Mixed Conductive and Sensorineural Hearing Loss, BilateralNCT01529333
Middle-Ear Implant With MET V Transducer (Aka MET V System)
A study testing Middle Ear Implant with MET V Transducer in people with Mixed Conductive and Sensorineural Hearing Loss, Bilateral, run by Otologics LLC.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mixed Conductive and Sensorineural Hearing Loss, Bilateral
- What is being tested?
- Middle Ear Implant with MET V Transducer
- Type of treatment
- Medical device
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- May 2012to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Word recognition appropriate for sensorineural component of loss
- Non-fluctuating and stable hearing status
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Being tested
- Middle Ear Implant with MET V Transducer
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Middle Ear Implant with MET V TransducerDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Occurs at 3, 6, and 12 month follow-up visits
Secondary outcomes (1)
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.
Measured: Will be monitored to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2012 (estimated)
- Study startMay 2012
- Primary completionJul 2012 (estimated)
- Study completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mixed Conductive and Sensorineural Hearing Loss, BilateralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Otologics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01529333
- Sponsor's protocol ID
- G070237
- Status last verified
- Feb 2012
- First submitted
- 2 Feb 2012
- Last updated
- 8 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Middle Ear Implant With MET V for Mixed Hearing Loss
- ClinicalTrials.gov ID
- NCT01529333
- Acronym / sponsor ID
- G070237
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Otologics LLCIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 8 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Middle Ear Implant with MET V TransducerThe 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. | Device | – |
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.
1 secondary outcome
BKB-SIN and Subject Questionnaires
Time frame: Will be monitored to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Middle Ear Implant with MET V Transducer in people with Mixed Conductive and Sensorineural Hearing Loss, Bilateral, run by Otologics LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jim R. Easter, MS, ME, PE (303-996-8203, easterj@otologics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CNC Word Recognition Scores (time frame: Occurs at 3, 6, and 12 month follow-up visits). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2012.