Mixed Conductive and Sensorineural Hearing Loss, Bilateral Clinical Trial
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.
| Status | Not yet recruiting |
| Enrollment | 130 |
| Est. completion date | August 2012 |
| Est. primary completion date | July 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Otologics LLC |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. |
Occurs at 3, 6, and 12 month follow-up visits | Yes |
| Secondary | 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. |
Will be monitored to 12 months | Yes |