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.

OBJECTIVES: To 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. METHODS: A 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. RESULTS: 31 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. CONCLUSION: Implant 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.

Five year clinical outcomes and evaluation following implantation of the Oticon™ wide bone anchored hearing system in 47 children.

OBJECTIVES: The Oticon™ wide implant system was launched in 2009 and used at Birmingham Children's Hospital from 2014. To evaluate clinical outcomes of the Oticon™ wide implant (Oticon Medical), with a focus on skin complication rates and fixture loss over a 5-year period in a tertiary paediatric hospital in the UK. METHODS: Retrospective 5-year longitudinal case record review of 47 children who were implanted with the Oticon™ wide implant system at Birmingham Children's Hospital (BCH) between January 2014 and January 2016. RESULTS: 47 children (27 M:20F) were implanted with 70 Oticon wide implants 23 bilateral, 27 unilateral. Mean age at the time of implantation was 9y 6 m. The follow up was for a mean of 5.4 years. Significant soft tissue complications requiring treatment was found in 11% (n = 8) of loaded fixtures, abutment tightening on two patients, abutment exchange 6% (n = 4) and a 10% (n = 7) fixture failure. CONCLUSION: The Oticon™ wide implant system produces favourable results with regards to peri-abutment skin complications, fixture stability and revision surgery rates when compared to similar cohorts of children studied at Birmingham Children's Hospital.

Longitudinal study of use of the pressure free, adhesive bone conducting hearing system in children at a tertiary centre.

OBJECTIVES: To assess the long-term compliance and usability of the non-implantable, adhesive bone conduction hearing aid system in children. Review of patient demographics, compliance and continued use. Identification of factors that impact on future patient selection. METHODS: Retrospective case series review of all children aged 5 and above fitted with the adhesive bone conduction hearing aid at a paediatric tertiary centre in the UK between 2015 and 2019. Data collected from medical and audiological records. Patient demographics, skin complications, patient feedback and changes in hearing aid provision were recorded. RESULTS: 82 children (40 female, 42 male) were provided with 89 adhesive hearing devices. To date 72 (87.8%) of the fitted patients, continue to use the device daily with minimal reported skin complications. Of the 10 patients that no longer use the adhesive aid, 5 no longer use any hearing device at all and the remaining 5 patients use an alternative hearing system. These include spectacle aids (n = 2) and bone anchored hearing implant (n = 3). CONCLUSION: Adhesive aid products are reported to provide comparable audiological results to the commercial softband hearing aids. They provide an excellent alternative in the treatment of conductive hearing loss without the costs and possible complications of a surgical intervention. A compliance rate of 87.8% of all patients fitted with the adhesive system demonstrates a high level of patient satisfaction. The device may also provide an appropriate stepping stone to implanted device once a child reaches the age in which an autonomous decision can be made. Limitations of the device have been the variability in the longevity of the adhesive adaptor and interference with headscarves, hats and glasses with a low frequency of transient minor skin reactions reported.

First Pediatric Experience With a Novel, Adhesive Adapter Retained, Bone Conduction Hearing Aid System.

OBJECTIVES: To assess the audiological outcomes, practicalities, and impact on quality of life of a new, nonimplantable, adhesive retained bone conduction hearing aid in children. STUDY DESIGN: A prospective, single-subject repeat measure, cohort study. SETTING: Community and in pediatric assessment center. PATIENTS: Twenty-one children aged between 5 and 15 years with a conductive hearing loss of >/=25 dB HL in the better hearing ear. INTERVENTION: Audiological comparisons were made using pure-tone thresholds; unaided, with a softband aid, and with the new adhesive retained bone conducting system. MAIN OUTCOME MEASURES: Comparison of hearing threshold levels. Data analysis via paired t-testing, significance set at p value <0.01. Quality of life was assessed via the Glasgow Children's Benefit Inventory and a 10 cm linear analogue scale. A hearing aid review questionnaire provided insight into practical use. RESULTS: Statistically significant improvement in thresholds of 7.3 dB HL (p=0.0001) was demonstrated with the adhesive system as compared with softband aids. After 4 weeks of usage, the mean hearing thresholds for the adhesive hearing system improved from 55 dB HL ±â€Š2.4 to 31 dB HL± 7.9 in unaided and aided conditions.Improvements in QOL were demonstrated with LAS and GCBI. Four children reported mild skin reactions. Eighty-six percent reported improved self-confidence. CONCLUSION: The adhesive aid produces comparable audiological results to the commercial softband hearing aids. It provides an excellent alternative in the treatment of conductive hearing loss without the possible complications and costs of a surgical intervention. Furthermore, it preserves skin envelope over the mastoid for those who wish to proceed with an autologous pinna reconstruction in the future.

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

OBJECTIVE: Bone 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. METHODS: A retrospective case note analysis was performed to identify outcomes in all children who underwent BIA300 implantation between 2011 and 2013. RESULTS: 52 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. CONCLUSIONS: The 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.