STUDIES AT A GLANCE

New scientific studies summarized for you

Study: Long-term, multi-center results with the BONEBRIDGE

(Original title:

Long-Term, Multicenter Results With the First Transcutaneous Bone Conduction Implant, Otol Neurotol. 2021 Jul 1;42(6):858-866.; Sprinzl GM et al.)

Take home message:

The BONEBRIDGE is a long-term safe and effective transcutaneous bone-conduction implant for children and adults.

Background:

Short-term safety and effectiveness of the transcutaneous BONEBRIDGE implant has already been demonstrated. This study is looking at safety and results up to 36 months postoperatively, in children and adults.

Method:

• 57 patients
  • 49 adults (18-76 years)
  • 8 children (5-17 years)
• Multicenter, prospective study

 Results:

Device Safety:

• Minor adverse device effects (ADE): 24.6%
• 3% rated as serious ADE and resolved by revision surgery
• All ADE were resolved by the end of the study (change in magnet strength, painkillers,…)

Audiological outcomes:

• Preservation of hearing: patients’ AC and BC thresholds remained stable over study period
• Mean PT4 thresholds, soundfield thresholds and word recognition scores improved significantly at all time points following implantation.

Device satisfaction:

• Subjects were stably satisfied to very satisfied with the BONEBRIDGE device at 3 and 36 months postoperative, reflecting also in high wearing time.

Read the study here: Long-Term, Multicenter Results With the First Transcutaneous Bone Conduction Implant – PubMed (nih.gov)