Long-Term, Multicenter Results With the First Transcutaneous Bone Conduction Implant.

Area of Science:

• Otolaryngology
• Audiology
• Biomedical Engineering

Background:

• Conductive or mixed hearing loss can significantly impair speech perception.
• Transcutaneous bone conduction implants (tBCI) offer a potential solution for hearing restoration.
• Long-term safety and performance data are crucial for evaluating implantable hearing devices.

Purpose of the Study:

• To investigate the long-term safety and performance of the Bonebridge transcutaneous bone conduction implant (tBCI).
• To evaluate audiological outcomes and quality of life in adult and pediatric patients up to 36 months post-implantation.

Main Methods:

• Prospective, single-subject repeated-measures design involving 57 patients (49 adults, 8 children) with conductive or mixed hearing loss.
• Implantation of the Bonebridge tBCI.
• Audiometric testing (PTA4, WRS, SRT50%) and adverse event monitoring up to 36 months postoperatively.

Main Results:

• Significant improvements in speech perception (WRS, SRT50%) and sound field thresholds were observed at all postoperative visits.
• Residual unaided hearing was preserved, as indicated by stable air and bone conduction thresholds.
• All reported adverse events were resolved by the study's end, demonstrating a favorable safety profile.

Conclusions:

• The Bonebridge tBCI demonstrates long-term safety and efficacy in both adult and pediatric populations.
• The implant provides significant audiological benefits for patients with conductive or mixed hearing loss.
• The study confirms the preservation of residual hearing, a key factor in audiological rehabilitation.