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

Otologics

Status: Unknown

Conditions: Mixed Conductive and Sensorineural Hearing Loss, Bilateral

Treatments: Device: Middle Ear Implant with MET V Transducer

Study type: Interventional

Funder types: Industry

Identifiers

NCT01529333

G070237

Details and patient eligibility

About

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.

Full 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.

Enrollment: 130 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)