Objective: To investigate safety and efficacy of a new transcutaneous bone conduction hearing implant, over a 3-month follow-up period.
Study Design: Prospective, single-subject repeated-measures design in which each subject serves as his/her own control.
Setting: Departments of Otolaryngology at 4 hospitals in Germany and Austria.
Objectives: 1) To evaluate speech understanding in noise by comparing signal-to-noise ratios for 50% correct word understanding (SNR50) using an omnidirectional and a directional microphone audio processor (AP) in 4 different noise conditions. 2) To compare subjective speech understanding abilities, spatial hearing abilities, and qualitative hearing performance with the 2 processors.
Study Design: A prospective, single-subjects repeated-measures study design was used to compare speech understanding performance with the 2 APs acutely and after 6 weeks' acclimatization time.
Objective: The primary objective was to report on experiences regarding the safety and efficacy of the Vibrant Soundbridge (VSB) using a floating mass transducer (FMT)-partial/total ossicular replacement prosthesis (PORP/TORP) assembly as a treatment for conductive and mixed hearing losses of mild-to-moderate/severe degree. The secondary objective was to gather information regarding device fitting, as well as to refine surgical procedures.
Patients: Five German-speaking adults from 2 European study sites were implanted with a VSB using an FMT-PORP/TORP assembly and evaluated before and after surgery for air-and bone-conduction thresholds and speech recognition performance.