar (13.6%), Trisomy 21 (13.6%), and Nager (9.1%). Syndromic patients were more frequently given higher ASA scores: 2 ( p = 0.003) and 3 ( p = 0.014). All cases of implant extrusion were in syndromic patients: two posttraumatic and two failures to osseointegrate. Nine (40.9%) syndromic patients experienced a Holgers Grade 4 skin reaction at one of their postoperative follow-up visits as compared to 0% of nonsyndromic patients ( p < 0.001). Implant stability was similar between cohorts at all postoperative time-points, except for significantly greater nonsyndromic implant stability quotient scores at 16 weeks ( p = 0.027) and 31+ weeks ( p = 0.016). Percutaneous BAHI surgery is a successful rehabilitation option in syndromic patients. However, it presents a relatively higher incidence of implant extrusion and severe postoperative skin reactions as compared to nonsyndromic patients. In light of these findings, syndromic patients may be great candidates for novel transcutaneous bone conduction implants.

Hearing rehabilitation in patients with congenital aural atresia: an observational study in a tertiary center

BackgroundCongenital aural atresia (CAA) and stenosis is a rare defect affecting the external auditory canal which causes varying degrees of hearing impairment. This malformation may be unilateral or bilateral. Timely hearing rehabilitation in these patients is paramount to ensure appropriate speech and language development. Thus, early detection and hearing assessment with timely intervention in the form of hearing device is crucial. There is a wide range of hearing amplification devices available for these patients, catering to individual needs and preferences. This study investigated the options and choices of hearing rehabilitation among patients with CAA in our center. This study also compared the hearing gain of different types of hearing devices and patient satisfaction levels.MethodsThis was a retrospective analysis of 55 patients with congenital aural atresia or stenosis under follow-up at the Otorhinolaryngology and Audiology Clinic of a tertiary academic institution. Data on the timing of hearing loss diagnosis and intervention, type of hearing rehabilitation, hearing gain, Jahrsdoerfer score from temporal bone computed tomography, and patient satisfaction level was collected and analyzed.ResultsFifty-five patients were recruited with ages between 3.6 months to 58 years old. The majority of patients (63.6%) had moderate hearing loss, followed by severe hearing loss (18.2%), mild hearing loss (9.1%) and profound hearing loss (7.3%). 32.7% of patients had early hearing loss diagnosed by 3 months old, while 67.3% were diagnosed after 3 months of age. Bone anchored hearing implant (BAHA Attract/Connect) gave the highest mean hearing gain of 35.23 dB (SD ± 9.75) compared to air conduction hearing aid, bone conduction hearing aid, and canalplasty. Patients implanted with BAHA Attract/Connect reported the highest average satisfaction scores of 7.74.ConclusionA significant proportion of patients have delayed diagnosis and intervention. Bone-anchored hearing implants provide excellent hearing improvements in patients with CAA with good patient satisfaction.

Prospective 5 year outcomes of different implant designs and surgical techniques in 68 patients with bone anchored hearing implants.

Prospective 5 year outcomes of different implant designs and surgical techniques in 68 patients with bone anchored hearing implants.

Initial Experience With Two Active Transcutaneous Bone-Anchored Hearing Implants.

