Sophono in Pediatric Patients: The Experience of an Italian Tertiary Care Center.

Objective: Since 2011, a transcutaneous bone-anchored auditory implant (Sophono) has been available for patients affected by bilateral, conductive hearing loss that cannot be corrected by surgery. To date, very few cases of device application in the pediatric population have been described. The aim of the present study is to report on complications, functional outcome, and health-related quality of life of the first pediatric cases in Italy.

Study Design: Case series with planned data collection.

Setting: Tertiary care pediatric center.

Subjects And Methods: Of 25 candidates with bilateral, conductive hearing loss screened between January 2012 and July 2013, 6 were included in the study (3 male and 3 female; median age, 9 years; age range, 5-17 years). Data concerning surgery, complications, functional outcome, and health-related quality of life were gathered prospectively.

Results: No major intraoperative complications occurred. Postoperative complications included 1 patient developing a skin ulceration below the external magnet and 1 patient reporting pain from using the device for more than 4 hours a day consecutively. Median free-field pure tone average (0.5-3 kHz) with the device was 32.5 dB HL, and median functional gain was 33 dB HL. Median Glasgow Children's Benefit Inventory score was +42.

Conclusion: Sophono implants can be a valuable alternative to percutaneous implants in patients with bilateral, conductive hearing loss. To ensure the success of the treatment, several precautions should be taken, including a careful preoperative assessment of skull bone thickness and a close postoperative follow-up of the skin under the external processor, especially over the first months.