Purpose

The purpose of this investigation is to expand FDA-approved labeling for MED-EL cochlear implants to include adults who have moderate to profound sensorineural hearing loss and obtain limited benefit from appropriately fit hearing aids.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Adults, 18 years of age or older at the time of implantation
  • Moderate to profound hearing loss in the low frequencies and severe to profound hearing loss in the high frequencies, bilaterally as defined by: Low-frequency PTA (250, 500, and 1000 Hz) greater than 40 dB High-frequencies not better than 65 dB (3000 Hz - 8000 Hz)
  • Sensorineural hearing loss, demonstrated by an air-bone gap of less than or equal to 10dB
  • Limited benefit from appropriately fit hearing aids, defined by CNC word score in quiet of 60% or less in the ear to be implanted and 70% or less in the non-implanted ear
  • CNC word score in quiet of greater than or equal to 10% in the ear to be implanted
  • Evidence of appropriately fit hearing aids as determined by the audiologist
  • Bilateral hearing aids should be considered standard of care, except in situations where the audiologist, physician, or potential subject determines that unilateral fit is optimal
  • Hearing aid fit should be verified through accepted measures such as functional gain or real-ear verification
  • If appropriately fit hearing aids have not been worn within the last year, a 30-day hearing aid trial must be completed prior to enrollment in the study
  • Fluent in English
  • No radiological contraindications
  • Ability to undergo general anesthesia
  • Appropriate motivation and expectation levels
  • Stated willingness to comply with all study procedures for the duration of the study

Exclusion Criteria

  • Evidence that hearing loss is retrocochlear in origin
  • Active middle ear infection
  • Skin or scalp condition precluding use of external audio processor- Suspected cognitive impairment or organic brain dysfunction
  • History of prior use of a hearing implant

Study Design

Phase
N/A
Study Type
Interventional
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Recruiting Locations

Vanderbilt University
Nashville, Tennessee 37232
Contact:
Sara Unrein, AuD
615-322-0333
Sara.c.unrein@vanderbilt.edu

More Details

NCT ID
NCT03236909
Status
Recruiting
Sponsor
Med-El Corporation

Study Contact

Allison Racey, AuD
888-633-3524
allison.racey@medel.com

Detailed Description

Fifty (50) subjects, 18 years of age and older, will be implanted across the United States and Canada. Subjects with moderate to profound bilateral sensorineural hearing loss will be implanted with the MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System. .

Limited benefit from amplification is defined by test scores of 60% correct or less in the ear to be implanted (70% or less in the nonimplanted ear) on monosyllabic words in quiet. Subjects will be followed for twelve (12) months post-activation of the SONNETEAS Audio Processor.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.