Alternative Frequency Mapping for Cochlear Implant Users

Overseen By Mario A. Svirsky, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Under 18, Ear abnormality, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

22 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this study is to study the adaptation process in newly implanted Single-Sided Deaf Cochlear Implant (SSD-CI) users. Subjects will use four frequency maps for the first month after CI activation. One of these maps will be standard of care and the other three will have higher low frequency edges than the standard of care default maps. These maps will alternate daily during the first month (with exceptions made for situations when the subject is allowed to use a preferred map rather than the map predetermined for use that day), and after that point each subject will make a selection at the beginning of the week to compare all four maps and decide which one to use at the beginning of the following week. The goal of this study is to investigate how reducing place-pitch mismatch in SSD CI users affects 1) sound quality, 2) device use, and 3) speech perception.

Who Is on the Research Team?

Mario A. Svirsky, PhD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for individuals who have recently received a cochlear implant to address single-sided deafness. Participants should be new users of the device, ready to test different frequency mapping strategies over the first month post-activation.

Inclusion Criteria

English speaking

My hearing in the opposite ear is normal or nearly normal.

I do not have any known ear abnormalities.

Exclusion Criteria

I am under 18 years old.

Non-English speaking

My implanted ear has a documented structural abnormality.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use four frequency maps for the first month after CI activation, alternating daily, to study adaptation in SSD-CI users.

4 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for speech perception and sound quality using various frequency maps.

12 months

Monthly visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Alternative Frequency Mapping

Trial Overview The study tests how newly implanted cochlear implant users adapt using four different frequency maps. One map follows standard care while the others vary in low-frequency edges. Subjects will switch maps daily initially, then weekly choose which they prefer.

How Is the Trial Designed?

Group I: Newly implanted Single-Sided Deaf Cochlear Implant (SSD-CI) Users Experimental Treatment 1 Intervention

Subjects will use four frequency maps for the first month after CI activation. One of these maps will be standard of care (i.e., 188-7938 Hz for Cochlear users) and the other three will have higher low frequency edges than the standard of care default maps (starting at 313, 438, and 563 Hz, respectively). These maps will alternate daily during the first month (with exceptions made for situations when the subject is allowed to use a preferred map rather than the map predetermined for use that day), and after that point each subject will make a selection at the beginning of the week to compare all four maps and decide which one to use at the beginning of the following week.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+