Multicenter Clinical Investigation of a New Active Osseointegrated Steady-State Implant System.

ABSTRACT:

Objective

A new active transcutaneous bone conduction hearing implant system that uses piezoelectric technology has been developed: an active osseointegrated steady-state implant system (OSI). This was the first clinical investigation undertaken to demonstrate clinical performance, safety, and benefit of the new implant system.

Study design and setting

A multicenter prospective within-subject clinical investigation was conducted.

Patients

Fifty-one adult subjects with mixed and conductive hearing loss (MHL/CHL, n = 37) and single-sided sensorineural deafness (SSD, n = 14) were included.

Main outcome measure

Audiological evaluations included audiometric thresholds, speech recognition in noise, and quiet. Hearing and health-related patient-reported outcomes (PROs

SUBMITTER: Mylanus EAM 

PROVIDER: S-EPMC7497889 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature