The Bonebridge BCI 602 Safety and Performance 1 Year Post-Implantation in Adults and Children: A Multicentric Post-Market Study.

ABSTRACT:

Objective

To confirm the long-term safety and performance of the Bonebridge BCI 602 in patients suffering from conductive or mixed hearing loss (CMHL) or single-sided deafness (SSD) over a 12-month period post-implantation.

Study design

Multicentric, multinational, ambidirectional, observational Post-Market Clinical Follow-Up (PMCF) study.

Setting

Eight tertiary referral hospitals.

Participants

Fifty-two participants in 3 categories: adults CMHL (N=24), children CMHL (N=17), and SSD (N=11; 9 adults and 2 children).

Intervention

Participants were implanted with the Bonebridge BCI 602 device.

Main outcome measures

Outcome measures focused on sound field thresholds (SF), word recognition scores (WRS), speech reception thresholds (SRT) in both quiet a

SUBMITTER: Plontke SK 

PROVIDER: S-EPMC12677345 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature