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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Otologics LLC.
Recruitment status was  Not yet recruiting
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

February 2, 2012
February 6, 2012
May 2012
July 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01529333 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Middle-Ear Implant With MET V Transducer (Aka MET V System)
Middle Ear Implant With MET V for Mixed Hearing Loss

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.

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Mixed Conductive and Sensorineural Hearing Loss, Bilateral
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
130
August 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Jim R. Easter, MS, ME, PE 303-996-8203 easterj@otologics.com
Contact: Susan P Urquhart, CCRP 303-996-8234 urquharts@otologics.com
Not Provided
 
NCT01529333
G070237
No
Otologics LLC
Otologics LLC
Not Provided
Not Provided
Otologics LLC
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP