Expanded Indications in the Adult Cochlear Implant Population
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03236909|
Recruitment Status : Recruiting
First Posted : August 2, 2017
Last Update Posted : September 12, 2019
|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|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Expanded Indications in the Adult Cochlear Implant Population|
|Actual Study Start Date :||April 16, 2018|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||September 2020|
- 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.
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
|Contact: Allison Racey, AuDfirstname.lastname@example.org|
|Contact: Jennifer Bullsemail@example.com|
|United States, California|
|Stanford, California, United States, 94305|
|Contact: Matthew Fitzgerald, PhD firstname.lastname@example.org|
|Contact: Janine Larky, MA 650-723-5281 email@example.com|
|Principal Investigator: Matthew Fitzgerald, PhD|
|Sub-Investigator: Janine Larky, MA|
|United States, Florida|
|University of Miami||Recruiting|
|Miami, Florida, United States, 33136|
|Contact: Sandy Prentiss, AuD 305-243-1667 firstname.lastname@example.org|
|Contact: Constanza Pelluso 305-243-7102 email@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator: Margaret Dillon, AuD|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37232|
|Contact: Sara Unrein, AuD 615-322-0333 Sara.email@example.com|
|Contact: Kathleen M VonWahlde, MJ, CCRP 615-322-0333 kate.vonwahlde@Vanderbilt.Edu|
|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 firstname.lastname@example.org|
|Contact: Sarah Mleziva email@example.com|
|Principal Investigator: Christina Runge|
|Sunnybrook Health Sciences Centre||Recruiting|
|Toronto, Ontario, Canada, M4N 3M5|
|Contact: Kari Smilsky, M.CI.Sc 416-480-6100 ext 4148 Kari.firstname.lastname@example.org|
|Contact: Varia Sajeniouk, CRC 416-480-6100 ext 85392 email@example.com|
|Principal Investigator: Kari Smilsky, M.Cl.Sc|