Three-year Outcomes of a Randomized Controlled Trial Comparing a 4.5-mm-Wide to a 3.75-mm-Wide Titanium Implant for Bone Conduction Hearing

Kok

Bosman

et al. 2019

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Section: Methodsmentioning

confidence: 99%

Three-Year Clinical and Audiological Outcomes of Percutaneous Implants for Bone Conduction Devices: Comparison Between Tissue Preservation Technique and Tissue Reduction Technique

Kok

Bosman

et al. 2019

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“…Although recent modifications in percutaneous implant design and surgical techniques have resulted in a reduction of adverse skin reactions (observed in <6.3% of the visits) ( 4 – 7 ) and implant loss rates (occurring in approximately 4.2% of patients with up to 5-year follow-up) ( 8 – 10 ), the concept of transcutaneous coupling remained attractive, as the intact skin could potentially further diminish skin reactions and could be considered to be cosmetically appealing. As such, a new passive transcutaneous implant for bone conduction hearing was introduced in 2013.…”

mentioning

confidence: 99%

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

Monksfield

Skarżyński

et al. 2020

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

“…Patients aged more than or equal to 18 years with normal bone quality and those indicated for percutaneous BAHI surgery with a Ponto Wide implant (Oticon Medical AB, Askim, Sweden) or a Cochlear BI300 implant (Cochlear Bone Anchored Solutions AB, Mölnlycke, Sweden) were included. Patients were excluded according to the standard exclusion criteria used in clinical trials conducted at our center, namely: 1) reimplantation surgery, 2) a medical history of disease and/or treatment compromising bone quality at the implant site, e.g., radiation therapy or osteoporosis, 3) mental disability or a medical history of psychiatric disease, and 4) inability to participate in the follow-up ( 15 – 19 ). The included patients were randomly divided into four groups: groups A, B, C, and D. Group A consisted of 30 patients, and groups B, C, and D consisted of 10 patients each.…”

Section: Methodsmentioning

confidence: 99%

Patient Preferences in Sound Processor Loading Time After BAHI Surgery

Caspers

Mylanus

et al. 2020

Objective: Sound processor loading times after bone-anchored hearing implant (BAHI) surgery have gradually decreased over time. This study assessed patient preferences in loading time. Study Design: Prospective patient questionnaire study. Setting: Tertiary referral center. Patients: Patients indicated for BAHI surgery received two questionnaires preoperatively: the validated Glasgow Health Status Inventory (GHSI) and a nonvalidated questionnaire that assessed patient preference for loading time and the rationale behind it. This preference questionnaire was also provided immediately, 7 days and 3 weeks (moment of sound processor loading at our center) postoperatively. Main Outcome Measures: The preoperative and postoperative preferred loading time and the postoperative changes in preference were determined. Correlations between preference and patient-specific variables were assessed. Results: Sixty patients were included. Preoperatively, 70% preferred loading within 1 week after surgery. Of all patients, 43% preferred loading on the day of surgery, mainly motivated by the fast hearing rehabilitation and practical considerations. These preferences were not correlated with the total GHSI score or duration of hearing loss. Directly postoperatively, no change in preference was observed. However, 7 days and 3 weeks after surgery, significantly more patients preferred loading at a later moment. At 7 days and at 3 weeks, 50 and 40% preferred loading within 1 week, and 12.5 and 7.5% preferred loading on the day of surgery, respectively. Conclusion: The preference for the timing of sound processor loading varied among patients and differed pre- and postoperatively. Despite the postoperative decline in patients preferring earlier loading, approximately half of all patients preferred sound processor loading within 1 week after BAHI surgery.