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

NCT ID: NCT01529333

Last Updated: 2012-02-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2012-08-31

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.

Conditions

Mixed Conductive and Sensorineural Hearing Loss, Bilateral

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otologics LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Jim R. Easter, MS, ME, PE

Role: CONTACT

easterj@otologics.com

303-996-8203

Susan P Urquhart, CCRP

Role: CONTACT

urquharts@otologics.com

303-996-8234

Other Identifiers

G070237

Identifier Type: -

Identifier Source: org_study_id