Expanded Indications in the Adult Cochlear Implant Population

August 4, 2023 updated by: Med-El Corporation
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre
  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College Of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single-arm
Single-arm, repeated-measures study design with all subjects receiving a MED-EL cochlear implant
Device: MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System
Subjects will be implanted with the MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System with +FLEX28 or +FLEXSOFT electrode arrays. Subjects will be fit with the SONNETEAS (ear-level) and/or RONDO (single-unit) external audio processors.
Other Names:
  • SYNCHRONY +FLEXSOFT
  • SYNCHRONY +FLEX28

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent correct words recognition in quiet in implanted ear
Time Frame: Up to twelve (12 months) post-activation
CNC (Consonant Nucleus Consonant) word scores will be calculated as percent correct at baseline through 6 months and reported as percentage points improved.
Up to twelve (12 months) post-activation
Percent correct of words identified for sentences in noise in implanted ear
Time Frame: Up to twelve (12 months) post-activation
AzBio sentence recognition in noise scores will be calculated as percent correct of words in each sentence at baseline through 6 months and reported as percentage points improved.
Up to twelve (12 months) post-activation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient reported improvement in everyday listening conditions
Time Frame: Up to twelve (12 months) post -activation
APHAB (ABBREVIATED PROFILE OF HEARING AID BENEFIT) and SSQ (Spatial and Qualities of Hearing) questionnaires will be used to assess subjective outcomes and reported as improvements from baseline to 6 months post-activation.
Up to twelve (12 months) post -activation
Number and proportion of subjects experiencing device related adverse events
Time Frame: Up to twelve (12 months) post-activation
Adverse events will be collected and reported throughout the duration of the study.
Up to twelve (12 months) post-activation
Residual low frequency hearing
Time Frame: Up to twelve (12) months post-activation
HEARRING scale will be used to calculate the percent of hearing preservation for each subject. This data will be summarized through 6 months post-activation.
Up to twelve (12) months post-activation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Med-El Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2018

Primary Completion (Actual)

March 27, 2023

Study Completion (Actual)

March 27, 2023

Study Registration Dates

First Submitted

July 28, 2017

First Submitted That Met QC Criteria

July 28, 2017

First Posted (Actual)

August 2, 2017

Study Record Updates

Last Update Posted (Actual)

August 8, 2023

Last Update Submitted That Met QC Criteria

August 4, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G170111

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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