An interventional study of Middle Ear Implant with MET V Transducer in Mixed Conductive and Sensorineural Hearing Loss, Bilateral, sponsored by Otologics LLC. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-02-08.
Sponsored by Otologics LLC · Not applicable, Interventional, and Treatment
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.
1,092 studies on the registry are indexed under Hearing Loss; 235 are open to participants now.
This study's planned enrollment of 130 is above the median of 40 across 764 interventional studies indexed under Hearing Loss.
Browse Hearing Loss studies →This is the only study on the registry with Otologics LLC as lead sponsor.
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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:
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.
Exclusion Criteria:
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.
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.
Time frame: Occurs at 3, 6, and 12 month follow-up visits
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.
Time frame: Will be monitored to 12 months
No study locations are listed for this record.
This study is status unknown, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.
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