Clinical and surgical safety in patients transitioning from percutaneous to transcutaneous active bone conduction implants

Abstract

Purpose: The primary aim of this study was to assess clinical and surgical safety for patients who underwent transition surgery from a percutaneous to an active transcutaneous bone conduction implant. A secondary aim was to report audiological changes and outcomes for quality of life post the transition surgery.

Methods: An observational, descriptive and prospective study was performed in a tertiary referral center. Patients who underwent transition surgery as part of their treatment were included. Clinical and surgical safety were assessed through intraoperative and postoperative complications and adverse events. The audiological outcomes were assessed with the Hearing in Noise Test, both fixed noise and adaptative noise measurements. Quality of life changes were evaluated using the Glasgow Benefit Inventory, postoperatively.

Results: The study of 23 cases (18 patients) found minor complications in 5.3% (6/113 follow-up points) and no major complications. Audiometric results showed no significant differences in speech understanding (fixed noise=-0.011%, p = 0.99; adaptive noise = 0.236dB, p = 0.617). Quality of life scores increased moderately (+ 27.0 ± 33.9), with notable gains in general health (+ 29.9) and social support (+ 31.8), and a modest improvement in physical well-being (+ 10.6).

Conclusions: The study showed that transitioning from a passive percutaneous to an active transcutaneous bone conduction implant is safe, with no major adverse events and only a few minor complications. The audiological outcomes with transcutaneous implants were maintained with respect to percutaneous implants, while quality of life improvements were notable in general health and social support. Clinicians should use these insights to guide patient discussions and tailor post-operative care.

Keywords: Audiological findings; Bone anchored hearing aids; Conductive hearing loss; Follow-up study; Mixed hearing loss; Quality of life; Surgical outcomes.

Fig. 1

A patient with a percutaneous BCI who required transition to an active transcutaneous BCI due to recurrent skin complications. A patient with microtia and atresia of the right external auditory canal underwent implantation of a percutaneous osseointegrated device using dermatome technique with an inferior pedicled flap. The patient experienced excellent auditory outcomes and used the BCI for 19 years. However, recurrent skin reactions necessitated multiple courses of topical and systemic antibiotics, as well as cutaneous BCIorticosteroid infiltrations. Ultimately, the patient underwent transition surgery to an active transc

Fig. 2

Surgical technique for transitioning from a percutaneous osseointegrated (BAHA Connect™) to an active transcutaneous (Osia™) BCI. The surgical procedure involves several key steps to ensure optimal implant placement and minimize complications: (a) Preparation of the surgical site, (b, c) measurement of flap thickness to ensure optimal coupling and information transmission (recommended thickness ≤ 9 mm), (d) removal of the abutment, (e) resection of the skin and, (f) subcutaneous tissues to minimize bacterial colonies, (g) thorough cleaning of the area with chlorhexidine for at least 5 min, limited to the implant site, (h) layered closure of the incision, (i) initiation of the surgical approach for the transcutaneous implant, selecting an incision that avoids previous dissection areas, following the manufacturer recommendations for Osia™ placement, (j) assessment of bone bed regularity; if irregularities are present, bone polishing is performed to achieve a uniform surface, (k) placement of the OSI200™ implant, (l) layered closure of the incision (l). Images m-p illustrate a separate case of transition surgery using the BI300™ implant from BAHA Connect™ (in this case, a dormant implant), (m) the patient experienced pedestal dislodgement, leading to secondary intention wound closure. After surgical field preparation and marking, an incision was made, and skin and subcutaneous tissue were resected over the percutaneous implant site, (n) the current BI300™ implant was exposed, and it was decided that the dormant implant was to be used, (o) a homogeneous bone bed was confirmed, followed by OSI200™ implant placement, (p) the final surgical outcome is shown after layered closure of the incision

Fig. 3

Flowchart of patients included in the study * Comparative audiological analysis between preoperative versus postoperative outcomes (HINT) and measurements of change in QoL (GBI) BCI: Bone conduction implant. QoL: Quality of life. CHL: Conductive hearing loss. MHL: Mixed hearing loss. HINT: Hear In Noise Test. GBI: Glasgow Benefit Inventory

Fig. 4

Patient follow-up of study and clinical events during this period