Early Outcomes of a New Active Transcutaneous Bone Conduction Implant in Pediatric Patients

Abstract

Objective:To describe the early surgical and audiometric outcomes in pediatric patients implanted with a new active transcutaneous bone conduction implant system.Study Design:Retrospective case review.Setting:Tertiary pediatric hospital.Patients:Pediatric patients (18 or younger) with conductive or mixed hearing loss that completed postoperative aided testing following implantation with the Cochlear Osia system from December 2019 to December 2020.Intervention:Rehabilitative.Main Outcome Measure:Preoperative air conduction (AC), preoperative bone conduction (BC), and postoperative aided thresholds were compared. Pure-tone averages (PTA), air-bone gap (ABG), and functional gain were calculated. Surgical complications and patient satisfaction were summarized from the chart review.Results:Sixteen patients (20 implants) met the inclusion criteria. The average age at the time of implantation was 12.9 ± 2.4 years. The preoperative AC and BC thresholds were 64.4 dB (±11.9 dB) and 7.9 dB (±4.90 dB), respectively, with an average ABG of 56.5 dB (±12.8 dB). The average postoperative aided threshold was 21.2 dB (± 4.25 dB) with a mean functional gain of 43.1 dB (±10.2 dB). One patient developed seroma postoperatively, which was treated conservatively. No other complications were reported over a mean follow-up time of 7.1 ± 4 months. For 13 patients with previous passive bone conduction implants or devices, the Osia system was universally favored.Conclusions:The new active transcutaneous bone conduction system showed favorable early clinical and audiometric outcomes. Repeated processor connectivity issues represent a potential area for future device development. This is the largest pediatric case series to date.Level of Evidence: Level 4—Retrospective Review.

Subtemporalis Muscle Middle Cranial Fossa Bone-Island Craniotomy Technique for Placement of an Active Transcutaneous Bone-Conduction Implant

“…Overall, the audiologic outcomes were excellent. Patients in the CMHL group had highly statistically significant functional gain with the device (mean, 35.3 dB HL; p < 0.0001), which was consistent with previous studies ( 5 , 25 – 27 ). Aided air-bone gaps were also similar to a study that used a related middle fossa technique but with an older version of the device (the BCI601) ( 22 ).…”

“…Bone-conduction implants (BCIs) are useful in the rehabilitation of hearing loss in both children (1)(2)(3)(4)(5) and adults (6)(7)(8)(9). BCIs transmit sound by vibration of the skull, transmitting sound energy directly into to the cochlea.…”

Integrated microtia and aural atresia management

“…Active implants with direct bone conduction without skin penetration (Osia ® , BoneBridge TM ) are currently FDA approved for patients 12 years of age and older. At the time of this writing, successful implantation in younger patients has been reported both in and outside of the United States ( 21 , 22 ). These provide optimal hearing amplification without penetrating the skin.…”

How I do it: Cochlear Osia 2 System surgery placement

“…It uses digital piezoelectric stimulation to bypass non-functional areas of the natural hearing system and send sound directly to the cochlea. This implant is designed to meet the needs of patients with unilateral and bilateral conductive or mixed hearing loss and single-sided deafness [ 1 , 2 ].…”

“…Early experiences with the Osia bone conduction implant (BCI) have shown favorable results in adults. In fact, it was shown that digital piezoelectric stimulation delivers improved high frequency gain for optimizing speech perception, and maintains safety while providing excellent patient satisfaction [ 2 – 4 ].…”