ENI-Based Programming for Hearing Loss
What You Need to Know Before You Apply
What is the purpose of this trial?
Cochlear implants are devices placed in the inner ear through surgery to help people with severe to profound hearing loss. While these devices work well overall, results vary widely from person to person. Many people with cochlear implants still have trouble understanding speech in noisy places and enjoying music.
This study looks at whether customizing the way a cochlear implant is programmed, based on the health of the hearing nerve in different areas of the ear, can help people understand speech better in noisy settings. The researchers will adjust or turn off certain electrodes in areas where the nerve appears weaker, then test whether this improves hearing compared to each person's everyday program. They will also examine whether giving people time to get used to the new program leads to better results.
Who Is on the Research Team?
Julie Arenberg, PhD, CCC-A
Principal Investigator
Massachusetts Eye and Ear
Are You a Good Fit for This Trial?
This trial is for adults aged 18-80 who have severe hearing loss in both ears, use a cochlear implant from Advanced Bionics (Clarion Hi-Focus I or newer), and have used their implant for at least 6 months. Participants should speak American English or be multilingual.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Trial Overview
The study compares two new ways of programming cochlear implants—customized based on nerve health—with the standard everyday program. Researchers will see if these personalized settings help users understand speech better in noisy places.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
This is a within-subjects study in which all enrolled participants receive every condition. Each participant's everyday clinical listening program serves as the control and is compared against two experimental sound-processing strategies based on electrode-neuron interface (ENI) estimates. In the in-lab phase (Sub-Aim 1.1), all programs are compared acutely. In the take-home phase (Sub-Aim 1.2), participants complete a 12-week crossover consisting of 4 weeks with their clinical program followed by 4 weeks with each experimental strategy, with the order of programs randomized.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts Eye and Ear Infirmary
Lead Sponsor
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