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

This study is not yet open for participant recruitment.
Verified February 2012 by Otologics LLC
Sponsor:
Information provided by (Responsible Party):
Otologics LLC
ClinicalTrials.gov Identifier:
NCT01529333
First received: February 2, 2012
Last updated: February 6, 2012
Last verified: February 2012
History of Changes
  Purpose

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 Intervention
Mixed Conductive and Sensorineural Hearing Loss, Bilateral
 Device: Middle Ear Implant with MET V Transducer

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Middle Ear Implant With MET V for Mixed Hearing Loss

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Otologics LLC:

Primary Outcome Measures:
  • CNC Word Recognition Scores [ Time Frame: Occurs at 3, 6, and 12 month follow-up visits ] [ Designated as safety issue: Yes ]
    • 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:
  • BKB-SIN and Subject Questionnaires [ Time Frame: Will be monitored to 12 months ] [ Designated as safety issue: Yes ]
    • 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.


Estimated Enrollment: 130
Study Start Date: May 2012
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01529333

Contacts
Contact: Jim R. Easter, MS, ME, PE 303-996-8203 easterj@otologics.com
Contact: Susan P Urquhart, CCRP 303-996-8234 urquharts@otologics.com

Sponsors and Collaborators
Otologics LLC
  More Information

No publications provided

Responsible Party: Otologics LLC
ClinicalTrials.gov Identifier: NCT01529333     History of Changes
Other Study ID Numbers: G070237
Study First Received: February 2, 2012
Last Updated: February 6, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Loss, Bilateral
Hearing Loss, Sensorineural
Hearing Loss, Mixed Conductive-Sensorineural
Hearing Disorders
 Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013