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

Abstract

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.

Complications of Transcutaneous Protheses – A Systematic Review of Publications Over the Past 10 Years

“…However, these complication rates decreased during follow-up, being reported only sporadically in the last follow-up consultation. 23,24 In the present study, a lower complication rate of 22.8% was observed with the Sophono implant, and the most frequent complication described was a minor one, related to pain or pressure around the external unit, with the symptoms being relieved by decreasing magnet intensity, as previously reported by Shin (2016). 25 However, some studies, such as the one by Marsella (2014), also report the persistence of this symptom, even with a decrease in the intensity of the magnet, making it unfeasible for the patient to use the device due to pain, which constitutes a major complication.…”

“…However, these complication rates decreased during follow-up, being reported only sporadically in the last follow-up consultation. 23 24 …”

“…These complications were linked to, at most, momentary discontinuation of implant use, and more aggressive conducts, such as explantations, were not required. According to Kruyt (2020) and Gawecki (2019), in a prospective cohort in which Baha Attract was used, it was evidenced that most patients initially reported experiencing some degree of pain or discomfort and numbness. However, these complication rates decreased during follow-up, being reported only sporadically in the last follow-up consultation.…”

The Bonebridge BCI 602 Active Transcutaneous Bone Conduction Implant in Children: Objective and Subjective Benefits

“…A better solution, as demonstrated by many studies, is the use of a BCI. Bone conduction hearing systems have become the standard solution for patients suffering from conductive, mixed, and unilateral hearing loss [5]. Currently, there are many bone conduction devices available on the market.…”

Association of Bone Conduction Devices for Single-Sided Sensorineural Deafness With Quality of Life

“…After the screening of titles and abstracts, 84 articles were retrieved, and full manuscript review was performed. After applying inclusion and exclusion criteria, the final 11 studies were selected to be included in the meta-analysis . Ten studies were prospective, nonrandomized, preintervention and postintervention studies.…”