To analyze our institutional experience with two active transcutaneous bone-anchored hearing aids. Retrospective cohort study. Tertiary academic otology-neurotology practice. Patients with conductive or mixed hearing losses meeting criteria to receive active transcutaneous bone-anchored hearing aids. Implantation with one of two active transcutaneous bone-anchored hearing aids. Operative time, dural exposure and decompression, use of lifts, implant position, ease of use, qualitative patient satisfaction, complication rates. Ten patients received Implant 1 and 11 patients received Implant 2. The most common underlying etiologies of hearing loss were chronic suppurative otitis media in 33.3%, atresia/microtia in 23.8%, and cholesteatoma in 23.8%. Average operative times were 99.3 minutes for Implant 1 and 80.9 minutes for Implant 2 ( p = 0.263). Implant 1 required lifts in 60%, dural exposure in 50%, and dural compression in 30%. Overall, placement was difficult in 47.6% of cases. There were no intraoperative complications. There were higher rates of issues with sound quality (27.3% versus 0.0%, p = 0.123) and poor cosmesis (36.4% versus 10.0%, p = 0.360) with Implant 2. Functional gain was not recorded, but all patients derived qualitative benefit from their implant. Three patients had local wound complications that self-resolved or were treated with antibiotics. One patient implanted at an outside institution required explant because of multiple infections. There were no statistically significant differences in outcomes comparing Implants 1 and 2; however, Implant 2 had much higher rates of issues with audio quality and poor cosmesis. Placing Implant 1 often required special techniques.

Single-Center Experience Evaluating Clinical Outcomes of a Novel-Guided Drill System for Percutaneous Bone-Anchored Hearing Implant.

Evaluate intraoperative and postoperative outcomes of a novel guided drill system for percutaneous bone-anchored hearing implants. Between January 2016 and February 2021, patients age ≥18 years deemed potential candidates for a bone-anchored hearing device, were formally assessed for candidacy and counseling. Those that qualified and opted to proceed were added to a prospectively maintained database, including demographic, clinical, and audiologic data. Intraoperative findings were reported, as were clinical outcomes at 7 days, 4 weeks, 3 months and 6 months postoperatively. The Holgers index was used to grade soft tissue reactions. One hundred patients underwent the procedure. There were 56 women, and mean age was 54 years (18-84 yr). Ninety-six were done under local anesthetic. Mean surgical time was 13 minutes (9-27 min). No significant intraoperative events were noted. There were nine cases of implant loss, all in the first 50 cases. Mean duration of implant loss was 3.6 weeks (range, 2-5 wk). At the first postoperative visit, 82 had Holgers 0, 16 Holgers 1, 2 Holgers 2, and none Holgers 3. At the second postoperative visit, excluding the 9 with implant loss, 83 (91%) had Holgers 0, 6 (7%) Holgers 1, and 2 (2%) Holgers 2. None were Holgers 3. The current study represents, to our knowledge, the largest series on the novel guided drill technique. Results show it is safe and efficient with low soft tissue complication rates. Drill bit design and technical modifications may have helped lower implant loss rate in this series over time.

In-office Bone-Anchored Hearing Implants via Minimally Invasive Punch Technique in a Veteran Population.

Describe the feasibility and safety of completing bone-anchored hearing implants via the minimally invasive punch technique in the in-office setting. This single-institution case series included 20 patients who underwent in-office bone-anchored hearing implant placement under local anesthesia from 2018 to 2021. Veterans Affairs Northern California Healthcare System. Following completion of the case series, patients were retrospectively surveyed regarding their satisfaction with this approach via a modified SSQ-8 (Surgical Satisfaction Questionnaire) to fit our purposes. A total of 23 implants were completed in the in-office setting on 20 patients. Intra- and postoperative complication rates, including skin changes, irritation, infection, and poor wound healing, were similar to or better than currently published complication rates in the literature. In addition, patients reported overwhelmingly positive responses on the SSQ-8, almost universally stating that they were "very satisfied" with their clinic experience. This case series suggests that it is feasible and safe to complete this procedure in the clinic under local anesthesia, but further prospective studies are needed to evaluate this in a more generalized population.

Bone-Anchored Hearing Implants: Surgical and Audiological Comparison of Different Surgical Techniques.

