Middle-Ear Implant With MET V Transducer (Aka MET V System) | NCT01529333 | Trialant

Middle-Ear Implant With MET V Transducer (Aka MET V System) | NCT01529333 | Trialant

Arms/Interventions Module

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Middle Ear Implant with MET V Transducer	Device	The MET V System is indicated for use in addressing the amplification needs of adults, 18 years of age and older, who have mixed hearing loss.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
CNC Word Recognition Scores	The primary efficacy endpoint is the mean change in the implant ear from CNC word recognition (unaided for mixed hearing loss and aided with hearing aid for sensorineural hearing loss) scores at the six month follow-up. The secondary efficacy endpoints include a speech perception outcome (BKB-SIN) measure and a subjective questionnaire (APHAB). The endpoint for the BKB-SIN is the mean change in score at the six month follow-up compared to the control. The endpoint for the subjective questionnaire (APHAB)is post-operative responses compared to the pre-operative control responses.	Occurs at 3, 6, and 12 month follow-up visits

Secondary Outcomes

Measure	Description	Time Frame
BKB-SIN and Subject Questionnaires	Primary safety endpoint is the mean change from baseline (average across 0.5, 1, 2, 3 4 kHz) in the implanted ear for pure tone bone conduction thresholds at the 6-month study visit, and safety will be monitored to 12 months. Secondary safety endpoints include assessments of adverse events and device failures.	Will be monitored to 12 months

Contacts/Locations Module

Condition Browse Module

Intervention Browse Module