Expanded Indications in the Adult Cochlear Implant Population
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ClinicalTrials.gov Identifier: NCT03236909 |
Recruitment Status :
Recruiting
First Posted : August 2, 2017
Last Update Posted : November 16, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hearing Loss, Sensorineural | Device: MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System | Not Applicable |
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 (Clinical Trial) |
Estimated Enrollment : | 50 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Expanded Indications in the Adult Cochlear Implant Population |
Actual Study Start Date : | April 16, 2018 |
Estimated Primary Completion Date : | December 2022 |
Estimated Study Completion Date : | December 2022 |

- 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
- 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.
- 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.
- 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.
- 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.
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03236909
United States, California | |
Stanford University | Withdrawn |
Stanford, California, United States, 94305 | |
United States, Florida | |
University of Miami | Recruiting |
Miami, Florida, United States, 33136 | |
Contact: Sandy Prentiss, AuD 305-243-1667 s.prentiss@med.miami.edu | |
Contact: Constanza Pelluso 305-243-7102 cpelusso@med.miami.edu | |
Sub-Investigator: Fred Telischi, MD | |
Principal Investigator: Sandy Prentiss, PhD | |
United States, North Carolina | |
University of North Carolina | Recruiting |
Chapel Hill, North Carolina, United States, 27599 | |
Contact: Margaret Dillon, AuD 919-966-5251 mdillon@med.unc.edu | |
Contact: Meredith Rooth, AuD 919-966-5251 meredith_rooth@med.unc.edu | |
Principal Investigator: Margaret Dillon, AuD | |
Sub-Investigator: Meredith Rooth, AuD | |
United States, Tennessee | |
Vanderbilt University | Recruiting |
Nashville, Tennessee, United States, 37232 | |
Contact: Sara Unrein, AuD 615-322-0333 sara.c.unrein@vumc.org | |
Contact: Ashudee M Kirk, MS 615-322-0333 ashudee.kirk@vumc.org | |
Principal Investigator: David Haynes, MD | |
Principal Investigator: Sara Unrein, AuD | |
United States, Wisconsin | |
Medical College of Wisconsin | Recruiting |
Milwaukee, Wisconsin, United States, 53226 | |
Contact: Christina Runge, PhD 414-955-0822 crunge@mcw.edu | |
Contact: Sarah Mleziva 414-955-0822 smleziva@mcw.edu | |
Principal Investigator: Christina Runge | |
Canada, Ontario | |
Sunnybrook Health Sciences Centre | Recruiting |
Toronto, Ontario, Canada, M4N 3M5 | |
Contact: Kari Smilsky, M.CI.Sc 416-480-6100 Kari.smilsky@sunnybrook.ca | |
Contact: Varia Sajeniouk, CRC 416-480-6100 varia.sajeniouk@sunnybrook.ca | |
Principal Investigator: Kari Smilsky, M.Cl.Sc |
Responsible Party: | Med-El Corporation |
ClinicalTrials.gov Identifier: | NCT03236909 |
Other Study ID Numbers: |
G170111 |
First Posted: | August 2, 2017 Key Record Dates |
Last Update Posted: | November 16, 2021 |
Last Verified: | November 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Hearing Loss Hearing Loss, Sensorineural Hearing Disorders Ear Diseases |
Otorhinolaryngologic Diseases Sensation Disorders Neurologic Manifestations Nervous System Diseases |