Introduction The bone-anchored hearing implant system (BAHS) is an effective amplification system that transmits the sounds received by an external operating system to the inner ear by bypassing the middle ear placed in the temporal bone. Objective This study compares the results of patients who underwent bone-anchored hearing implant system (BAHS) surgery using two different surgical methods in terms of preoperative and postoperative complications, surgical time, audiological findings, and patient satisfaction. Methods The results of 22 patients who underwent BAHS were evaluated retrospectively from video records and audiological results, The Turkish Version of the Glasgow Benefit Inventory (GBI) questionnaire were evaluated. Two different surgical approaches were used for implantation: the linear incision technique ( n = 9) and the punch technique ( n = 13). Results Mean surgical durations were 9.67 ± 2.85 and 47.65 ± 6.13 minutes for Groups A and B, respectively, and these were significantly different ( p < 0.001). There were no significant differences between the groups' speech recognition scores for a signal-to-noise ratio (SNR) of +5 ( p = 0.173), SNR of 0 ( p = 0.315), or SNR of -5 ( p = 0.360) and results of the GBI scores. Conclusion The punch technique has a significant advantage due to a shorter surgery duration without increased surgical complications. Additionally, the punch technique showed no significant difference in hearing performance or satisfaction compared with linear incision.

Percutaneous Bone-Anchored Hearing Implant: Is It Clinically Useful in Korean?

BackgroundThe aim of this study is to investigate the clinical effectiveness of Ponto in Korea, a recently released percutaneous bone-anchored hearing implant.Methods16 patients with single-sided deafness (SSD) and mixed or conductive hearing loss who underwent Ponto implantation from December 2018 to September 2020 were enrolled in the study. Puretone audiometry, the Korean version of the Hearing in Noise Test (K-HINT), sound localization test (SLT), and Pupillometry were performed pre- and three months post-operation. Standardized questionnaires, the Hearing Handicap Inventory for the Elderly (HHIE) and Speech, Spatial and Qualities of Hearing Scale (SSQ), were administered.ResultsThe mean age of subjects was 55.5 (range, 48–67) years. Four males and 12 females participated in the study. The mean puretone average was 73.17 dB hearing level (HL) before surgery and significantly improved to 36.72 dB HL three months after surgery. The mean word recognition score improved from 26.0% to 90.75% after implantation. In the case of K-HINT, there was a significant difference in summation (Z = −2.250, P = 0.024) and head shadow effects (Z = −3.103, P = 0.002). There was no significant difference in root mean square error degree (RMSE) and hemifield identification scores for SLT testing. Pupillometry was performed to measure listening effort and the results revealed that the degree of pupillary dilatation decreased under the condition of quiet, 0 dB signal to noise ratio (SNR) and 3 dB SNR. The total score for HHIE decreased significantly (Z = −3.130, P = 0.002) while the SSQ score increased significantly (Z = −2.216, P = 0.027).ConclusionsThe Ponto bone-anchored hearing system showed significant clinical benefit in Korean patients with conductive and mixed hearing loss and SSD.

Clinical Evaluation of a Novel Laser-Ablated Titanium Implant System for Bone Anchored Hearing Systems in a Pediatric Population and the Relationship of Resonance Frequency Analysis With Implant Survival.

Objective:To evaluate the clinical outcomes of pediatric patients implanted a novel 4.5 mm wide laser ablated titanium bone anchored implant system and to evaluate the implant stability over the first 12-month period.Study Design:A prospective, single-subject, repeated measure, cohort study. Participants served as their own controls.Setting:Community and tertiary referral hospital pediatric assessment center.Patients:A total of 115 consecutive pediatric patients aged 4 to 15 years were implanted with 176 laser ablated titanium bone anchored implants from January 2016 to January 2019.Main Outcome Measure:Clinical outcomes, implant failure rates, and post implantation implant stability quotient (ISQ) scores were studied over the first 12-month period. Data were analyzed for statistical significance through mixed effect modeling, with the significance level p = 0.01.Results:A median 12-month survival of 96.6% was observed. Six implants (3.5%) were lost in total, one of these (0.6%) was lost due to trauma. Adverse skin reactions (Holgers grade 2–4) were observed in 4.4% of all postoperative visits, occurring in 22 individuals (19.1%). Neither the ISQ high (ISQH) nor ISQ low (ISQL) values increased significantly between the stage 1 and 2 surgeries. In contrast, the ISQ results, irrespective of abutment size, demonstrated an increasing trend from 49.1 to 57 over the 12 months review period. A statistically significant change was only demonstrated from the 3 months follow up onwards.Conclusion:The use of 4.5 mm wide laser-ablated titanium bone anchored hearing implants resulted in superior survival rates and excellent clinical outcomes compared with previous implant systems.

