Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Otologics LLC

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.

Condition or disease Intervention/treatment Phase
Mixed Conductive and Sensorineural Hearing Loss, Bilateral Device: Middle Ear Implant with MET V Transducer Not Applicable

Detailed Description:
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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Intervention Details:
  • Device: Middle Ear Implant with MET V Transducer
    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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult men or women, 18 years of age or older
  • Moderate to severe mixed hearing loss, as a result of a combination of sensorineural hearing loss and chronic ear disease, prior failed tympanoplasties, severe otosclerosis, radical mastoidectomy, or congenital abnormality as evidenced by the following in the ear to be implanted:

    • Bone conduction thresholds are measurable at 0.5,1,2,3 and 4 kHz
    • Bone conduction thresholds are 20 dB or poorer at greater than 2 kHz
    • Air conduction thresholds are 35 dB or poorer at 0.5,1,2,3 and 4 kHz
  • Air-bone gap in ear to be implanted is greater than 15 dB at three or more frequencies from 0.5 - 4 kHz
  • Word recognition appropriate for sensorineural component of loss
  • Non-fluctuating and stable hearing status

    a. as defined as by no significant change or progression in the bone conduction thresholds >15dB at two consecutive octaves for at least 12 months.

  • English Speaking (fluent)
  • Realistic expectations for the device
  • Willingness to sign the informed consent and participate in the study

Exclusion Criteria:

  • Vestibular disorder, including Meniere's Syndrome
  • Recurring otitis media over the past year (>2/year)
  • Non-organic hearing loss
  • Retrocochlear hearing loss
  • Central auditory nervous system disorder
  • Medical contraindications to surgery or use of the device
  • Women who are pregnant or at risk of becoming pregnant
  • Developmentally delayed or manifesting organic brain dysfunction
  • Persons with physical or geographic limitations that may render them incapable of completing scheduled study visits

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01529333

Layout table for location contacts
Contact: Jim R. Easter, MS, ME, PE 303-996-8203
Contact: Susan P Urquhart, CCRP 303-996-8234

Sponsors and Collaborators
Otologics LLC

Layout table for additonal information
Responsible Party: Otologics LLC Identifier: NCT01529333     History of Changes
Other Study ID Numbers: G070237
First Posted: February 8, 2012    Key Record Dates
Last Update Posted: February 8, 2012
Last Verified: February 2012
Additional relevant MeSH terms:
Layout table for MeSH terms
Hearing Loss
Hearing Loss, Sensorineural
Hearing Loss, Bilateral
Hearing Loss, Mixed Conductive-Sensorineural
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms