Clinical performance, safety, and patient-reported outcomes of an active osseointegrated bone-conduction hearing implant system at 24-month follow-up.

ABSTRACT:

Purpose

To investigate 2-year post-operative hearing performance, safety, and patient-reported outcomes of hearing-impaired adults treated with the Osia^® 2 System, an active osseointegrated bone-conduction hearing implant that uses piezoelectric technology.

Methods

A prospective, multicenter, open-label, single-arm, within-subject clinical study conducted at three tertiary referral clinical centers located in Melbourne, Sydney and Hong Kong. Twenty adult recipients of the Osia 2 System were enrolled and followed up between 12 and 24 months post-implantation: 17 with mixed or conductive hearing loss and 3 with single-sided sensorineural deafness. Safety data, audiological thresholds, speech recognition thresholds in noise, and patient-reported outcomes were collect

SUBMITTER: Cowan R 

PROVIDER: S-EPMC10796683 | biostudies-literature | 2024 Feb

REPOSITORIES: biostudies-literature