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Completed

NCT Number: NCT03236909

Expanded Indications in the Adult Cochlear Implant Population

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.

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Key information

Conditions

Hearing Loss, Sensorineural Ear Diseases Hearing Disorders Hearing Loss Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System

Device

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

Primary outcomes

  1. Change in Percent Correct on Word Recognition in Quiet in Implanted Ear

    Time frame: 6 months post-activation

    CNC (Consonant Nucleus Consonant) word scores will be calculated as percent correct at baseline and at 6 months post-activation and reported as mean percentage-point improvement at 6 months post-activation compared to baseline.

  2. Change in Percent Correct of Words Identified for Sentences in Noise in Implanted Ear

    Time frame: 6 months post-activation

    AzBio sentence recognition in noise scores will be calculated as percent correct of words in each sentence at baseline and at 6 months post-activation and reported as mean percentage-point improvement at 6 months post-activation compared to baseline.

Secondary outcomes

  1. Change in Global Score on Patient-reported Outcomes in Everyday Listening Condition

    Time frame: 6 months post-activation

    APHAB (ABBREVIATED PROFILE OF HEARING AID BENEFIT) questionnaire will be used to assess subjective outcomes and reported as change in mean Global Score at 6 months post-activation compared to baseline. Letter responses from A to G on each question have a percent value, and the Global Score is an average percent value of all letters. A lower score shows less difficulty (better performance).

  2. Number of Participants Experiencing an Adverse Device Effect (ADE)

    Time frame: Through study completion, or at least 1 year, 4 months post-implantation

    Adverse device effects will be collected for all participants through study completion and reported as the number of participants experiencing an ADE.

  3. Number of Participants With Residual Low-frequency Hearing

    Time frame: 6 months post-activation

    HEARRING scale will be used to calculate the percent of hearing preservation for each subject by comparing average hearing thresholds from 125 to 1000 Hz at 6 months post-activation to the average at baseline.

  4. Change in Overall Score on Patient-reported Outcomes in Everyday Listening Condition

    Time frame: 6 months post-activation

    The SSQ (Spatial and Qualities of Hearing) questionnaire will be used to assess subjective outcomes and reported as change in mean Overall Score at 6 months post-activation compared to baseline. SSQ is scored on a 10-point Likert scale where 10 shows better listening skills/experiences than 0.

Sponsors and collaborators

Lead sponsor

Med-El Corporation

Industry

Registry information

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Aug 2, 2017
Registry last updated
Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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