Clinical evaluation and resonance frequency analysis of laser-ablated titanium bone-anchored hearing implant system in children with Down Syndrome

ObjectivesTo evaluate complication rates and resonance frequency analysis (RFA) of the stability of a new laser-ablated titanium Bone Anchored hearing Implant system in children with Down syndrome. MethodsA prospective, single-subject, repeat measure, cohort study in which each participant served as their own control. Consecutive paediatric patients 4yrs- 15 years old, with a primary diagnosis of Down syndrome (trisomy 21) were implanted between January 2015–January 2020 with BHX Oticon wide implants. Evaluation of soft tissue reactions, fixture failure rates and post implantation Implant stability Quotient (ISQ) at both fixtures and abutment levels were studied over a 12-month period. Data was analysed for statistical significance through mixed effect modelling with significance set at p = 0.01. Results31 consecutive paediatric patients with a diagnosis of Down syndrome were implanted with 43 Ponto BHX Oticon™ implant system. Twelve children had bilateral implants and nineteen were unilateral. Over the 12 month follow up 2 fixtures (4.6%) were lost, and adverse skin reactions (Holgers >2) were recorded in 3.2% of all clinical reviews. Implant level stability quotient showed no statically significant change between first and second stage 71.1–71.7. Abutment level ISQ increased from 46.2 to 56.7 p = 0.0001 at the 12-month review point as compared to that recorded at loading. ConclusionImplant survival and adverse skin reactions were found to be in keeping with those in published literature and much improved compared to previous implant systems placed at this centre. Although abutment level ISQ showed an increase over the review period no correlation between this and implant loss can be concluded.

A Clinical Evaluation of Minimally Invasive Ponto Surgery With a Modified Drill System for Inserting Bone-Anchored Hearing Implants.

Objective:To compare 6-months outcomes of the modified minimally invasive Ponto surgery (m-MIPS) to both the linear incision technique with soft tissue preservation (LIT-TP), and original MIPS (o-MIPS) for inserting bone-anchored hearing implants (BAHIs).Study design:Exploratory pilot study with one test group and two historical control groups.Setting:Tertiary referral center.Patients:In the test group, 24 patients (25 implants) were prospectively included. Each control group comprised 25 patients (25 implants) who participated in previously conducted clinical trials.Interventions:The test group received a BAHI using m-MIPS. The two control groups underwent surgery using the LIT-TP and o-MIPS, respectively.Main outcome measures:Implant survival, implant stability, and surgery-related variables were compared between the test and control groups. Soft tissue status, skin sensibility, and subjective numbness were compared between m-MIPS and LIT-TP only.Results:Implant survival was comparable between m-MIPS and LIT-TP, whereas implant stability measurements were slightly lower for m-MIPS. M-MIPS resulted in comparable adverse skin reactions and skin sensibility, significantly reduced surgical time and slightly improved subjective numbness, compared with LIT-TP. Between m-MIPS and o-MIPS, no statistically significant differences in implant survival, implant stability and surgical time were observed.Conclusions:A trend toward lower implant loss rates after m-MIPS was observed, when compared with o-MIPS. M-MIPS seems to be a good alternative to LIT-TP for inserting BAHIs, since most clinical outcomes were either comparable or slightly better for m-MIPS. Upon deciding on which technique to use, larger studies on implant survival should be performed. Furthermore, other aspects such as costs, training aspects and surgical experience should be evaluated.