Back to resultsMiddle-Ear Implant With MET V Transducer (Aka MET V System)
Primary Purpose
Mixed Conductive and Sensorineural Hearing Loss, Bilateral
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Middle Ear Implant with MET V Transducer
Sponsored by
About this trial
This is an interventional treatment trial for Mixed Conductive and Sensorineural Hearing Loss, Bilateral
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
CNC Word Recognition Scores
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01529333
Brief Title
Middle-Ear Implant With MET V Transducer (Aka MET V System)
Official Title
Middle Ear Implant With MET V for Mixed Hearing Loss
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Unknown status
Study Start Date
May 2012 (undefined)
Primary Completion Date
July 2012 (Anticipated)
Study Completion Date
August 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otologics LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mixed Conductive and Sensorineural Hearing Loss, Bilateral
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
130 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Middle Ear Implant with MET V Transducer
Intervention Description
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 Measure Information:
Title
CNC Word Recognition Scores
Description
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.
Time Frame
Occurs at 3, 6, and 12 month follow-up visits
Secondary Outcome Measure Information:
Title
BKB-SIN and Subject Questionnaires
Description
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.
Time Frame
Will be monitored to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jim R. Easter, MS, ME, PE
Phone
303-996-8203
Email
easterj@otologics.com
First Name & Middle Initial & Last Name or Official Title & Degree
Susan P Urquhart, CCRP
Phone
303-996-8234
Email
urquharts@otologics.com
12. IPD Sharing Statement
Learn more about this trial
Middle-Ear Implant With MET V Transducer (Aka MET V System)
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