Middle-Ear Implant With MET V Transducer (Aka MET V System)
|ClinicalTrials.gov Identifier: NCT01529333|
Recruitment Status : Unknown
Verified February 2012 by Otologics LLC.
Recruitment status was: Not yet recruiting
First Posted : February 8, 2012
Last Update Posted : February 8, 2012
|Condition or disease||Intervention/treatment||Phase|
|Mixed Conductive and Sensorineural Hearing Loss, Bilateral||Device: Middle Ear Implant with MET V Transducer||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Middle Ear Implant With MET V for Mixed Hearing Loss|
|Study Start Date :||May 2012|
|Estimated Primary Completion Date :||July 2012|
|Estimated Study Completion Date :||August 2012|
Device: Middle Ear Implant with MET V Transducer
- CNC Word Recognition Scores [ Time Frame: Occurs at 3, 6, and 12 month follow-up visits ]
- 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.
- BKB-SIN and Subject Questionnaires [ Time Frame: Will be monitored to 12 months ]
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01529333
|Contact: Jim R. Easter, MS, ME, PEfirstname.lastname@example.org|
|Contact: Susan P Urquhart, CCRPemail@example.com|