Clinical Trial: Middle-Ear Implant With MET V Transducer (Aka MET V System)

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Middle Ear Implant With MET V for Mixed Hearing Loss

Brief Summary: The purpose and objective of this study is to evaluate the safety and efficacy of the MET V System for the treatment of individuals with mixed hearing loss.

Detailed Summary: The MET V System is an investigational, fully-implantable middle ear hearing prosthesis. A mixed hearing loss has both a sensorineural component and a conductive component that results when sound being delivered to an impaired cochlea is attenuated by a disordered outer or middle ear.
Sponsor: Otologics LLC

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: 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.


Original Secondary Outcome: Same as current

Information By: Otologics LLC

Dates:
Date Received: February 2, 2012
Date Started: May 2012
Date Completion: August 2012
Last Updated: February 6, 2012
Last Verified: February 2012